South Korea’s drug regulator should consider revising orphan drug definitions or allow more new innovative drugs to be excluded from pharmacoeconomic assessments, which are required for new drugs to be reimbursed under Korea’s single-payer system, the European Chamber of Commerce in Korea said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Biogen, Decibel, Eureka, GSK, Kira, Mereo, Minerva, Telix.
The FDA’s Center for Drug Evaluation and Research (CDER) came out punching Oct. 17 at the start of a three-day hearing before the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on whether Covis Pharma BV’s Makena (17-hydroxyprogesterone caproate), a branded version of a drug that’s been used since 1956 to prevent preterm births, should be withdrawn from the market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atara, Beigene, Biomea, Mirum, Novartis, Phanes, Prestige, Reata, Regeneron, Takeda, Travere.
The U.S. FDA’s regulation of commercial speech under the First Amendment has been controversial and has handed the agency several losses in court, but Arun Rao of the U.S. Department of Justice let it be known that DOJ is still keen on commercial speech enforcement. Rao said the case of Gonzalez v. Google, which will be heard by the Supreme Court, is an example of potentially precedent-setting litigation, and that manufacturers of drugs and devices may experience an uptick in enforcement depending on where the Supreme Court lands in Gonzalez.
A vaccine for dengue fever, an advanced therapy for a complication after transplants, and a potential first-in-class drug for a form of psoriasis were among medicines recommended for approval by European regulators on Oct. 14.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Hangzhou Yuyuan, Lixte, Obseva, Remegen.
Prescription drug names are generally invented words that are often easier to spell than they are to pronounce. And, for the most part, they’re meaningless until they’ve been associated with a drug.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim, Biomind, Eagle, Elevar, Galectin, Merck & Co., Moerna, Pfizer, Regeneron, Sisaf.
It was a busy day at Moderna Inc. as Merck & Co. Inc. exercised its option to jointly develop and commercialize a personalized cancer vaccine with Moderna in a deal the two companies inked in 2016. Moderna also notched another emergency use authorization (EUA) for its COVID-19 vaccine, this one targeting the omicron variant, for use by those under age 18.
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