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  • BridgeBio’s ATTR drug Attruby posts strong Q2 sales surge as Alnylam trims Amvuttra outlook
    BridgeBio Pharma reported that its transthyretin amyloidosis treatment Attruby generated $222.4 million in second‑quarter sales, more than triple the $71.5 million earned in the same period a year…
    BioSpace · 7d agoEarningsPositive↗ source
  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 7d agoApprovalPositive↗ source
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Infectious Disease346
  • Experts warn of deaths linked to Neurocrine's Vykat XR for Prader-Willi syndrome
    A coalition of specialists in Prader-Willi syndrome has raised serious concerns about the safety profile of Neurocrine Biosciences' drug Vykat XR. The experts point to a series of adverse events,…
    Endpoints · 7d agoRegulatoryNegative↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 7d agoPositive↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 7d agoDealPositive↗ source
  • AbCellera, Silence and InduPro secure major funding rounds as AbCellera completes $200M share sale
    Vancouver based biotech AbCellera announced a $200 million share offering after meeting its efficacy targets in a Phase 2 hot flashes trial. The capital raise follows the company achieving its pred…
    Endpoints · 7d agoDealPositive↗ source
  • Sentynl inks up to $475M licensing deal to commercialize Mereo’s alvelestat for rare lung disease
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, signed an agreement to obtain exclusive U.S. rights to market alvelestat, Mereo BioPharma’s investigational therapy for alpha-1 antitrypsin…
    BioSpace · 7d agoDealPositive↗ source
  • FDA outlines new onshoring incentives and meeting types for generic drug applicants under GDUFA IV
    The FDA released its GDUFA IV commitments, indicating that review timelines for generic drug submissions will remain largely consistent through 2032, mirroring the schedule of the previous five yea…
    Endpoints · 7d agoRegulatoryNeutral↗ source
  • Eli Lilly sues six U.S. entities over illegal retatrutide sales, urges broader crackdown
    Eli Lilly announced legal action against six U.S. entities accused of selling its experimental obesity drug retatrutide on the black market. The lawsuits target compounding pharmacies, medical spa…
    BioSpace · 7d agoRegulatoryNeutral↗ source
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 7d agoPositive readoutPositive↗ source
  • Boulevard Bio raises $65M to expand immunology pipeline, eyes Vera's IgAN candidate
    Boulevard Bio announced it has secured $65 million in financing to broaden its immunology portfolio. The new capital will support the development of two immune‑resetting drugs the company discovere…
    Endpoints · 7d agoDealPositive↗ source
  • Aardvark Therapeutics abandons phase 3 trials after workforce cuts and FDA hold
    Aardvark Therapeutics announced it is walking away from its recently terminated phase 3 trials, stating there are no plans to resume them as originally designed. The decision follows a reduction i…
    Fierce Biotech · 7d agoRegulatoryNegative↗ source
  • Samsung gets FDA clearance for Galaxy Buds hearing-aid features
    Samsung Electronics received FDA clearance for new software features in its Galaxy Buds earphones that let them function as over-the-counter hearing aids and conduct hearing tests. The hearing tes…
    Fierce Biotech · 8d agoApprovalPositive↗ source
  • AI-focused biotech firms drive biopharma toward a 'fail-fast' drug development model
    AI is quickly becoming a central force in drug development as tech capital pours into biopharma, reshaping how new medicines are discovered. Tyrone Lam, chief business officer at GATC Health, says…
    BioSpace · 8d agoPositive↗ source
  • Medline issues correction for convenience kits containing recalled ICU Medical pain management components
    Medline announced a correction for certain convenience kits that include ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified…
    fda medwatch · 8d agoCRLNegative↗ source
  • FDA issues early alert on non-sterile BD ChloraPrep applicators in Medline convenience kits
    The FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators th…
    fda medwatch · 8d agoRegulatoryNeutral↗ source
  • Eli Lilly sues six U.S. firms over alleged black-market sales of investigational drug retatrutide
    Eli Lilly has filed lawsuits against six U.S. companies it says are selling its investigational diabetes and weight-loss drug retatrutide. The companies are accused of operating a black-market for…
    Endpoints · 7d agoNegative↗ source
  • Vaccine makers say splitting MMR vaccine is impractical despite presidential directive
    Vaccine manufacturers responded to a recent order from President Donald Trump to separate the combined measles, mumps and rubella (MMR) vaccine, noting that while the concept is theoretically possi…
    Endpoints · 7d agoNeutral↗ source
  • North Carolina biopharma job postings jump 26% as seven companies announce dozens of openings
    Bio NC’s hotbed is seeing a surge in employment opportunities, with BioSpace data showing a 26% year‑over‑year rise in job postings in July and an upward trend since November. Seven companies are…
    BioSpace · 7d agoPositive↗ source
  • Endpoints News recaps Boston China biotech debate on industry’s China outlook
    Last week Endpoints News hosted a live debate in Boston that brought together leading voices in biopharma to discuss China’s growing role in the industry. The panel featured executives and investo…
    Endpoints · 7d agoNeutral↗ source
  • Missed promotion often reflects organizational timing, not personal failure
    A missed promotion can feel like a verdict on one’s potential, yet the source notes that employees and organizations often develop at different speeds. Executive coach Angela Justice recounts a ca…
    BioSpace · 8d agoNeutral↗ source
  • Definium's LSD-based therapy shows strong Phase 3 results in generalized anxiety disorder
    Definium Therapeutics reported that its LSD-derived oral tablet, DT120, met its primary endpoint in a Phase 3 trial for generalized anxiety disorder. The study enrolled over 200 participants and co…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Eli Lilly fronts $2 billion for vaccine biotech deals as Infinimmune secures $75 million funding
    Eli Lilly announced it has paid $2 billion up front as part of its ongoing strategy to acquire vaccine‑focused biotechnology companies, a portion of a larger deal that could total up to $3.8 billio…
    Endpoints · 8d agoDealPositive↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Insilico Medicine CEO touts billions in pipeline deals at BIO International Convention
    At the BIO International Convention in June, Insilico Medicine chief Alex Zhavoronkov made a high‑energy appearance that attracted considerable attention. Zhavoronkov handed out a postcard‑sized l…
    BioSpace · 8d agoDealPositive↗ source