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3,535 stories matching this filter · ← front page

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  • Federal judge blocks narrow Medicaid frailty definition, expanding work-requirement exemptions
    Federal judge Richard D. Stearns in Massachusetts issued a permanent injunction against the new federal definition of “medical frailty” used to limit Medicaid work‑requirement exemptions. The judg…
    STAT · 12d agoRegulatoryNeutral↗ source
  • HHS permits compounding of six experimental peptides despite FDA scientists' safety concerns
    HHS issued a temporary policy that lets licensed pharmacies and physicians compound six experimental peptides without risk of federal enforcement. The list includes the injury-recovery duo BPC-157…
    STAT · 13d agoRegulatoryPositive↗ source
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  • Lilly can’t stop, won’t stop as revenue climbs 39% thanks to GLP-1 bestsellers
    Eli Lilly’s shares rose 4% in early morning trading after reporting revenue of $24.4 billion, well past consensus estimates.
    BioSpace · 13d agoEarningsNeutral↗ source
  • HHS issues temporary policy permitting compounding pharmacies to produce certain peptide drugs
    The U.S. Department of Health and Human Services announced a new policy that temporarily authorizes compounding pharmacies to manufacture specific peptide products that are not otherwise commercial…
    STAT · 13d agoRegulatoryNeutral↗ source
  • HHS adopts enforcement discretion allowing compounding pharmacies to produce six unapproved peptides
    HHS announced an "enforcement discretion" policy that permits compounding pharmacies to make six peptide products that have not received FDA approval. The list includes BPC-157 and TB-500, which a…
    BioSpace · 13d agoRegulatoryNeutral↗ source
  • SLR Food Distribution recalls Wise Wife ground cinnamon over possible lead contamination
    SLR Food Distribution Inc., based in Hicksville, New York, announced a voluntary recall of its Wise Wife brand ground cinnamon. The recall was issued because the product may be contaminated with e…
    fda recalls · 12d agoRegulatoryNegative↗ source
  • STAT Health Tech newsletter previews EPIC probe, Teladoc surprise and AI payment challenges
    The latest STAT Health Tech newsletter, authored by correspondent Mario Aguilar, highlights several emerging topics in health technology. It flags an upcoming investigation into EPIC, the electroni…
    STAT · 13d agoNeutral↗ source
  • RFK Jr. Addresses Iowa Rally Calling for Covid Vaccine Removal and Highlighting MAHA Movement
    At a rally in Clive, Iowa, a group calling themselves Make America Healthy Again gathered with Republican candidates to criticize big agriculture and demand the removal of the Covid-19 vaccine from…
    STAT · 13d agoNeutral↗ source
  • Biostatistician Martin Kulldorff Criticizes NIH Gatekeepers Over Measles Claims
    Martin Kulldorff, a biostatistician known for his opposition to Covid lockdowns, delivered a lecture at the National Institutes of Health in which he challenged the role of scientific gatekeepers.…
    STAT · 13d agoNeutral↗ source
  • STAT+: Federal judge rejects new Medicaid ‘frailty’ definition for work requirements
    A judge ruled that federal regulators exceeded their authority in narrowing the exceptions to Medicaid work requirements for people with medical issues.
    STAT · 12d ago↗ source
  • Genmab’s bispecific antibody petosemtamab plus Keytruda cuts death risk by half in Phase 3 head‑and‑neck cancer trial
    Genmab announced that its bispecific antibody petosemtamab, combined with Merck’s Keytruda, met both co‑primary endpoints in a Phase 3 trial for head‑and‑neck squamous cell carcinoma. The LiGeR‑HN…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Genmab's bispecific combo with Keytruda halves death risk in phase 3 head‑neck cancer trial
    Genmab announced interim results from its phase 3 LiGeR-HN1 study, showing that adding the bispecific antibody petosemtamab to Merck's Keytruda significantly improved outcomes for patients with PD-…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Lilly's retatrutide outperforms Ozempic in weight loss and blood sugar reduction in head-to-head diabetes trial
    Eli Lilly reported that its experimental drug retatrutide showed greater efficacy than Novo Nordisk’s Ozempic in a large diabetes trial. After 80 weeks, participants receiving the highest dose of…
    STAT · 14d agoPositive readoutPositive↗ source
  • Lilly's retatrutide outperforms Ozempic in phase 3 trial, cutting blood sugar and weight more
    Eli Lilly tested its triple-G candidate retatrutide against Novo Nordisk's Ozempic (semaglutide) in an open-label phase 3 study involving about 1,300 adults with type 2 diabetes whose glucose was n…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Big pharma holds $188 bn for M&A, J&J seen as most likely buyer, analysis shows
    The latest Leerink Partners analysis finds that the largest pharmaceutical companies collectively have about $188 billion in cash available for mergers and acquisitions. All but one of the firms su…
    BioSpace · 14d agoDealPositive↗ source
  • FDA issues draft guidance to streamline approval of personalized gene therapies and expands CMS access model
    The Food and Drug Administration released a draft guidance that lets a single biologics license application cover multiple variants of a gene‑therapy product. The guidance introduces an Individuali…
    BioSpace · 14d agoRegulatoryPositive↗ source
  • Astellas signs up to $1.34 billion option deal for Audax's DAX-044 immuno-oncology candidate
    Astellas Pharma announced it will pay up to $1.34 billion for an exclusive option to license Audax Biosciences' investigational antibody-cytokine fusion, DAX-044. The agreement includes an undiscl…
    BioSpace · 14d agoDealPositive↗ source
  • Astellas commits up to $285M upfront for Audax's preclinical IL-12 program, with potential $1.05B milestones
    Astellas Pharma has entered a licensing agreement with Audax Biosciences to gain rights to the latter’s IL-12 immuno‑oncology candidate DAX‑044. Under the deal, Astellas will pay up to $285 millio…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Geron halts phase 3 Rytelo trial after data monitoring panel deems unlikely to improve survival in JAK-inhibitor-pretreated myelofibrosis
    Geron announced the discontinuation of its phase 3 IMpactMF trial of Rytelo (imetelstat) in patients with myelofibrosis who had previously failed JAK inhibitor therapy. The decision followed an in…
    Fierce Biotech · 13d agoNegative readoutNegative↗ source
  • Biogen sees continued revenue growth and pipeline readouts, M&A not essential, CEO says
    Biogen reported third‑quarter earnings, marking a third straight quarter of revenue growth driven by its marketed products. The increase stemmed from higher sales of the Alzheimer’s therapy Leqemb…
    BioSpace · 14d agoEarningsPositive↗ source
  • FDA drafts guidance to speed approvals of individualized gene therapies, hailed as win for rare disease patients
    The U.S. Food and Drug Administration released draft guidance aimed at streamlining the approval process for certain individualized gene therapies. The proposal would allow sponsors to avoid filing…
    STAT · 14d agoRegulatoryNeutral↗ source
  • Biogen posts third consecutive quarter of revenue growth, driven by Leqembi, Spinraza and Apellis products
    Biogen reported $2.8 billion in revenue for the third quarter, marking its third straight period of top‑line growth. The company credited its growth portfolio, led by the Alzheimer’s therapy Leqem…
    BioSpace · 14d agoEarningsPositive↗ source
  • Five newly approved drugs achieve strong launches by offering superior efficacy, pricing and access
    Over the past year several newly approved therapies have entered the market with sales and uptake that far exceed analyst expectations, driven by strong clinical data, reasonable pricing and easy p…
    BioSpace · 14d agoPositive↗ source
  • Biotech firms must adopt global regulatory strategies to commercialize drugs independently
    Biotech developers are increasingly able to fund the pursuit of regulatory approval and commercial launch on their own, rather than selling their assets early. This new option is driven by a reboun…
    BioSpace · 14d agoRegulatoryPositive↗ source
  • Oura and UC San Diego Health launch trial linking smart ring data to obesity treatment outcomes
    Oura and UC San Diego Health have partnered on a multi-year clinical trial called SMART-BMI to explore how continuous data from the Oura Ring may reflect patient response to obesity therapies. The…
    Fierce Biotech · 13d agoPositive↗ source