Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Irthythm, Verily.
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.
Smiths Medical Inc., of Minneapolis, has undertaken a recall of its Medfusion 3500 and 4000 series of syringe infusion pumps because of software issues that could lead to over- or under-infusion of the drug. The U.S. FDA said the devices swept up in this class I recall are associated with seven serious injuries and one fatality, although the manufacturer indicated that a software update is in the works.
Data privacy laws are springing up more regularly in the past couple of years, including in several U.S. states, but Congress seems inclined to step in to avoid a patchwork of regulations across the 50 states. The House Energy and Commerce Committee gave a ringing endorsement of new legislation via a 53-2 vote for H.R. 8152, a bill that would largely preempt the growing list of state privacy laws, but makers of health apps and other digital products might eventually be subject to private litigation under the terms of the bill.
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).
The U.K.’s competition watchdog has found that a subsidiary of Pfizer Inc. and a generics firm jacked up the price of a life-saving epilepsy drug by up to 2,600%, fining them a total of £70 million (US$83.72 million). The Competition and Markets Authority’s decision is part of a long-running dispute against subsidiary Pfizer Ltd. and the generics firm Flynn Pharma Ltd.
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