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  • Six wellness peptides win backing from FDA advisory committee
    After two days of meetings, an FDA advisory committee last week voted to lift restrictions on six popular health and wellness peptides, setting aside FDA staff concerns about a lack of safety and e…
    Endpoints · 2d agoRegulatoryNeutral↗ source
  • ‘This could be a large market’: Novo Holdings-backed Claris secures $118M for corneal disease drug
    A new biotech has come into view with a $118 million series B and a vision for making the front of the eye front-of-mind.
    Fierce Biotech · 2d agoNeutral↗ source
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  • MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 2d agoNeutral↗ source
  • MapLight’s schizophrenia drug disappoints once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 2d agoNeutral↗ source
  • Legend CEO Ying Huang resigns; Carvykti chief named interim leader
    Legend Biotech, the developer of the blockbuster cancer therapy Carvykti, is in the market for a new CEO. Ying Huang stepped down Friday after serving as CEO since November 2020, Legend announced in a
    Endpoints · 2d agoNeutral↗ source
  • Sarepta turns to Michael Severino as CEO, looking to move past recent turmoil
    Sarepta Therapeutics has found its new CEO as it seeks to recover from a calamitous past year. Michael Severino will replace the company’s longtime leader Doug Ingram on Tuesday. Severino joins fro…
    Endpoints · 2d agoNeutral↗ source
  • AstraZeneca looks to AI to ease risk in late-stage trials, speed up filings
    AstraZeneca’s use of AI in drug design and development has not yet yielded any clinical-stage candidates, CEO Pascal Soriot said Monday, but he added it could be useful in boosting the success of l…
    Endpoints · 2d agoNeutral↗ source
  • Updated: AstraZeneca foresees blockbuster sales for Claudin 18.2 ADC, but Ultomiris flops in rare disease
    AstraZeneca said Monday that a key late-stage trial of its Claudin 18.2-targeting ADC in stomach cancer had succeeded, albeit with a caveat — but another Phase 3 trial of Ultomiris yielded subpar r…
    Endpoints · 2d agoNeutral↗ source
  • Schrödinger debuts AI agent Bunsen to use its physics software
    Three years ago, Schrödinger CEO Ramy Farid ruffled some feathers by pushing back on the AI fever of the moment. He said AI hype was at "dangerous" and "insane" levels, warning there ...
    Endpoints · 2d agoNeutral↗ source
  • Apnimed aspires for up to $160M IPO as sleep apnea pill launch nears
    Apnimed has detailed its plans for an initial public offering, with the biotech intending to raise as much as $160 million to fund the launch of its sleep apnea pill.
    Fierce Biotech · 2d agoNeutral↗ source
  • MapLight shares sink on mixed phase 2 schizophrenia readout
    MapLight Therapeutics’ stock plummeted more than 60% this morning after the neuro outfit dropped mixed results for a phase 2 trial of its experimental schizophrenia treatment.
    Fierce Biotech · 2d agoNeutral↗ source
  • Legend Biotech CEO abruptly steps down without permanent replacement
    In a sudden leadership shift, Legend Biotech announced that its CEO, Ying Huang, Ph.D., resigned on Friday, with no permanent replacement yet named.
    Fierce Biotech · 2d agoNeutral↗ source
  • Upcoming Q2 earnings from Moderna, AstraZeneca, GSK and others highlighted in weekly pharma preview
    The Endpoints Weekly newsletter signals a busy earnings week for major pharmaceutical companies, with Q2 results slated from Moderna, AstraZeneca, GSK, Bristol Myers Squibb and several others. It…
    Endpoints · 4d agoEarningsNeutral↗ source
  • Amgen submits new analysis to FDA to defend continued availability of Tavneos
    Amgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns. The company says the independent reevaluation supports the dr…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Amgen sheds around 40 staffers amid continuing struggles
    Amgen has laid off around 40 employees as part of “organizational changes” meant to better align operations with the company’s strategic objectives, Fierce has learned.
    Fierce Biotech · 5d ago↗ source
  • Ipsen’s Bylvay fails key trial in children with rare liver disease
    Ipsen disclosed that Bylvay failed a Phase 3 study for biliary atresia, a serious liver disease that leads the bile ducts to become blocked in babies. Babies with the disease can get a Kasai proced…
    Endpoints · 5d ago↗ source
  • Biogen’s Alzheimer’s data spur excitement, confusion about tau-targeting drugs
    LONDON — One of the most anticipated Alzheimer’s studies in the past few years has created both enthusiasm and confusion, according to conversations Endpoints News recently had with about 20 scient…
    Endpoints · 5d ago↗ source
  • Novo asks court to block Lilly ads; Merck strikes HIV PrEP deal
    Plus news about Abbvie and Genmab, Johnson & Johnson and Mannkind. Novo urges court to block Lilly’s GLP-1 ads: Novo Nordisk asked a New Jersey federal court on Friday to temporarily block what it…
    Endpoints · 5d ago↗ source
  • CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa
    Minoryx Therapeutics finally scored backing from EU regulators for its neurological drug that’s faced multiple hurdles. Meanwhile, Zevra’s rare disease drug got a setback in Europe almost two years…
    Endpoints · 5d ago↗ source
  • Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects
    A new analysis of patients who took part in clinical trials for Kite Pharma’s CAR-T cell therapy Yescarta has revealed genetic signatures of toxicity risk, potentially providing a path forward for…
    Fierce Biotech · 5d ago↗ source
  • Michael Ehlers joins Formation Bio to lead R&D; Black Diamond co-founder dies at 67
    Michael Ehlers left his CEO role at Ascidian Therapeutics, the exon editing company he co-founded, to run R&D at the AI biotech Formation Bio. It’s not often that biotech executives leave ...
    Endpoints · 5d ago↗ source
  • Sanofi nixes Kymab-originated OX40L antibody in atopic dermatitis
    Sanofi has decided to stop working on a drug for eczema it had hoped would be a successor to its immunological megablockbuster Dupixent. The French pharma said that it won’t seek ...
    Endpoints · 5d ago↗ source
  • Merck stages expanded access to monthly HIV PrEP pill ahead of approval
    Following in the footsteps of Gilead, Merck has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir ahead of any regulatory submissions.
    Fierce Biotech · 5d ago↗ source
  • Sanofi abandons plan to seek approval for eczema drug from $1.1B Kymab buyout
    Sanofi has abandoned plans to seek approval for amlitelimab in atopic dermatitis, admitting that a drug once tipped as a potential blockbuster “would not represent a meaningful improvement” to exis…
    Fierce Biotech · 5d ago↗ source
  • Early Alert: Percutaneous Catheter Issue from Boston Scientific
    ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use
    fda medwatch · 5d ago↗ source