The U.S. FDA approved Shionogi & Co. Ltd.’s Xocova (ensitrelvir) as the first oral post-exposure prophylactic option in the U.S. to prevent COVID-19, with the decision coming ahead of a PDUFA target date of June 16.
At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, Revolution Medicines Inc. followed up its stellar top-line data with the details from the phase III RASolute 302 study of its pan-RAS inhibitor daraxonrasib in patients with previously treated, metastatic pancreatic ductal adenocarcinoma. The results were simultaneously published in The New England Journal of Medicine.
New data from Grail Inc.’s randomized study of its Galleri multicancer early detection test could not alter the fact that the U.K. trial missed the primary endpoint of reducing the number of cancers diagnosed at stage III and stage IV. But the company is now suggesting that discounting the initial screen, when most late stage cancers were detected, would be more representative of a real-life steady state screening program.
The Trump administration’s efforts to ensure U.S. federal grants align with its policies may soon be coming to fruition. The White House Office of Management and Budget released a proposed rulemaking to revise its Guidance for Federal Financial Assistance.
Edgewise Therapeutics Inc. is pulling in $1.55 billion up front by selling its muscular dystrophy business, including its fast skeletal myosin inhibitor, sevasemten (EDG-5506), to Servier SA. The deal is potentially worth up to $2.65 billion when including a potential $1.1 billion in milestone payments.
Turn Therapeutics Inc. made public strongly positive findings from an interim analysis that involves the first 50 subjects in the ongoing phase II atopic dermatitis (AD) trial with IL-36 inhibitor GX-03.
The much-awaited phase III readout from Oculis Holding AG’s OCS-01 in diabetic macular edema (DME) fell short of expectations, delaying the possibility of a topical eye drop option for DME patients and prompting the company to shuffle its pipeline priorities, with a focus on late-stage programs targeting optic neuropathies and dry eye disease.
Hanmi Pharmaceutical Co. Ltd. secured a $1.26 billion deal with Eli Lilly and Co. to out-license ex-Korea rights to sonefpeglutide (HM-15912), a Lapscovery-based glucagon-like peptide-2 analog in development for multiple indications, including an ongoing phase II study of short bowel syndrome. It was one of two billion-dollar Asian company deals signed by Lilly on June 1, with the second transaction involving Haisco Pharmaceutical Group Co. Ltd., of Beijing.
Pfizer Inc. is paying Innovent Biologics Co. Ltd. $650 million up front and up to $9.85 billion in milestones, plus royalties, to collaborate across 12 early stage and de novo antibody-drug conjugates (ADCs) and multispecific antibodies for oncology.
China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards.