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1,425 stories matching this filter · ← front page

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  • Jazz Pharmaceuticals to acquire Actio Biosciences in deal worth over $1.3 billion
    Jazz Pharmaceuticals announced an agreement to purchase Actio Biosciences, a San Diego biotech focused on genetic epilepsies. The transaction could total just over $1.3 billion, with $820 million…
    BioPharma Dive · 10d agoDealPositive↗ source
  • AbCellera reports striking Phase 2 results for hot-flash treatment, shares jump 31%
    AbCellera Biologics announced positive Phase 2 data for its neurokinin-3 receptor antagonist aimed at relieving vasomotor symptoms such as hot flashes. The company described the results as strikin…
    Endpoints · 10d agoPositive readoutPositive↗ source
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  • Jazz Pharmaceuticals to acquire Actio Biosciences for $820 million upfront, targeting ultra-rare epilepsy
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, a company developing an ultra‑rare epilepsy therapy. The transaction includes an upfront cash payment of $820 million, with the p…
    Endpoints · 10d agoDealPositive↗ source
  • Jazz Pharma to acquire Actio Biosciences for $820M, adding KCNT1+ epilepsy drug to its pipeline
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences for an upfront payment of $820 million, expanding its portfolio of epilepsy medicines. The deal brings Actio’s lead candidate, ABS…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 10d agoRegulatoryNeutral↗ source
  • Trump orders MMR vaccine to be administered as three separate shots, citing autism concerns
    President Donald Trump announced via an executive order that the combined measles, mumps and rubella (MMR) vaccine should be split into three individual injections for children. He claimed the cha…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • FDA rejects ITM's radiopharma drug for neuroendocrine tumors over manufacturing issues
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical candidate from ITM Isotope Technologies Munich intended for treating neuroendocrine tumors. The agency cited manu…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • Bristol Myers Squibb announces $2.3 billion manufacturing campus in Houston
    Bristol Myers Squibb disclosed plans to build a new manufacturing campus in Houston, Texas, with an estimated cost of $2.3 billion. The campus will expand the company's domestic production capacit…
    Endpoints · 10d agoDealPositive↗ source
  • Federal judge suspends Pentagon's designation of WuXi AppTec as a Chinese military-linked firm
    A U.S. district judge has temporarily halted the Pentagon’s effort to label WuXi AppTec as a company with ties to the Chinese military. The ruling was issued by Judge James Boasberg, who found the…
    Endpoints · 10d agoRegulatoryNeutral↗ source
  • Sionna’s cystic fibrosis candidate misses primary endpoint in Phase 2 trial, shares plunge
    Sionna Therapeutics announced that its experimental cystic fibrosis drug SION-719 failed to meet the primary endpoint in a Phase 2 trial that added the drug to Vertex Pharmaceuticals' Trikafta. Th…
    BioPharma Dive · 10d agoNegative readoutNegative↗ source
  • Sionna Therapeutics reports early-stage cystic fibrosis trial failure, dampening challenge to Vertex
    Sionna Therapeutics said its lead cystic fibrosis drug did not meet primary endpoints in an early-stage study, marking a setback for the company. The result reduces expectations that Sionna could…
    Endpoints · 10d agoNegative readoutNegative↗ source
  • Vaderis raises $152 million Series B to launch Phase 3 trial for rare vascular disease
    Vaderis Therapeutics announced it has closed an oversubscribed $152 million Series B round to fund its AKT inhibitor program. The capital will support a newly launched Phase 3 study of the oral dr…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 10d agoPositive readoutPositive↗ source
  • FDA issues complete response letter rejecting ITM’s neuroendocrine tumor drug over manufacturing concerns
    The U.S. Food and Drug Administration sent a complete response letter to ITM Isotopes Technologies, refusing approval of its lead candidate for gastroenteropancreatic neuroendocrine tumors because…
    Fierce Biotech · 10d agoCRLNegative↗ source
  • Scholar Rock removes Novo Nordisk's Catalent plant from FDA filing for SMA drug apitegromab
    Scholar Rock announced it will no longer list Novo Nordisk’s legacy Catalent facility as a contract manufacturer in its FDA resubmission for apitegromab, its spinal muscular atrophy (SMA) candidate…
    Fierce Biotech · 10d agoRegulatoryNeutral↗ source
  • MoonLake reports all endpoints met in phase 3 trial of sonelokimab for psoriatic arthritis
    MoonLake Immunotherapeutics said its lead nanobody sonelokimab achieved positive topline results in a phase 3 study of patients with psoriatic arthritis. At week 16, 42.1% of participants reached…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source
  • FDA approves Labcorp's BRAF melanoma companion diagnostic
    The FDA has granted approval to Labcorp's companion diagnostic for advanced melanoma patients with specific BRAF mutations. The test, called PGDx elio tissue complete CDx, uses next-generation seq…
    Fierce Biotech · 10d agoApprovalPositive↗ source
  • Arpeggio Biosciences shuts down after Nrf2 drug program encounters off-target toxicity
    Arpeggio Biosciences, founded in 2018 in Boulder, Colorado, built its platform around a large nascent‑RNA sequence database and aimed to develop a small‑molecule degrader of the Nrf2 transcription…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • aTyr Pharma cuts 60% of staff to fund second phase 3 trial of lung disease drug efzofitimod
    aTyr Pharma announced it will reduce its workforce by about 60%, leaving roughly 20 employees, to reallocate resources toward its lung disease program. The cut follows the company's previous phase…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firms
    The FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks. The agency also cited two additional OTC m…
    raps · 10d agoRegulatoryNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapses
    The U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency. In addition…
    raps · 10d agoRegulatoryNegative↗ source
  • Regeneron Ventures leads $75 million Series A for eczema-focused antibody startup Infinimmune
    Infinimmune, a Bay Area biotech developing antibody therapies for eczema, announced a $75 million Series A financing round. The round was co-led by Regeneron Ventures and Playground Global, with p…
    Fierce Biotech · 10d agoDealPositive↗ source
  • RevMed partners with BeOne for Asian rights to RAS drugs as MoonLake reports Phase 3 success
    RevMed and BeOne have entered a partnership granting BeOne rights to commercialize RevMed’s RAS pathway drugs in selected Asian markets. The agreement also includes collaboration on upcoming clini…
    Endpoints · 10d agoDealPositive↗ source
  • BioNTech veteran secures $25M seed round for virtual cancer surveillance startup
    A new virtual cancer surveillance company has closed a $25 million seed round, with the funding led by investors attracted to its novel approach to monitoring tumors. The company is headed by Ryan…
    Endpoints · 10d agoDealPositive↗ source