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  • Novartis shareholder urges board overhaul after costly Avidity acquisition setbacks
    Novartis investor David Samra, managing director at Artisan Partners, told Reuters that the company’s board should be reshaped to improve oversight of its dealmaking activities. He said the board n…
    Fierce Biotech · 5h agoDealNegative↗ source
  • Encoded Therapeutics secures $275M Series F to advance gene therapy for Dravet syndrome
    Encoded Therapeutics announced a $275 million Series F financing round aimed at moving its lead gene‑therapy candidate, ETX101, toward pivotal trials for Dravet syndrome. In the ongoing Phase 1/2…
    BioSpace · 2h agoDealPositive↗ source
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  • Cancer drug shortages persist at US centers, survey shows many face multiple medication gaps
    An ongoing shortage of cancer medicines is forcing leading US cancer centers to adopt work-around strategies, and a majority say clinical trials have been disrupted, a new survey reports. All cent…
    STAT · 2h agoRegulatoryNegative↗ source
  • FDA pauses enrollment in Biohaven's epilepsy trials after earlier depression trial failure
    FDA placed a partial clinical hold on Biohaven's Kv7 potassium channel agonist, BHV-7000 (opakalim), halting enrollment of new patients in two late-stage focal epilepsy studies. The pause follows…
    BioSpace · 1h agoRegulatoryNegative↗ source
  • Novartis shareholder urges board overhaul after share plunge tied to trial setbacks
    A prominent Novartis investor has publicly called for a revamp of the company’s board, arguing that stronger governance is needed after the stock experienced a record decline. The demand was voice…
    STAT · 2h agoNegative↗ source
  • FDA expands approval for Bayer's lung cancer therapy
    The U.S. Food and Drug Administration announced an expansion of the approved use of Bayer's lung cancer drug. The decision broadens the patient population eligible for the treatment, reflecting th…
    STAT · 2h agoApprovalPositive↗ source
  • Drugmakers Rethink Launch Strategies as MFN Pricing Rules Shake Market
    A new Numerof & Associates report says that the rollout of Most Favored Nation (MFN) pricing rules is forcing drugmakers to overhaul how they choose launch markets. Executives surveyed said the Un…
    BioSpace · 2h agoRegulatoryNegative↗ source
  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 4h agoDealNegative↗ source
  • Roivant's mosliciguat shows strong efficacy in Phase 2 PH-ILD trial
    Roivant's experimental drug mosliciguat achieved strong efficacy signals in a Phase 2 study of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The mid-stage trial met its…
    STAT · 5h agoPositive readoutPositive↗ source
  • FDA places partial hold on Biohaven epilepsy drug BHV-7000 amid $350 million licensing deal
    The U.S. Food and Drug Administration issued a partial clinical hold on enrollment for Biohaven’s epilepsy candidate BHV-7000 after rodent studies raised questions about drug metabolites. The hold…
    Fierce Biotech · 5h agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire after string of recent FDA approvals
    Takeda's long-serving research and development president Andy Plump will step down in June. He joined the Japanese drugmaker in 2015 from Sanofi and has led the R&D organization since then. His ex…
    Fierce Biotech · 6h agoPositive↗ source
  • Midterm races in Iowa, Florida and others could shape US vaccine policy
    Vaccine policy has emerged as a prominent issue in the lead‑up to the November midterms, spurred by the president and health secretary’s skeptical stance. In Iowa, the Republican candidate for gov…
    STAT · 7h agoNeutral↗ source
  • FDA proposes 50% fee cut for US early-stage trials, but industry says speed matters more
    The FDA announced a proposal to cut the application fee by half for drugs that run their early-stage trials in the United States. The reduction, about $2.3 million at current rates, is intended to…
    BioSpace · 11h agoRegulatoryNegative↗ source
  • Tyra Biosciences shares tumble as bladder cancer pill shows lower-than-expected complete response
    Tyra Biosciences presented Phase 2 SURF302 data for its investigational oral drug dabogratinib in patients with low‑grade intermediate‑risk non‑muscle invasive bladder cancer. The trial reported th…
    BioSpace · 3h agoNegative readoutNegative↗ source
  • UniQure to release four-year Huntington’s gene therapy results by September
    UniQure, a biotech firm, will report four-year data from its Huntington’s disease gene therapy trial before the end of September. The therapy, AMT-130, has already been submitted to regulators in…
    STAT · 5h agoPositive readoutNeutral↗ source
  • August 2026 biopharma layoffs affect just over 500 workers, a 90% drop from a year earlier
    In August 2026, twelve biotech and pharmaceutical firms announced workforce reductions, impacting a total of about 526 employees. This represents a sharp 90% decline in the number of people affecte…
    BioSpace · 8h agoLayoffsNegative↗ source
  • Trump officials turn to AI to address rural health care challenges as nominees await Senate confirmation
    The article notes that nominees for top federal health positions will soon be questioned by Congress, highlighting upcoming scrutiny of health leadership. It also reports that officials in the Tru…
    STAT · 1h agoNeutral↗ source
  • CMS chief Mehmet Oz touts AI avatars for rural health, but some hospital leaders remain skeptical
    Centers for Medicare and Medicaid Services (CMS) head Mehmet Oz announced that artificial-intelligence based avatars could help deliver medical care to patients in rural communities. The proposal…
    STAT · 4h agoNeutral↗ source
  • CDMOs Redefine Pharma Supply Chains with AI, Cold-Chain Logistics and Smart Sourcing
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer Smith-Parker talks with Arvind Singh, vice-president and global head of supply chain at SK Pharmteco. The discussion is presented…
    BioSpace · 4h agoNeutral↗ source
  • AI transforms talent strategy in life-science companies, moving from tools to strategic intelligence
    Applying artificial intelligence and automation has moved from experimental use to a core topic in talent strategy discussions across life‑science firms. Early efforts focused on testing tools and…
    BioSpace · 8h agoPositive↗ source
  • BioSpace reports 11 California biopharma firms posting over 400 jobs as openings rise 31% YoY
    BioSpace's latest job trend data shows a sharp increase in biopharma openings in California, with postings up 31% year-over-year in August. More than 400 positions are currently listed, reflecting…
    BioSpace · 8h agoNeutral↗ source
  • Trump administration touts AI as solution for rural health care, experts remain skeptical
    Rural health care providers are confronting nearly $1 trillion in Medicaid cuts projected over the next decade, prompting the Trump administration to promote artificial intelligence tools as a resc…
    STAT · 7h agoNeutral↗ source
  • Senator John Fetterman's post-stroke conduct sparks debate on brain health and politics
    Neurologists Michael P.H. Stanley and Isaiah Kletenik wrote an opinion piece highlighting how Senator John Fetterman's behavior after his 2022 stroke has become a focal point for discussions about…
    STAT · 7h agoNegative↗ source
  • Frazier Life Sciences nets $1.1B in long-running fund aimed at small, midsize biotechs
    Frazier Life Sciences (FLS) has stacked up another sizable biotech-focused capital commitment, netting more than $1.1 billion for its long-running public fund.
    Fierce Biotech · 6h ago↗ source
  • Novo Nordisk halts two IL-6 heart trials as Novartis suffers Phase 3 setbacks; Ionis wins first Alexander disease approval
    Novo Nordisk announced it has ended two late‑stage studies of its investigational IL‑6 inhibitor ziltivekimab, which was being evaluated for cardiovascular disease. The decision follows an earlier…
    BioSpace · 1d agoNegative↗ source