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.
Sarepta Therapeutics Inc. has filed a clinical trial application (CTA) in New Zealand seeking clearance to initiate a first-in-human trial of SRP-1005 (formerly ARO-HTT). Pending approval, the INSIGHTT trial is anticipated to begin in the second quarter of this year.
Ottimo Pharma Ltd. has obtained IND clearance from the FDA and advanced OTP-01 (jankistomig), an anti-PD-1/VEGFR2 antibody, into phase I for solid tumors. The first patient has been dosed and the study is open at sites in the U.S. and Australia.
Arbele Pte Ltd.’s ARB-1002 has been awarded orphan drug designation by the FDA for the treatment of pancreatic cancer. ARB-1002 is an antibody-drug conjugate comprising an anti-CDH17 monoclonal antibody chemically linked to a potent cytotoxic agent.
South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing.
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).
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