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  • InstallatørGruppen reports insider share transaction involving board members' associate
    InstallatørGruppen A/S has filed a Market Abuse Regulation (EU) No. 596/2014 notification under article 19, disclosing a recent share transaction. The transaction was executed by Absalon Holdings…
    globenewswire health · 13d agoRegulatoryNeutral↗ source
  • 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 · 13d agoNegative↗ source
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  • 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 · 13d agoRegulatoryNeutral↗ source
  • 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 · 14d agoRegulatoryNegative↗ source
  • Eli Lilly posts $23 B Q2 revenue, beats forecasts as Foundayo lags behind Novo's oral GLP-1
    Eli Lilly reported second‑quarter revenue of $23 billion, a 48% increase from the prior year and well above analysts' expectations. The strong top‑line helped the company deliver a sizable earnings…
    BioSpace · 14d agoEarningsNeutral↗ source
  • Lilly and FDA clash over retatrutide classification as company nears submission
    Eli Lilly is preparing to file its obesity drug candidate retatrutide for approval while a legal dispute with the FDA over the drug's classification intensifies. The agency has concluded that reta…
    BioSpace · 14d agoRegulatoryNeutral↗ source
  • 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 recalls · 14d agoCRLNegative↗ 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 · 14d agoApprovalPositive↗ source
  • Lilly's Foundayo obesity pill posts $98 million Q2 sales, trails Novo's Wegovy
    Eli Lilly introduced its oral obesity treatment Foundayo after receiving FDA approval in April 2025. The drug entered the market in the second quarter of 2026, marking Lilly's first foray into an o…
    BioSpace · 14d agoNegative readoutNeutral↗ source
  • Analysts spot several biotech firms as likely M&A targets amid rising pharma deal activity
    Pharma companies are actively looking for acquisition opportunities, and analysts have identified a handful of biotech firms that could be next in line for buyouts. Recent transactions have center…
    BioSpace · 14d agoDealNeutral↗ 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 · 14d 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 · 14d 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 · 14d agoNegative↗ 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d agoEarningsNeutral↗ 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 · 14d 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 · 14d 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 · 14d 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 · 14d agoPositive↗ 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 · 14d 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 · 14d agoPositive readoutPositive↗ 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 · 14d agoNeutral↗ source