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  • Biopharma seeks data scientists as U.S. job market projected to grow 35%
    Biopharma companies are ramping up hiring for data scientists as the U.S. Bureau of Labor Statistics forecasts a 35% increase in data science jobs over the next decade. The surge reflects the growi…
    BioSpace · 2mo agoNeutral↗ source
  • Ultragenyx's Angelman syndrome drug fails Phase 3 trial, halting development
    Ultragenyx reported that its experimental antisense oligonucleotide designed for Angelman syndrome did not meet primary endpoints in a Phase 3 study. The trial, which enrolled patients with the ra…
    Endpoints · 2mo agoNegative readoutNegative↗ source
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  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 2mo agoRegulatoryPositive↗ source
  • FDA advisory panels for Capricor and Replimune highlight need for rare-disease specialist input
    Recent FDA advisory committee meetings reviewing therapies from Capricor Therapeutics and Replimune produced markedly different outcomes, underscoring how the agency’s reliance on specialist input…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • Pfizer grants Medicus co-development rights to CD228-targeted ADC PF-08046031
    Pfizer announced it is transferring co-development rights for its CD228-targeted antibody-drug conjugate, PF-08046031, to Medicus Pharma. The ADC, originally discovered by Seagen, will now be adva…
    Endpoints · 2mo agoDealNeutral↗ source
  • Benelux biotech strength hampered by fragmented investment, experts discuss path to unified corridor
    In a recent episode of BioSpace's "Denatured" podcast, host Jennifer C. Smith-Parker talks with Christina Takke of V-Bio Ventures and Mariette van der Velden‑Roesink of Curie Capital about the biot…
    BioSpace · 2mo agoNeutral↗ source
  • Novartis licenses Alteogen’s hyaluronidase enzyme ALT-B4 in new drug delivery partnership
    Novartis announced a licensing agreement with South Korean biotech Alteogen to use its hyaluronidase enzyme ALT-B4 for drug delivery applications. The enzyme will be produced using Alteogen’s prop…
    Endpoints · 2mo agoDealNeutral↗ source
  • Novartis and BMS pause CAR‑T trials after patient deaths while Revolution Medicines gains early FDA approval for pancreatic cancer drug
    Novartis has placed several trials of its CAR‑T therapy rapcabtagene autoleucel on hold after three patients receiving the treatment died. Bristol Myers Squibb also voluntarily froze its autoimmun…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • BMS faces steep risk if milvexian trial fails, could spark mega-cap merger frenzy
    BMS is heading toward a readout for its oral FXIa inhibitor milvexian, a trial that analysts say could be pivotal for the company's future growth. The recent collapse of merger talks with AstraZen…
    BioSpace · 2mo agoNegative readoutNegative↗ source
  • FDA to tighten oversight of foreign clinical trial sites as China trial volume soars
    FDA officials wrote an editorial stating that inspection access is not an administrative footnote and announced plans to expand oversight of foreign clinical trial sites. The initiative follows th…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • Deaths of two Chinese children receiving CRISPR therapy spark safety debate
    Two children in China died after receiving experimental CRISPR-based gene therapies, according to a recent report. The fatalities have unsettled researchers in the United States who are developing…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 2mo agoNeutral↗ source
  • Novartis CAR-T trial deaths spark safety concerns for autoimmune applications
    Novartis disclosed that three participants in its CAR-T cell therapy trials for autoimmune disease have died. The company said the deaths were reported to health authorities and are under investiga…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 2mo agoNegative readoutNegative↗ source
  • FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy Tudriqev
    A senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
    Endpoints · 2mo agoApprovalPositive↗ source
  • UniQure files FDA priority review request for Huntington’s gene therapy AMT-130
    UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • UniQure submits FDA and UK applications for first Huntington’s disease gene therapy
    UniQure has filed a biologics license application (BLA) with the U.S. FDA and a separate submission with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its experimental gene…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • UK regulator suspends new patients from receiving Tavneos (Avacopan Vifor) amid data concerns
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to stop prescribing Tavneos, known locally as Avacopan Vifor, to any new patients. The decision follows the regulator’…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • FDA vows tighter review of foreign clinical trial data amid rising Chinese influence
    Top FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • UK regulator suspends Tavneos sales as MHRA follows EMA decision; UniQure files for Huntington's gene therapy approval
    The UK Medicines and Healthcare products Regulatory Agency has ordered a halt to the sale of the drug Tavneos, citing concerns that align with a recent decision by the European Medicines Agency. T…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Teva's experimental antibody cuts intestinal damage in celiac patients after gluten challenge
    Teva reported that a single injection of an experimental antibody markedly lowered intestinal damage in participants with celiac disease who continued to consume gluten daily. The study was a glut…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Novartis’ BTK inhibitor remibrutinib cuts MS relapse rates in Phase 3, setting up FDA filing
    Novartis reported that its BTK inhibitor remibrutinib, already approved for chronic spontaneous urticaria, lowered annualized relapse rates in two Phase 3 studies of relapsing multiple sclerosis wh…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • Typewriter secures $56M to advance jumping-gene platform and in vivo CAR-T therapies
    Typewriter, a biotech startup, announced it has closed a $56 million financing round. The capital will be used to develop its jumping-gene platform, which seeks to deliver full genes without viral…
    Endpoints · 2mo agoDealPositive↗ source
  • Funding announcements can hint at upcoming biotech hiring opportunities
    Funding announcements serve as early signals that a biotech company may soon expand its workforce, giving job seekers a chance to reach out before roles are formally posted. Alex Benjamin, vice pr…
    BioSpace · 2mo agoNeutral↗ source