Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Beam, Maat, Pheast, Sanofi, Spinogenix, Teijin, Tenpoint.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agenus, Alto, Aspera, Bioage, Bionet, Chase, Haya, Intragrand, Jikang, Kiora, PT Bio Farma, Redwire, Senju, Talentec, Titan, Transpire, Zydus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amicus, Ascentage, Beyondspring, Cardiff Oncology, Corcept, Experimental Drug Development Centre, Genmab, Ichnos Glenmark, Immuneoncia, Immunitybio, Imunon, Innovent, Jazz, Johnson & Johnson, Kura, Kyowa Kirin, Nasus, OSE, PDS, Perspective, Remegen, Roche, Traws, Vigil Neuroscience.
New hires and promotions in the biopharma industry, including: A&As: Ability, Ardelyx, Asgard, Entrada, Harvard, Lobe, Priothera, Protara, Sernova, Tenpoint.
The U.S. FDA gave Sarepta Therapeutics Inc.’s rAAVrh74 viral vector, used in an investigational gene therapy for the treatment of limb-girdle muscular dystrophy, a step up, making it one of the first platforms to receive the agency’s platform technology designation.
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s LYN/BTK dual inhibitor, DZD-8586, saw tumor shrinkage in 94.1% of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma following Bruton's tyrosine kinase inhibitors, the company reported during an oral presentation at the American Society of Clinical Oncology (ASCO) 2025 conference.
It’s a good week to be working on drugs targeting STAT6. Kymera Therapeutics Inc.’s, KT-621, the first oral STAT6 degrader candidate to enter the clinic, surpassed expectations with impressive safety, pharmacokinetic and biomarker data from a phase I trial, while potential fast-followers from Nurix Therapeutics Inc. and Recludix Pharma Inc. advanced via respective partnerships with Sanofi SA.
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