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925 stories matching this filter · ← front page

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  • 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 · 25d agoPositive↗ 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 · 26d agoPositive readoutPositive↗ source
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  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 26d 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 · 25d 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 · 26d 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 · 26d 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 · 26d agoNeutral↗ source
  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 25d agoRegulatoryNeutral↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump is reported to be selecting Deputy Director of the White House Domestic Policy Council Heidi Overton, a physician, to be the next FDA commissioner, pending Senate confirmatio…
    BioSpace · 26d agoRegulatoryNeutral↗ source
  • Biopharma hiring surges in New Jersey, 11 companies post dozens of new roles
    BioSpace data shows job postings for biopharma positions in New Jersey have risen year over year, with a notable 73% jump in July compared with the same month last year. The upward trend has persi…
    BioSpace · 26d agoPositive↗ source
  • Amylyx reports promising GLP-1 blocker results while Summit faces survival setbacks and Definium shows anxiety therapy benefit
    Amylyx said its investigational GLP-1 blocker avexitide cut the combined rate of level 2 and level 3 hypoglycemic events by about 55% in patients with post‑bariatric hypoglycemia, beating analyst e…
    BioSpace · 26d agoNeutral↗ source
  • LabCentral partners with Hong Kong Science and Technology Parks to link biotech founders across US and China
    LabCentral, a Massachusetts biotech accelerator, signed a memorandum of understanding with Hong Kong Science and Technology Parks Corporation (HKSTP) in June at the BIO International Convention. T…
    BioSpace · 26d agoDealPositive↗ source
  • Why Biopharma Executives Should Hire an ‘Implementer’ to Turn Ideas into Action
    Leadership Lab is a new column aimed at biopharma leaders facing real‑world pressures. In the opening piece, Michael Pietrack of Kaye/Bassman International argues that the most valuable hire for an…
    BioSpace · 26d agoPositive↗ source
  • AstraZeneca’s Tagrisso plus Orpathys improves survival in MET-mutated lung cancer
    A new combination therapy using AstraZeneca’s Tagrisso together with Hutchmed’s Orpathys has shown a survival benefit for patients with a specific form of non‑small cell lung cancer. The study focu…
    BioPharma Dive · 26d agoPositive readoutPositive↗ source
  • Leo Pharma to acquire experimental rare-skin disease drug dersimelagon in up to $435 million deal
    Leo Pharma announced it will acquire the rights to dersimelagon, an experimental oral therapy currently under FDA review, in a transaction that could total up to $435 million in upfront and near‑te…
    BioPharma Dive · 26d agoDealNeutral↗ source
  • Amylyx reports avexitide cuts severe hypoglycemia by 55% in bariatric surgery patients
    Amylyx Pharmaceuticals announced that its GLP-1 blocker avexitide achieved the primary endpoint in a late‑stage trial, reducing serious to severe hypoglycemic events by 55% compared with placebo in…
    BioPharma Dive · 27d agoPositive readoutPositive↗ source
  • BioMarin to buy Alesta Therapeutics for $275M, adding rare bone disease drug to pipeline
    BioMarin announced Tuesday that it will acquire privately held Alesta Therapeutics, paying $275 million upfront with potential additional payments tied to milestones. The deal, expected to close b…
    BioPharma Dive · 26d agoDealPositive↗ source
  • LEO Pharma spends $435 million to acquire rare-disease skin drug dersimelagon
    LEO Pharma announced it will pay $435 million to buy the rights to dersimelagon, an oral MC1R agonist originally developed by Tanabe Pharma. The drug has completed Phase 3 trials for two rare phot…
    BioSpace · 27d agoDealPositive↗ source
  • Biotech funding rebound set to boost CDMO demand by early 2027
    Analysts note that demand for pharma services has historically lagged behind biotech funding, but a recent surge in venture capital is expected to drive activity for contract development and manufa…
    BioSpace · 27d agoPositive↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial after safety concerns
    Regeneron announced termination of a Phase 1/2 study of its investigational anti-inflammatory antibody REGN7041, which was being evaluated for non-infectious uveitis. The company said the decision…
    BioSpace · 27d agoNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial over unfavorable risk-benefit profile
    Regeneron has stopped a Phase 1/2 study of its anti‑inflammatory antibody REGN7041 in non‑infectious uveitis, citing an unfavorable benefit‑risk assessment. The antibody targets CD3 on immune cell…
    BioSpace · 27d agoNegative readoutNegative↗ source
  • Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemia
    Amylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass s…
    BioSpace · 27d agoRegulatoryPositive↗ source
  • Sandoz inks $322M Henlius deal for rights to as many as 10 biosimilars
    The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.
    BioSpace · 27d agoDealNeutral↗ source
  • AI and data sharing essential for safer cell and gene therapies, says industry leader
    The author argues that keeping data secret in cell and gene therapy harms patients, and that a commitment to transparency and artificial intelligence is needed to make these treatments safer and mo…
    BioSpace · 27d agoPositive↗ source
  • BD advises recall of sodium chloride ampules in convenience kits after Huons Co. issue
    The FDA issued an Early Alert after Becton Dickinson (BD) sent a letter to customers about a potential high‑risk device issue. The alert concerns convenience kits and procedural trays that contain…
    fda medwatch · 27d agoRegulatoryNegative↗ source