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  • Long-term unemployment pushes many biopharma professionals to quit job searches
    A recent BioSpace LinkedIn poll shows that about one-quarter of biopharma workers who have been unemployed for six months or more have stopped looking for new positions, and a similar share are con…
    BioSpace · 1mo agoNegative↗ source
  • Scaling delivery is key for CAR T therapies to succeed in autoimmune diseases
    Biopharma companies are exploring CAR T cell therapies as a potential cure for autoimmune disorders, a market that could be twice the size of oncology. While current treatments manage symptoms, the…
    BioSpace · 1mo agoNeutral↗ source
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Generate Bio drops as data accidentally leaked ahead of European conference
Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
BioSpace · 1mo agoRegulatoryNeutral↗ source
  • FDA review highlights expanding role of manufacturing process models in drug applications
    The FDA released a review outlining how manufacturers can incorporate process modeling into their regulatory submissions. Process models are described as a growing scientific area and are being us…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Experts discuss hurdles and prospects for the first approved Fragile X therapy
    In a recent episode of BioSpace's "Denatured" podcast, Hilary Rosselot of the National Fragile X Foundation and Jordi Fàbrega, co‑founder and CEO of CONNECTA Therapeutics, talked about the current…
    BioSpace · 1mo agoNeutral↗ source
  • Biopharma hiring gaps: experts cite four key mismatches between companies and candidates
    Recruiting specialists highlighted persistent disconnects between biopharma employers and job seekers, noting that misaligned expectations can slow hiring and discourage talent. One major issue st…
    BioSpace · 1mo agoNeutral↗ source
  • MHRA revises guidance on periodic safety update reports for UK products
    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update to its pharmacovigilance procedures guidance. The revision focuses on the preparation and submission of periodic…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA considers new deputy commissioner roles as Trump prepares to announce additional MFN drug pricing agreements
    The Food and Drug Administration is evaluating the establishment of new deputy commissioner positions to support its expanding portfolio of responsibilities. The proposal reflects ongoing efforts…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA grants early approval to RevMed's pancreatic cancer drug Rasonque
    FDA granted early approval to Revolution Medicines' daraxonrasib, now named Rasonque, for pancreatic adenocarcinoma, arriving 6.5 months before the FDA deadline. The oral RAS inhibitor demonstrate…
    BioSpace · 1mo agoApprovalPositive↗ source
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 1mo agoApprovalPositive↗ source
  • Summit Therapeutics and Akeso report Phase 3 survival benefit for ivonescimab in Chinese biliary tract cancer
    Summit Therapeutics and its Chinese partner Akeso said their bispecific antibody ivonescimab combined with chemotherapy improved overall survival for patients with first-line biliary tract cancer i…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancer
    The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gas…
    BioSpace · 1mo agoApprovalPositive↗ source
  • Vitruvias Therapeutics shuts down after recalling potentially superpotent thyroid tablets
    Vitruvias Therapeutics announced it is ceasing operations and has voluntarily recalled a batch of its generic thyroid tablets because the product may be superpotent. The recall covers 3,655 units…
    BioSpace · 1mo agoCRLNegative↗ source
  • BMS terminates Cellares partnership after cell therapy platform fails to meet Breyanzi production needs, prompting layoffs
    Bristol Myers Squibb has ended its collaboration with manufacturing specialist Cellares after the Cell Shuttle system could not satisfy the requirements for producing the approved CAR‑T therapy Bre…
    BioSpace · 1mo agoDealNegative↗ source
  • Biohaven signs up to $795 million deal with SK Biopharma to license Kv7 platform and epilepsy asset
    Biohaven announced a licensing agreement with South Korean SK Biopharma centered on its Kv7 ion channel platform and lead epilepsy candidate opakalim. The deal could deliver up to $795 million, in…
    BioSpace · 1mo agoDealPositive↗ source
  • FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy review
    The FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • CDMO hiring struggles as demand for specialized talent outpaces supply
    Contract development and manufacturing organizations are finding it harder to fill positions, according to a search expert who tracks life-science talent. The surge in outsourcing has created a gap…
    BioSpace · 1mo agoNeutral↗ source
  • Inside the Gulf biotech deal model, ahead of RGMBS 2026 in Riyadh
    Sovereign capital, guaranteed offtake, and localization mandates are reshaping how biotech deals get structured in the Gulf, ahead of the Riyadh Global Medical Biotechnology Summit (RGMBS) 2026, 14…
    BioSpace · 1mo agoDealNeutral↗ source
  • FDA reportedly weighing two new deputy commissioner roles, one for health AI and one for drugs
    The Food and Drug Administration is said to be considering the creation of two additional deputy commissioner positions. The proposal is being reported by media outlets but has not been confirmed b…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Industry groups call for clearer FDA guidance on QRIs in expedited IND pilot
    Pharmaceutical trade groups have voiced concerns about the FDA's proposed expedited IND pilot, which aims to speed entry of drug candidates into first‑in‑human studies. The groups say the FDA need…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 1mo agoApprovalPositive↗ source
  • Eli Lilly launches oral obesity drug Foundayo in the UK
    Eli Lilly has introduced its oral weight‑loss pill Foundayo to the United Kingdom market, positioning the small‑molecule therapy as a price‑sensitive alternative to injectable options. The UK Medi…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Haisco partners with US VCs to launch immunology biotech Sentivera with up to $1.5B funding
    Haisco Pharmaceutical Group announced the creation of a new immunology-focused biotech called Sentivera, backed by two American venture‑capital firms, Population Health Partners and ARCH Venture Pa…
    BioSpace · 1mo agoDealPositive↗ source
  • Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' Pluvicto
    Curium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • FDA expands labels for J&J’s Imaavy and Jazz’s Ziihera; Teva under Turkish antitrust probe
    The U.S. Food and Drug Administration has broadened the approved uses for Johnson & Johnson’s oncology drug Imaavy and Jazz Pharmaceuticals’ Ziihera, adding new indications to each label. These la…
    raps · 1mo agoRegulatoryNeutral↗ source