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  • 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 · 24d 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 · 24d agoNeutral↗ source
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Infectious Disease456
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 · 24d agoDealPositive↗ source
  • President Trump nominates White House aide Heidi Overton as FDA Commissioner
    President Donald Trump announced on his Truth Social platform that Heidi Overton, a White House aide, will be nominated to lead the U.S. Food and Drug Administration. Overton is set to replace Mar…
    raps · 24d agoRegulatoryNeutral↗ 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 · 24d 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 · 24d 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 · 25d 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 · 25d 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 · 24d agoDealPositive↗ source
  • FDA releases discussion paper seeking input on regulation of generative AI medical devices
    The U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…
    fda press · 25d agoRegulatoryNeutral↗ 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 · 25d 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 · 25d 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 · 25d 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 · 25d 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 · 25d agoRegulatoryPositive↗ source
  • FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reform
    The U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
    raps · 25d agoRegulatoryNeutral↗ 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 · 25d 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 · 25d agoPositive↗ source
  • FDA updates guidance to clarify ANDA and 505(b)(2) approval pathways
    The FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…
    raps · 25d agoRegulatoryNeutral↗ source
  • Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
    More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices sugg…
    raps · 25d agoRegulatoryNeutral↗ source
  • Study finds measuring non-clinical influences on FDA approvals is complex
    A new study examined how non-clinical factors might affect the U.S. Food and Drug Administration's drug approval decisions. Researchers concluded that quantifying such influences is challenging be…
    raps · 25d agoRegulatoryNeutral↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 25d agoRegulatoryNeutral↗ source
  • FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax
    Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.
    BioPharma Dive · 26d agoApprovalPositive↗ source
  • Argenx reports positive Phase 3 results for Vyvgart Hytrulo in myositis
    Argenx announced that its subcutaneous formulation of Vyvgart, named Vyvgart Hytrulo, met the primary endpoint in a late‑stage Phase 3 trial in patients with myositis. The trial combined participa…
    BioPharma Dive · 25d agoPositive readoutPositive↗ source
  • FDA approves Zenbexus for multiple myeloma as NSAI looks to sell MDR notified body unit
    The U.S. Food and Drug Administration has granted approval for Zenbexus to be used in the treatment of multiple myeloma, marking a new therapeutic option for patients with this blood cancer. The a…
    raps · 26d agoApprovalPositive↗ source