Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cstone, Dermata, Elpiscience, Eureka, Gamida, Glenmark, Polypid, Qurient, Sanotize, Synthetic Biologics.
The FDA has issued a safety notification regarding the tubes used in enteral feeding sets, which can lead to inadvertent strangulation of infants and toddlers. The agency said it has received two reports of deaths of toddlers due to strangulation in 2021, but at this time is only recommending that caregivers exercise special caution in ensuring that tubes not be left where strangulation is a possibility.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Sirtex.
Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
U.S. Health and Human Services Secretary Xavier Becerra is getting more pressure to take the unprecedented step of marching in on the patent rights protecting Astellas Pharma Inc.’s prostate cancer drug, Xtandi (enzalutamide), because of its U.S. price. Referencing the provision under the Bayh-Dole Act that allows federal agencies to march in on licensed patents stemming from federally funded research when the products are not available to the public on “reasonable terms,” a dozen Democratic congressional members wrote to Becerra Feb. 8 urging him to move forward on the Xtandi patents.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Angelini, Destiny, Eyenovia, Nicox, Novo Nordisk.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atheart Medical, Carestream, Cerevasc.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
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