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  • U.S. experts to evaluate if measles elimination status still holds amid rising cases
    Noel T. Brewer, chair of the U.S. National Verification Committee, explains that his group will review the CDC’s annual measles report to decide if the United States continues to meet elimination c…
    STAT · 5d agoNegative↗ source
  • InstallatørGruppen reports share transaction by board linked entity Absalon Holdings
    InstallatørGruppen A/S filed a notification under the EU Market Abuse Regulation, article 19, to disclose a share transaction involving a person discharging managerial responsibilities and their cl…
    globenewswire health · 5d agoRegulatoryNeutral↗ source
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  • Second child death reported in Chinese CRISPR trial for Duchenne muscular dystrophy raises safety concerns
    A second child death has been reported from a Chinese CRISPR gene-editing trial aimed at treating Duchenne muscular dystrophy, reviving concerns about the safety and transparency of such studies.…
    STAT · 5d agoRegulatoryNegative↗ source
  • Eli Lilly Q2 revenue hits $23 billion, topping forecasts as tirzepatide drives two-thirds of sales
    Eli Lilly reported second-quarter revenue of $23 billion, roughly $3 billion above analysts' estimates. Tirzepatide contributed about 64% of the total, highlighting its central role in the company…
    Endpoints · 6d agoEarningsPositive↗ source
  • FDA approves Takeda's orexin drug for narcolepsy type 1
    Takeda has received FDA approval for its orexin agonist intended to treat narcolepsy type 1. The decision ends a closely watched commercial race to bring an orexin-based therapy to market. With a…
    Endpoints · 5d agoApprovalPositive↗ source
  • FDA approves Takeda’s orexin receptor agonist for narcolepsy, opening new drug class
    The FDA has granted approval to Takeda's novel narcolepsy medication, the first orexin receptor agonist to receive clearance. The twice‑daily pill, marketed as Orzeyful, is indicated for narcoleps…
    STAT · 5d agoApprovalPositive↗ source
  • Novo Nordisk looks to bolt-on acquisitions as pipeline setbacks mount
    Novo Nordisk CEO Maziar Mike Doustdar said on a media call that the pharma industry is tough for those who dislike setbacks and failure. He highlighted recent disappointments in the company's pipe…
    Endpoints · 6d agoDealNeutral↗ source
  • Attovia Therapeutics raises $289 million in IPO, adding third I&I drug to market debut
    Attovia Therapeutics, a biotech focused on immunology and inflammation, completed an initial public offering that raised about $289 million. The funds will support the development of three I&I dru…
    Endpoints · 6d agoDealPositive↗ 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 · 6d agoEarningsPositive↗ source
  • 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 · 5d agoRegulatoryNeutral↗ 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 · 5d agoDealNeutral↗ 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 · 5d agoRegulatoryNeutral↗ 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 · 6d agoDealPositive↗ 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 · 6d 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 · 6d agoRegulatoryNeutral↗ 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 · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 6d 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 · 6d 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 · 6d 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 · 5d agoRegulatoryNeutral↗ source
  • Senate confirms Erica Schwartz as new CDC director
    The U.S. Senate voted 51 to 44 on Wednesday to confirm Erica Schwartz as the next director of the Centers for Disease Control and Prevention. Schwartz, a former deputy surgeon general and a vetera…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Atossa Therapeutics CEO Steven Quay likely to become NIAID director
    Steven Quay, founder and CEO of Atossa Therapeutics, is reported to be the likely choice for director of NIH's National Institute of Allergy and Infectious Diseases. The report notes his backgroun…
    Endpoints · 5d agoNeutral↗ source