In its case to a U.S. FDA advisory committee, the Center for Drug Evaluation and Research makes no bones about its dislike of Makena, (17-hydroxyprogesterone caproate), a drug for preventing miscarriages. It simply doesn’t work, the group maintains.
Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
Long considered a make-or-break market for novel drugs and biologics and a success story for generics, the U.S. has been more challenging for biosimilars than many experts initially expected. U.S. biosimilar “uptake has been good, but not great,” Steven Lucio, senior principal for pharmacy solutions at Vizient Inc., told BioWorld. That could change next year when at least seven biosimilars referencing Abbvie Inc.’s immunosuppressive drug, Humira (adalimumab), are expected to launch in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Diurnal, Hugel, Knight, Lyell, Revive.
The European Commission (EC) has proposed updates to rules regarding product liability, one of which is an update to strict liability policy for pharmaceuticals (and presumably medical devices) that would expand the term of liability to 15 years. The proposal for artificial intelligence (AI) liability would up the ante on transparency into these algorithms, and the combination of the two novel policies would suggest that life science companies may face a more uniform, but potentially more hazardous legal landscape in the EU should these proposals be adopted.
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Annovis, Clarametyx, Crinetics, Eiger, Eli Lilly, Entera, Evofem, Humanetics, Immutep, Kiromic, Nova Mentis, Takeda, Transcenta.
The U.S. Congress has reauthorized several user fee programs at the FDA, and the agency has published the user fee levels for several product types, with most of those fees increasing significantly, an example of which is the increase for new drug applications (NDAs) requiring clinical data from $3.12 million to $3.24 million. Fees for medical device premarket approval (PMA) filings will jump from $375,000 to $442,000, including some hefty adjustments for persistent inflation, a problem that may plague the user fee schedules for fiscal 2024 as well.
The Biden administration has released a blueprint for an artificial intelligence bill of rights, which is accompanied by an acknowledgement that these algorithms can be crucial in guiding treatment of cancer patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue, Galapagos, Immutep, Kezar, Kira, Oncternal and Theratechnologies.
RSS
