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  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Biotech firms raise record funds in 2026, with $2.1 bn round for Isomorphic Labs
    After a few slow years, the biotech financing landscape is showing signs of recovery, though investors remain cautious about where they place capital. A recent PharmaVoice reader poll found that 2…
    BioPharma Dive · 1mo agoDealNeutral↗ source
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  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • European regulators give second chance approval to Acadia’s Daybu for Rett syndrome
    European Medicines Agency's CHMP has reversed its earlier negative vote and now recommends marketing authorization for Acadia Pharmaceuticals' drug Daybu (trofinetide) for Rett syndrome. The posit…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • FDA accepts resubmission of Replimune’s RP1 cancer therapy, decision due Aug. 2; Merck KGaA announces $11 B life-sciences spend
    The U.S. Food and Drug Administration has accepted Replimune's resubmitted application for its cancer drug RP1, with a final decision slated for August 2 and an advisory committee meeting planned f…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • US biotech faces regulatory push as China licensing deals spark security concerns
    A surge in licensing agreements between Chinese pharmaceutical firms and U.S. biotech companies has been noted, with nearly 100 deals announced since early 2025, prompting worry among investors and…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • Alkermes CEO targets orexin market after strong narcolepsy pill data
    Alkermes' incoming chief executive outlined a strategy to compete with larger rivals in the emerging orexin drug class. Recent mid-June trial results showed the experimental oral compound alixorex…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Precision strategies help de-risk rare disease therapy launches
    Commercializing a rare disease therapy presents a high‑risk, high‑reward scenario for biotech firms. Small patient populations, stringent regulatory requirements, and the need to sustain value beyo…
    Fierce Biotech · 2mo agoNeutral↗ source
  • FDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
    The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older. The 9-0 vote allows Moder…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • cAMPfield lands $180M to build gut disease drug
    The biotech is advancing an anti-inflammatory drug that originated with vTv for inflammatory bowel diseases, leaning on a better side effect profile.
    BioPharma Dive · 2mo ago↗ source
  • Biogen adds more immune drugs in $1B buyout of secretive startup RayThera
    The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues.
    BioPharma Dive · 2mo ago↗ source
  • Pfizer CFO to step down; Denali sells a regulatory fast-pass
    A search is underway for a successor to Dave Denton, who took a job outside the pharmaceutical industry. Elsewhere, a new kind of Duchenne gene therapy got venture backing and a GSK deal paid divid…
    BioPharma Dive · 2mo ago↗ source
  • Kardigan extends biotech’s streak of big IPOs with $400M haul
    Including the heart drug developer’s offering, four biotechs in 2026 have raised at least $400 million in IPO proceeds — the most in a single year since 2021, according to BioPharma Dive data.
    BioPharma Dive · 2mo ago↗ source
  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
    The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
    BioPharma Dive · 2mo ago↗ source
  • Jazz zeroes in on next-gen T cell engagers with AbCellera deal
    The potentially $4 billion collaboration is the latest example of drugmakers working to broaden the use of T cell engagers, which, so far, have had limited success outside of certain blood cancers.
    BioPharma Dive · 2mo ago↗ source
  • A new Westlake-backed biotech takes aim at migraines
    Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention.
    BioPharma Dive · 2mo ago↗ source
  • Lilly buys non-opioid pain drugmaker 4E
    It’s the latest in a string of deals for Lilly, which has sunk more than $18 billion into acquisitions over the past few years.
    BioPharma Dive · 2mo ago↗ source
  • Express Scripts, PCMA sue to block Tennesee law breaking up PBMs and pharmacies
    Express Scripts and the PBM lobby are following in CVS Caremark’s footsteps in filing complaints challenging the FAIR Rx Act, which was passed earlier this year despite vehement opposition from PBMs.
    BioPharma Dive · 2mo ago↗ source
  • FDA staff scrutinizes evidence supporting Moderna’s flu vaccine
    Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year.
    BioPharma Dive · 2mo ago↗ source
  • Edgewise heart drug passes key trial test
    Still, the results leave somewhat unclear how different the company’s drug is than marketed hypertrophic cardiomyopathy medicines from Bristol Myers Squibb and Cytokinetics.
    BioPharma Dive · 2mo ago↗ source
  • Neumora depression drug fails; EnGene to cut 50% of staff
    Neumora’s stumble is the latest setback for a once-promising class of brain drugs. Elsewhere, a cell therapy manufacturing specialist took steps toward an IPO and J&J made its latest U.S investment.
    BioPharma Dive · 2mo ago↗ source
  • Medicare drug price rule may target under-the-skin Keytruda and Opdivo
    For 2029, a federal rule proposes closing a "loophole" that protects medicines transitioning from intravenous administration from price protection.
    BioPharma Dive · 2mo ago↗ source
  • Lilly scores early positive data for new JAK drug
    Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.
    BioPharma Dive · 2mo ago↗ source
  • J&J multiple myeloma drug gains edge in earlier stage disease
    The latest results studying Talvey in combination with Darzalex Faspro support J&J’s efforts to expand the immunotherapy's use.
    BioPharma Dive · 2mo ago↗ source