Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Duality, Glenmark, Macrogenics, Modular Medical, Novo Nordisk.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: 23andMe, Assertio, Ataraxis, Biomérieux, BMS, Cartherics, Cartography, Catalent, Cosette, Daiichi, Deck Bio, Eli Lilly, Garda, Gilead, GE, Imagene, Kymera, Medical Microinstruments, Myndtec, Nxera, Oxford, Paindrainer.
Realta Life Sciences Inc. raised an additional $40 million in the final tranche of its series A investment, bringing the total the company has raised to more than $150 million through mission-driven investors and a family-office model.
Amending his previous two-year-renewal of the standard charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), Health and Human Services Secretary Robert Kennedy made monitoring adverse vaccine events a primary function of the committee and expanded its liaison membership to include organizations that have challenged vaccine safety.>
Teleflex Inc. reported that Stephen Klasko will step down as chair of the board, and said it intends to establish a new Growth and Operating Committee as well as repurchase $1 billion of its shares. The moves come amid pressure from activist investor Irenic Capital Management, which owns a 2% stake and recently urged the company to take a more constructive and responsible approach to evaluating strategic alternatives, after Teleflex declined to engage with potential acquirors despite interest from multiple credible parties.
The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
Stryker Corp. revealed that the cyberattack which occurred last month had a material impact on its operations and will impact its financial results for the first quarter of 2026. However, the company said in an SEC filing that it is now fully operational and does not expect the incident to have a material impact on its 2026 full-year guidance.