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3,206 stories matching this filter · ← front page

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  • GSK to launch large trial testing shingles vaccine’s potential to reduce Alzheimer’s risk
    GSK announced it will conduct a large-scale clinical study to evaluate whether the shingles vaccine can lower the risk of developing Alzheimer’s disease. The move follows observations from analyses…
    Endpoints · 3mo agoNeutral↗ source
  • GSK drops chronic cough drug camlipixant after mixed Phase 3 results
    GSK announced it will stop investing in camlipixant for refractory chronic cough after the drug failed to meet key endpoints in a late-stage trial. The company had run two Phase 3 studies, CALM-1…
    BioSpace · 3mo agoNegative readoutNegative↗ source
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  • San Diego biotech BlossomHill files for IPO to fund EGFR lung-cancer drug program
    BlossomHill Therapeutics, a San Diego oncology biotech focused on small‑molecule drugs, has filed an S‑1 registration statement to become a public company. The company, founded in February 2024 by…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Insmed's inhaled PAH therapy shows durable efficacy in 12-month extension, bolstering $6B sales outlook
    Insmed reported that its inhalable prostanoid candidate, treprostinil palmitil inhalation powder (TPIP), maintained functional and biomarker benefits through a 12‑month open‑label extension in pati…
    BioSpace · 3mo agoPositive readoutPositive↗ source
  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 3mo agoRegulatoryNegative↗ source
  • GSK halts Phase 3 chronic cough drug camlipixant, jeopardizing $2 billion Bellus Health acquisition
    GSK announced it is ending development of camlipixant, a drug aimed at treating refractory chronic cough, after completing Phase 3 trials. The move comes as the company proceeds with its planned $…
    Endpoints · 3mo agoNegative↗ source
  • Jasper Therapeutics merges with Kira Pharmaceuticals, divests Tavneos rival to Mirador
    Jasper Therapeutics announced a merger with Nasdaq‑listed Kira Pharmaceuticals, positioning the combined company for a fresh strategic direction. The deal follows a difficult period for Jasper, whi…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • GSK halts camlipixant development after mixed Phase 3 results curb blockbuster hopes
    GSK announced it is stopping work on camlipixant, a P2X3 receptor antagonist it bought when acquiring Bellus Health in 2023, after the drug produced mixed results in two Phase 3 chronic cough trial…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • Biotronik Neuro acquires Soin Neuroscience spinal cord stimulation patent portfolio to boost next-gen pain therapy
    Biotronik Neuro, the neuromodulation arm of Berlin-based medtech firm Biotronik, announced it has purchased a collection of spinal cord stimulation patents from Ohio-based Soin Neuroscience. The a…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 3mo agoRegulatoryNegative↗ source
  • Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changes
    The pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertising
    FDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…
    raps · 3mo agoRegulatoryNegative↗ source
  • Fierce Biotech flags five cities poised to become next biotech powerhouses
    Fierce Biotech’s latest special report identifies five cities that could emerge as major biotech hubs. The podcast episode of “The Top Line” highlights Boston, San Francisco, Beijing, Seattle and C…
    Fierce Biotech · 3mo agoPositive↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 3mo agoDealPositive↗ source
  • Zealand Pharma appoints former Lilly executive as US marketing head
    Silvia Luque announced on LinkedIn that she will lead US marketing for Zealand Pharma. The appointment follows a 13-year tenure at Eli Lilly, where she held several roles in the company's obesity f…
    Endpoints · 3mo agoNeutral↗ source
  • Merck wins FDA nod for first oral PCSK9 inhibitor, Lipfendra, to treat high LDL cholesterol
    Merck announced that the U.S. Food and Drug Administration has approved its once-daily oral PCSK9 inhibitor, enlicitide, marketed as Lipfendra, for adults with elevated LDL cholesterol. The drug i…
    BioSpace · 3mo agoApprovalPositive↗ source
  • Merck secures US approval for the first oral PCSK9 cholesterol-lowering pill, edging out AstraZeneca
    Merck has received the United States regulatory clearance for an oral PCSK9 inhibitor, marking the first time a pill of this class has been approved for cholesterol management. The approval comes…
    Endpoints · 3mo agoApprovalPositive↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 3mo agoApprovalPositive↗ source
  • Eli Lilly to acquire AtaiBeckley in up to $3.8 billion deal, entering psychedelics market
    Eli Lilly announced it will buy AtaiBeckley, offering $6.75 per share for the company’s common stock. The transaction includes an upfront commitment of about $2.8 billion and a contingent value rig…
    BioSpace · 3mo agoDealPositive↗ source
  • US drug shortages climb for third consecutive quarter, many rely on single suppliers
    The latest data show that the count of medicines in shortage across the United States increased again in the most recent quarter, marking the third straight period of growth. Analysts note that ne…
    Endpoints · 3mo agoNegative↗ source
  • Takeda's zasocitinib clears scalp psoriasis in 75% of patients in phase 3 data
    Takeda released updated results from its two phase 3 trials of the oral TYK2 inhibitor zasocitinib, enrolling a total of 1,801 patients with moderate-to-severe plaque psoriasis. The data showed th…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
  • InnoCare’s TYK2 inhibitor soficitinib meets primary endpoint in phase 2 vitiligo trial
    InnoCare Pharma announced that its TYK2 inhibitor soficitinib achieved the primary endpoint in a phase 2 study of non‑segmental vitiligo conducted at sites in China. The trial evaluated daily oral…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
  • Biopharma layoffs may exceed 14,000 jobs in H1 as Takeda, BioNTech and Viatris cut staff
    Biopharma firms are preparing for a wave of job cuts in the first half of 2026, with total layoffs projected to affect more than 14,000 employees, according to data compiled by BioSpace. The bulk…
    BioSpace · 3mo agoLayoffsNegative↗ source
  • Mirador Therapeutics announces partnership to acquire Kira drug, positioning it against Tavneos
    Mirador Therapeutics, a San Diego‑based biotech focused on immune diseases and backed by more than $650 million in venture capital, has disclosed a new element of its development pipeline. The com…
    Endpoints · 3mo agoDealPositive↗ source
  • Alzheimer researcher Betty Tijms urges broader view beyond amyloid and tau
    Betty Tijms, head of science at the Alzheimer Center Amsterdam, says it is time to stop treating Alzheimer’s as a single disease. For more than a century, research has focused on two proteins, amy…
    Endpoints · 3mo agoNeutral↗ source