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  • FDA shelves Commissioner’s National Priority Voucher program ahead of Heidi Overton confirmation vote
    The Food and Drug Administration has halted the Commissioner’s National Priority Voucher (CNPV) program as the Senate prepares to vote on Heidi Overton’s nomination as the agency’s next commissione…
    BioSpace · 3h agoRegulatoryNeutral↗ source
  • Biopharma hiring surge in New Jersey as BioSpace lists ~300 open positions across 10 companies
    BioSpace job postings in New Jersey increased year over year in October 2026, with around 300 positions now listed. While postings fell 25% from September to October, overall year-over-year number…
    BioSpace · 14h agoNeutral↗ source
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  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 3h agoLayoffsNegative↗ source
  • FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapies
    The U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors. The g…
    raps · 1d agoRegulatoryNeutral↗ source
  • Coherus trims workforce by 30% as Gyre Therapeutics also cuts staff after acquisition
    Coherus Oncology announced a 30% reduction in its workforce as part of a reorganization that narrows its pipeline. The cuts follow a decision to deprioritize a combination therapy across multiple…
    BioSpace · 2d agoLayoffsNegative↗ source
  • Acting FDA commissioner reports strong public interest in new expedited IND pilot
    Acting FDA Commissioner Kyle Diamantas told attendees at the Friends of Cancer Research annual meeting that the agency’s newly launched Expedited IND pilot has attracted considerable public attenti…
    raps · 2d agoRegulatoryPositive↗ source
  • Amneal and BridgeBio top BioSpace 2027 Best Places to Work list
    BioSpace released its 2027 Best Places to Work list, recognizing 50 life‑science employers with U.S. operations. Amneal Pharmaceuticals, based in Bridgewater, New Jersey, took the top spot among l…
    BioSpace · 2d agoPositive↗ source
  • Argenx to acquire peptide specialist Unnatural Products in deal worth up to $1.15 billion
    Argenx announced it will purchase Unnatural Products, a peptide discovery biotech, in a transaction that could total up to $1.15 billion. The deal provides $550 million upfront, with additional co…
    BioSpace · 3d agoDealPositive↗ source
  • Novartis' Phase 3 HORIZON trial shows pelacarsen lowers Lp(a) but fails to cut cardiovascular events
    Novartis and Ionis reported that the Phase 3 HORIZON trial of the antisense drug pelacarsen did not improve major adverse cardiovascular events despite markedly lowering lipoprotein(a) levels. The…
    BioSpace · 3d agoNegative readoutNegative↗ source
  • Vir Biotechnology reports 44% undetectable hepatitis delta virus in Phase 3 trial, eyes mid-2027 filing
    Vir Biotechnology announced results from its Phase 3 Eclipse 1 trial of a monthly subcutaneous combination of siRNA therapy elebsiran and monoclonal antibody tobevibart for chronic hepatitis delta.…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • Update: FDA investigates Novartis' Zolgensma following 9 cases of tumors in treated patients
    After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgens…
    BioSpace · 3d ago↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 3d ago↗ source
  • Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trial
    Merck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…
    BioSpace · 6d agoPositive readoutPositive↗ source
  • Moderna reports 29% revenue rise as COVID vaccine sales stay steady amid global uptake
    Moderna said its quarterly revenue jumped 29% to $1.3 billion, driven by continued demand for its COVID-19 shots. The company has generated $1.8 billion in revenue so far this year, according to CF…
    BioSpace · 6d agoEarningsPositive↗ source
  • Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November
    Also lined up are target action dates for Sanofi’s Gaucher disease therapy, GSK’s lung cancer medicine and BridgeBio’s muscular dystrophy drug.
    BioSpace · 6d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 6d agoApprovalPositive↗ source
  • RevMed's pancreatic cancer drug Rasonque generates $198M in Q3, far exceeding forecasts
    RevMed reported $198 million in revenue from its newly launched pancreatic cancer therapy Rasonque during the third quarter, roughly ten times the $19 million estimate from Truist Securities. The…
    BioSpace · 7d agoPositive readoutPositive↗ source
  • AstraZeneca reportedly bids $10 billion for metabolic biotech Rhythm Pharmaceuticals
    AstraZeneca is said to have made a $10 billion offer to acquire Rhythm Pharmaceuticals, a biotech that develops treatments for rare neuroendocrine disorders. The proposal values Rhythm at $124 per…
    BioSpace · 7d agoDealPositive↗ source
  • Novartis reports nine tumor cases in patients treated with Zolgensma gene therapy
    Novartis has confirmed that nine cases of tumors have been reported in patients who received its spinal muscular atrophy gene therapy, Zolgensma. The company says two cases are confirmed and seven…
    BioSpace · 7d agoNegative↗ source
  • British biotech T-Therapeutics raises $133 million Series B to advance bispecific T-cell engagers
    T-Therapeutics, a British biotech, announced a $133 million Series B financing to advance its next-generation T-cell engager therapeutics. The round was co-led by Advent Life Sciences and the Brit…
    BioSpace · 7d agoDealPositive↗ source
  • Madrigal’s 2024 MASH drug sparks new wave of diagnosis and personalized treatment approaches
    The article argues that the field of metabolic dysfunction‑associated steatohepatitis (MASH) is entering a period of rapid innovation, and that the industry must broaden efforts in diagnosis, monit…
    BioSpace · 7d agoPositive↗ source
  • Podcast explores how intratumoral injections may spark systemic cancer immunity
    In a recent episode of BioSpace's Denatured podcast, host Jennifer C. Smith-Parker spoke with Lewis Bender, CEO of Intensity Therapeutics, and Paul-Peter Tak, president and CEO of Candel Therapeuti…
    BioSpace · 7d agoNeutral↗ source
  • BioSpace lists top 12 biopharma employers hiring in July 2026
    BioSpace released a list of the twelve biopharma firms with the most job postings in July 2026. The list includes AbbVie, Regeneron, Amgen, Eli Lilly, Sanofi, Novo Nordisk, Moderna, Insmed, Freder…
    BioSpace · 7d agoNeutral↗ source
  • Recon: Sino, Boehringer ink cancer drug deal worth $7B; CVS to split pharmacy business from insurance
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 7d ago↗ source
  • China targets five $1 billion blockbuster drugs by 2030, two already achieved
    China's latest five-year plan aims to develop five domestically created drugs that each generate over $1 billion in global sales by 2030. According to industry analysts, two drugs have already sur…
    BioSpace · 8d agoPositive↗ source