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.
There are new data to chew over in the ongoing controversy about obesity being diagnosed as a disease from a study tracking 157,159 participants in the UK Biobank over 13 years. This shows that even in the absence of any metabolic disturbance such as elevated lipids, high blood pressure or diabetes, there is an increased risk of heart attack, stroke, peripheral arterial disease, heart failure and liver disease in people with a body mass index over 30.
Oricell Therapeutics Holdings Ltd closed a $110 million pre-IPO round to expand its global footprint and advance its lead candidate, a GPC3-targeted autologous CAR T therapy for liver cancer to registrational trials.
The loss of regenerative capacity in mammals over the course of evolution may be linked to certain environmental conditions rather than to a genetic limitation. Tissue stiffness around an amputated area, oxygen availability, or epigenetic regulation could determine this ability, according to two simultaneously published but independent studies published in Science, as reported by BioWorld yesterday.
The loss of regenerative capacity in mammals over the course of evolution may be linked to certain environmental conditions rather than to a genetic limitation. Tissue stiffness around an amputated area, oxygen availability, or epigenetic regulation could determine this ability, according to two simultaneously published but independent studies published in Science today.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Anumana, Bausch + Lomb, Becton Dickinson, Cortec, Endospan, Etiometry, GSK, Plus, United, Waters.