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1,119 stories matching this filter · ← front page

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  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 29d agoApprovalPositive↗ source
  • Gilead invests up to $1.87 B in Vir Biotechnology for three T-cell engagers
    Gilead Sciences announced a licensing agreement with Vir Biotechnology that includes an equity investment and potential milestone payments totalling up to $1.87 billion. The upfront component is $…
    BioSpace · 29d agoDealPositive↗ source
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  • Verastem reports robust response in pancreatic cancer subgroup where Revolution's drug lagged
    Verastem Oncology announced that its KRAS G12D‑targeting inhibitor VS‑7375 showed strong activity in a Phase 1/2 trial that includes patients with advanced solid tumors. In the pancreatic cancer co…
    BioSpace · 29d agoPositive readoutPositive↗ source
  • Zealand Pharma to invest up to $1.2 billion in Generate’s AI platform for obesity drug development
    Zealand Pharma announced a partnership with Generate:Biomedicines to use the latter's generative‑AI platform for creating new multispecific drug candidates aimed at obesity and metabolic disorders.…
    BioSpace · 29d agoDealPositive↗ source
  • J&J Q3 earnings fall short of expectations as stock slides, BMS reports mixed trial outcomes and RevMed highlights subgroup data
    Johnson & Johnson reported third‑quarter results that met analyst forecasts, driven by its innovative medicines segment, but the company’s stock dropped about 4% as the med‑tech division lagged beh…
    BioSpace · 29d agoEarningsNegative↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 29d agoRegulatoryPositive↗ source
  • GSK to cut over 1,200 jobs at Belgian sites as $2.5 bn restructuring continues
    GSK announced it will eliminate more than 1,200 positions across its Belgian facilities, following an earlier closure of a German vaccine plant that cut about 650 jobs. The reductions are part of…
    BioSpace · 29d agoLayoffsNegative↗ source
  • UK regulator MHRA unveils multi-year plan to speed AI-driven drug oversight
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a multi-year strategy aimed at keeping its regulatory framework patient-focused as artificial intelligence and persona…
    raps · 29d agoRegulatoryNeutral↗ source
  • European biotech CEOs divided on whether US or China will lead future partnership deals, Europe seen as lagging
    A BIO-Europe survey of 81 leaders from privately‑owned European biotech companies found the group split on which region will dominate future innovation partnerships. Twenty‑nine respondents said th…
    BioSpace · 29d agoNeutral↗ source
  • Jazz CEO urges industry to boost gender diversity in biopharma leadership
    Renee Gala, the newly appointed chief executive of Jazz, said her own sponsors took chances on her and urged the biopharma sector to do the same to revive momentum for gender equity in leadership.…
    BioSpace · 29d agoNeutral↗ source
  • FTC seeks contempt ruling against Martin Shkreli for breaching lifetime pharma ban
    The Federal Trade Commission has asked a judge to hold Martin Shkreli in contempt for allegedly breaching the lifetime ban that was imposed after his 2022 release from prison. The agency alleges t…
    BioSpace · 29d agoRegulatoryNegative↗ source
  • Verdiva ends mid-stage study of oral GLP-1 amid ‘market evolution’
    The candidate is an oral version of ecnoglutide, a subcutaneous formulation of which is approved in China for type 2 diabetes and weight management. Pfizer owns commercialization rights for ecnoglu…
    BioSpace · 29d ago↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 1mo agoRegulatoryPositive↗ source
  • BioNTech's head and neck cancer mRNA vaccine fails to extend progression-free survival in Phase 3 trial
    BioNTech reported that its experimental mRNA immunotherapy BNT113 did not meet its primary endpoint in a Phase 3 trial for a specific head and neck cancer, failing to improve progression-free survi…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Syndax halts Niktimvo trial for idiopathic pulmonary fibrosis after mid-stage failure
    Syndax announced it will stop testing Niktimvo (axatilimab) in idiopathic pulmonary fibrosis after the Phase 2 MAXPIRe trial failed to meet its primary endpoint. The study enrolled 145 patients an…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Pfizer strikes over $500M partnership with Enodia to develop Sec61-targeting small-molecule drugs
    Pfizer's venture arm helped fund Enodia Therapeutics with a $25 million seed round earlier this year. The two companies have now announced a collaboration that could be worth more than $500 millio…
    BioSpace · 1mo agoDealPositive↗ source
  • Analysts focus on RevMed pancreatic cancer launch and Merck data push ahead of Q3 earnings
    Johnson & Johnson is set to open the third quarter earnings reporting period, with analysts keen to hear about any business development news and launch execution updates. RevMed’s upcoming launch…
    BioSpace · 1mo agoEarningsNeutral↗ source
  • Stakeholders urge FDA to adopt flexible approach for psychedelic drug regulation
    Various individuals and groups have submitted comments urging the U.S. Food and Drug Administration to be flexible in regulating psychedelic medicines that could treat major depressive disorder and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Roche signs $1.2B partnership with China’s Rona for obesity drug as Stryker pours $400M into CMR Surgical
    Roche has entered a $1.2 billion agreement with Chinese firm Rona to advance an obesity treatment, targeting the growing market for weight‑loss therapies in China. The deal will combine Roche’s dr…
    raps · 1mo agoDealPositive↗ source
  • Roche expands obesity R&D footprint with Rona deal worth $1B+
    Roche has gained access to a genetic obesity approach from China's Rona Therapeutics for up to $100 million in upfront and near-term payments.
    BioSpace · 1mo agoDealNeutral↗ source
  • J&J’s innovative medicines carried Q3 as medtech disappoints, but newer medicines absent
    While innovative medicine supported Johnson & Johnson’s “in line” earnings for the third quarter of 2026, investors were disappointed to see older medicines carrying the bag.
    BioSpace · 1mo agoEarningsNeutral↗ source
  • Pan Pepín recalls Para Bien Al Grano cereal batches over undeclared sesame allergen
    Pan Pepín Inc., based in Bayamón, Puerto Rico, issued a voluntary recall of certain lots of its Para Bien Al Grano product after discovering that sesame, an undeclared allergen, is present. The co…
    fda recalls · 1mo agoCRLNegative↗ source
  • Pan Pepin recalls Para Bien Al Grano boxes after discovering undeclared sesame
    Pan Pepin Inc., based in Bayamón, Puerto Rico, announced a recall of certain lots of its 24‑oz Para Bien Al Grano product because sesame was present but not listed on the label. The undeclared ses…
    fda recalls · 1mo agoCRLNegative↗ source
  • BMS reports Phase 3 success for RYZ101 in GEP-NET trial
    Bristol Myers Squibb said its radiopharmaceutical candidate RYZ101 met the primary endpoint in a late‑stage Phase 3 study. The drug was acquired in BMS's $4.1 billion purchase of RayzeBio, complete…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Strategic CDMO partnerships shift from transactional to collaborative, emphasizing risk sharing and regulatory expertise
    CDMO-sponsor relationships are moving away from simple outsourcing toward deeper strategic collaboration. Companies now look for partners who share risk, understand regulatory requirements, and pro…
    BioSpace · 1mo agoPositive↗ source