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  • Cerevance's solengepras cuts Parkinson off-time by 0.6 hours in Phase 3, advancing toward FDA review
    Cerevance, a spinout from Takeda, reported that a high 150‑mg dose of its Parkinson's drug solengepras reduced daily "off time" by an average of 0.61 hours compared with placebo in the Phase 3 ARIS…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Epkinly shows 51% lower risk of progression in frontline DLBCL trial, boosting hopes for expanded approval
    New Phase 3 data from the Epkinly and R-CHOP combination in diffuse large B cell lymphoma showed a 51% reduction in the risk of disease progression or death compared with standard therapy. The stud…
    BioSpace · 1mo agoPositive readoutPositive
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↗ source
  • Optogenetics therapy restores light sensitivity in half of retinitis pigmentosa patients in early trial
    A small clinical study examined an optogenetics‑based approach for treating retinitis pigmentosa, a genetic disorder that progressively destroys retinal light‑sensing cells and often leads to legal…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Dutch court orders Merck to halt subcutaneous Keytruda sales in eight European countries
    A Dutch court has issued an injunction that requires Merck to stop manufacturing and selling the injectable, subcutaneous formulation of its cancer immunotherapy Keytruda in eight European countrie…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Zuckerberg’s Biohub secures $1.8 billion to expand AI-driven virtual cell platform with Meta and Google
    Mark Zuckerberg and Priscilla Chan's nonprofit Biohub announced an expansion of its virtual cell initiative, now backed by $1.8 billion in funding. The new capital comes from a coalition that incl…
    Endpoints · 1mo agoPositive↗ source
  • ArriVent BioPharma's Phase 3 lung cancer trial misses primary endpoint, shares tumble
    ArriVent BioPharma reported that its investigational EGFR tyrosine kinase inhibitor firmonertinib did not achieve a statistically significant improvement in progression-free survival in the Phase 3…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Cadrenal Therapeutics launches strategic review to explore sale or partnership for its late-stage cardiology pipeline
    Cadrenal Therapeutics, a heart-focused biotech, announced a strategic review of its late-stage cardiology pipeline, seeking to offload assets or the entire company. The board is evaluating options…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • Caribou Biosciences to halt R&D and cut staff as financing for allogeneic CAR-T dries up
    Caribou Biosciences, co‑founded by Nobel laureate Jennifer Doudna, announced it will stop all clinical‑stage work and lay off staff because of a financing freeze in the allogeneic CAR‑T market. Th…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • 2026 Nobel Chemistry Prize honors research on chiral molecules with implications for drug development
    Henri B. Kagan, 95, and Kenso Soai, 76, received the 2026 Nobel Prize in chemistry for their work on asymmetric organic synthesis. Their research uncovered how certain reactions can act as their o…
    STAT · 1mo agoPositive↗ source
  • Matchpoint Therapeutics raises $150M Series B to advance oral covalent therapies for autoimmune disease
    Matchpoint Therapeutics announced a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures, Digitalis Ventures, Invus, BB…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Trump administration proposes $70,000 fee for OPT program, raising concerns for biotech talent pipeline
    The Department of Homeland Security announced a proposal to charge $70,000 for the Optional Practical Training (OPT) program, which allows international students on F-1 visas to work in the United…
    STAT · 1mo agoRegulatoryNegative↗ source
  • PhRMA files lawsuit against Trump administration over GLOBE drug pricing demonstration program
    PhRMA, the leading trade association for the pharmaceutical industry, has filed a lawsuit against the U.S. government challenging the Centers for Medicare & Medicaid Services' GLOBE drug pricing de…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Ultragenyx sells priority review voucher for $210 million, retains another to monetize
    Ultragenyx Pharmaceutical announced it has sold a priority review voucher to an undisclosed buyer for $210 million. The transaction is among the highest-priced voucher sales this year, providing a…
    Endpoints · 1mo agoDealPositive↗ source
  • WHO advises against GLP-1 obesity drugs for children under 10, limits use in teens
    The World Health Organization issued guidance recommending that GLP-1 drugs not be used to treat obesity in children younger than ten years old. For adolescents aged 10 to 19, the WHO says these m…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • PhRMA sues Trump administration over Medicare GLOBE price pilot
    PhRMA filed a lawsuit in the U.S. District Court for the District of Columbia challenging the Trump administration's GLOBE pilot that would tie Medicare Part B drug prices to those in peer nations.…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda in several European markets
    A Dutch court has ruled that Merck infringed a patent covering a subcutaneous formulation of its cancer drug Keytruda. The decision requires the company to stop manufacturing and marketing that ver…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Novartis-partnered Matchpoint Therapeutics raises $150 million Series B to fund clinical entry
    Matchpoint Therapeutics, a biotech company working with Novartis, announced the close of a new financing round. The round raised $150 million in Series B funding. The capital will be used to advan…
    Endpoints · 1mo agoDealPositive↗ source
  • Forbion secures $2.6 billion in its biggest European venture fund to date
    Forbion, a leading European venture capital firm, announced it has closed a $2.6 billion fund, the largest it has raised and among the biggest recent funds in the region. The new capital will be d…
    STAT · 1mo agoDealPositive↗ source
  • Biotech VC Forbion raises record €2.3 bn ($2.6 bn) to back 30 high-potential life-science companies
    Forbion announced a record fundraising of €2.3 bn ($2.6 bn) across two new funds, bringing its assets under management to about €7.5 bn ($8.4 bn). The capital will be allocated through the Forbion…
    BioSpace · 1mo agoDealPositive↗ source
  • DOJ expands fraud enforcement to include drug and device makers under FD&C Act
    The Justice Department's National Fraud Enforcement Division released a new directive aimed at combating white-collar fraud, highlighting violations of the Federal Food, Drug, and Cosmetic Act. In…
    STAT · 1mo agoRegulatoryNegative↗ source
  • TCGX launches $600 million Asia-focused biotech fund to back life-science companies in China and the region
    TCGX, a biotech investment firm led by Chen Yu and Dandan Dong, announced a new $600 million fund aimed at the Asian market. The fund will make direct investments in life-science companies located…
    Endpoints · 1mo agoDealPositive↗ source
  • ARPA-H launches Surpass program to speed and broaden clinical trials
    The U.S. Department of Health and Human Services announced a new initiative called Surpass, aimed at removing obstacles that slow clinical development and changing how trials are designed and run.…
    Fierce Biotech · 1mo agoPositive↗ source
  • Bayer invests $2.2 billion in Ohio to build pharma manufacturing plant
    Bayer announced a $2.2 billion investment to construct a new pharmaceutical manufacturing complex in New Albany, Ohio. The plant will produce drug substances and finished products for oncology, ca…
    BioSpace · 1mo agoDealNeutral↗ source
  • CAR-T biotech Caribou Biosciences halts two programs and seeks exit after funding shortfall
    Caribou Biosciences announced it is suspending two of its allogeneic CAR-T cell therapy projects. The company said it could not obtain the financing needed to keep the programs alive and is now lo…
    Endpoints · 1mo agoNegative↗ source