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  • Study finds rising patent thickets may slow generic drug competition
    A recent special communication in JAMA reports that the number of patents linked to FDA‑approved small‑molecule drugs has risen over the past 15 years. The increase is driven largely by non‑primary…
    raps · 1mo agoNeutral↗ source
  • City Therapeutics plans $158 million IPO as Iambic eyes $135 million Nasdaq debut
    City Therapeutics, an RNAi startup founded by former Alnylam Pharmaceuticals executives, announced plans for an initial public offering targeting roughly $158 million. The company intends to sell a…
    Endpoints · 1mo agoDealNeutral↗ source
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  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Curium lists Bexlutry at $63,524 per infusion, roughly 5% cheaper than Novartis' Lutathera
    Curium announced the list price for its radioligand Bexlutry, a generic version of Novartis' Lutathera. The price is set at $63,524 per infusion, which represents about a five percent discount com…
    Endpoints · 1mo agoNeutral↗ source
  • Viking Therapeutics commercial chief exits after nine months; Gilead eyes BeOne executive for China growth
    Viking Therapeutics' chief commercial officer Neil Aubuchon left the company after only nine months in the role, according to Peer Review. His brief tenure has sparked speculation about the compan…
    Endpoints · 1mo agoNeutral↗ source
  • Acting HHS General Counsel Bob Foster Departs Agency
    The acting general counsel for the U.S. Department of Health and Human Services, Bob Foster, is no longer employed by the agency. Endpoints News attempted to reach him via his government email and…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Argenx halts Phase 3 Sjögren's trial as celiac disease data brings mixed results
    Argenx disclosed on Thursday that it is ending its Phase 3 trial in Sjögren's syndrome after the study failed to meet its primary endpoint. The decision came alongside the release of encouraging r…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion, expanding its non‑opioid pain portfolio
    Viatris, a maker of generic and branded medicines, announced a cash purchase of commercial‑stage Pacira BioSciences for $1.65 billion. The deal adds Pacira’s non‑opioid pain treatments to Viatris’…
    Endpoints · 1mo agoDealPositive↗ source
  • Ono Pharmaceutical pays Biohaven $80 million for protein degrader as UK pulls Valneva's chikungunya vaccine
    Tokyo-based Ono Pharmaceutical announced it will pay Biohaven $80 million upfront to license a pan‑IgG protein degrader technology. The agreement gives Ono rights to develop the degrader, while Bi…
    Endpoints · 1mo agoDealNeutral↗ source
  • Endeavor BioMedicines reports mid-stage trial success for IPF drug, suggests disease reversal potential
    Endeavor BioMedicines announced that its experimental therapy for idiopathic pulmonary fibrosis has met its primary goals in a Phase 2 study. The company said the mid‑stage trial showed signs that…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Zealand and Roche report positive Phase 2 results for amylin drug petrelintide in obesity and diabetes
    Zealand Pharma and Roche announced topline results from a Phase 2 trial of their amylin analogue petrelintide in patients with obesity and type 2 diabetes. The interim data showed that participant…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Roche signs near-$1 billion partnership with Chinese biotech Defand on degrader therapies
    Roche has entered into a new collaboration with Defand, a relatively unknown biotech based in Hangzhou, China. The agreement is the fourth China-focused deal the Swiss drugmaker has signed since Au…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA unveils transparency roadmap with plans for public NDA/BLA disclosures and inspection report publishing
    The FDA published a transparency roadmap that outlines its FY 2026 achievements and sets out priorities for FY 2027. One key priority is a proposal to require public disclosure of new drug applica…
    raps · 1mo agoRegulatoryNeutral↗ source
  • New PDUFA agreement earmarks funds to rehire FDA reviewers after recent layoffs
    Trade groups report that the latest PDUFA reauthorization includes a specific funding pool for the FDA. The money is intended to replace reviewers who were let go after recent HHS staffing reducti…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Robotics biotech firm Multiply Labs raises $75M Series B as NorthStar secures up to $185M
    Multiply Labs, a robotics-driven biomanufacturing startup, announced a $75 million Series B financing round. The capital will be used to expand production capacity and hire additional staff as the…
    Endpoints · 1mo agoDealPositive↗ source
  • WHO and biotech firms turn attention to preeclampsia, a leading cause of maternal and newborn complications
    Preeclampsia, a hypertension condition that develops during pregnancy, affects millions of mothers and their newborns each year, contributing to serious health complications. The World Health Orga…
    Endpoints · 1mo agoNeutral↗ source
  • General Medicine secures $120 million to launch all-in-one healthcare marketplace
    General Medicine, a health‑tech startup, announced it has raised $120 million in a financing round. The capital will be used to develop a digital platform that functions as a one‑stop shop for med…
    Endpoints · 1mo agoDealPositive↗ source
  • EU Commission urges EMA to fast-track Biotech Act preparations
    The European Commission has issued a statement urging the European Medicines Agency to accelerate work on the upcoming Biotech Act, which aims to streamline regulation of advanced therapies. The C…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Grindr launches telehealth service offering erectile dysfunction and weight loss prescriptions
    Grindr has moved beyond its dating platform by introducing a telehealth service that connects users with clinicians for virtual consultations. The offering enables users to receive prescriptions f…
    Endpoints · 1mo agoNeutral↗ source
  • Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight Europea...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1mo ago↗ source
  • Dutch court orders Merck to halt subcutaneous Keytruda sales in eight European countries
    A Dutch court has issued an injunction that requires Merck to stop manufacturing and selling the injectable, subcutaneous formulation of its cancer immunotherapy Keytruda in eight European countrie…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Zuckerberg’s Biohub secures $1.8 billion to expand AI-driven virtual cell platform with Meta and Google
    Mark Zuckerberg and Priscilla Chan's nonprofit Biohub announced an expansion of its virtual cell initiative, now backed by $1.8 billion in funding. The new capital comes from a coalition that incl…
    Endpoints · 1mo agoPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 1mo agoRegulatoryNeutral↗ source
  • PhRMA files lawsuit against Trump administration over GLOBE drug pricing demonstration program
    PhRMA, the leading trade association for the pharmaceutical industry, has filed a lawsuit against the U.S. government challenging the Centers for Medicare & Medicaid Services' GLOBE drug pricing de…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Ultragenyx sells priority review voucher for $210 million, retains another to monetize
    Ultragenyx Pharmaceutical announced it has sold a priority review voucher to an undisclosed buyer for $210 million. The transaction is among the highest-priced voucher sales this year, providing a…
    Endpoints · 1mo agoDealPositive↗ source