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  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 2mo agoNeutral↗ source
  • UniQure submits FDA and UK applications for first Huntington’s disease gene therapy
    UniQure has filed a biologics license application (BLA) with the U.S. FDA and a separate submission with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its experimental gene…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
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  • UK regulator suspends new patients from receiving Tavneos (Avacopan Vifor) amid data concerns
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to stop prescribing Tavneos, known locally as Avacopan Vifor, to any new patients. The decision follows the regulator’…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • Novartis’ BTK inhibitor remibrutinib cuts MS relapse rates in Phase 3, setting up FDA filing
    Novartis reported that its BTK inhibitor remibrutinib, already approved for chronic spontaneous urticaria, lowered annualized relapse rates in two Phase 3 studies of relapsing multiple sclerosis wh…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • Funding announcements can hint at upcoming biotech hiring opportunities
    Funding announcements serve as early signals that a biotech company may soon expand its workforce, giving job seekers a chance to reach out before roles are formally posted. Alex Benjamin, vice pr…
    BioSpace · 2mo agoNeutral↗ source
  • Biotech reverse mergers surge 1,600% in Q3, matching number of IPOs in 2026
    Biotech companies are turning to reverse mergers as a faster, less volatile route to the public markets. In the third quarter of 2026, 17 reverse mergers were completed or announced, a 1,600% incre…
    BioSpace · 2mo agoDealNeutral↗ source
  • EMA starts voluntary data-sharing pilot to boost confidence in new approach methods and cut animal testing
    The European Medicines Agency announced a voluntary data submission pilot that allows drug developers to upload data generated by new approach methodologies (NAMs). The pilot is designed to build…
    raps · 2mo agoRegulatoryPositive↗ source
  • Frutas y Hortalizas del Sur expands recall to include Great Value organic triple berry blend over possible E. coli O145 contamination
    On September 2, 2026, Frutas y Hortalizas del Sur S.A. announced that it is expanding the recall it issued on July 3, 2026 for frozen organic IQF blueberries. The expansion adds one lot of Great V…
    fda recalls · 2mo agoCRLNegative↗ source
  • Novartis and BMS pause CAR-T trials after fatal immune syndrome cases
    Novartis has halted several immunology and neurology studies of its CAR T candidate rapcabtagene autoleucel after three patients experienced fatal immune effector cell‑associated hemophagocytic syn…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • Roche partners with China's Simcere Zaiming on $1.5 billion T-cell engager for B-cell diseases
    Roche announced a licensing agreement with Simcere Zaiming, a subsidiary of China's Simcere Pharmaceutical Group, to develop a trispecific T-cell engager called SIM0660. The deal includes an upfro…
    BioSpace · 2mo agoDealPositive↗ source
  • GSK to start Phase 3 trial of mRNA flu vaccine after strong mid-stage results
    GSK announced it will begin a Phase 3 trial of its mRNA-based influenza vaccine, with enrollment slated to start in September. In a Phase 2 study of 971 adults, the investigational vaccine, which…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • Nine midsize biopharma firms join Trump MFN drug pricing program, covering 89% of branded market
    Nine midsize biopharma companies have agreed to voluntarily participate in the Trump administration's Most Favored Nation drug pricing program, adding to the 17 large pharmaceutical firms that prev…
    BioSpace · 2mo agoRegulatoryPositive↗ source
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 2mo agoDealNeutral↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in vivo CAR-T therapy
    Arsenal Biosciences announced another round of layoffs, eliminating 99 positions, which represents the majority of its workforce after a prior 50% reduction last year. The cuts are part of a strat…
    BioSpace · 2mo agoLayoffsNegative↗ source
  • Biomarin nabs big royalties in achondroplasia patent settlement with Ascendis
    Biomarin has granted Ascendis a non-exclusive, worldwide license to use navepegritide, the active ingredient in the latter company’s recently approved achondroplasia drug Yuviwel, in exchange for 1…
    BioSpace · 2mo agoApprovalPositive↗ source
  • Takeda and Protagonist Therapeutics receive FDA approval for rusfertide (Mimrylo) to treat polycythemia vera
    The FDA approved rusfertide, to be sold as Mimrylo, for the treatment of polycythemia vera, a rare blood cancer, marking a key win for Takeda and its partner Protagonist Therapeutics. The decision…
    BioSpace · 2mo agoApprovalPositive↗ source
  • US biotech edge erodes as China overtakes in trials and research, raising security concerns
    The United States is losing its lead in biotech as China now conducts more clinical trials and publishes more natural‑science papers. China passed the U.S. six years ago in trial numbers and soon…
    BioSpace · 2mo agoNegative↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 2mo agoDealPositive↗ source
  • Eli Lilly to acquire Merida Biosciences in up to $2.9 billion deal for precision antibody-degrading therapies
    Eli Lilly announced it will purchase Massachusetts‑based Merida Biosciences, adding a platform that can selectively degrade disease‑causing antibodies. The transaction could total up to $2.875 bil…
    BioSpace · 2mo agoDealPositive↗ source
  • Arrowhead’s plozasiran shows favorable safety in severe hypertriglyceridemia late-stage trials
    Arrowhead presented late-stage data for its RNA interference therapy plozasiran, marketed as Redemplo, in severe hypertriglyceridemia at the European Society of Cardiology 2026 meeting in Munich.…
    BioSpace · 2mo agoPositive readoutNeutral↗ source
  • BMS leverages Celgene merger to revive neuroscience pipeline amid delayed readouts
    Bristol Myers Squibb, long recognized for its oncology work, is re‑investing in neurological and psychiatric disease programs, a move rooted in assets gained from its 2019 $74 billion Celgene merge…
    BioSpace · 2mo agoNeutral↗ source
  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Crystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs
    Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run th…
    fda recalls · 2mo agoRegulatoryNeutral↗ source