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  • WCG launches AI-driven Activation Intelligence to speed clinical trial start-ups
    WCG, a provider of clinical trial solutions, announced a new AI-powered program called Activation Intelligence aimed at accelerating the start-up phase of studies. In early access, the tool report…
    Fierce Biotech · 28d agoPositive↗ source
  • Insulet launches full U.S. release of Omnipod Discover data platform for Omnipod 5 users
    Insulet announced that its Omnipod Discover platform is now fully available across the United States. The web-based service is built to work with the company’s Omnipod 5 automated insulin delivery…
    Fierce Biotech · 28d agoPositive↗ source
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Paragon spinout Velaris Therapeutics goes public via reverse merger with Alaunos, raising $350 million
Paragon Labs, a biotechnology incubator, announced that its latest spinout, Velaris Therapeutics, became a public company through a reverse merger with Alaunos Therapeutics. The transaction places…
BioPharma Dive · 28d agoDealPositive↗ source
  • Novartis secures supplemental FDA approval to market repurposed antibiotic Lamprene in the US
    Novartis has obtained a supplemental approval from the U.S. Food and Drug Administration for its drug Lamprene, allowing it to be sold as an antibiotic. Lamprene, originally developed decades ago…
    Endpoints · 28d agoApprovalPositive↗ source
  • BioNTech's mRNA cancer therapy fails to improve progression-free survival in head-neck cancer trial
    BioNTech reported that its experimental mRNA cancer immunotherapy, BNT 113, combined with Keytruda, did not meet the primary endpoint of progression-free survival in an interim analysis of a late-s…
    BioPharma Dive · 28d agoNegative readoutNegative↗ source
  • BioNTech's head and neck cancer vaccine fails to meet first primary endpoint in pivotal trial
    BioNTech reported that its experimental mRNA vaccine targeting head and neck cancer did not achieve one of the two primary goals in a pivotal study. The trial was designed to evaluate the vaccine’…
    Endpoints · 28d agoNegative readoutNegative↗ source
  • Readily secures $11 million to expand AI compliance platform for insurers
    Readily, a San Francisco‑based startup, uses artificial intelligence to monitor and flag changes in government regulations that affect insurance companies. The company announced it has closed an $…
    Endpoints · 28d agoDealPositive↗ source
  • Rudy Tanzi says he may be nearing a cheap, safe Alzheimer’s prevention pill
    Rudolph Tanzi has spent decades pursuing a way to stop Alzheimer’s disease before it starts. As a leading researcher, he has long spoken about the need for a simple, widely accessible solution. T…
    Endpoints · 28d agoPositive↗ source
  • Former Apogee Therapeutics leaders join Paragon Labs to expand R&D and company creation platform
    Michael Henderson, who previously led Apogee Therapeutics, is now serving as chief executive officer of Paragon Labs. He is accompanied by five other former Apogee executives who have moved to Par…
    Endpoints · 28d agoPositive↗ source
  • Paragon Labs hires former Apogee leadership after AbbVie acquisition and spins out hypertension unit
    Paragon Labs announced it has brought several former Apogee Therapeutics executives onto its senior team following AbbVie's $10.9 billion purchase of Apogee. The incoming leaders include Michael H…
    Fierce Biotech · 28d agoDealNeutral↗ source
  • FTC and seven states seek contempt order against Martin Shkreli for breaching lifetime pharma ban
    Martin Shkreli is again under investigation by the Federal Trade Commission. The FTC, together with seven states, filed a petition in a New York federal court asking that Shkreli be held in contem…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • Health tech firms expand AI scribing tools toward prescribing and billing functions
    Health technology companies are accelerating development of artificial‑intelligence driven scribing solutions that can be deployed across health systems. While early versions focused on documentin…
    Endpoints · 28d agoNeutral↗ source
  • Syndax halts development of Niktimvo after Phase 2 failure in IPF trial
    Syndax announced it is stopping work on its experimental drug Niktimvo for idiopathic pulmonary fibrosis (IPF) after the compound did not meet its primary endpoints in a placebo-controlled Phase 2…
    Endpoints · 28d agoNegative readoutNegative↗ source
  • Nurix halts development of BTK degrader zelebrudomide after phase 1 review
    Nurix announced it will discontinue clinical development of its BTK degrader zelebrudomide, also known as NX-2127, following completion of enrollment in a phase 1 trial for aggressive non‑Hodgkin l…
    Fierce Biotech · 28d agoNegative↗ source
  • Pharma faces $500B risk as patents expire, with Merck most exposed by 2028
    More than $500 billion in global prescription sales could be threatened by generic competition between 2026 and 2032, according to Norstella data cited by Evaluate. Merck is the most immediately e…
    BioPharma Dive · 29d agoNeutral↗ source
  • BMS reports phase 3 successes in IPF drug and neuroendocrine tumor radiotherapy
    Bristol Myers Squibb announced that two of its phase 3 trials have met primary endpoints, marking important milestones as the company seeks growth beyond its patent expirations. The Aloft-IPF stud…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Mirum's Livmarli cuts itching in ultra-rare liver disease trial, showing significant benefit
    Mirum Pharmaceuticals reported that its ileal bile acid transporter inhibitor Livmarli achieved a statistically significant reduction in cholestatic pruritus compared with placebo in a late‑stage s…
    Endpoints · 29d agoPositive readoutPositive↗ source
  • Asahi Kasei Therapeutics receives FDA approval for HSV drug acquired in $1 billion deal
    Asahi Kasei Therapeutics announced that the U.S. Food and Drug Administration granted approval for its herpes simplex virus (HSV) therapy. The drug, called Hovilpri, was purchased by Asahi Kasei e…
    Endpoints · 29d agoApprovalPositive↗ source
  • Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision
    Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for Ju…
    Fierce Biotech · 29d agoRegulatoryPositive↗ source
  • Aspen Neuroscience files for Nasdaq IPO to fund Parkinson’s cell therapy program
    Aspen Neuroscience, founded in 2018, announced plans to list on Nasdaq, aiming to raise additional capital for its Parkinson’s disease cell therapy program. The company's lead candidate, sasinepro…
    BioPharma Dive · 29d agoDealNeutral↗ source
  • Bristol Myers' lung drug admilparant meets Phase 3 goal at low dose, high dose falls short
    Bristol Myers Squibb reported that its experimental idiopathic pulmonary fibrosis therapy admilparant achieved its primary endpoint in a Phase 3 trial, showing a statistically significant slowing o…
    BioPharma Dive · 29d agoPositive readoutNeutral↗ source
  • Bristol Myers reports two Phase 3 successes for fibrosis and RayzeBio drug
    Bristol Myers Squibb announced Monday that two of its late-stage trials have met primary endpoints. The first trial involved its fibrosis program, where the experimental therapy demonstrated the e…
    Endpoints · 29d agoPositive readoutPositive↗ source
  • GSK allocates over $800 million to expand R&D and manufacturing hub in Pennsylvania
    GSK announced it will invest more than $800 million to expand its presence in Pennsylvania, marking its second expansion in the state within two years. The funds will be used to build a new resear…
    Endpoints · 29d agoDealPositive↗ source
  • Tortugas Neuroscience's obuprazine shows significant improvement in phase 2b schizophrenia trial in China
    Tortugas Neuroscience, a biotech founded by former Sage Therapeutics staff with $106 million in funding, reported positive data from a phase 2b study of its schizophrenia candidate obuprazine, lice…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • First Tracks reports positive early-stage results for celiac drug ANB033
    First Tracks Biotherapeutics announced that its experimental celiac disease drug ANB033 showed statistically significant improvement in a six‑week early‑stage trial compared with placebo. The trial…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source