Cardiac drug developer Braveheart banks more than $382M in IPO
Cardiac drug developer Braveheart banks more than $382M in IPO
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Cardiac drug developer Braveheart banks more than $382M in IPO
RiboX Therapeutics Announces FDA IND Clearance for RXIM002, the first Circular RNA-Based in vivo CAR Therapy for Autoimmune Cytopenias
'Significant' demand for Revolution drug; Intellia pinpoints liver toxicity culprit
Trump administration tries again to institute rebates in 340B
A COPD drug from China draws $115M in venture funding
Alnylam plunges as earnings deliver 'one-two punch'
An AstraZeneca-Bristol Myers megamerger? Wall Street isn't thrilled.
Attovia adds to biotech IPO momentum with $289M offering
BioMarin axes $270M asset after missing phase 3 endpoint
BioNTech brings in Sobi CEO—Chutes & Ladders
BioNTech taps Sobi executive Oelkers as its next CEO
BlossomHill, Latigo outshine IPO expectations
Drug patents protect pharma profits. Track when they'll expire.
Elanco's CLiK™ Extra (dicyclanil topical suspension) Wound Spray Receives FDA Emergency Use Authorization for Application on or Around Wounds for Prevention of New World Screwworm in Variety of Liv...
Ensoma sheds more staff, pauses preclinical programs
Erica Schwartz confirmed as next CDC director
FDA approves Moderna's mRNA flu vaccine
FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and Swine
Fresenius Kabi recalls morphine lot that could lead to death
Intellia finds genetic suspect for liver safety signals with ATTR gene therapy
The STAT Readout newsletter explores Boston's biotech brain drain to Silicon Valley, a Medicare policy shift that could delay drug price negotiations, and new Alzheimer's tau research pointing toward novel therapeutic strategies.
J&J pharma leader to retire; Krystal slumps on gene therapy miss
Lilly climbs, Novo falls as obesity drug battle intensifies
Novo Nordisk makes Omnicom agency of record for US media buying
Novo Nordisk’s CFO reflects on ‘pressure’ to drive growth
Novo setback casts doubt on a new way to treat heart disease
Pfizer expands multibillion-dollar cost-cutting plan
Replimune melanoma drug wins support of FDA panel
Replimune to ride wave of physician support to launch advanced melanoma therapy
Resilience and Lilly invest $750M to boost Cincinnati drug production
Sanofi to 'rebuild trust' with Regeneron; Apnimed adds to string of 'upsized' biotech IPOs
Supernus, Indivior merge to beef up brain drug portfolio
Takeda, Daiichi, Astellas and more—Fierce Pharma Asia
Actimed Therapeutics has regained rights to its cachexia drug after terminating its $126 million deal with Faraday Pharmaceuticals.
BioVie's stock fell by half after a Phase 2 readout in Parkinson's disease failed to impress, with the company pointing to a composite endpoint analysis.
Braveheart Bio has priced an upsized $382.5 million IPO to fund a Hengrui-licensed cardiometabolic drug, extending the biotech IPO streak.
Co-Diagnostics has submitted a dual 510(k) premarket notification, with a concurrent CLIA waiver request, to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument.
Context Therapeutics is discontinuing its bispecific antibody trial to conserve cash and extend its runway deeper into 2027.
Vistagen's anxiety nasal spray failed to beat placebo in two Phase 2 trials, another setback for the company's pipeline.
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
IceCure Medical adds Adventist Health as U.S. clinical site for its post-marketing choice study for low-risk breast cancer cryoablation treatment.
LifeMine revived by $188M fundraise backed by Gates and Bezos
Pacific Biosciences' CEO is stepping down as the sequencing company reported a wider second-quarter loss.
Sanofi has been asked to change its Dupixent advertising after a challenge from Galderma over the campaign's claims.
Sanofi has paused a mid-stage chronic lung disease study as new CEO Belen Garijo applies rigorous portfolio prioritization to the pipeline.
Sarepta's new CEO faces critical tests to prove growth
Tarsus Pharmaceuticals is paying $450 million to acquire Alkeus Pharmaceuticals and its Phase 3 Stargardt disease drug, expanding into retinal disease.
Tarsus to expand eye disease pipeline with up to $800 million Alkeus acquisition
The next treatment-resistant depression paradigm
The U.S. government is moving to shut down a Kentucky organ donation group accused of continuing plans for organ retrieval from some patients who unexpectedly showed signs of life.
US FDA approves first mRNA flu shot from Moderna, includes gallery
VerilyMe, Bausch + Lomb partner up on dry eye education
ViiV Healthcare is rolling out a new long-acting HIV campaign aimed at 'future you', promoting its long-acting treatment options.
1Elevan Biopharmaceuticals Is Building the Infrastructure to Be the Partner of Choice for Peptide Medicine
BioSpace rounds up four biotechs seen as potential M&A targets plus a likely Johnson & Johnson acquisition bet as pharma dealmaking heats up.
Five BioSpace NextGen honorees went public this year; most are looking for biopharma professionals to join their teams.
Amgen discontinued an early-stage obesity candidate, leaving MariTide as its lead obesity asset while analysts push for more M&A.
AstraZeneca and China's CSPC Pharmaceutical Group are forming a biologics manufacturing joint venture.
Attovia Therapeutics aims to raise $289 million in an IPO to advance three immunology and inflammation drug candidates, including a bid to challenge Dupixent in itch.
The Federal Circuit affirmed a district court ruling that Aveva Drug Delivery Systems' generic ZTlido product does not infringe Scilex's patents, preparing the company for an imminent launch of its generic product with 180-day exclusivity.
Jennifer Doudna's Aurora Therapeutics is abandoning its lead PKU gene-editing program and cutting 'several' staffers seven months after launching with $16 million in seed financing, citing growing competition in the field.
BioVie shares halve on murky Parkinson’s disease readout
Braveheart pumps more life into biotech IPO market with $382M expected debut
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
UCB announced that Epilepsia Open published findings from a post hoc analysis of FINTEPLA (fenfluramine) effectiveness and safety, including dose changes over time, in patients with Lennox-Gastaut syndrome.
The Senate has confirmed Erica Schwartz as CDC director, filling a nearly yearlong vacancy at the agency.
The FDA has approved the first drug to treat the full range of narcolepsy Type 1 symptoms, including the sudden muscle weakness episodes known as cataplexy.
FDA approves Moderna’s mRNA flu vaccine, the first to use the technology
Galibra Neuroscience Receives FDA Orphan Drug and Rare Pediatric Disease Designations for SSADH Deficiency Gene Therapy
Gilead's inflammation portfolio faces a packed back half of 2026 as the company works to expand beyond its HIV franchise.
Organ transplant biotech LifeMine Therapeutics has raised a combined $263 million — a $75 million Series D and an oversubscribed $188 million Series F — to support the clinical program for LIFE-001, under development to prevent organ failure.
Eli Lilly is dropping another gene therapy program acquired in its roughly $1 billion Prevail Therapeutics buyout, extending a series of portfolio reductions.
A legal dispute between the FDA and Eli Lilly over whether the obesity candidate retatrutide is a biologic has come to a head as the company's submission nears.
Eli Lilly delivered a big Q2 earnings beat with 48% revenue growth to $23 billion, though its oral GLP-1 candidate Foundayo trailed Novo Nordisk's rival pill.
Moderna begins first human trial of Bundibugyo Ebola vaccine
Moderna's mRNA flu shot has won FDA approval, bouncing back after a refusal-to-file letter earlier this year and becoming the first approved mRNA flu vaccine.
Doctors debate whether biopsies are overused at the expense of MRI scans in prostate cancer screening, as most U.S. men don't receive MRIs even though the scans are standard in most western countries.
Emergent BioSolutions is eliminating the role of chief medical officer and head of R&D in a sweeping restructuring that leaves the Narcan maker without a dedicated C-suite R&D leader.
Novo Nordisk CEO Maziar Mike Doustdar says the company is focused on building out its pipeline to move past recent clinical roadblocks.
A poll finds more than one-third of biopharma and biotech professionals stay in their jobs primarily for health insurance benefits.
Reckitt announced FDA approval of Mucinex 12HR Cold & Fever Multi-Symptom, the first and only FDA-approved OTC cold and flu medication that treats fever, cough, chest congestion and body pain for 12 hours — the company's first new drug approval.
Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms
Expedition Therapeutics raised $115 million to advance its lead oral DPP1 inhibitor EXPD-101 into a global Phase 2 COPD trial.
Sanofi suspends chronic lung disease phase 2 study
Takeda’s narcolepsy nod opens orexin doors
Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
Vistagen’s repeat-dose anxiety nasal spray can’t beat placebo in mid-stage study
Amgen sees continued momentum for its cholesterol drug Repatha, expecting the cardiology product's sales growth to keep rolling.
Aqua Medical named Bob Haggerty as CEO as the company targets type 2 diabetes.
Bayer CEO Bill Anderson is staying the course on the company's multi-year turnaround plan, pledging improvement in every quarter.
The Ebola outbreak in eastern Democratic Republic of Congo has now killed 1,700 people, making it the fastest-growing outbreak of the virus on record.
Gilead prevailed in a yearslong HIV drug innovation lawsuit after the California Supreme Court ruled drugmakers have no duty to innovate.
Contract research organization Icon has partnered with Anthropic to deploy its Claude AI assistant across clinical trial operations.
Jazz Pharmaceuticals will withdraw Zepzelca from the second-line small cell lung cancer setting after a confirmatory trial failure.
Jennifer Taubert, head of Johnson & Johnson's innovative medicine division, is set to retire.
KKR has signed a $5.7 billion deal to take medical device manufacturer Integer Holdings private.
Latigo Biotherapeutics has set terms for a $247 million IPO to fund its non-opioid pain drug rival to Vertex's Journavx.
Lisata Therapeutics is cutting 72% of its staff and suing Kuva after their planned merger fell through.
Lisata Therapeutics is laying off 72% of its staff and suing Kuva Therapeutics after their proposed merger fell apart.
MellingMedical and NIDEK USA are partnering to advance vision care technology for veterans and broader patient populations.
The FDA has made Merck's Lipfendra a poster child for its CNPV pilot as Merck charts a long-term path for the first oral PCSK9 pill.
Merck's $10.8 billion Prometheus acquisition delivered one mid-stage win and one Phase 2b miss in inflammatory disease trials.
Pfizer unveiled an additional $2.5 billion in planned cost savings through 2029 as it continues cutting costs and programs.
New England Biolabs launched its Monarch Mag Cell-free RNA (cfRNA) Extraction Kit to enable total cfRNA isolation from biofluids.
NIPRO is bringing its expanded hemodialysis approach to U.S. providers with the ELISIO-HX medium-cutoff dialyzer following FDA 510(k) clearance.
AI-enabled oncology biotech Pathos AI signed back-to-back cancer deals with AstraZeneca and China's Alphamab worth up to $2.2 billion.
Pfizer has dropped an obesity asset it acquired from Metsera along with a GIPR-targeting prospect as part of its portfolio pruning.
Pfizer beats earnings estimates, targets $2.5 billion in additional cost cuts, includes gallery
Pfizer CEO Albert Bourla defended the company's $7 billion bolt-on M&A strategy as peers rush to make larger acquisitions.
The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals' antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling. BioSpace looks at five contenders advancing ATTR assets and where they stand.
Amgen reports hackers stole company and patient information in a data breach, noticing unauthorized activity affecting data stored on cloud platforms hosted by third-party providers in July.
Ascletis has initiated a global Phase III program for oral small molecule GLP-1 ASC30, which will enroll approximately 4,600 participants with obesity or overweight, and reported positive preclinical data for its first-in-class oral GLP-1/G
AstraZeneca and Bristol Myers Squibb are in merger talks per the Financial Times; AZ is worth roughly $265B and BMS about $133B, and the talks may not lead to a deal.
As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with the injectable market.
BioNTech downgraded its sales forecast amid slumping demand for its COVID-19 vaccine.
BioNTech has named Guido Oelkers its new CEO, replacing co-founder Ugur Sahin; Oelkers most recently led Swedish biopharma company Sobi.
BioNTech names Sobi CEO Guido Oelkers as its next chief executive, effective by Feb. 1, 2027, as Uğur Şahin exits and the company refocuses on oncology.
The FDA's new investigational new drug pilot program, part of HHS's broader clinical trial modernization initiatives, has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won't tip the scales alone.
BlossomHill Therapeutics eyes a $112M IPO to bankroll development of a potential challenger to AstraZeneca's blockbuster EGFR inhibitor Tagrisso.
Curium acquires Lantheus for $102.5/share (~$8B); Sandoz settles price-fixing claims for $478.5M; Latigo eyes a $247M IPO for non-opioid LTG-001; BlossomHill targets a $111M IPO.
Acurx has received FDA guidance from a July 2026 Type C meeting on ibezapolstat's Phase 3 clinical program, including the potential for a single-Phase 3-trial registration plan and a trial design supporting both treatment and reduction of r
Patients often get weaker waiting in the hospital for heart transplant. A cardiologist had an idea: inpatient prehabilitation.
Otsuka's Voyxact stabilized kidney function decline in IgAN patients in a Phase 3 trial, a first for the indication.
Invenio Imaging, a leader in fresh tissue imaging and artificial intelligence, announced completion of patient enrollment in a landmark study of AI-based image analysis for lung cancer.
The $750M investment will expand Resilience's US capacity to make the KwikPen device Eli Lilly uses to deliver its injectable diabetes and obesity medicines.
Q&A: MapLight Therapeutics CEO Christopher Kroeger discusses what investors missed in the biotech's schizophrenia trial data.
Michigan has reported the first two U.S. deaths linked to the ongoing cyclospora outbreak, which has surged to record levels this summer.
A new study adds evidence for the VASCADE MVP XL system's effectiveness in electrophysiology procedures using large-bore sheaths, per an announcement from Haemonetics.
Novartis' radioligand therapy Pluvicto leaps ahead into earlier manifestations of prostate cancer, unlocking a substantially larger patient pool.
Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week's Phase 3 failure dashed not just the Danish pharma's hopes but those of the broader inflammatio
Pfizer is cutting an additional $2.5 billion across R&D and manufacturing as part of its ongoing restructuring.
Supernus and Indivior agree to an all-stock merger creating a $2.2B CNS biopharma led by CEO Jack Khattar, closing Q4 2026.
‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever
As China's biotech sector accelerates, executives at Sironax, Candid, InduPro and others weigh in on work-ethic gaps with US counterparts.
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