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  • Trump executive order accelerates psychedelic drug development with priority review vouchers, funding and expanded right-to-try
    President Trump signed an executive order that aims to speed the development and approval of psychedelic medicines. The order directs the FDA to issue priority review vouchers, expands right-to-tr…
    STAT · 6mo agoRegulatoryPositive↗ source
  • Eli Lilly to invest $4.5 billion in new manufacturing facilities across Indiana
    Eli Lilly announced a $4.5 billion allocation for new manufacturing projects in Indiana. The company said the funds will be used to build and upgrade production sites across the state, expanding it…
    Endpoints · 6mo agoPositive↗ source
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  • Avalo Therapeutics reports Phase 2 success in inflammatory skin disorder and secures $375M financing
    Avalo Therapeutics announced on May 6, 2026 that its experimental immunology drug met its primary endpoints in a Phase 2 study of an inflammatory skin condition. The trial tested two dose levels,…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Avalo's Phase 2 data lifts shares 45% as skin drug shows 42% response in hidradenitis suppurativa
    Avalo Therapeutics reported that its experimental therapy abdakibart met the primary goal of a Phase 2 trial in patients with hidradenitis suppurativa. Both low and high dose groups achieved respon…
    BioPharma Dive · 6mo agoPositive readoutPositive↗ source
  • Novo Nordisk reports 1 million Wegovy patients and 2.3 bn DKK sales in Q1 amid pricing pressure
    Novo Nordisk's CEO Mike Doustad said the company saw about one million patients using its obesity drug Wegovy during the first quarter. The pill generated sales of roughly 2.3 billion Danish krone…
    Endpoints · 6mo agoEarningsNeutral↗ source
  • Gene therapy leaders in Rome flag FDA regulatory shifts as key challenge
    Gene therapy manufacturers gathered in Rome to discuss the sector’s outlook in Europe, with the U.S. Food and Drug Administration’s recent actions dominating conversation. Speakers highlighted rec…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • White House drug strategy endorses treatment but tightens funding for fentanyl test strips
    The White House released a new drug‑policy document on May 4 that lists public‑health measures such as wider access to the overdose‑reversal drug naloxone, medication‑assisted treatment, and the di…
    STAT · 6mo agoRegulatoryNegative↗ source
  • Lonza plans new ADC manufacturing site and workforce boost to capture commercial market
    Lonza said it aims to become a leading supplier of antibody-drug conjugates (ADCs) for commercial use. The Swiss contract manufacturing organization highlighted the growing demand for ADCs and its…
    Endpoints · 6mo agoPositive↗ source
  • Administration releases detailed report on most-favored-nation drug pricing, projects $529 billion savings
    The White House Council of Economic Advisers released its most detailed analysis yet of the administration's most-favored-nation drug pricing policy. The report defines the MFN pricing approach, w…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • CellCentric secures $220 million Series D to advance multiple myeloma oral therapy
    CellCentric, a 22-year-old biotech operating across the Atlantic, announced it has closed a $220 million Series D financing round. The capital will be used to complete development and prepare for…
    Endpoints · 6mo agoDealPositive↗ source
  • CellCentric secures $220 million Series D to advance oral multiple myeloma drug inobrodib
    CellCentric, a biotech focused on multiple myeloma, announced a $220 million Series D financing led by Venrock. The capital will fund ongoing Phase 2 trials and a planned Phase 3 study of its oral…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Bayer agrees to acquire ophthalmology biotech Perfuse Therapeutics for $300 million upfront
    Bayer announced it will purchase Perfuse Therapeutics, a company focused on eye-disease treatments, for an upfront payment of $300 million. The acquisition includes Perfuse's mid-stage program that…
    Endpoints · 6mo agoDealNeutral↗ source
  • Amgen and AbbVie report Inflation Reduction Act negotiations dent Q1 sales
    Amgen and AbbVie disclosed in their first-quarter earnings that the Inflation Reduction Act is already affecting their sales. The companies said the first set of drug-price negotiations required b…
    Endpoints · 6mo agoEarningsNegative↗ source
  • Sanofi requests removal of teplizumab from FDA fast-track voucher program after director dispute
    Sanofi has formally asked the Food and Drug Administration to withdraw its type 1 diabetes therapy, teplizumab, from the new speedy review voucher program overseen by Commissioner Marty Makary. Th…
    STAT · 6mo agoRegulatoryNegative↗ source
  • Bayer to buy Perfuse for up to $2.45B, bolstering eye drug pipeline
    Centered around a glaucoma therapy in mid-stage testing, the deal is Bayer’s first drug company acquisition in several years and potentially its largest since it purchased AskBio in 2020.
    BioPharma Dive · 6mo agoDealNeutral↗ source
  • Color Health expands into cancer treatment coordination with virtual tumor boards
    Color Health, a telehealth firm that currently coordinates cancer screening, is moving into providing and coordinating actual cancer care services. CEO Othman Laraki says the growing complexity of…
    STAT · 6mo agoPositive↗ source
  • FDA authorizes fruit-flavored vapes amid political pressure, sparking debate over youth risk and quitting aid
    The U.S. Food and Drug Administration granted its first authorization for fruit-flavored e-cigarettes on Tuesday, adding mango- and blueberry-tasting products from Los Angeles-based Glas to its app…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Madrigal's Rezdiffra sales top forecasts as Gilead announces job cuts
    Madrigal Pharmaceuticals reported first‑quarter sales of its MASH drug Rezdiffra at $311 million, roughly $10 million above analyst expectations, according to TD Cowen. The outperformance highligh…
    Endpoints · 6mo agoEarningsNeutral↗ source
  • Former Orbital scientists launch ParcelBio with $13 million seed round to boost mRNA therapy durability
    Two former Orbital Therapeutics scientists, Chris Carlson and David Weinberg, have founded a new company called ParcelBio. The startup aims to address a technical limitation that has hindered the…
    Endpoints · 6mo agoDealPositive↗ source
  • PhRMA launches seven-figure ad campaign against 340B drug discount program
    PhRMA, the leading pharmaceutical lobbying group, announced a new advertising push aimed at the federal 340B drug discount program. The campaign, described as a seven-figure effort, is set to begi…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • BeOne Medicines trims five cancer programs and an autoimmune Phase 2 candidate
    BeOne Medicines has significantly broadened its research portfolio, adding 18 new molecular entities slated for development in 2024 and 2025. Despite the expansion, the company announced it will d…
    Endpoints · 6mo agoNegative↗ source
  • STAT+: How a global effort to explore the ‘dark proteome’ is upending our understanding of human disease
    An international team has found thousands of mini-proteins, including some involved in cell division and DNA repair, as well as several unique to cancer cells.
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Health AI progress limited by bad data, newsletter notes
    The latest AI Prognosis newsletter highlights that the quality of health data is a major obstacle for building useful AI tools in medicine. The author explains that many existing datasets contain…
    STAT · 6mo agoNeutral↗ source
  • HHS focuses on overmedication as cruise ship hantavirus outbreak prompts port change
    The Health and Human Services department announced new efforts to curb excessive prescribing, highlighting concerns about overmedication in the United States. At the same time, a cruise ship ancho…
    STAT · 6mo agoNeutral↗ source
  • OpenAI’s health AI policy blueprint seen as reasonable yet self‑serving, experts say
    OpenAI has expanded its health‑focused AI tools, rolling out ChatGPT Health for consumers, a hospital‑oriented ChatGPT for Healthcare, and a version for clinicians. Alongside the clinician chatbot,…
    STAT · 6mo agoRegulatoryNegative↗ source