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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 · 6d agoRegulatoryNegative↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 6d agoPositive readoutPositive↗ source
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  • 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 · 6d 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 · 6d 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 · 6d agoDealNeutral↗ source
  • Alumis' TYK2 inhibitor flunks mid-stage lupus trial, shares drop 55%
    Alumis reported that its experimental TYK2 inhibitor, envudeucitinib, failed to meet any primary or secondary endpoints in a mid-stage study of systemic lupus erythematosus. The company highlighte…
    BioPharma Dive · 7d agoNegative readoutNegative↗ source
  • Novartis reports Phase 3 success for MS pill remibrutinib, beats Aubagio and shows no liver safety issues
    Novartis announced that its BTK inhibitor remibrutinib met primary endpoints in two Phase 3 trials in patients with relapsing multiple sclerosis. The studies showed the drug reduced annualized rel…
    BioPharma Dive · 7d agoPositive readoutPositive↗ 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 · 7d 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 · 7d 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 · 7d 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 · 7d agoRegulatoryPositive↗ 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 · 7d agoLayoffsNegative↗ source
  • Mid-size biotechs join White House Medicaid pricing program, gain tariff relief
    Nine mid-size drugmakers announced they will take part in the White House’s GENEROUS Medicaid pricing model, which ties U.S. Medicaid payments to the lowest prices paid abroad. In return, the comp…
    BioPharma Dive · 7d agoRegulatoryNeutral↗ source
  • FDA clears Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera, opening potential $2 billion market
    The Food and Drug Administration has granted clearance to rusfertide, sold under the brand name Mimrylo, for the treatment of polycythemia vera, a rare blood disorder that causes excess red blood c…
    BioPharma Dive · 8d agoApprovalPositive↗ 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 · 8d 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 · 8d agoApprovalPositive↗ source
  • Eli Lilly to acquire Merida Biosciences in near-$2.9 billion deal to expand immune-disease pipeline
    Eli Lilly announced it will buy privately held Merida Biosciences, a company that has created a technology to target and break down malfunctioning antibodies that drive many autoimmune disorders.…
    BioPharma Dive · 8d agoDealPositive↗ 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 · 8d agoNegative↗ source
  • Cytokinetics reports Phase 3 success for Myqorzo but shares tumble as investors weigh market impact
    At the European Society of Cardiology meeting, Cytokinetics presented Phase 3 data for Myqorzo in non‑obstructive hypertrophic cardiomyopathy, showing benefit in both forms of the disease and disti…
    BioPharma Dive · 8d agoPositive readoutNeutral↗ 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 · 8d agoDealPositive↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after safety concerns
    Novartis announced a temporary hold on its personalized CAR-T therapy rap-cel after three patients experienced immune effector cell-associated hemophagocytic syndrome, a rare and potentially life-t…
    BioPharma Dive · 7d agoRegulatoryNegative↗ 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 · 8d agoPositive readoutNeutral↗ source
  • Verily, NVIDIA and NIH launch first multimodal AI model combining EHR and genomics
    Verily Health, in partnership with NVIDIA and the NIH All of Us Research Program, announced the development of a new foundation model that merges electronic health record data with genomic informat…
    BioPharma Dive · 8d agoPositive↗ 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 · 8d agoNeutral↗ source
  • Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
    The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
    BioSpace · 11d agoApprovalPositive↗ source