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  • 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 · 26d 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 · 26d agoLayoffsNegative
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  • 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 · 27d 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 · 27d agoNeutral↗ source
  • BD and CareFusion recall Alaris Pump infusion sets due to serious performance risks
    The FDA has classified the recall of BD Alaris Pump infusion sets as the most serious type, warning that continued use could cause serious injury or death. BD and its subsidiary CareFusion sent an…
    fda medwatch · 27d agoCRLNegative↗ 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 · 26d 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 · 26d ago↗ source
  • Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
    Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.
    fda medwatch · 27d ago↗ 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 · 27d 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 · 27d 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 · 28d 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 · 28d 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 · 28d agoCRLNegative↗ 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 · 27d 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 · 27d agoEarningsNeutral↗ 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 · 28d 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 · 29d agoPositive↗ 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 · 28d 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 · 28d 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 · 29d agoDealPositive↗ 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 · 29d agoNeutral↗ source
  • Novartis licenses Abogen’s mRNA CD19×CD3 engager in $575M upfront deal
    Abogen Biosciences saw its COVID vaccine miss the market, prompting questions about whether its mRNA platform could be leveraged for other therapies. Novartis agreed to pay $575 million up front f…
    BioSpace · 1mo agoDealPositive↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion to expand non‑opioid pain portfolio
    Viatris announced a $1.65 billion acquisition of Pacira BioSciences, aiming to broaden its non‑opioid pain‑relief offerings. The deal includes Pacira's marketed products Exparel and Zilretta, which…
    BioSpace · 1mo agoDealPositive↗ source
  • Par Health recalls two lots of Brevital Sodium injection over cellulose particles
    Par Health announced a voluntary recall of two lots of its Brevital® Sodium 500 mg/vial for injection after detecting particulate matter identified as cellulose. The recall is being executed at th…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • TRexBio and Retension raise $161.7M in IPOs as biotech fundraising surge continues
    TRexBio and Retension Pharmaceuticals are slated to begin trading on Friday, together raising $161.7 million. Their offerings push the number of biotech IPOs this year to 29, underscoring a continu…
    BioSpace · 1mo agoDealPositive↗ source