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  • Biotech execs push for Rick Pazdur as FDA chief while Takeda announces 4,500 layoffs
    Hundreds of biotechnology executives, investors and patient advocates have signed a petition urging President Trump to nominate Rick Pazdur as the next FDA commissioner. Pazdur, a longtime FDA vet…
    BioPharma Dive · 3mo agoLayoffsNeutral↗ source
  • Supreme Court blocks lower court ruling, keeps mail-order access to abortion pill mifepristone
    The Supreme Court issued an indefinite stay that preserves mail-order access to the abortion medication mifepristone. The order maintains the ability for providers to prescribe the drug through pha…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
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  • Regenxbio reports key gene therapy results, moves toward FDA accelerated clearance for Duchenne
    Regenxbio said its experimental gene therapy RGX-202 met the primary endpoint in a pivotal Duchenne muscular dystrophy trial, positioning the company to file for accelerated FDA clearance. In the…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • FDA leadership gap deepens uncertainty for biotech as acting officials take charge
    Marty Makary's resignation as FDA commissioner has left the agency without a permanent head. Kyle Diamantas is serving as the temporary leader, while three senior drug-review positions are filled b…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Lilly data show lower-dose GLP-1 injections and oral pill help sustain weight loss
    Eli Lilly presented new research on how patients who have lost weight with GLP‑1 medicines can maintain that loss over time. The studies followed people who had achieved significant reductions usin…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Assertio rejects Garda bid, accepts Zydus offer valuing company at $23.50 per share
    Assertio Holdings announced it has terminated its pending acquisition by Garda Therapeutics after the board approved a higher offer from another suitor. The new proposal from Zydus Worldwide value…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Podcast Highlights Community Oncology’s Growing Role in U.S. Cancer Care
    A new sponsored podcast episode explores how community oncology clinics are becoming a vital part of the U.S. cancer‑care landscape. The program, released in May 2026, discusses why these local cen…
    BioPharma Dive · 3mo agoPositive↗ source
  • FDA chief Marty Makary resigns, ending turbulent tenure
    FDA chief Marty Makary has resigned, ending a tenure described as turbulent with leadership upheaval, mass layoffs, political pressure and public disputes with drugmakers. President Trump announce…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • Bristol Myers Squibb and China's Hengrui Pharma launch $15.2 billion alliance covering up to 13 early-stage drugs
    Bristol Myers Squibb announced a new partnership with Chinese drugmaker Hengrui Pharma that could be worth more than $15.2 billion and includes up to 13 early-stage drug candidates. The deal refle…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Pain drug research gains momentum a year after Vertex launch as new startups revive sodium channel targets
    A year after Vertex introduced its breakthrough pain medication, the field of pain drug development is at a pivotal crossroads. Analysts note that renewed scientific focus and investor interest are…
    BioPharma Dive · 4mo agoPositive↗ source
  • Arvinas and Pfizer license newly approved PROTAC breast cancer drug Veppanu to Rigel Pharmaceuticals
    Arvinas and Pfizer have signed a licensing agreement that transfers ownership of their newly approved breast cancer drug, Veppanu, to San Francisco‑based Rigel Pharmaceuticals. The deal gives Arvi…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Inhibrx reports 44% response rate when paired with Keytruda in head-and-neck cancer Phase 2 trial
    Inhibrx Biosciences said its experimental agent INBRX-106 boosted the activity of Merck's Keytruda in a Phase 2 study of a head-and-neck cancer. The combination achieved a 44% overall response rate…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • GSK partners with Sino Biopharma to expand access to hepatitis B drug bepirovirsen in China
    GSK announced a marketing agreement with Sino Biopharmaceutical to distribute its experimental hepatitis B therapy bepirovirsen in China. Sino's subsidiary will purchase a supply of the drug and u…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Biotech layoffs slow as companies like BioNTech cut nearly 1,900 jobs amid market pressures
    The biotech sector has seen more than 40 layoff announcements through the end of April 2026, a decline from the over 50 rounds reported in the final months of 2025. Analysts had expected the pace t…
    BioPharma Dive · 4mo agoLayoffsNegative↗ source
  • Specialized logistics critical for delivering next-generation cell and gene therapies
    The article explains that personalized medicines such as cell and gene therapies are transforming treatment for rare diseases and cancers. Unlike conventional drugs, these therapies are often made…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Biopharma capacity crunch shifts focus to ready-now manufacturing hubs like Middlesex County, NJ
    Demand for biopharma manufacturing, especially cell and gene therapies, is growing faster than the ability to build new GMP-ready facilities, which can take years to complete. To keep pace, compan…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Lilly adds $4.5 billion to Indiana manufacturing to boost weight-loss drug supply
    Eli Lilly & Co. announced an additional $4.5 billion investment in two of its three manufacturing sites in Lebanon, Indiana. The funding is aimed at expanding capacity for both its genetic therapie…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Odyssey Therapeutics raises $279 million in IPO, adds $25 million private sale
    Odyssey Therapeutics, a biotech focused on autoimmune diseases, completed an initial public offering that generated $279 million by selling 15.5 million shares at $18 each. The company also secured…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Pierre Fabre aligns with FDA on resubmission of Ebvallo cell therapy
    Pierre Fabre Laboratories announced that it has reached an agreement with the U.S. Food and Drug Administration on a new path for its cell therapy Ebvallo, which had been rejected twice. The FDA w…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Lilly, Gilead lead pharma’s M&A boom
    Deal volume in 2026 is substantially outpacing last year, and activity is being driven by interest in cancer and autoimmune disease drugs.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Angelini to acquire Catalyst Pharmaceuticals for $4.1 billion, adding rare CNS drug portfolio
    Angelini Pharma announced it will purchase Catalyst Pharmaceuticals in a cash transaction valued at about $4.1 billion. The agreement pays $31.50 per Catalyst share, representing a 21% premium to…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Sarepta's Elevidys sales beat forecasts but dip again, prompting stock slide and shift to RNA pipeline
    Sarepta Therapeutics reported that its gene therapy Elevidys generated net product revenue that exceeded Wall Street estimates for the first quarter. However, sales continued to decline compared wi…
    BioPharma Dive · 4mo agoEarningsNegative↗ source
  • Entrada Therapeutics shares plunge after Duchenne trial shows modest dystrophin increase
    Entrada Therapeutics reported early data from a Phase 1/2 study of its RNA‑based therapy ENTR‑601‑44 for Duchenne muscular dystrophy, noting favorable safety and tolerability. The trial showed a d…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source