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  • Blackstone bets $1.5B on Pfizer’s obesity drug
    The deal will support a sprawling Phase 3 program for a monthly GLP-1 shot Pfizer acquired by winning a bidding war for the drug’s previous owner, Metsera.
    BioPharma Dive · 1d ago↗ source
  • Novartis' Zolgensma linked to tumors as FDA probes gene therapy and orders GLP-1 eye risk warnings
    Novartis confirmed that nine patients who received its Zolgensma gene therapy for spinal muscular atrophy have developed tumors, prompting the FDA to open an investigation into the approved treatme…
    BioSpace · 2d agoRegulatoryNegative↗ source
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China’s five-year plan positions it to become a global leader in innovative biopharma by 2030
China’s latest five‑year plan sets an ambitious target to turn the country into a major source of innovative medicines for the world market. Experts cited by BioSpace say the goal is within reach,…
BioSpace · 2d agoRegulatoryPositive↗ source
  • Capricor boosts manufacturing capacity as FDA decision on DMD cell therapy looms
    Capricor Therapeutics, a biotech developing a cell therapy for Duchenne muscular dystrophy, is preparing for an FDA decision expected by late November. The company’s third-quarter operating expens…
    BioSpace · 2d agoRegulatoryNeutral↗ source
  • Study warns German drug price hikes could raise US Medicaid spending by $300 million
    A new Harvard Medical School study examined the effect of Germany's drug price increases on the United States under President Trump's most‑favored‑nation policy, which ties US federal drug pricing…
    BioPharma Dive · 2d agoNegative↗ source
  • PepGen stock surges as DM1 oligonucleotide PGN-EDODM1 shows record splicing correction in Phase 2
    PepGen reported that its experimental oligonucleotide PGN-EDODM1 achieved a mean splicing correction of 46.5% at week 13 in a Phase 2 trial for myotonic dystrophy type 1 (DM1). This performance exc…
    BioSpace · 2d agoPositive readoutPositive↗ source
  • AstraZeneca acquires Omniose to boost conjugate vaccine platform as FDA flags vision-loss risk for GLP-1 drugs
    AstraZeneca announced it has acquired vaccine startup Omniose, though the financial terms were not disclosed. The purchase gives AstraZeneca access to Omniose's bioconjugation technology, a method…
    BioPharma Dive · 2d agoDealNeutral↗ source
  • US biotech faces growth slowdown as China’s coordinated investment threatens industry
    During a BioSpace webinar, industry experts warned that uncertainty in U.S. policy is slowing biotech growth while China accelerates its life-science sector with deliberate investment. Strand Ther…
    BioSpace · 2d agoRegulatoryNegative↗ source
  • FDA issues warning letters to two Chinese API makers for refusing record requests
    The U.S. Food and Drug Administration sent warning letters to Chongqing Qiancan Technology and Tianjin Healthcare Medical Technology after both companies declined to provide records the agency requ…
    BioSpace · 2d agoRegulatoryNegative↗ source
  • Capricor trims 10% of workforce as FDA decision on Duchenne cell therapy approaches
    Capricor Therapeutics announced it is cutting about 10% of its staff ahead of an upcoming FDA decision on its Duchenne muscular dystrophy cell therapy, deramiocel. The biotech said it had 231 full…
    BioSpace · 2d 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 · 2d agoRegulatoryNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 2d agoNeutral↗ source
  • Bayer's Sunharbo becomes first FDA-approved factor XIa inhibitor blood thinner
    Bayer's oral anticoagulant Sunharbo, known as asundexian, has received FDA approval, making it the first factor XIa inhibitor cleared for use in the United States. The drug is intended to lower th…
    BioSpace · 3d agoApprovalPositive↗ source
  • Beam Therapeutics reports successful pivotal trial of base editing sickle cell therapy
    Beam Therapeutics announced that its base editing treatment, ristoglogene autogetemcel (risto‑cel), met its primary goal in a pivotal trial for sickle cell disease. The trial showed the therapy cou…
    BioPharma Dive · 3d agoPositive readoutNegative↗ source
  • Beam Therapeutics' base-edited risto-cel shows 12-month pain-crisis freedom in sickle cell trial, paving way for FDA filing
    Beam Therapeutics reported that its base-edited cell therapy, risto-cel, achieved at least 12 consecutive months without severe vaso-occlusive crises in patients with sickle cell disease during a m…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • FDA's new rare-disease framework faces first test with Capricor's Duchenne therapy decision
    The FDA announced a new "fit-for-purpose" rare disease framework that aims to evaluate therapies based on patient need and realistically attainable evidence. The first real test of the approach wi…
    BioSpace · 2d agoRegulatoryNeutral↗ source
  • BIO proposes seven-point plan to keep US biotech ahead of China
    BIO, a major biotech lobbying organization, released a seven‑part “BioAdvance” action plan aimed at preserving U.S. leadership in biotechnology as China rolls out its own five‑year strategy. The p…
    BioPharma Dive · 3d agoRegulatoryPositive↗ 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 · 3d agoLayoffsNegative↗ source
  • London biotech Oyster raises $60 million to develop tau-targeting protein degraders
    Oyster Therapeutics, a London-based biotech, announced it has secured $60 million in an extension of its Series A financing round. The funding will support its lead program that uses a modified pr…
    BioPharma Dive · 3d agoDealPositive↗ 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 · 3d agoRegulatoryPositive↗ source
  • BIO urges US to create White House biotech office and streamline trials to stay ahead of China
    The Biotechnology Innovation Organization (BIO) released a seven-point "Bio Advance" plan aimed at strengthening the United States' biotech sector. The proposals call for easing the start-up of cli…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Altimmune to discuss Phase 3 design for alcohol use disorder drug with FDA
    Altimmune is preparing to meet the FDA in December to discuss the design of a pivotal Phase 3 trial for its glucagon/GLP-1 dual receptor agonist pemvidutide. The Phase 2 RECLAIM study enrolled abo…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Delix raises $100M to advance at-home psychedelic without hallucinatory effects
    The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Experts urge pharma firms to build regulatory intelligence before laws take effect
    Regulatory specialists advise companies not to wait for legislation to be finalized before creating a regulatory intelligence framework. They argue that early preparation helps firms stay ahead of…
    raps · 3d agoRegulatoryNeutral↗ 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 · 3d agoPositive↗ source