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  • Draig Therapeutics raises $65 million Series B to push depression drug targeting synapse repair
    Draig Therapeutics announced it has closed a $65 million Series B financing round that was oversubscribed. The capital will be used to advance its neuropsychiatry pipeline, with the lead program f…
    Endpoints · 1mo agoDealPositive↗ source
  • Lyora Therapeutics launches to revive early-stage genetic eye disease programs from Editas and Biogen
    Lyora Therapeutics announced its formation as a new genetic‑medicine company focused on eye diseases. The firm will take over several early‑stage programs that were previously in the pipelines of E…
    Endpoints · 1mo agoPositive↗ source
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  • Former Akero executives launch Avere Therapeutics, unveiling China-sourced pipeline drug and reverse merger plan
    The former leadership team of Akero Therapeutics announced the creation of a new in‑licensing company called Avere Therapeutics. The launch was made public on Tuesday and includes a pipeline drug…
    Endpoints · 1mo agoDealNeutral↗ source
  • Baxter issues urgent correction for Volara breathing device circuits due to leak risk
    Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA issues final guidance for psychedelic drug developers and announces public hearing
    The FDA has completed a set of clinical guidance documents aimed at companies developing psychedelic medicines. The guidance outlines expectations for trial design, safety monitoring, and data col…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Digital health funding jumps to $7.4 billion in first half of 2026
    Digital health startups secured $7.4 billion in venture capital during the first six months of 2026, according to research firm Rock Health. This represents a $1 billion increase compared with the…
    Endpoints · 1mo agoDealPositive↗ source
  • Biopharma M&A Surge Sets Tone for 2026 Earnings Season
    The biopharma sector is entering the second half of 2026 after a year marked by unusually high merger and acquisition activity. Companies have been busy negotiating and closing deals, signaling con…
    Endpoints · 1mo agoDealNeutral↗ source
  • FDA issues complete response letter rejecting Tris Pharma’s narcolepsy candidate; Agenus halts Phase 3 colorectal cancer trial
    The U.S. Food and Drug Administration sent Tris Pharma a complete response letter for its experimental treatment for narcolepsy, stating that additional data are required before approval can be con…
    Endpoints · 1mo agoCRLNegative↗ source
  • Medtronic recalls Harmony delivery catheter system after tip detachment risk
    Medtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA proposes new rule to streamline registration of drug manufacturers' factories
    The FDA announced a proposed rule aimed at changing how factories that produce drugs for the U.S. market are registered with the agency. The change is intended to simplify the registration process…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Cayman court orders Apple Tree Partners to lose control of its venture fund
    A Cayman Islands court ruled that Apple Tree Partners' general partner must give up control of its venture fund. The decision follows a dispute with the fund's main limited partner, and the judge…
    Endpoints · 1mo agoNeutral↗ source
  • Weekly roundup highlights Biohaven’s challenge to Eli Lilly and industry competition with China
    The latest Endpoints Weekly issue focuses on a series of recent deals across the biotech sector, offering readers a snapshot of market activity. Among the items highlighted is Biohaven’s strategic…
    Endpoints · 1mo agoDealNeutral↗ source
  • FDA rejects Hengrui-Elevar liver cancer drug combo for third time over manufacturing issues
    FDA has again turned down a liver cancer drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics. This is the third rejection in roughly two years, with the agency citing per…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • US biotech firms grow more secretive amid rising competition from Chinese industry
    US biotech companies are becoming more secretive as competition from China’s rapidly expanding biotech sector intensifies. Janine Sengstack, a senior scientist at Junevity, says her team may have…
    Endpoints · 1mo agoNegative↗ source
  • German parliament approves cost-cutting health bill, pharma industry warns of exit risk
    German federal parliament voted to pass a bill aimed at reducing domestic healthcare expenditures. The legislation seeks to curb spending on medicines and other health services as part of a broade…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Hansoh reports Phase 3 success for GSK‑partnered ADC in SCLC as FDA clears Sanofi on‑body injector
    Hansoh announced that its Phase 3 trial of the antibody‑drug conjugate Ris‑Rez met the primary endpoint in patients with small cell lung cancer. The study was conducted in partnership with GSK and…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Apnimed announces IPO plans while FDA reviews its sleep-apnea therapy
    Apnimed, a Cambridge, Massachusetts biotech, disclosed that it will pursue an initial public offering on Nasdaq. The move comes as the company’s lead sleep‑apnea candidate is under review by the U…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA resumes publishing pharma rejection letters, posting 14 new CRLs
    The FDA announced on Friday that it has posted fourteen new complete response letters (CRLs) to pharmaceutical companies on its website. This marks a return to the agency’s regular practice of mak…
    Endpoints · 1mo agoCRLNeutral↗ source
  • Pfizer promotes Danna Breen to lead obesity discovery, succeeding Kendra Bence
    Pfizer announced that Danna Breen has been promoted to head of its obesity discovery program, according to a LinkedIn post. Breen takes over from Kendra Bence and brings nearly 14 years of experie…
    Endpoints · 1mo agoNeutral↗ source
  • FDA’s drug review center adds over 100 staff in a quarter, first net gain since late 2024
    The FDA’s Center for Drug Evaluation and Research (CDER) reported hiring more than 100 new employees in the most recent quarter. This net increase is the first time the drug center has added more…
    Endpoints · 1mo agoNeutral↗ source
  • Cellular Intelligence hires neurologist to assess Novo Nordisk's Parkinson's stem cell program
    Cellular Intelligence, an AI‑driven biotech, announced it is evaluating Novo Nordisk's Parkinson's stem cell therapy after Novo shut down its cell therapy unit. The company engaged neurologist and…
    Endpoints · 1mo agoDealNeutral↗ source
  • ARPA-H earmarks $160 million for custom gene-editing therapies, sparking debate on adequacy
    ARPA-H announced a $160 million investment to support development of bespoke gene‑editing treatments. This follows a recent case where an infant was rescued from a lethal disease using a personaliz…
    Endpoints · 1mo agoNeutral↗ source
  • HHS proposes new rule to compensate Covid-19 vaccine injury claims
    The U.S. Department of Health and Human Services has issued a proposed rule that would create a compensation mechanism for people who say they were injured by Covid-19 vaccines. The new system is…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Roche halts development of Huntington’s disease drug tominersen after ten years of trials
    Roche announced it is stopping work on tominersen, its experimental therapy for Huntington’s disease. The decision follows a Phase 2 study in which the drug performed no better than placebo. The c…
    Endpoints · 1mo agoNegative↗ source
  • UK regulator advises stopping reimbursement for Amgen's lung cancer drug Lumakras for new patients
    The National Institute for Health and Care Excellence (NICE) in the United Kingdom released draft guidance recommending that government reimbursement for Amgen’s lung cancer therapy Lumakras be dis…
    Endpoints · 1mo agoRegulatoryNegative↗ source