The chaos Health and Human Services Secretary Robert Kennedy has injected into the U.S. vaccine market could have long-term consequences as vaccine makers reevaluate business decisions and pipelines.
The U.S. FDA’s September 2022 final guidance for clinical decision support (CDS) systems set a dismal record for pushback, but the new administration at the FDA has reissued the guidance with provisions that industry will undoubtedly find encouraging.
The U.K. National Institute for Health and Care Excellence has offered a thumbs-up for eight digital technologies to help patients with asthma manage their conditions. The sponsors of these products have three years to turn out enough evidence to persuade NICE to fully endorse those products, after which these platforms could have access to a market of more than five million patients.
Crescent Biopharma Inc. has announced regulatory clearances of IND applications for CR-001 (SKB-118), a PD-1 x VEGF bispecific antibody, and CR-003 (SKB-105), an integrin β-6 (ITGB6)-targeted antibody drug-conjugate (ADC), both being developed for the treatment of advanced solid tumors.
Cansino Biologics Inc. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for the company’s 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (PCV24).
Ascentage Pharma Group International has obtained IND approval from the FDA for its BTK-targeted protein degrader APG-3288. A phase I study will be conducted in patients with relapsed or refractory B-cell malignancies.
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
South Korea’s National Assembly approved the largest budgets for its health ministries in 2026, including the Ministry of Health and Welfare, Ministry of Food and Drug Safety and Korea Disease Control and Prevention Agency.
It doesn’t take a meteorologist to predict another stormy year for the biopharma sector, not just in the U.S., but also in Europe. Lurking within those storms, though, could be a few silver linings.
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