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  • 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
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  • Biotech venture funding hits $9.1 billion in H1 2026, but small startups lag behind
    Venture capital funding for biotech startups surged in the first half of 2026, with nearly 70 companies securing more than $9.1 billion, according to BioPharma Dive data. The bulk of the money cam…
    BioPharma Dive · 1mo agoDealNeutral↗ 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
  • ARPA-H awards $160 M to accelerate bespoke gene‑editing therapies for rare diseases
    ARPA-H announced a $160 million, five‑year investment through its THRIVE program to speed the development of personalized gene‑editing treatments for rare genetic conditions. The awardees include…
    BioPharma Dive · 1mo agoNeutral↗ 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
  • FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks
    The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
    fda press · 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
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ 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
  • FDA reprimands Lundbeck Seattle Biopharmaceuticals for inflated claims on Vyepti migraine webpages
    The U.S. Food and Drug Administration issued an untitled letter to Lundbeck Seattle Biopharmaceuticals criticizing two promotional webpages about its migraine treatment Vyepti. The agency said the…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • GSK ends $2.2 billion brain drug partnership with Alector after trial failures
    GSK and California‑based biotech Alector have ended their collaboration after both experimental brain drugs failed to meet development milestones. The partnership, announced in July 2021, gave GSK…
    BioPharma Dive · 1mo agoDealNegative↗ source
  • FDA pauses public release of Complete Response Letters to limit litigation risk
    The FDA announced it has temporarily halted the routine public posting of Complete Response Letters (CRLs), which are letters sent to drug sponsors when the agency does not approve a marketing appl…
    Endpoints · 1mo agoCRLNeutral↗ source