Turkey needs to provide a level playing field for foreign and domestic drug producers. That’s the recommendation of three World Trade Organization (WTO) arbitrators in a dispute resolution between Turkey and the EU.
Insider trading appears to be the U.S. SEC violation du jour. The agency filed insider trading charges against 10 individuals July 25, including a former FBI trainee and his friend who made about $82,000 and $1.3 million, respectively, from illegally trading ahead of the February 2021 announcement of Merck & Co. Inc.’s $1.85 billion tender offer to acquire Pandion Therapeutics Inc.
It was bound to happen someday. With more and more prescription drugs coming to the U.S. market, the FDA is running out of unique combinations for the 10-digit national drug code given to each product.
Alnylam Pharmaceuticals Inc.’s Amvuttra (vutrisiran), a treatment for the rare disease hereditary transthyretin-mediated amyloidosis, was among medicines recommended for approval by regulators from Europe’s Committee for Medicinal Products for Human Use (CHMP) in a busy sitting.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Incannex, Junshi, Karyopharm, NLS, Obsidian, Olema, Pliant, Recursion, Sandoz, Sangamo.
Citing “the current political conditions,” Russian Minister of Health Mikhail Murashko laid out ways for Russia to strengthen its international role in the health care sector, including the development of innovative radiopharmaceuticals.
Two study coordinators at the Miami-based Tellus Clinical Research Inc. pleaded guilty July 20 in connection with a conspiracy to falsify data in trials evaluating treatments for medical conditions including opioid dependency, irritable bowel syndrome and diabetic nephropathy.
Continuing its evaluation of cancer drugs already on the U.S. market, the FDA will convene its Oncologic Drugs Advisory Committee (ODAC) Sept. 22 and 23 to consider two more approved drugs – Oncopeptides AB’s Pepaxto (melphalan flufenamide) and Secura Bio Inc.’s Copiktra (duvelisib).
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