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1,215 stories matching this filter · ← front page

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  • Roche signs $1 billion deal with China’s Rona Therapeutics for RNAi obesity drug
    Roche announced a new agreement with Chinese biotech Rona Therapeutics to acquire an experimental RNA interference therapy targeting the protein ALK7 for obesity. Under the terms, Roche will pay $…
    BioPharma Dive · 7d agoDealPositive↗ source
  • Connectivity in fluid management systems key to reducing process variability
    The sponsored article, authored by Chris McCoy of Cytiva, highlights the often‑overlooked role of fluid‑management components such as tubing, connectors, and sensors in bioprocesses. It argues tha…
    BioPharma Dive · 7d agoPositive↗ source
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  • 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 · 7d agoNegative readoutNegative↗ source
  • Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants
    Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
    fda recalls · 7d agoRegulatoryNegative↗ 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 · 7d 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 · 7d 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 · 7d agoEarningsNeutral↗ source
  • Medline pulls convenience kits containing recalled BD ChloraPrep applicators due to contamination risk
    Medline has advised that certain convenience kits it distributes must be removed from use and destroyed because they contain BD ChloraPrep applicators that are subject to a recall over possible fun…
    fda medwatch · 7d agoCRLNegative↗ source
  • Paragon spinout Velaris Therapeutics goes public via reverse merger with Alaunos, raising $350 million
    Paragon Labs, a biotechnology incubator, announced that its latest spinout, Velaris Therapeutics, became a public company through a reverse merger with Alaunos Therapeutics. The transaction places…
    BioPharma Dive · 7d agoDealPositive↗ source
  • BioNTech's mRNA cancer therapy fails to improve progression-free survival in head-neck cancer trial
    BioNTech reported that its experimental mRNA cancer immunotherapy, BNT 113, combined with Keytruda, did not meet the primary endpoint of progression-free survival in an interim analysis of a late-s…
    BioPharma Dive · 7d agoNegative readoutNegative↗ 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 · 7d 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 · 7d 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 · 7d 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 · 7d agoCRLNegative↗ source
  • Pharma faces $500B risk as patents expire, with Merck most exposed by 2028
    More than $500 billion in global prescription sales could be threatened by generic competition between 2026 and 2032, according to Norstella data cited by Evaluate. Merck is the most immediately e…
    BioPharma Dive · 8d agoNeutral↗ 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 · 8d 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 · 8d agoPositive↗ source
  • Aspen Neuroscience files for Nasdaq IPO to fund Parkinson’s cell therapy program
    Aspen Neuroscience, founded in 2018, announced plans to list on Nasdaq, aiming to raise additional capital for its Parkinson’s disease cell therapy program. The company's lead candidate, sasinepro…
    BioPharma Dive · 8d agoDealNeutral↗ source
  • Bristol Myers' lung drug admilparant meets Phase 3 goal at low dose, high dose falls short
    Bristol Myers Squibb reported that its experimental idiopathic pulmonary fibrosis therapy admilparant achieved its primary endpoint in a Phase 3 trial, showing a statistically significant slowing o…
    BioPharma Dive · 8d agoPositive readoutNeutral↗ source
  • BMS lung drug meets low-dose endpoint in Phase 3 but high dose fails to improve lung function
    Bristol Myers Squibb reported that its LPA1 antagonist admilparant achieved the primary endpoint in a Phase 3 idiopathic pulmonary fibrosis study at the 60‑mg dose, showing a statistically signific…
    BioSpace · 8d agoPositive readoutNeutral↗ source
  • RevMed's pancreatic cancer drug Rasonque shows mixed results across KRAS subtypes, analysts stay optimistic
    FDA review documents revealed that Revolution Medicines' newly approved pancreatic cancer therapy, Rasonque, performed unevenly in a large subgroup of patients. The data highlight a lower objective…
    BioSpace · 8d agoNegative readoutNeutral↗ source
  • GSK to invest $800 million in new biologics manufacturing hub in Pennsylvania
    GSK announced it will spend more than $800 million to expand its Upper Merion site near Philadelphia, adding biologics production capacity. The plan includes demolishing existing structures next y…
    BioSpace · 8d agoDealPositive↗ source
  • First Tracks reports positive early-stage results for celiac drug ANB033
    First Tracks Biotherapeutics announced that its experimental celiac disease drug ANB033 showed statistically significant improvement in a six‑week early‑stage trial compared with placebo. The trial…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • Integrating Multiple Stability Measurements Improves Early Biologics Testing
    John Stenson of Malvern Panalytical argues that combining several stability assays on a single platform can increase both throughput and data quality for early‑stage biologics development. He note…
    BioSpace · 8d agoNeutral↗ source
  • Bausch + Lomb appoints board chair Thomas Appio as interim CEO after Brent Saunders departs
    Bausch + Lomb announced that board chair Thomas Appio will serve as interim chief executive, taking over immediately from Brent Saunders, who is leaving the role. Appio, who has held several leade…
    BioPharma Dive · 8d agoNeutral↗ source