AstraZeneca, Ionis drug fails big heart disease study in major setback
AstraZeneca, Ionis drug fails big heart disease study in major setback
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Aggregating recent news and profiling companies at the frontier of computational biology, generative molecular design, and AI-native clinical development.
Recent AI + Bio News
Caris Life Sciences Expands Precision Oncology in Metastatic Prostate Cancer with PTEN IHC Testing
/PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading patient-centric next-generation AI TechBio company and precision medicine pioneer, today...
Chai brews up $400M series C to fuel AI used by Lilly and Pfizer
Chai brews up $400M series C to fuel AI used by Lilly and Pfizer
FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug, includes gallery
FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug, includes gallery
Newronika Receives CE Mark for αDBS®, Advancing Its Mission to Make Adaptive Therapy the Standard of Care
/PRNewswire/ -- Newronika S.p.A., the Milan-based medtech company redefining deep brain stimulation therapy, has received CE Mark certification for the latest...
Real Chemistry builds body of AI tools with Anatomi launch
Real Chemistry builds body of AI tools with Anatomi launch
Summit sells failed antibiotic to OpenAI-backed startup
Summit sells failed antibiotic to OpenAI-backed startup
AB Science ends 3 studies in multiple sclerosis, other immune conditions
The trials, which were testing the tyrosine kinase inhibitor masitinib, had previously been paused. AB Science’s decision not to resume them was a matter of prioritization, not safety, the biotech said. AB Science is formally terminating three studies for immune-mediated diseases in what it characterizes as an effort to better focus the biotech’s resources on its priority programs. The French company is axing a mid-stage study in mast cell activation syndrome (MCAS), a late-stage trial in mastoc
Agenus scraps ph. 3 colorectal study to narrow focus to colon
Agenus has scrapped a phase 3 study of its combo therapy in colorectal cancer after just three months in order to go all-in on colon cancer. The biotech launched the late-stage Battman study in April to evaluate a combination of its CTLA-4 inhibitor botensilimab and an anti-PD-1 antibody balstilimab in unresectable microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The aim was to enroll 830 patients across Canada, France, Australia and New Zealand.
AstraZeneca takes another China trip, picking Dizal’s lung cancer drug for up to $1.5B
Dizal Pharmaceutical’s Zegfrovy is approved in the U.S. for locally advanced or metastatic non-small cell lung cancer. For $600 million upfront, AstraZeneca will gain global rights to advance and commercialize the asset.
Biogen, Eisai win FDA nod for starter dose of subcutaneous Leqembi
Biogen, Eisai win FDA nod for starter dose of subcutaneous Leqembi
Exit of Roche’s embattled Huntington’s drug ‘tightens’ case for Wave’s more selective ASO
The failure of Roche’s Ionis-partnered tominersen in Huntington’s disease may indicate that Wave Life Sciences’ allele-specific antisense oligonucleotide candidate WVE-003 is on the right track, according to analysts at Rodman & Renshaw.
FDA posts new rejection letters days after confirming pause
The FDA last week confirmed that it would suspend the release of complete response letters pending the resolution of a citizen petition from an unnamed pharma company. Nevertheless, 14 new CRLs are now available on the agency’s portal. Just days after it confirmed a temporary suspension to its public disclosure of complete response letters, the FDA seems to have uploaded another batch of such documents to its online portal.
FDA proposes streamlined requirements for ‘hub-and-spoke’ manufacturing models
Through the proposal, the FDA could clear barriers to distributed manufacturing approaches intended to enhance emergency preparedness and supply chain resilience.
Germany approves controversial healthcare reform package
Even as the effort has met with fierce pushback from drugmakers, trade groups and opposition parties in the country’s own government, German lawmakers late Friday voted to pass health insurance reforms aiming to cut healthcare costs next year, in part by hiking up mandatory rebates that pharmas must pay on branded medicines. Still, previous resistance appears to have spared the pharmaceutical industry from at least one negative outcome in the central European nation, which often serves as a prov
GSK to seek FDA approval for Jemperli in high-profile cancer use
In what GSK says represents a potential way to transform treatment for patients with certain types of rectal cancer, the company’s Jemperli has met the main goal of a phase 2 trial, teeing up an application with the FDA. Interim results from the phase 2 AZUR-1 study showed a “meaningful and sustained” clinical complete response rate for Jemperli at 12 months in stage 2/3 mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, GSK said Monday.
Insilico’s partner pens $177M pact for ‘mass market’ CNS target
Insilico Medicine Licensing deals central nervous system China Pharma platform company China Medical System Holdings (CMS) has tapped up existing partner Insilico for a 1.2 billion yuan ($177 million) collaboration aimed at a “mass-market” central nervous system (CNS) indication. The pact will involve Insilico’s AI platform PandaOmics joining forces with CMS’ “experienced R&D team and deep therapeutic expertise,” according to the July 12 release. While the companies didn’t divulge the specific C
Island Pharma drug cleared for Bundibugyo Ebola use
Island Pharma drug cleared for Bundibugyo Ebola use Island Pharma has been granted the regulatory approvals needed to allow compassionate use of its antiviral galidesivir in the Bundibugyo Ebola outbreak in Uganda. The Melbourne, Australia-based biotech said it expects galidesivir to be deployed in the country this year, giving it an opportunity to generate "prospective human efficacy, safety and virological data" during an active outbreak of an Ebola virus species.
NICE aims to cut funding for Amgen lung cancer drug Lumykras
NICE aims to cut funding for Amgen lung cancer drug Lumykras Lumykras, which is known as Lumakras in some markets, will no longer be covered by the Cancer Drugs Fund, according to the health technology assessment (HTA) agency. Amgen has reacted with consternation to the news that treatment with its KRAS inhibitor Lumykras will no longer be funded in England and Wales, saying the decision does not reflect experience with the lung cancer therapy since it was first made available four years ago.
NICE backs NHS use of non-invasive endometriosis tests
NICE backs NHS use of non-invasive endometriosis tests Women with endometriosis in England could soon be offered simple non-invasive tests for diagnosis of their condition, rather than a diagnostic laparoscopy, a surgical procedure that is costly and carries risk. The debilitating condition – where tissue similar to the lining of the womb grows elsewhere in the body – affects one in 10 women of reproductive age in the UK, and causes symptoms like pain and extreme tiredness and, if untreated, can
Q32’s stock jumps 60% on latest phase 2 alopecia data
The latest phase 2 readout for Q32 Bio’s alopecia hopeful received a warm reception from investors, backing up the biotech’s claim that the drug could offer a more durable alternative to JAK inhibitors. The data, released Monday morning, come from part B of the Signal-AA study, which enrolled 33 patients with severe or very severe alopecia areata to receive the anti-IL-7R antibody bempikibart. Patients received a 200-mg subcutaneous dose weekly for four weeks, followed by 200 mg every other week
Top emerging biotech hubs in 2026
When it comes to centers for biotech innovation and expansion, well-established locations such as Boston and South San Francisco have long dominated the field. But in the last few years, an array of other cities have emerged to stake their claim by offering government incentives, new developments, a lower cost of living and other advantages. These regions hope to ride the wave of the life sciences industry’s increased prominence since the pandemic. That attention has helped spark a global real e
UK first in Europe to clear Boehringer's IPF drug Jascayd
UK first in Europe to clear Boehringer's IPF drug Jascayd Boehringer Ingelheim has the first European approval for its new idiopathic pulmonary fibrosis (IPF) therapy, Jascayd, after the UK's MHRA gave a green light to the drug. Phosphodiesterase (PDE) 4B inhibitor Jascayd (nerandomilast) has been cleared as a twice-daily, oral therapy for adults with IPF as well as progressive pulmonary fibrosis (PPF), an umbrella term for diseases caused by progressive scarring to the lungs.
Apnimed dreams of IPO to fund launch of sleep apnea pill
Apnimed is having sweet dreams of an IPO that could fund the planned commercial launch of an obstructive sleep apnea (OSA) therapy that is currently awaiting an FDA approval decision. The therapy, called Oxnimbi or AD109, is a drug combination that targets a cause of upper airway collapse in people with OSA. Apnimed reported two phase 3 wins for AD109 in 2025 and submitted an approval application to the FDA in April this year.
Biotechs forced to learn new patent tricks to protect pipelines
For a biotech, your intellectual property is your most prized asset. But a new era of increased global competition means that strong patents, longer stealth periods and even some misdirection can be required to ensure drug developers retain an edge. A growing source of competition is China, where science can move quickly and cheaply. The Asia Society—a global organization dedicated to understanding Asia’s role in the world—reported last year that Chinese biotechs recruit trial patients two to th
AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space
BioSpace reports: AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space.
AZ's China deals, Kailera-Hengrui—Fierce Pharma Asia
Fierce Pharma reports: AZ's China deals, Kailera-Hengrui—Fierce Pharma Asia.
Bausch + Lomb gives up on glaucoma eye drop hopeful after fail
Fierce Biotech reports: Bausch + Lomb gives up on glaucoma eye drop hopeful after fail.
Bayer scores €3B capital equity infusion in deal with Apollo
Bayer has agreed to a €3 billion capital and equity infusion from Apollo for a stake in its contraceptives business, providing balance-sheet support amid ongoing litigation and pipeline pressure.
Young people with PKU take the mic in BioMarin podcast series
BioMarin is amplifying teen voices living with phenylketonuria (PKU) through a podcast series and TikTok campaign, aiming to build community around its rare-disease franchise.
AstraZeneca, Ionis slip as ATTR-CM drug fails Phase 3
AstraZeneca, Ionis slip as ATTR-CM drug fails Phase 3 (BioSpace.)
AstraZeneca's Wainua fails key heart disease trial, shares tumble
AstraZeneca's Wainua fails key heart disease trial, shares tumble
Biotech M&A is accelerating. Track the deals that are happening here.
In the business of drug development, deals can be just as important as scientific breakthroughs. Many of today’s most lucrative medicines, from the life-saving cancer treatment Keytruda to the anti-inflammatory agent Enbrel, might not have become so without mergers and acquisitions. The end of the last decade brought record highs in pharmaceutical M&A as larger companies turned again and again to young biotechs for innovation. Often, these deals focused on cancer, rare diseases and immune system
GSK ends brain drug alliance with Alector
BioPharma Dive reports: GSK ends brain drug alliance with Alector.
Ipsen’s Botox rival Dysport posts dual ph. 3 wins in migraine
Ipsen’s Botox rival Dysport posts dual ph. 3 wins in migraine (Fierce Pharma.)
Kailera says obesity pill succeeds in late-stage trial in China
BioPharma Dive reports: Kailera says obesity pill succeeds in late-stage trial in China.
Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
BioPharma Dive reports: Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal.
Psychedelics surge again as Compass, Definium provide more clinical validation
BioSpace reports: Psychedelics surge again as Compass, Definium provide more clinical validation.
Affordable Care Act insurers want more premium increases as enrollment sags
Affordable Care Act insurers want more premium increases as enrollment sags (STAT News.)
Amgen recalls almost 1 million bottles of heart failure drug over quality issue
Amgen recalls almost 1 million bottles of heart failure drug over quality issue (reported by BioSpace)
Hengrui, Kailera’s oral GLP-1 clears late-stage bar in China but US results still pending
Hengrui, Kailera’s oral GLP-1 clears late-stage bar in China but US results still pending (reported by BioSpace)
Lundbeck hit with untitled letter over Vyepti efficacy claims
Lundbeck hit with untitled letter over Vyepti efficacy claims (Fierce Pharma.)
Novartis slashes New Jersey workforce again, cutting 322 employees
Novartis slashes New Jersey workforce again, cutting 322 employees (reported by BioSpace)
Satellos’ ‘intriguing’ DMD data raise hopes ahead of key readout
Satellos’ ‘intriguing’ DMD data raise hopes ahead of key readout (reported by Fierce Biotech)
Secretive AI drug hunter Xaira dips toe into dealmaking with hunt for partners
Secretive AI drug hunter Xaira dips toe into dealmaking with hunt for partners (reported by BioSpace)
Trial results set up Keenova to gain 3rd indication for Xiaflex
Trial results set up Keenova to gain 3rd indication for Xiaflex (Fierce Pharma.)
Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil
Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil (reported by BioSpace)
AI care partner Heidi touts positive side effects in campaign
AI care partner Heidi touts positive side effects in campaign (reported by Fierce Pharma)
BMS details Krazati confirmatory fail in colorectal cancer
BMS details Krazati confirmatory fail in colorectal cancer (reported by Fierce Pharma)
Caidya and Simbec-Orion unite in global CRO combo
Caidya and Simbec-Orion unite in global CRO combo (reported by Fierce Biotech)
FDA Clears CliniComp PACS Viewer (MIMPS), Unifying Diagnostic Imaging, Enterprise EHR, and Native AI in a Single Platform
FDA Clears CliniComp PACS Viewer (MIMPS), Unifying Diagnostic Imaging, Enterprise EHR, and Native AI in a Single Platform (reported by PR Newswire)
Presage Technologies Earns FDA Clearance for Contactless Vital Signs, Makes Them Available for Free
Presage Technologies Earns FDA Clearance for Contactless Vital Signs, Makes Them Available for Free (reported by PR Newswire)
Hair loss biotech Veradermics, up 656% since its IPO, credits the obesity boom
Hair loss biotech Veradermics, up 656% since its IPO, credits the obesity boom (reported by BioSpace)
Anthropic launches Claude Science for pharma researchers
Anthropic launches Claude Science for pharma researchers. (Pharmaphorum.)
AstraZeneca pays CSPC $30M to form kidney drug discovery pact
AstraZeneca pays CSPC $30M to form kidney drug discovery pact — Fierce Biotech coverage of biopharma industry developments.
After landmark deal, AstraZeneca goes to CSPC again in up to $1.7B pact
After landmark deal, AstraZeneca goes to CSPC again in up to $1.7B pact — Endpoints News coverage of biopharma industry developments.
AstraZeneca taps China’s CSPC again, betting up to $1.77B to target kidney diseases
AstraZeneca taps China’s CSPC again, betting up to $1.77B to target kidney diseases. (BioSpace.)
When clinical AI gets real
When clinical AI gets real — Endpoints News coverage of biopharma industry developments.
A $1B Acquisition Gives Novartis a Way to Stand Out in Crowded Area of Cancer
Myricx Bio brings to Novartis antibody drug conjugates with a novel cancer-killing payload called an NMT inhibitor. Novartis says Myricx’s drugs could have advantages over currently available ADCs as well as those still in clinical development.
Glaucoma Drug Fails Trial, But Bausch + Lomb Sees Opportunity in Another Eye Disease
Glaucoma Drug Fails Trial, But Bausch + Lomb Sees Opportunity in Another Eye Disease
Haleon joins the AI deal wave with Microsoft collab
Haleon joins the AI deal wave with Microsoft collab. (Fierce Pharma.)
Lung-Focused Celea Secures $180M for Pivotal Test of Pulmonary Fibrosis Drug
Celea Therapeutics raises $180M to fund a pivotal clinical trial of its lead idiopathic pulmonary fibrosis drug candidate. (Source: MedCity News, 2026-07-01)
Old cancer drug may help restore fertility for certain women
Old cancer drug may help restore fertility for certain women
Phase 3 Failure Keeps AstraZeneca and Ionis Out of a Growing Heart Disease Market
Phase 3 Failure Keeps AstraZeneca and Ionis Out of a Growing Heart Disease Market
Sarepta secures early 2027 FDA decision for Duchenne drugs, pushing past confirmatory fail
Sarepta secures early 2027 FDA decision for Duchenne drugs, pushing past confirmatory fail — BioSpace coverage of biopharma industry developments.
Tenpoint brings blurry vision hassles to life in new campaign
Tenpoint brings blurry vision hassles to life in new campaign. (Fierce Pharma.)
The top biopharma conferences remaining in 2026
The top biopharma conferences remaining in 2026. (BioPharma Dive.)
Vistagen in freefall as social anxiety drug fails Phase 3
Vistagen in freefall as social anxiety drug fails Phase 3 — BioSpace coverage of biopharma industry developments.
With New Phase 3 Data, Roche Claims an Edge Over Amgen and BMS Lung Cancer Drugs
With New Phase 3 Data, Roche Claims an Edge Over Amgen and BMS Lung Cancer Drugs — MedCity News coverage of biopharma industry developments.
With New Phase 3 Data, Roche Claims an Edge Over Amgen and BMS Lung Cancer Drugs
With New Phase 3 Data, Roche Claims an Edge Over Amgen and BMS Lung Cancer Drugs (MedCity News.)
Bain-backed Angitia drops lead spinal fusion candidate
Bain-backed Angitia drops lead spinal fusion candidate — Fierce Biotech coverage of biopharma industry developments.
Beeline adds $126M to Bain-backed immunology pipeline from Bristol Myers
Beeline adds $126M to Bain-backed immunology pipeline from Bristol Myers
Evommune ends development of lead asset in chronic hives after mid-stage efficacy woes
Evommune is discontinuing development of its lead chronic spontaneous urticaria candidate after a mid-stage trial failed to meet efficacy benchmarks.
Klick bags Oxford PharmaGenesis in 3rd takeover in 18 months
Klick Health acquired UK-based medical communications firm Oxford PharmaGenesis, the third takeover in 18 months as the agency expands its global medical-affairs footprint.
The top biopharma conferences remaining in 2026
The top biopharma conferences remaining in 2026 (BioPharma Dive.)
After trial fail, Teravance is bought out by Zymeworks for $929M
Zymeworks is acquiring Theravance Biopharma in a $929 million deal, taking out the struggling drugmaker after a Phase 3 failure of its lead respiratory candidate.
Evommune's lead drug fails in chronic hives, stock sinks
Endpoints News reports that Evommune's lead clinical candidate failed to meet primary endpoints in chronic hives, sending shares down on the readout.
FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
The FDA announced the seven participants in its PreCheck Pilot Program, which is designed to streamline regulatory pathways and incentivize domestic pharmaceutical manufacturing.
BIO 2026: AI, federal policy impacts, and general vibes
BIO 2026: AI, federal policy impacts, and general vibes (STAT News.)
BIO 2026: Making biotech IPOs great again and the forgotten pharma antitrust review
BIO 2026: Making biotech IPOs great again and the forgotten pharma antitrust review
EC begins antitrust probe into Sanofi's flu shot campaign
EC begins antitrust probe into Sanofi's flu shot campaign.
EU Commission opens antitrust probe into Sanofi's flu vaccine campaign
EU Commission opens antitrust probe into Sanofi's flu vaccine campaign
EU Hits France's Sanofi With Flu Vaccine Antitrust Probe
European Commission launched an antitrust investigation into Sanofi over concerns it pursued a misleading communication campaign to disparage Fluad by portraying it as inferior to Efluelda.
FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
The FDA proposed a new rule targeting foreign tobacco product manufacturers, aiming to close regulatory gaps and strengthen enforcement against non-compliant imported products.
Jails are the frontline in fielding dangerous new type of drug withdrawal
Jails are the frontline in fielding dangerous new type of drug withdrawal.
Lycia raises $75M for food allergy and Graves’ disease
Lycia raises $75M for food allergy and Graves’ disease
Aidoc Receives FDA Breakthrough Device Designation for AI That Drafts Radiology Reports Aidoc, the clinical AI company support
Aidoc Receives FDA Breakthrough Device Designation for AI That Drafts Radiology Reports Aidoc, the clinical AI company support
Bipartisan bill seeks to allow direct prescribing of methadone for opioid addiction
Methadone for opioid addiction has been available only at specialty clinics. A bipartisan bill would greatly expand access.
Recordati licenses Ionis drug; Vaxart's BARDA funding is cut
Daily briefs: Recordati licenses Ionis' zilganersen for ex-US rights; Vaxart's BARDA award cut by $116M; plus Leyden Labs, Otsuka, Pfizer and Hutchmed.
SCOTUS ruling blunts state-level claims against Bayer's Roundup
SCOTUS ruling blunts state-level claims against Bayer's Roundup.
Supreme Court ruling blocks thousands of lawsuits against maker of Roundup weedkiller
Supreme Court ruling blocks thousands of lawsuits against maker of Roundup weedkiller.
AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more
AbbVie scooped up immunology player Apogee Therapeutics for nearly $11 billion in one of the year’s top deals to-date, while Sanofi made a big play to survive its upcoming Dupixent patent cliff; FDA uncertainty continues as the agency changes direction on gene therapies by uniQure and REGENXBIO;…
BIO 2026: US needs to dodge China’s ‘inescapable dependencies’ to protect biotech
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
FDA hiring 2,200 people to staff up after last year’s DOGE cuts
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Icon names Microsoft tech partner as Q1 results grow analyst confidence
Irish CRO giant ICON this week made Microsoft its technology partner as the organization advances its plan to increase investment in AI over the next three years. | Irish CRO giant Icon this week made Microsoft its technology partner as the organization advances its plan to increase investment in AI over the next three years. Microsoft’s Copilot and data infrastructure will be implemented enterpri
Mapp, Gilead antivirals to be deployed in DRC Ebola trial: WHO chief
As health officials grapple with a fast-moving outbreak of the Bundibugyo ebolavirus in the Democratic Republic | Officials are planning to study Mapp Biopharmaceutical’s MBP134 and Gilead Sciences’ remdesivir, which gained prominence during the COVID-19 pandemic, against the Bundibugyo ebolavirus.
Ollin Biosciences Announces Oversubscribed $330M Series B Financing
Ollin Biosciences raised $330M in an oversubscribed Series B to advance global Phase 3 development of OLN324 in DME and wet AMD, studies commencing in second half of 2026.
Ollin parlays Vabysmo beat into $330M raise to test eye disease drug in Phase 3
With positive feedback on a Phase 3 trial design, Ollin Biosciences has collected a $330 million series B to advance its VEGF/Ang2 antibody, which bested Genentech’s therapy in a head-to-head study.
UK biotech secures $115M to advance portfolio of virus-targeting antibodies
RQ Bio has clinched $115 million in a Series A raise to advance a preclinical pipeline of virus-targeting antibodies.
US military requires flu vaccine for some after outbreak in Texas training center
US military requires flu vaccine for some after outbreak in Texas training center. (Reuters Biopharma.)
Whoop dodges FDA enforcement action
The FDA said it will not take enforcement action against Whoop, nearly a year after it warned the wearable maker over its blood pressure tracker.
A different kind of AI entrant in healthcare
A different kind of AI entrant in healthcare.
Exclusive: Brent Saunders' latest dermatology bet gets $20M for skin longevity
Brent Saunders' latest dermatology startup raised $20M to develop skin longevity therapeutics, marking his return to the specialty he built Allergen around.
Exclusive: Flagship's Abiologics uses AI to build mirror-image proteins for new drugs
Flagship Pioneering's Abiologics emerged from stealth, using AI to design mirror-image proteins as a new modality for drug development.
Exelixis' TKI falls short in colorectal cancer subgroup as FDA reviews approval in all-comers
Exelixis' zanzalintinib (TKI) failed to meet the dual primary endpoint in a subgroup of patients with previously treated metastatic colorectal cancer who did not have active liver metastases, despite numerical improvement in overall survival.
Genentech, Novartis accused of Xolair kickback scheme in lawsuit
A whistleblower lawsuit accuses Genentech and Novartis of running a decades-long kickback scheme around the allergic asthma drug Xolair.
HHS details plan to regain the US's edge in clinical trials
HHS details plan to regain the US's edge in clinical trials.
Judge rules government can't stop SNAP dollars from buying candy and sugary drinks
The federal government can't block benefits from the nation's largest food aid program from being used to buy candy, soda, and other sugary drinks, a judge ruled.
Nuvectis, Haisco ink up to $1.4B deal for two late-stage programs
Nuvectis Pharmaceuticals signed a deal worth up to $1.4B with Haisco Pharmaceutical for two late-stage oncology programs.
Pfizer delivers ‘disappointing’ late-stage lung cancer data for ADC from $43B Seagen buy
Despite an overall survival miss, Leerink Partners said Pfizer’s antibody-drug conjugate showed “promising” signals of efficacy in a subgroup of patients who had undergone only one prior line of treatment.
Pfizer's $43B Seagen bet sours further as ADC fails in late-stage lung cancer trial
Pfizer's $43B Seagen acquisition faced another setback as a key ADC failed in late-stage lung cancer trials, raising fresh questions about the deal's strategic value.
Texas doctor charged in $89M fraud case as administration pushes health care crackdown
Federal prosecutors charged a Texas doctor in an $89M healthcare fraud case as the Trump administration intensifies its crackdown on Medicare and Medicaid fraud.
The Catch-22 for disabled workers hidden in Medicaid's new work requirements
New Medicaid work requirements create a Catch-22 for disabled workers who lack medical proof of their disability, threatening to strip them of coverage.
UPDATE: Lilly, Astellas circle Sangamo assets as biotech files for bankruptcy
Sangamo Therapeutics will lay off 51 members of its workforce while retaining 77 people to continue work on the programs central to Astellas and Eli Lilly's bids.
With onshoring ‘having a moment,’ Aquestive CEO shares lessons from 20 years of US manufacturing
Having stuck with local production in the years when offshoring to lower-cost locations was in fashion, Aquestive’s CEO is well placed to explain what the recent reshoring drive means for manufacturers.
AbbVie inks $10.9B Apogee buyout to bag eczema prospect
Fierce Biotech reports AbbVie is acquiring Apogee Therapeutics for $10.9B to gain control of a late-phase eczema drug candidate that could compete with Lilly, Regeneron, and Sanofi.
Swoop Acquires Nimble, Adding Prescription Fulfillment and Pharmacy Connectivity to Portfolio
Swoop Acquires Nimble, Adding Prescription Fulfillment and Pharmacy Connectivity to Portfolio.
AH-008 Achieves Dual Regulatory Milestones with U.S. FDA IND Clearance and Taiwan CDE Index Case Designation AnHorn Medicines
AH-008 Achieves Dual Regulatory Milestones with U.S. FDA IND Clearance and Taiwan CDE Index Case Designation AnHorn Medicines
Alnylam scolded over promotional activity after Pfizer complaint
Alnylam Pharmaceuticals faces regulatory scrutiny over promotional practices following a complaint by Pfizer.
Alnylam scolded over promotional activity after Pfizer complaint
Alnylam drew regulatory scrutiny over its promotional activity after a complaint from Pfizer, highlighting ongoing tension between innovators and generic / biosimilar competitors.
Insilico's AI design engine bags Korean biotech deal worth possible $2.5B+
Insilico Medicine signs a deal with a Korean biotech to use its AI-driven drug design engine, with biobucks potentially exceeding $2.5 billion.
BioArctic and Lilly sign research and collaboration agreement combining Lilly compound with BioArctic's BrainTransporter technology
BioArctic and Lilly sign research and collaboration agreement combining Lilly compound with BioArctic's BrainTransporter technology.
Lilly bets up to $800M for BioArctic’s brain delivery tech
Eli Lilly plans to use BioArctic’s technology to shuttle an undisclosed drug candidate into the brain. The pharma hasn’t specified which neurodegenerative disease it will target.
MapLight Announces Topline Results from Phase 2 IRIS Study for ML-004 in Autism Spectrum Disorder
MapLight Therapeutics announced topline results from the Phase 2 IRIS study of ML-004 (a novel mechanism) in autism spectrum disorder. Despite Phase 2 results, the company is engaging with FDA on the path forward for the program.
Nura raises $73.8M to target ALS through a unique target
Nura Bio will use the series B financing to carry two neuroprotective drug candidates through early- to mid-stage clinical studies, one targeting ALS and the other for a broader neurological profile.
Sanofi's R&D head exits, with AI biotech Xaira's exec stepping in
Sanofi loses its R&D head to AI biotech Xaira Therapeutics, which is contributing its executive to the pharma giant.
MapLight Announces Topline Results From Phase 2 IRIS Study for ML-004
MapLight Announces Topline Results From Phase 2 IRIS Study for ML-004.
Inside Pfizer's $10B deal with Innovent: a 5-month sprint
Fierce Biotech details the rapid-fire negotiations behind Pfizer's $10 billion deal with Innovent Biologics.
Denali sells FDA voucher for $195M to support neurodegenerative pipeline
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
FDA's new voucher program hints at broader policy agenda, making many 'uncomfortable'
Experts say the FDA Commissioner's National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency's senior leaders topping the list.
Memento brings home $93M Series A souvenir, picks up bispecific for eye diseases
Memento raises $93M in Series A funding and in-licenses a bispecific antibody for ophthalmology indications.
No investors. A 50/50 split everyone warned us against. How Endpoints survived its first decade — and ended up at the FT
No investors. A 50/50 split everyone warned us against. How Endpoints survived its first decade — and ended up at the FT.
US launches investigation into German drug pricing, citing unfair R&D burden
The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts.
AI’s growing appetite for power is a public health issue. Here’s a fix
AI’s growing appetite for power is a public health issue. Here’s a fix.
At FDA, 'caretaker mode' is better than power trip mode
FDA acting commissioner Kyle Diamantas approves uniQure's Huntington's gene therapy path while keeping the agency in a 'caretaker' posture, raising questions about long-term durability of flexible decisions once a permanent commissioner is seated.
Eli Lilly cuts hospitals' 340B pricing over data policy dispute
Eli Lilly is cutting 340B drug pricing to hospitals that fail to comply with its claims data policy.
Exclusive: Lilly's TuneLab crosses 100-member mark, adds AI models from buzzy startup Chai
Lilly's TuneLab AI platform has crossed the 100-member mark and added AI models from Chai.
'Familiarity' with oral Wegovy has triggered its quick uptake
Spherix data shows Novo Nordisk's oral Wegovy pill is being adopted rapidly because of prescriber and patient 'familiarity' with the semaglutide class, accelerating uptake against Lilly's Foundayo.
Insilico Medicine And SK Biopharmaceuticals Achieved AI-powered Drug Discovery Collaboration Worth Potential $2.5B+
Insilico Medicine and SK Biopharmaceuticals achieved a major AI-powered drug discovery collaboration worth potentially $2.5 billion+, leveraging Insilico's AI drug discovery platform to develop novel therapeutics.
Kardigan Announces Pricing of Upsized Initial Public Offering
Kardigan's common stock began trading on the Nasdaq Global Market on June 18, 2026, under ticker KARD, with the offering expected to close on June 22, 2026.
Novocure device fails to improve brain cancer patients' survival in Phase 3 test
Novocure device fails to improve brain cancer patients' survival in Phase 3 test.
Ones to watch: 4 biotechs with recent Series B raises (that are also hiring)
Four biotechs that closed recent Series B financings are actively hiring across R&D, clinical, and operations roles as they scale toward lead asset milestones.
Prepping for peptides
The pharmaceutical industry is racing to prepare peptide manufacturing capacity as GLP-1 demand and a wave of next-gen peptide therapies strain existing production infrastructure.
RA, Forbion and Sanofi Ventures appear to back new eye drug from Korea
RA Capital, Forbion and Sanofi Ventures are backing a new Korean ophthalmology biotech developing a novel eye drug, with financing details expected to be announced in the coming weeks.
Be Bio bins hemophilia B cell therapy trial-the biotech's lead program
Be Bio discontinues its lead hemophilia B cell therapy program after a clinical review, raising questions about the company's engineered B cell platform strategy and pipeline direction.
Edgewise slides as cardiomyopathy challenger to BMS, Cytokinetics falls short
Edgewise Therapeutics' lead cardiac myosin modulator underwhelmed in a Phase 2 readout, sending shares lower and raising doubts about its competitive standing against BMS and Cytokinetics in the HCM space.
Hackers Claim Responsibility for Novo Nordisk Cyberattack
Hackers Claim Responsibility for Novo Nordisk Cyberattack.
Triveni Bio raises $65M ahead of upcoming readouts on eczema drugs
Triveni Bio raises $65M ahead of upcoming readouts on its eczema drug programs, advancing its antibody-based pipeline for immune and inflammatory diseases.
UK waitlist for Novo's Wegovy pill triples in week after approval, major online pharmacy says
Waitlist for Novo Nordisk's oral Wegovy in the UK has tripled in the week following MHRA approval, per a major online pharmacy, signaling strong consumer demand for the pill form.
UniQure plans Q3 submission for Huntington’s gene therapy after FDA reverses course—again
After a regulatory odyssey that delayed a filing for what would be the first genetic medicine for Huntington’s disease, the FDA has agreed that three-year data from uniQure’s Phase 1/2 trial are sufficient to support an accelerated biologics license application.
Vedana Therapeutics Launches With $46 Million Series A Financing
Vedana Therapeutics emerged from stealth with $46M Series A financing (co-led by Westlake BioPartners and Canaan Partners) to advance next-generation therapies for migraine prevention.
Big Pharma's 10 highest-paid CEOs of 2025
Fierce Pharma's annual ranking of the top 10 highest-paid CEOs among big pharmaceutical companies for 2025, including total compensation packages and stock awards.
Exclusive: UCSF spinout Kopra Bio nets $9.1M to test virus therapy for brain cancer in China
Kopra Bio, a UCSF spinout developing viral immunotherapy for glioblastoma, has raised $9.1M to begin a China clinical trial of its InViTE platform that uses genetically engineered viruses to selectively destroy tumor cells.
FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
The FDA expanded access to over-the-counter naloxone nasal spray, making the opioid-overdose reversal agent more widely available without a prescription.
FDA, MHRA strengthen transatlantic alliance with liaison program
The FDA and the UK's MHRA announced a new liaison program to deepen transatlantic regulatory cooperation, including shared reviews and joint inspections.
Lilly bolsters non-opioid pain portfolio with 4E Therapeutics buy
Lilly bolsters non-opioid pain portfolio with 4E Therapeutics buy.
Verge Labs Unveils vBx: A Breakthrough Foundation Model for Precision Neurology
Verge Labs (formerly Verge Genomics) has unveiled vBx, a new foundation model designed for precision neurology. The model leverages Verge's multi-modal human tissue database to solve patient stratification problems for neurology clinical trials.
CMS seeks to close Medicare negotiation 'loophole'
The Centers for Medicare & Medicaid Services has proposed a rule to close a loophole in the Medicare drug price negotiation program that some manufacturers have used to delay negotiations.
Eisai Gets UK Backing as It Expands Plant for Leqembi Production
Eisai is expanding its UK packaging and manufacturing footprint for Leqembi with a £65M government-backed investment, securing capacity for the Alzheimer's antibody as global demand ramps post-FDA approval.
Elicio's KRAS Cancer Vaccine Fails in Phase 2, Shares Plummet
Elicio Therapeutics' KRAS-targeted cancer vaccine failed to meet its primary Phase 2 endpoint in metastatic pancreatic cancer, sending shares down more than 60% and forcing a strategic review of the platform.
Elicio Crashes on Midstage Pancreatic Cancer Miss But Will Advance to Phase 3
Elicio Therapeutics' KRAS-targeted cancer vaccine missed its Phase 2 primary endpoint in pancreatic cancer, cratering the stock, but the company said it will still advance the program to a Phase 3 trial based on a subpopulation signal.
Germany scraps variable discount plan meant to cut costs: report
Germany has scrapped a planned variable discount pricing scheme aimed at cutting drug costs, marking a reversal after industry pushback and parallel concerns from companies like Lilly and Boehringer Ingelheim.
Funding: HMNC and the Long Road to Precision Psychiatry
Funding: HMNC and the Long Road to Precision Psychiatry.
Funding: HMNC and the Long Road to Precision Psychiatry
Funding: HMNC and the Long Road to Precision Psychiatry.
How Does Ibogaine Work? Understanding Matrix Logic to Make a Safer Drug
Researchers are using matrix logic and modern receptor pharmacology to design safer ibogaine analogs that retain the psychedelic's anti-addiction potential while avoiding the cardiac and neurotoxicity risks of the parent compound.
Despite FDA Trial Clearance, Ibogaine Metabolite Won't Receive Red Carpet Treatment
DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for the controversial psychedelic despite a long history of safety concerns and a still-cautious FDA posture.
IQVIA Taps AI to Put Overlooked Prescribers on Marketers' Maps
IQVIA is rolling out an AI-driven prescriber identification tool designed to surface community physicians and nurse practitioners whose prescribing patterns are routinely missed by traditional pharma targeting models.
Lilly sees quick return on $2.3B Ajax buy as blood cancer drug shows early efficacy
Eli Lilly’s new JAK2 inhibitor—which it obtained from the recent acquisition of Ajax Therapeutics—reduced spleen volume by more than a third in 70% of patients with myelofibrosis.
Neumora Discards Depression Asset, Lays Off Staffers After Pair of Late-Stage Flops
Neumora Therapeutics is laying off 35% of its workforce and discontinuing its lead depression drug after the asset failed two Phase 3 trials, sending shares down sharply and forcing a major pipeline reset.
Neumora discards depression asset, lays off staffers after pair of late-stage flops
Neumora discards depression asset, lays off staffers after pair of late-stage flops.
FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients With Stage 3 Type 1 Diabetes
The FDA has approved Sanofi's type 1 diabetes therapy Tzield (teplizumab) for children with stage 3 disease, expanding the disease-modifying treatment to a much younger patient population.
ADA: AstraZeneca Hands Structure a Win With 'Relatively Underwhelming' GLP-1 Pill Data
Structure Therapeutics' oral GLP-1 pill produced a 'relatively underwhelming' but still positive Phase 2 readout in diabetes, with analysts questioning commercial viability against Lilly's Foundayo and Novo's Wegovy pill.
ADA: Lilly Bests Novo Again, Takes GLP-1 Pill Foundayo to FDA for Diabetes Approval
Eli Lilly has submitted Foundayo, its oral GLP-1 receptor agonist, to the FDA for diabetes approval on the strength of head-to-head Phase 3 data presented at ADA showing superior A1C reduction versus Novo Nordisk's Wegovy pill.
Astellas, Takeda, RA Capital: This Week in Asia-Pacific Pharma
Astellas laid out a five-year strategic plan, Takeda's TYK2 inhibitor beat BMS's Sotyktu in a head-to-head psoriasis trial, and RA Capital launched a new China bridge program. Fierce Pharma Asia's weekly roundup of the region's most consequential biopharma moves.
Parabilis Medicines IPO Prices at $20 per Share, Raising $670M
Parabilis Medicines IPO Prices at $20 per Share, Raising $670M.
Biopharma Sentiment Index | Q2 2026
The Q2 2026 Endpoints Biopharma Sentiment Index shows industry confidence continuing its 2026 rebound, with sentiment rising across small-molecule, biologics, and AI-driven drug discovery subsectors.
Biotech Stocks Are on a Tear Again: Signal Insights
Endpoints Signal Insights recaps the latest biotech stock surge, with the XBI hitting multi-year highs on the back of strong IPOs, M&A activity, and policy stability after a brutal 2023-2024 bear market.
Programming biology: next-gen AI firms raise billions to design better
Nature Biotechnology analysis of the next-generation AI biology firms that are raising billions of dollars to design better drugs and proteins, including deep dives into the approaches being used and the scientific questions they aim to answer.
Eli Lilly Invests in Startup Abridge for Clinical Trial Recruitment
Eli Lilly has made a strategic investment in Abridge, the AI medical scribe company, to accelerate clinical trial recruitment and reduce site burden, deepening the pharma's footprint in generative AI healthcare tools.
Where Does Biopharma Go From Here?
Endpoints' Q2 2026 sentiment survey captures industry executives' views on capital availability, R&D productivity, M&A activity, and policy outlook heading into the second half of the year.
Enliven Prices $400M Offering; Jazz Drug Zepzelca Fails Confirmatory Study
Enliven Therapeutics priced a $400 million public offering, while Jazz Pharmaceuticals and PharmaMar announced that Zepzelca failed its confirmatory Phase 3 study in small cell lung cancer, dealing a fresh blow to the partners' strategy of positioning the drug in earlier lines of therapy.
FDA Imposes Import Alert on Dabur India's Plant After Inspectors Flag GMP Failings
The FDA has imposed an import alert against Dabur India after inspectors found bird droppings, an unidentified black substance on warehouse ceilings, and data integrity deficiencies at one of the company's facilities, potentially allowing authorities to detain shipments of antibiotics, dietary supplements, and other drugs.
Beyond Sunshine: Iberia's Biotech Moment Has Arrived With Developing Capital Networks
Spain and Portugal are emerging as a credible European biotech hub beyond the traditional Catalonia/Madrid axis, with growing capital networks and a new wave of funding vehicles starting to compete with Paris and London for biotech creation.
Merck, Gilead Serve 'Sweet and Sour' Spread After HIV Win, Cancer Stumble
Merck and Gilead posted mixed data at a major oncology-HIV conference, with Merck's HIV program delivering a positive pivotal readout while Gilead's Trodelvy missed again in lung cancer, dragging on the company's oncology narrative.
Novartis Dystrophy Data Tee Up Regulatory Talks on Avidity Drug
Novartis executives said the company's muscular dystrophy data—built around the $12B Avidity Biosciences acquisition—pave the way for near-term regulatory submissions in DM1 and DMD.
Novo Nordisk Hit With Cybersecurity Breach, Urges Vigilance Among Trial Participants
Novo Nordisk disclosed a cybersecurity breach affecting clinical trial participant data, urging patients to remain vigilant. The incident follows a broader pattern of cyberattacks targeting pharma and adds to Novo's 2026 challenges.
The Oral GLP-1 Tracker: Novo's Wegovy Pill Keeps Gaining Ground
Fierce Pharma's quarterly oral GLP-1 launch tracker shows Novo Nordisk's Wegovy pill continuing to capture scripts at a faster rate than Eli Lilly's Foundayo in early launch markets, with both drugs now expanding into new indications.
WuXi AppTec Sues Pentagon in Challenge Over Inclusion on Chinese Military List
WuXi AppTec has filed suit against the U.S. Department of Defense, challenging its inclusion on the Chinese military companies list. The lawsuit escalates a multi-year dispute that has shaped the biotech supply chain and raised concerns from pharma clients about outsourcing to Chinese CDMOs.
Zepzelca Saga Takes Another Turn With Ph. 3 Lung Cancer Flop
Jazz Pharmaceuticals and partner PharmaMar's Zepzelca (lurbinectedin) has failed a confirmatory Phase 3 study in small cell lung cancer, raising fresh questions about the drug's accelerated approval and Jazz's oncology strategy.
Abridge wants to be the operating system for medicine—and NVIDIA and Eli Lilly are helping build it
Abridge announced strategic partnerships with Eli Lilly (a strategic investment) and NVIDIA (a co-developed foundation model for clinical conversations) as the AI documentation company expands beyond documentation into a broader clinical operating platform.
Astellas Outlines CEO's 5-Year Plan to Counter the Xtandi Patent Cliff
Astellas CEO Naoki Okamura detailed a five-year strategic plan centered on the company's post-Xtandi oncology and women's health franchises, projecting a path back to growth as the prostate cancer blockbuster faces generic competition later this decade.
The Wait Continues: Pressure to Operate Lean Among Factors Behind Slow Biopharma Job Market
Just 23% of respondents to a BioSpace LinkedIn poll expect the biopharma job market to rebound in 2026. Three experts discuss when they see a turnaround happening and how increasing emphasis on cost efficiency is impacting hiring practices across the industry.
Biopharma pay report: Top-paid CSOs, CMOs of 2025
Biopharma pay report: Top-paid CSOs, CMOs of 2025.
Here Are Biopharma's 10 Highest-Paid Scientists and Doctors for 2025
Endpoints' annual ranking of the 10 highest-paid biopharma scientists and doctors in 2025, with a methodology note on how cash, equity, and performance-share structures shifted versus 2024.
Nonprofit Blood Cancer United Buys Experimental Cancer Drug Luvelta to Maintain Patient Access
The nonprofit Blood Cancer United has acquired the experimental cancer drug Luvelta to ensure continued access for patients enrolled in ongoing trials after the developer signaled it would wind down the program, an unusual arrangement that highlights the financial pressure on small-molecule oncology development.
Camurus' Second CRL for Acromegaly Drug; Teva Details Workforce Cuts
Camurus received a second Complete Response Letter from FDA for its acromegaly candidate, while Teva provided fresh details on its multi-year workforce reduction plan covering both its generics and specialty operations.
Charles River CEO Says It Likely Won't Be the Last Manufacturer to Break Away From Cell and Gene Therapy
Charles River Laboratories' CEO said the company's recent decision to wind down its cell and gene therapy CDMO business is likely a leading indicator of broader industry rationalization, as capital costs and clinical failure rates reshape the manufacturing landscape.
Drugmakers Turn to Logistics Providers as Trade Disruptions Linger, DHL Exec Says
Pharmaceutical manufacturers are increasingly relying on third-party logistics providers to manage supply chain complexity as US-China trade tensions and tariff uncertainty persist, according to a senior DHL executive.
Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components
Enliven Therapeutics announced updated positive Phase 1 clinical data for its menin inhibitor in acute myeloid leukemia, with alignment with FDA on key Phase 3 trial design components. The drug targets a specific subtype of AML with high unmet need.
Germany's Health-Spending Plan Has Consequences as Lilly, Boehringer Scale Back
Eli Lilly and Boehringer Ingelheim are scaling back German operations in response to the country's proposed health-spending cuts, raising questions about Europe's largest pharma market's ability to attract R&D investment.
Kardigan Stitches Up $369M IPO Plan for Heart Drugs
Kardigan, the cardiology biotech led by a former MyoKardia executive, has filed to raise up to $369M in a US IPO to fund a pipeline of three in-licensed cardiovascular programs targeting cardiomyopathies and related heart conditions.
Madrigal Takes Giant Inflatable Liver on US Tour for Disease Awareness
Madrigal Pharmaceuticals is touring the United States with a giant inflatable liver to raise awareness of MASH (metabolic dysfunction-associated steatohepatitis) and its approved therapy Rezdiffra, the first FDA-approved drug for the disease.
May 2026 Biopharma Layoffs Hit Nearly 7,000, With Most Cuts From Takeda and BioNTech
For the second time in 2026, the number of biopharma professionals affected by made or projected workforce reductions rose year over year. In May, layoffs spiked nearly 50% to 6,956 employees, mainly due to Takeda and BioNTech axing a combined 6,360 employees.
Neion Bio Raises Oversubscribed $23 Million Series A to Advance Biologics Manufacturing Platform and Expand Pipeline
Neion Bio Raises Oversubscribed $23 Million Series A to Advance Biologics Manufacturing Platform and Expand Pipeline.
Neion Bio Raises Oversubscribed $23 Million Series A to Advance Biologics Manufacturing Platform and Expand Pipeline
Neion Bio Raises Oversubscribed $23 Million Series A to Advance Biologics Manufacturing Platform and Expand Pipeline.
Portugal, Spain, and the New Biotech Frontier
Iberia's biotech sector is emerging as a serious third hub behind the U.K. and Germany, with deep academic science, growing late-stage capital, and a new wave of cross-border partnerships.
Sky-High Parabilis, Kailera IPOs Spur Optimism—But Only for Derisked Biotechs
Two biotechs—Parabilis Medicines and Kailera—have set industry records with back-to-back IPOs, but experts caution that only derisked pipelines with validated mechanisms are reaping rewards while broader biotech sentiment remains cautious.
Takeda's AI-Designed Pill Bests BMS' Sotyktu in Head-to-Head Psoriasis Trial
Takeda's oral allosteric TYK2 inhibitor, designed with the help of generative AI, beat Bristol-Myers Squibb's Sotyktu in a head-to-head Phase 3 trial in moderate-to-severe plaque psoriasis, positioning it as a potential best-in-class oral therapy.
New Biotech Group Rises to Fuel American Rockets in China 'Space Race'
The American Biotech Innovation Alliance (ABIA) launched with the goal of building a national biotech strategy for the United States, modeled on China's coordinated approach to the sector, to maintain American competitiveness in life sciences innovation.
Eli Lilly's 340B Claims Data Deadline May Kick Off a New 340B Fight
Eli Lilly is moving forward with a hospital claims data submission deadline tied to its 340B drug pricing program, a step that could trigger a new round of disputes with safety-net hospitals and reshape how the contract pharmacy channel operates.
Ethyreal Lands $101M to Treat Both Graves' and Thyroid Eye Disease
Ethyreal Therapeutics closed a $101M financing to advance a dual-acting antibody aimed at both Graves' disease and thyroid eye disease, two autoimmune indications with overlapping biology but few targeted therapies.
FDA Details Flexibilities for New Cell and Gene Therapies to Leverage Past Data
The FDA has released new guidance clarifying how sponsors of cell and gene therapies can leverage prior clinical and CMC data from related programs to accelerate development timelines, in a move likely to speed the next wave of regenerative medicine approvals.
Explaining Unapproved Drugs to Payors: FDA Offers Pharma New Guidance to Avoid Pitfalls
The FDA has issued new draft guidance for pharmaceutical companies on how to communicate with payors about unapproved drugs and investigational uses, aiming to reduce off-label misinformation and clarify permissible pre-approval communication.
Local Trade Groups Must Support Life Sciences in These Difficult Times
An opinion column arguing that as the industry faces policy changes and significant cuts to federal funding, local life sciences trade groups can bolster companies through innovative resources to sustain growth and keep the US at the center of biomedical innovation.
Parabilis' $670M IPO Sets New Biotech Record, Will Fund Cancer Drug
Parabilis Medicines raised $670 million in an industry-record IPO, the largest biotech public offering to date, with proceeds earmarked to advance its lead cancer program into the clinic.
Shattuck Raises $75M; Servier Inks Neuro ASO Pact with n-Lorem Foundation
Shattuck Labs closed a $75M financing round, while Servier announced a partnership with the n-Lorem Foundation to develop antisense oligonucleotide (ASO) therapies for ultra-rare neurological diseases.
Big Pharma-Backed SonoThera Sounds Off With $125M Series B for Ultrasound-Based Gene Therapy
SonoThera, a biotech developing ultrasound-based, non-viral gene therapies, raised a $125 million Series B led by multiple Big Pharma partners. The funding will advance its lead programs in genetic medicine toward clinical trials.
City Therapeutics Gets $99M to Gather Data on Three RNAi Medicines
City Therapeutics has closed a $99M financing round to advance its pipeline of three RNAi medicines, betting on a next-generation small interfering RNA platform that aims to improve potency and durability over current standards.
USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk
The U.S. Pharmacopeia's annual drug shortages report finds rising discontinuations and hidden upstream supply-chain risk, with drug shortages remaining a systemic problem in the U.S. and affecting multiple therapeutic areas.
Trodelvy Misses Again in Lung Cancer, but Gilead and Merck Have an HIV Success to Soften the Blow
Gilead's Trodelvy failed a second late-stage lung cancer trial, further narrowing the ADC's commercial prospects outside of triple-negative breast cancer. Gilead and Merck separately reported positive HIV data, providing partial offset to the disappointing oncology readout.
ADA: Kailera 'Back at Work' After Record-Breaking IPO With China Data in Hand
Kailera Therapeutics executives said the obesity biotech is back to building pipeline after a record-breaking IPO, presenting Phase 2 data from China on its lead GLP-1/GIP candidate at the American Diabetes Association conference.
Japan pharmaceutical firm warns against rare diseases drug after 20 deaths
Japan pharmaceutical firm warns against rare diseases drug after 20 deaths.
Cavalry Biosciences Pursues $75M Series B to Test Eye and Muscle Disorder Drugs
Cavalry Biosciences is raising a $75 million Series B to advance its pipeline of oligonucleotide therapies for inherited eye and muscle disorders, joining a small group of well-capitalized genetic medicine startups building on the success of the modality in neuromuscular disease.
Sanofi, OpenAI, and Formation Bio Partner to Accelerate Drug Development
A first-of-its-kind collaboration to build AI-powered software and custom applications, aiming to bring new medicines to patients more efficiently by leveraging OpenAI's technology and Formation Bio's clinical platform.
Rethinking Hair Loss Treatment: New Mechanisms Move Into the Clinic
A new generation of hair-loss therapies is moving into clinical trials, targeting pathways beyond the JAK-IGF-1 axis that have dominated the field since the approval of JAK inhibitors for alopecia areata.
BrainStorm levels up, bringing on former FDA leader Peter Pitts for new ALS bid
For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.
FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients
The FDA issued draft guidance aimed at accelerating the development and review of cell and gene therapies, with a focus on rare-disease and unmet-medical-need applications.
Insilico Medicine Announces Nature Medicine Publication of Phase IIa Results Evaluating Rentosertib for IPF
Insilico Medicine announced publication of Phase IIa results in Nature Medicine for rentosertib (INS018_055), the novel TNIK inhibitor for idiopathic pulmonary fibrosis (IPF). The drug was discovered and designed with the company's pioneering AI approach. Phase 2 trials are ongoing.
Curse of the straight-A student
The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
The Biotech Hiring Market in 2026: Where Things Actually Stand
An analysis of the biotech hiring market in 2026 shows that bioinformatics and computational biology skills remain among the hardest-to-fill categories, with capital flowing into the sector faster than the talent infrastructure can support it. Demand for hybrid wet-lab plus data-science skills continues to outpace supply.
AHA urges HRSA to stop Novo Nordisk's new claims-data submission policy for 340B
On January 26, the AHA urged HRSA to take immediate action to stop Eli Lilly from requiring 340B covered entities to submit claims data for all dispensations of all Lilly drugs.
AI-Native Biopharma
Therapeutics developers leveraging computational biology and AI foundation models as core pipelines.
Abiologics
PrivateProfile of Abiologics created from news harvest. To be enriched by user.
HQ:Cambridge
Funding:N/A
Key Pipeline Asset:
Abridge
PrivateAbridge is a privately held healthcare AI company that builds ambient-AI clinical documentation and conversation-summarization tools used by physicians, nurses, and health systems. The platform listens to patient-clinician encounters and automatically generates structured clinical notes, billing codes, and patient summaries. In June 2026, Abridge announced parallel strategic partnerships with Nvidia (for compute infrastructure) and Eli Lilly (to deploy its platform in Lilly-sponsored clinical trial recruitment and consent workflows).
HQ:San Francisco
Funding:>$700M cumulative venture-backed funding through 2026
Key Pipeline Asset:
Alto Neuroscience
NYSE: ANROAlto Neuroscience is a clinical-stage biopharmaceutical company developing precision psychiatry medicines using biomarker-driven patient stratification to treat depression and other central nervous system disorders.
HQ:Mountain View
Funding:N/A
Key Pipeline Asset:
Autonomous Healthcare
PrivateAutonomous Healthcare is a medical device company developing AI-driven ventilator waveform analysis software. Their Syncron-E platform received FDA De Novo marketing authorization in July 2026, creating a new FDA device category for ventilator data software.
HQ:Newark
Funding:Disclosed via press releases
Key Pipeline Asset:
BioXcel Therapeutics
NASDAQ: BTAIBioXcel Therapeutics is a clinical-stage biopharmaceutical company leveraging artificial-intelligence–driven drug discovery to develop neuroscience and immuno-oncology medicines. Its lead commercial product IGALMI (sublingual dexmedetomidine) is FDA-approved for acute treatment of agitation associated with schizophrenia or bipolar I/II disorder, with an at-home sNDA under FDA review (PDUFA target action date November 14, 2026). The company is exploring strategic options for the IGALMI franchise after first-quarter 2026 IGALMI net revenue of $206K and an operating loss of $10.2M. Shareholders have previously authorized a 1-for-2 to 1-for-20 reverse split range to maintain Nasdaq bid-price compliance.
HQ:New Haven
Funding:N/A
Key Pipeline Asset:
Cadence
PrivateProfile of Cadence created from news harvest. To be enriched by user.
HQ:United States
Funding:N/A
Key Pipeline Asset:
Denali Therapeutics
NASDAQ: DNLIDenali Therapeutics (NASDAQ: DNLI) is a biotechnology company headquartered in South San Francisco, California, developing a broad portfolio of therapeutics for neurodegenerative diseases through its proprietary blood-brain barrier (BBB) delivery platform (the ATV/Otv platform, including Enzyme Transport Vehicle and Oligonucleotide Transport Vehicle technologies). Denali's clinical and preclinical pipeline targets Parkinson's disease (BIIB122/DNL151, partnered with Biogen), Hunter syndrome (DNL310, tividenofusp alfa), ALS (DNL343), and multiple other lysosomal storage diseases and neurodegenerative indications. The company was founded in 2015 by a team that included former Genentech scientists.
HQ:South San Francisco
Funding:N/A
Formation Bio
PrivateFormation Bio is an AI-native drug development company building a clinical-stage pipeline through in-licensing and asset acquisition, with a focus on using technology and AI to accelerate clinical trial execution. In early 2026, the company launched a new subsidiary, Kenmare Bio, to develop a miR-124 inhibitor licensed from a Chinese partner for inflammatory diseases.
HQ:New York
Funding:$600M+
Key Pipeline Asset:
ICON plc
NASDAQ: ICLRICON plc is one of the world's largest clinical research organizations (CROs), providing outsourced drug development services to pharmaceutical, biotechnology, and medical device companies. ICON announced a strategic technology partnership with Microsoft in 2026 to accelerate AI-driven clinical trial design and execution.
HQ:Dublin
Funding:N/A
Insilico Medicine
PrivateInsilico Medicine is an end-to-end generative artificial intelligence-driven drug discovery company connecting biology, chemistry, and clinical trials analysis.
HQ:Boston
Funding:$415M
Key Pipeline Asset:
Real Chemistry
PrivateReal Chemistry is a healthcare marketing and technology company that builds AI tools and data products for life sciences clients. Their Anatomi platform is part of a growing body of AI-driven healthcare marketing and analytics products.
HQ:San Francisco
Funding:See company disclosures
Key Pipeline Asset:
Slate Medicines
PrivateSlate Medicines is a clinical-stage biotechnology company developing anti-PACAP therapeutics for migraine and headache disorders. The company launched in 2026 with a $130M Series A to advance its lead program SLTE-1009 and other PACAP-pathway candidates, joining a competitive class of next-generation migraine developers seeking to challenge the CGRP inhibitor standard of care.
HQ:Raleigh
Funding:$130M
Key Pipeline Asset:
Verge Labs
PrivateVerge Labs (formerly Verge Genomics) is a frontier AI lab for human disease biology founded in 2015. The company develops world models of patient biology built on proprietary multi-modal human tissue data and partners with drug developers on target discovery, patient stratification, and biomarker prediction across CNS and beyond.
HQ:San Francisco
Funding:$130M+ to date
Key Pipeline Asset:
Xaira Therapeutics
PrivateAI-driven drug discovery company applying generative models and machine learning to small molecule and biologics design.
HQ:South San Francisco
Funding:$1B+ (initial funding)
Key Pipeline Asset:
AI Infrastructure & Software
Software platforms, digital notebooks, and LIMS offering GxP-compliant AI-powered co-pilots and analytics.
10x Genomics
Hardware10x Genomics is a life sciences technology company building instruments, consumables, and software for single-cell sequencing and spatial transcriptomics. Its platforms include Chromium (single-cell RNA-seq, ATAC-seq, multiome), Visium (spatial gene expression), and Xenium (in-situ RNA imaging). LIMS integrations are available through the Loupe Browser and Connect software.
Key Tool:
Chromium X SeriesSingle-cell partitioning and barcoding platform for gene expression, immune profiling, ATAC-seq, and multiome (RNA + ATAC) assays.
Accruent
SoftwareAccruent is an enterprise asset management and CMMS provider for healthcare and life sciences, with strong adoption in hospital systems and pharma facilities. Now part of Fortive (parent of Fluke, eMaint, Gatan, etc.), Accruent provides the TMS (Trakker Maintenance System) and the Connectiv healthcare technology management platform.
Key Tool:
Accruent TMS (Trakker Maintenance System)Enterprise CMMS / EAM for healthcare and life sciences facilities, with strong regulatory compliance and audit trails.
Arena Solutions (PTC)
SoftwareArena Solutions is a cloud QMS and PLM platform acquired by PTC in 2021. Strong in medical device, life sciences, and high-tech hardware companies needing integrated product lifecycle and quality management. Built on Salesforce.
Key Tool:
Arena Quality Management System (QMS)Cloud QMS for design controls, CAPA, document control, training, and supplier quality.
Aspen Technology
SoftwareAspen Technology (AspenTech) is a leading provider of asset optimization software for industrial process manufacturers, including pharmaceuticals, chemicals, and energy. The 2024 acquisition of Open Systems International (OSI) brought the OSIsoft PI System under AspenTech's umbrella — the de facto industrial time-series historian used in pharma continuous manufacturing, plus power, water, metals, and other process industries.
Key Tool:
Aspen Technology OSIsoft PI SystemIndustrial time-series data historian — captures, stores, and visualizes sensor and process data from manufacturing equipment.
Blue Mountain
SoftwareBlue Mountain Quality Resources provides calibration and maintenance management software (EAM) designed specifically for the life sciences industry, enabling paperless calibration, asset management, and GMP compliance.
Key Tool:
Blue Mountain RAMRegulatory Asset Manager platform integrating asset management, calibration management, and maintenance work orders in a compliant GxP environment.
ComplianceQuest
SoftwareComplianceQuest is a native Salesforce-based QMS for life sciences and medical devices. Provides document control, training, CAPA, audits, and supplier quality on the Salesforce platform, with 21 CFR Part 11 compliance and GxP templates out of the box.
Key Tool:
CQ Quality Management (EQMS)Native Salesforce QMS for document, training, CAPA, audit, change, and supplier quality.
Dotmatics
SoftwareDotmatics is a scientific informatics platform for drug discovery, providing electronic lab notebook (ELN), laboratory information management (LIMS), and scientific data management (SDMS) in a unified cloud platform. Acquired by Siemens AG in 2024, it now anchors Siemens' Life Sciences portfolio for the digital lab.
Key Tool:
StudiesCloud-based electronic lab notebook purpose-built for chemistry, biology, and assay workflows with structured data capture.
eLabNext
SoftwareeLabNext is a modern electronic lab notebook and sample management platform popular in European biotech and academic labs. Renamed from eLabJournal/MonkeyBin in 2020, it now provides a unified ELN, LIMS, and lab automation platform with strong API extensibility and the Add-on Marketplace.
Key Tool:
eLabNext ELNCloud electronic lab notebook with sample tracking, protocol execution, and a Marketplace of add-ons for qPCR, plate readers, and imaging.
eMaint (Fluke Corporation)
SoftwareeMaint is a CMMS for life sciences facilities and equipment maintenance, with strong adoption in pharma manufacturing. Now part of Fluke Corporation (a Fortive operating company), it offers work order management, preventive maintenance, calibration management, and GxP-compliant maintenance records.
Key Tool:
eMaint CMMSCloud CMMS for work orders, preventive maintenance, asset tracking, and parts inventory with GxP-compliant audit trails.
Emerson Electric's Automation Solutions segment provides process control, measurement, and analytical instrumentation. In pharma, Emerson is one of the two dominant DCS vendors (alongside Honeywell Experion), with DeltaV and Syncade MES used in batch and continuous manufacturing plants worldwide.
Key Tool:
DeltaV DCSDistributed control system (DCS) purpose-built for batch and continuous pharma manufacturing, with native S88 batch recipes and electronic signatures.
ETQ (Hexagon)
SoftwareETQ Reliance is an enterprise eQMS with deep pharma and biotech presence, particularly in document control, CAPA, audit management, and supplier quality. Acquired by Hexagon AB in 2023 to anchor its Manufacturing Intelligence division, and now part of Hexagon's Manufacturing Intelligence business unit.
Key Tool:
ETQ Reliance Quality Management SystemEnterprise eQMS for document control, CAPA, training, audits, and supplier quality, with deep pharma workflows.
Greenlight Guru
SoftwareGreenlight Guru is an eQMS purpose-built for medical device companies with built-in design controls, DHF (Design History File), risk management, and FDA 21 CFR Part 11 / ISO 13485 compliance. Acquired by Collabware in 2024 to scale into adjacent regulated industries.
Key Tool:
Greenlight Guru QMSMedical device QMS with design controls, DHF, CAPA, complaint handling, and FDA 21 CFR Part 11 compliance.
IQVIA
MixedIQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, offering Orchestrated Customer Engagement (OCE) and clinical data platforms.
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Orchestrated Customer Engagement (OCE)Life sciences commercial platform integrating CRM, marketing, and analytical tools tailored for healthcare sales.
LabArchives
SoftwareLabArchives is a leading electronic lab notebook (ELN) platform widely adopted by academic institutions, pharmaceutical companies, and biotech startups. It offers a Marketplace of integrations with SnapGene, GraphPad Prism, and other lab applications, plus a free tier for individual researchers.
Key Tool:
LabArchives NotebookCloud-based electronic lab notebook with rich-text editing, version history, e-signatures (21 CFR Part 11), and offline sync.
MaintainX
SoftwareMaintainX is a modern mobile-first CMMS for maintenance, inspections, and work order management. Used in manufacturing and life sciences facilities for uptime tracking, with strong mobile UX for technicians and a freemium model for small teams.
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MaintainX CMMSMobile-first CMMS with work orders, preventive maintenance, asset hierarchy, and procedures with photos/videos.
MasterControl
SoftwareMasterControl Inc. is a leading provider of cloud-based quality management systems (QMS) and manufacturing execution software (MES) for life sciences and other highly regulated industries.
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MasterControl Quality ExcellenceEnterprise QMS platform covering document control, training, CAPA, and audits to ensure GxP regulatory compliance.
Mettler-Toledo International
HardwareMettler-Toledo International is a leading global manufacturer of precision instruments and services for use in laboratories and manufacturing. Its portfolio includes laboratory balances, pipettes, pH meters, density meters, refractometers, and process analytics for pharma manufacturing. The LabX software platform centralizes instrument data management.
Key Tool:
Mettler Toledo XPR Analytical BalancesHigh-precision analytical and microbalances with integrated StatusLight, ProFACT advanced internal adjustment, and RFID-enabled SmartGrid weighing pans.
Qualio
SoftwareQualio is a cloud-based Quality Management System (QMS) built specifically for life sciences start-ups and growing companies in medical devices, pharmaceutical, and biotech sectors.
Key Tool:
Qualio QMSAn intuitive, cloud-native QMS built to automate document control, training logs, CAPA, and supplier management.
Sapio Sciences
SoftwareSapio Sciences is a modern cloud-based LIMS+ELN platform with a configurable scientific data model. Strong adoption in clinical genomics, cell therapy, antibody discovery, and pharma R&D, where labs need flexibility to model complex molecule-centric workflows.
Key Tool:
Sapio LIMSCloud LIMS with no-code workflow builder, sample tracking, and chain-of-custody for regulated labs.
SciNote
SoftwareSciNote is a modern electronic lab notebook with a free tier for individual labs and team plans for biotech, with strong integrations for molecular biology (SnapGene), statistics (GraphPad), and electronic signatures. Particularly strong in academic and small-biotech settings.
Key Tool:
SciNote ELNCloud electronic lab notebook with 21 CFR Part 11-ready electronic signatures, integrations, and offline mode.
Scispot
SoftwareScispot is a modern LIMS and ELN platform purpose-built for biotech and synthetic biology labs. Includes inventory, sample tracking, and AI-driven notebook features, with strong out-of-the-box support for plasmid design, cell line tracking, and bioprocess workflows.
Key Tool:
Scispot LIMS+Cloud LIMS with built-in plasmid/sequence registries, inventory, and bioprocess tracking — no code required.
Seal
SoftwareSeal (formerly Opvia) provides a modern, all-in-one GxP workspace for biotechnology and manufacturing teams, integrating quality management (QMS), electronic lab notebooks (ELN), and lab information systems (LIMS) with AI-powered co-pilots.
Key Tool:
Seal GxP PlatformA consolidated cloud platform designed to replace fragmented MES, LIMS, QMS, and ELN systems, featuring version-controlled blueprints and AI co-pilots.
Veeva Systems
SoftwareVeeva Systems Inc. is a leading provider of cloud-based software solutions for the global life sciences industry, specializing in clinical trial management, regulatory compliance, and customer relationship management.
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Veeva Vault ClinicalUnified suite of cloud applications designed to streamline clinical trial operations, data management, and documentation.
ZenQMS
SoftwareZenQMS is a modern cloud eQMS for life sciences with strong focus on GMP document control, training, and change management. Popular in mid-market pharma/biotech for its clean UX and quick implementation.
Key Tool:
ZenQMS eQMSCloud eQMS for document control, training, change control, deviations, and CAPA with GxP templates.