Clinical trial setup times fall sharply in UK
Clinical trial setup times fall sharply in UK
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BMS reveals death from septic pneumonia of multiple sclerosis patient in CAR T trial
BMS reveals death from septic pneumonia of multiple sclerosis patient in CAR T trial
Did the US just kill off China biotech deals?
Did the US just kill off China biotech deals?
GLP-1 boom in China, India, Brazil could create $22 bln market by 2035, J.P. Morgan says
GLP-1 boom in China, India, Brazil could create $22 bln market by 2035, J.P. Morgan says
Moderna sheds about $24 billion as cancer vaccine data triggers 'sell-the-news' retreat
Moderna sheds about $24 billion as cancer vaccine data triggers 'sell-the-news' retreat
Novo's Awiqli® receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older with type 2 diabetes
Novo's Awiqli® receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older with type 2 diabetes
STAT reporters react to the new Elizabeth Holmes documentary
STAT reporters react to the new Elizabeth Holmes documentary
U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease
U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease
AZ grabs FDA nod for Ultomiris in rare kidney disease IgAN
AZ grabs FDA nod for Ultomiris in rare kidney disease IgAN
Biohaven's previously rejected rare disease drug to get fresh FDA review
Biohaven's previously rejected rare disease drug to get fresh FDA review
FDA Launches New Program to Advance Neuroscience Medical Product Development
FDA Launches New Program to Advance Neuroscience Medical Product Development
Gilead shops in IL-23, inking $1.3B upfront I&I deal with China’s PepStar
Gilead shops in IL-23, inking $1.3B upfront I&I deal with China’s PepStar
GSK planning 1,200 job cuts in Belgium, says paper
GSK planning 1,200 job cuts in Belgium, says paper
Menarini gets Georgiamune preclinical cancer drug in $1B deal
Menarini gets Georgiamune preclinical cancer drug in $1B deal
Most new drugs are still too costly at launch, ICER says
Most new drugs are still too costly at launch, ICER says
Rebranded NodThera plans IPO to fund NLRP3 inhibitor program
Rebranded NodThera plans IPO to fund NLRP3 inhibitor program
Roche posts solid results ahead of looming patent cliff
Roche posts solid results ahead of looming patent cliff
Rznomics Granted Orphan Medicinal Product Designation for RZ-001 for the Treatment of Glioma by the European Commission
Rznomics Granted Orphan Medicinal Product Designation for RZ-001 for the Treatment of Glioma by the European Commission
UK trial 'could halve time to test Alzheimer's drugs'
UK trial 'could halve time to test Alzheimer's drugs'
Amid bepirovirsen triumph, GSK scraps trial of next-gen therapy
Amid bepirovirsen triumph, GSK scraps trial of next-gen therapy
Astellas links up with AI Proteins in $400M drug discovery deal
Astellas links up with AI Proteins in $400M drug discovery deal
Australia's CSL hit with shareholder class action suit over earnings guidance
Australia's CSL hit with shareholder class action suit over earnings guidance
Drug prices climb past $250K as US patients balk at the pharmacy
Drug prices climb past $250K as US patients balk at the pharmacy
FDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failings
FDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failings
GSK, Ionis win FDA nod for hepatitis B functional cure that controls virus after treatment
GSK, Ionis win FDA nod for hepatitis B functional cure that controls virus after treatment
Novo’s CagriSema achieves 25% weight loss in women, driven by younger patients
Novo’s CagriSema achieves 25% weight loss in women, driven by younger patients
Roche builds blockbuster case in MS as FDA decision approaches
Roche builds blockbuster case in MS as FDA decision approaches
Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
Roivant’s TYK2/JAK inhibitor reduces need for steroids in inflammatory eye disease
Roivant’s TYK2/JAK inhibitor reduces need for steroids in inflammatory eye disease
AI tool uses face photos to predict cancer survival
AI tool uses face photos to predict cancer survival
Ambrose inks $181M deal for former Pfizer target AM-Pharma
Ambrose inks $181M deal for former Pfizer target AM-Pharma
AZ and Oracle team up on AI platform for clinical trials
AZ and Oracle team up on AI platform for clinical trials
Eloxx Pharmaceuticals Finalizes 52-Week Phase 2 EXPRESS Study Design in Nonsense-Mutation ADPKD and Appoints T.R. Srinivas, M.D., Chief Medical Officer
Eloxx Pharmaceuticals Finalizes 52-Week Phase 2 EXPRESS Study Design in Nonsense-Mutation ADPKD and Appoints T.R. Srinivas, M.D., Chief Medical Officer
FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
FDA Issues Final Guidance on Prescription Drug Apps and Software
FDA Issues Final Guidance on Prescription Drug Apps and Software
Gilead’s ‘highly competitive’ mid-stage ulcerative colitis data ‘validate’ I&I push
Gilead’s ‘highly competitive’ mid-stage ulcerative colitis data ‘validate’ I&I push
Lilly puts $1.1B on the line for Hong Kong biotech’s AI drug delivery platform
Lilly puts $1.1B on the line for Hong Kong biotech’s AI drug delivery platform
Merck KGaA makes noise in hematology with $1.1B Silence buy
Merck KGaA makes noise in hematology with $1.1B Silence buy
Nano24’s exosome therapy reduces respiratory failure in ph. 2
Nano24’s exosome therapy reduces respiratory failure in ph. 2
Nuravax Receives FDA Fast Track Designation for AV‑1959R, an Investigational Vaccine Designed to Help Prevent Alzheimer's Disease Before Symptoms Begin
Nuravax Receives FDA Fast Track Designation for AV‑1959R, an Investigational Vaccine Designed to Help Prevent Alzheimer's Disease Before Symptoms Begin
Penumbra's CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT)
Penumbra's CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT)
Pfizer makes 'business decision' to end trial of autoimmune drug
Pfizer makes 'business decision' to end trial of autoimmune drug
Rapport ekes out bipolar mania win as lead asset ‘just hits’ in mid-stage trial
Rapport ekes out bipolar mania win as lead asset ‘just hits’ in mid-stage trial
Sanofi breaks ground on insulin plant after securing German government support
Sanofi breaks ground on insulin plant after securing German government support
Veradermics ph. 3 win backs up its stellar stock performance
Veradermics ph. 3 win backs up its stellar stock performance
Xylyx Bio announces FDA Orphan Drug Designation and $2.99M NIH SBIR grant award for its lead organ graft product, Inspirex™ Lung
Xylyx Bio announces FDA Orphan Drug Designation and $2.99M NIH SBIR grant award for its lead organ graft product, Inspirex™ Lung
AbbVie’s next-gen Crohn’s combo beats Skyrizi in ph. 2 test
AbbVie’s next-gen Crohn’s combo beats Skyrizi in ph. 2 test
Arcus kidney cancer data impresses analysts; TriGemX inks a SPAC deal
Arcus kidney cancer data impresses analysts; TriGemX inks a SPAC deal
Data reveal is promising for GSK's lung cancer drug ris-rez
The first data from GSK's international trial of B7-H3-targeted ADC ris-rez in small cell lung cancer back up earlier results from a Chinese study.
Disc spins past FDA setback with ‘overwhelmingly positive’ data
Disc spins past FDA setback with ‘overwhelmingly positive’ data
Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep
Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep
Enlivex lays off 60% of staff, 'substantially' cuts exec pay
Enlivex lays off 60% of staff, 'substantially' cuts exec pay
Experimental Arrowhead RNAi drug hints at Alzheimer's benefit
Experimental Arrowhead RNAi drug hints at Alzheimer's benefit
EyePoint to halve workforce after experimental drug fails second late-stage trial
EyePoint to halve workforce after experimental drug fails second late-stage trial
EyePoint will halve workforce, end pivotal wet AMD trials early following second fail
EyePoint will halve workforce, end pivotal wet AMD trials early following second fail
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
FDA 'reset' continues with new plan for reviewing rare disease drugs
FDA 'reset' continues with new plan for reviewing rare disease drugs
GLP-1 compounder issues recall for copycat Zepbound
GLP-1 compounder issues recall for copycat Zepbound
Lilly allies with Metis in $1.1B AI nanoparticle discovery deal
Eli Lilly has formed a partnership with Hong Kong's Metis TechBio worth up to $1.1 billion, gaining access to an AI drug delivery platform
Lilly's Omvoh to seek pediatric UC approval
Eli Lilly is betting on a pediatric expansion to give it's IL-23p19 inhibitor Omvoh an edge in the fiercely competitive inflammatory bowel disease (IBD) market.
Merck KGaA buys Silence in $1.3B deal for blood cancer drug
Germany's Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech's mid-stage success for its challenger to Takeda's Mimrylo.
Next-gen RNAi drugmaker City prices $200M IPO
Next-gen RNAi drugmaker City prices $200M IPO
Nouscom bags $135M for pivotal therapeutic cancer vaccine trial
Nouscom has reeled in 120 million euros ($135 million) in series D funds to take a cancer-preventing vaccine through a registration-enabling clinical trial.
Novartis ends mid-stage Fabhalta study in lupus, insists no efficacy or safety issues
Novartis will continue to study Fabhalta in other indications, with late-stage studies in two rare diseases—atypical haemolytic uraemic syndrome and generalized myasthenia gravis—expected to read out later this year and next year, respectively.
Novavax critic Shah Capital ends its activism campaign
Shah Capital has ended attempts to exert influence over vaccine firm Novavax, bringing more than years of pressure on management to an end.
Protego Announces FDA IND Clearance for Phase 2/3 Study of PROT-001 in AL Amyloidosis
Protego Biopharma said the FDA has cleared its IND for a Phase 2/3 study of PROT-001, a small-molecule pharmacological chaperone designed to stabilize amyloidogenic light-chain proteins, in AL amyloidosis.
Rigel Highlights New GAVRETO® (pralsetinib) Data Across RET Fusion-Positive Cancers in Oral and Poster Presentations at ESMO Congress 2026
Rigel Pharmaceuticals highlighted new GAVRETO (pralsetinib) data across RET fusion-positive cancers in oral and poster presentations at ESMO Congress 2026.
Roche pauses future Germany investments
Amid tensions over government healthcare cost-cutting policies, Roche has slammed the brakes on new investments in Germany, joining an expanding group of drugmakers pulling back from the European country.
Roche returns to China’s Hansoh for $15B biobucks ADC pact
A year after their first antibody-drug conjugate team-up, Roche has returned to Hansoh Pharmaceutical for a mammoth $15 billion biobucks pact.
Servier Announces First Patients Dosed in Pivotal Phase 2 EMBLEM-1 Cohort Evaluating Emiltatug Ledadotin (Emi-Le) in Adenoid Cystic Carcinoma
Servier said the first patients have been dosed in the pivotal Phase 2 EMBLEM-1 cohort of its Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in adenoid cystic carcinoma.
UK Biobank partners with industry on 'most detailed' immune ...
The UK Biobank has teamed up with industry partners to create 'the world’s most detailed, large-scale picture of the human immune system.'
RNAi biotech City hauls in $200m in upsized IPO
City Therapeutics has finalised its IPO, raising $200 million for a pipeline of RNA interference therapies headed by a novel anticoagulant.
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