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562 stories matching this filter · ← front page

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  • Health Secretary Kennedy criticizes CDC vaccine classification scheme and shared decision-making category
    Robert F. Kennedy Jr., serving as Health Secretary, has raised concerns about how the CDC categorizes vaccine recommendations. The CDC uses three categories: routine recommendations for universal…
    BioSpace · 14d agoRegulatoryNegative↗ source
  • Australian regulator TGA opens consultation on automated decision making for listed medicine variations
    The Therapeutic Goods Administration has launched a public consultation to gather input on proposed changes that would enable automated decision making for variation applications of listed medicine…
    raps · 14d agoRegulatoryNeutral↗ source
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  • Boehringer Ingelheim pauses Phase 1 study of oral candidate BI 3031185 after safety event
    Boehringer Ingelheim has placed a Phase 1 study of its oral candidate BI 3031185 on hold after a safety event was identified. The trial, run in Japan with healthy volunteers, was assessing tolerab…
    BioSpace · 14d agoCRLNegative↗ source
  • US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deaths
    Three recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…
    BioSpace · 17d agoRegulatoryNegative↗ source
  • Werewolf Therapeutics merges with Ambros in $150M deal to advance non‑opioid painkiller for rare limb injury syndrome
    Werewolf Therapeutics and Ambros Therapeutics announced a merger valued at $150 million, creating a new company that will retain the Ambros name. The deal includes a private placement to fund the…
    BioSpace · 17d agoDealPositive↗ source
  • Novo Nordisk launches Phase 3 trial of lower maintenance doses of oral Wegovy for obesity
    Novo Nordisk has begun a Phase 3, placebo-controlled study called OASIS 5 to evaluate two lower oral doses of its GLP-1 weight-loss drug Wegovy (semaglutide) in people who are obese or overweight.…
    BioSpace · 17d agoCRLNeutral↗ source
  • Capricor shareholders face board overhaul push as investors demand meeting and capital-preservation plan amid DMD cell therapy delay
    Kaos Capital, describing itself as a significant shareholder of Capricor Therapeutics, sent a letter to fellow investors calling for an immediate meeting, a change of the board, and a capital-prese…
    BioSpace · 17d agoNegative↗ source
  • Merck and Moderna’s melanoma vaccine shows positive Phase 3 results, boosting investor confidence
    Merck and Moderna announced that their personalized melanoma vaccine met the primary endpoint of recurrence‑free survival in a Phase 3 trial when given together with Keytruda. The study showed pati…
    BioSpace · 18d agoPositive readoutPositive↗ source
  • Roche commits $750 million to double Oregon plant capacity as obesity drug push grows
    Roche's Genentech announced a $750 million investment to enlarge its device fill-finish facility in Hillsboro, Oregon. The expansion will double the plant's size and add end-to-end capabilities fo…
    BioSpace · 18d agoDealPositive↗ source
  • Scribe Therapeutics’ early-stage IPO surges 43% as epigenetic cholesterol drug enters clinic
    Scribe Therapeutics filed for an IPO while its lead epigenetic therapy moves into early clinical testing, a rare combination in a market that prefers later-stage, de-risked offerings. The company…
    BioSpace · 18d agoPositive↗ source
  • Regeneron secures FDA approval for Pasatru, second U.S. treatment for rare bone disease FOP
    Regeneron received FDA approval for its antibody garetosmab, marketed as Pasatru, for treatment of fibrodysplasia ossificans progressiva (FOP) in adults. The approval makes Pasatru the second ther…
    BioSpace · 18d agoApprovalPositive↗ source
  • Layoffs hit over 1,300 workers across seven biopharma M&A deals in 2026
    Workforce reductions this year have affected at least seven biopharma companies that recently completed mergers or acquisitions, eliminating a minimum of 1,359 jobs, according to BioSpace data. Th…
    BioSpace · 18d agoLayoffsNegative↗ source
  • Trump nominates Heidi Overton as FDA Commissioner as agency releases CGT Q&A guidance
    The U.S. Food and Drug Administration issued final guidance that answers common questions about developing cellular and gene therapy products. The document aims to clarify regulatory expectations f…
    raps · 18d agoRegulatoryNeutral↗ source
  • Ultragenyx secures first gene therapy approval for GSDIa as Sanfilippo asset decision pending
    Ultragenyx received accelerated FDA approval for its gene therapy DTX401, marketed as Genglycos, to treat glycogen storage disease type Ia (GSDIa). The approval comes as the company awaits a secon…
    BioSpace · 18d agoApprovalPositive↗ source
  • Biotech firms EMD Serono and Exelixis cut remote R&D staff as they enforce office return policies
    Biopharma workers at two biotech companies are losing jobs as employers shift away from remote work. The changes affect research and development staff who were previously allowed to work from home.…
    BioSpace · 18d agoLayoffsNegative↗ source
  • FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation hurdles
    The U.S. Food and Drug Administration has granted approval to Ultragenyx's gene therapy aimed at treating a glycogen storage disorder. This marks a regulatory milestone for the company and the rare…
    raps · 18d agoApprovalPositive↗ source
  • Experts discuss persistent CMV challenges and new antiviral approaches for transplant patients
    In a recent episode of BioSpace's Denatured podcast, Ian McGowan, chief medical officer of Synklino, and James Hunter, an associate professor of transplantation at Oxford University, joined host Je…
    BioSpace · 18d agoNeutral↗ source
  • Pediatric rare cancer research draws steady investment despite biotech market volatility
    The article notes that pediatric rare cancers continue to attract investment because they address the greatest unmet medical needs and allow clear measurement of patient impact. Even as the biotec…
    BioSpace · 18d agoPositive↗ source
  • Experts call for modernizing rare disease evidence models using FDA plausible mechanism framework
    A recent paper in The Journal of Clinical Investigation argues that the evidentiary approach for rare diseases needs updating. The authors suggest applying the FDA’s plausible mechanism framework,…
    raps · 18d agoNeutral↗ source
  • EMA launches consultation on draft framework to speed adoption of data standards
    EMA has opened a public consultation on a draft framework aimed at accelerating the implementation of data standards across the pharmaceutical sector. The agency says the new framework is intended…
    raps · 18d agoRegulatoryNeutral↗ source
  • Moderna shares surge as Merck-Moderna mRNA melanoma vaccine meets Phase 3 endpoint
    Merck and Moderna reported that their personalized mRNA cancer vaccine, combined with Merck’s Keytruda, slowed melanoma recurrence in a Phase 3 study. The interim analysis showed a statistically si…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • Heidi Overton nominated as FDA commissioner, seen as boost for psychedelics and non-opioid pain drugs
    President Donald Trump announced that he will nominate Heidi Overton, a current White House policy advisor, to serve as the next FDA commissioner pending Senate confirmation. Analysts say Overton’…
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • Enveda’s oral obesity pill shows strong GI safety in Phase 1, paving way for trials in patients off GLP-1 drugs
    Enveda reported that its Phase 1 study of the oral obesity candidate ENV-308 demonstrated an exceptional gastrointestinal safety profile in healthy volunteers. The topline data, released on August…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • Takeda’s FDA-approved Orzeyful expands treatment to all narcolepsy symptoms, challenging existing sleep drugs
    The U.S. Food and Drug Administration approved Takeda's drug Orzeyful in August, marking the first therapy that addresses the full spectrum of narcolepsy symptoms, including cataplexy and excessive…
    BioSpace · 19d agoApprovalPositive↗ source
  • Novo Nordisk leads early in oral obesity market, but analysts doubt lasting advantage
    Novo Nordisk's oral formulation of Wegovy generated DKK 3.22 billion (about $496 million) in revenue in the second quarter of 2026, far outpacing Eli Lilly's newly approved oral weight‑loss pill Fo…
    BioSpace · 19d agoNeutral↗ source