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2,230 stories matching this filter · ← front page

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  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda medwatch · 16d agoCRLNegative↗ source
  • Gilead's HIV prevention shot Yeztugo posts $232 million Q2 sales, beating forecasts
    Gilead reported that its biannual injectable for HIV pre‑exposure prophylaxis, Yeztugo, generated $232 million in revenue during the second quarter. This figure exceeds analysts' consensus estimat…
    Endpoints · 16d agoEarningsPositive↗ source
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Infectious Disease360
  • Erica Schwartz confirmed as CDC director, ending year-long vacancy
    Erica Schwartz was confirmed on Wednesday as the director of the Centers for Disease Control and Prevention, ending a vacancy that lasted almost a year. The Senate approved her appointment by a 51-…
    STAT · 16d agoRegulatoryNeutral↗ source
  • AstraZeneca and BMS deny merger talks, Reuters says no deal
    Reuters reported that rumors of a merger between AstraZeneca and Bristol Myers Squibb have been dismissed. A senior source close to the matter told Reuters there is no deal and no discussions betw…
    BioSpace · 16d agoDealNeutral↗ source
  • Over a third of biotech and pharma workers stay in their jobs for health insurance, poll shows
    A recent BioSpace LinkedIn poll and a joint study by West Health and Gallup found that a significant share of biotech and pharma employees remain in their current roles primarily to keep health ins…
    BioSpace · 16d agoNegative↗ source
  • Arrowhead Pharma to pay $215 million for PRV in its latest acquisition
    Arrowhead Pharmaceuticals disclosed in an SEC filing that it will acquire PRV for $215 million, marking the highest price tag for a deal this year. The purchase aligns with Arrowhead's strategy of…
    Endpoints · 16d agoDealNeutral↗ source
  • FDA advisory committee meetings sow confusion, threaten trust with rare disease developers
    The Food and Drug Administration has been working to repair its relationship with rare-disease drug makers and patient groups since former commissioner Marty Makary left three months ago. Last wee…
    BioSpace · 16d agoRegulatoryNegative↗ source
  • Gilead pushes into inflammation and oncology as it seeks to diversify beyond HIV franchise
    Gilead reported that HIV remained its strongest franchise in the second quarter, but the company is actively building a pipeline outside virology. CEO Daniel O’Day told investors that diversificat…
    BioSpace · 16d agoNeutral↗ source
  • Medicare GUARD pilot faces biotech push to spare rare disease drugs as Moderna begins first-in-human Ebola vaccine trial
    The Medicare Part D GUARD pilot, designed to lower retail drug prices, is under scrutiny because excluding rare disease medicines would erase most of the projected savings, according to STAT. Biot…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Amgen drops Phase 1 obesity drug AMG 513, leaving MariTide as its only weight-loss candidate and eyes early-stage deals
    Amgen announced it is halting development of AMG 513, a Phase 1 obesity therapy, leaving MariTide as its sole weight‑loss asset. The company said its late‑stage pipeline is largely full, so future…
    BioSpace · 16d agoDealNeutral↗ source
  • Novo Nordisk CEO says innovation is essential as pipeline faces setbacks
    During Novo Nordisk's second-quarter earnings call, CEO Maziar Mike Doustdar said that failure is a normal part of drug development and emphasized that the company's survival depends on continual i…
    BioSpace · 16d agoEarningsNeutral↗ source
  • Expedition Therapeutics raises $115M Series B for China-sourced COPD candidate
    Expedition Therapeutics, a US biotech, announced a $115 million Series B financing round. The capital will be used to advance its COPD drug candidate that is being developed from a China-sourced p…
    Endpoints · 16d agoDealPositive↗ source
  • Merger talks between Bristol Myers Squibb and AstraZeneca fade as Q2 earnings roll out and FDA advisory meetings heat up
    Talks of a possible merger between Bristol Myers Squibb and AstraZeneca have receded after analysts highlighted antitrust hurdles. Both companies, each valued over $130 billion, were rumored to con…
    BioSpace · 16d agoDealNeutral↗ source
  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 16d agoNegative↗ source
  • Excluding orphan drugs from Medicare pricing pilots could erase most savings, analysis shows
    A Harvard researcher has calculated that removing rare disease treatments from two Medicare pilot programs-GLOBE and GUARD-would dramatically cut the projected cost savings. The pilots are designe…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Five BioSpace NextGen companies debut on US markets in 2026, four actively hiring
    BioSpace NextGen honorees accounted for about one third of the 14 U.S. biotech companies that went public in 2026. The five companies together raised roughly $1.5 billion in IPO proceeds, includin…
    BioSpace · 16d agoPositive↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 16d agoCRLNegative↗ source
  • Federal regulators hold closed-door meetings with tech firms to advance clinical AI adoption
    Federal health officials, including the FDA, CMS and HHS, convened a closed-door "clinical AI demo day" to discuss how to safely expand the use of artificial intelligence in clinical settings. The…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Early-stage trial shows fecal microbiome capsules improve peanut tolerance in some participants
    An early-phase clinical study examined whether oral capsules containing fecal microbiome material could help people with peanut allergy. Six volunteers received the treatment and were later exposed…
    STAT · 16d agoPositive readoutPositive↗ source
  • WuXi AppTec posts six-month revenue higher than Lonza for first time
    WuXi AppTec, a Chinese contract manufacturing organization, has reported that its revenue over the most recent six-month period exceeded that of Swiss CDMO Lonza for the first time. The increase c…
    Endpoints · 16d agoPositive↗ source
  • Moderna begins early-stage trial of mRNA Ebola vaccine
    Moderna announced the launch of an early-phase clinical trial testing an mRNA vaccine designed to protect against Ebola virus. The study will enroll healthy volunteers to evaluate the vaccine's saf…
    STAT · 16d agoNeutral↗ source
  • AstraZeneca and Bristol Myers Squibb abandon merger talks
    Reuters reported that AstraZeneca and Bristol Myers Squibb have ended discussions about a possible merger and will not pursue a deal. The collapse of the talks removes a potential consolidation th…
    Endpoints · 16d agoDealNegative↗ source
  • Medicaid policy shift could alter primary therapy for children with autism
    The article notes that the main therapy used for children with autism may be affected by upcoming Medicaid policy changes. It highlights that the therapy, which is a cornerstone of treatment for ma…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Senate probes alleged quid pro quo in Trump administration's easing of kratom and tobacco rules
    Senate Finance Committee's top Democrat has opened an inquiry into recent policy changes affecting flavored vaping products and kratom, alleging the Trump administration softened regulations in exc…
    STAT · 16d agoRegulatoryNegative↗ source
  • STAT+: Federal regulators invite industry, researchers, and lobbyists to closed-door meetings on clinical AI
    Federal health officials invited tech companies and lobbyists to closed-door meetings as they seek to boost adoption of clinical AI.
    STAT · 16d agoRegulatoryNeutral↗ source