The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance.
Responding to concerns about corporate insider trading, especially among life sciences companies, the U.S. SEC unanimously adopted final rules Dec. 14 establishing a 90-day cooling-off period before trades can be made under 10b5-1 plans that provide a safe harbor to insider trading.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anheart, Astrazeneca, Biomea, Biosyngen, CASI, Kintara, Merck & Co., Pharmather, Pliant, Regeneron, Sanofi, Soligenix, Thea, Xbrane.
The U.S. CMS has posted a second draft rule that would streamline prior authorizations by Medicare Advantage insurers, a move sure to draw support from patients and clinicians alike. This would be achieved by requiring that payers adopt the Health Level 7 interoperability standard, a requirement that may take every bit of the three years to achieve before a final rule would go into effect under the terms of the proposed rule.
The latest U.S. Federal Trade Commission (FTC) hearing on the merger between Illumina Inc., and Grail Inc., highlighted some sharp disagreements over the impact of the transaction on the market for multi-cancer early detection (MCED) tests, but Illumina has vowed to take steps to blunt any such effects in an open offer.
Given all the advances that have been made over the past decade, the U.S. FDA decided to issue a new draft guidance on developing antibacterial drugs to treat pulmonary tuberculosis (TB) rather than finalize the draft it issued in 2013. In releasing the new draft, the agency cited advancements made in nonclinical models, streamlined clinical development programs and growing interest in treatment-shortening combination regimens.
As the Feb. 28, 2023 PDUFA date for the compound nears, Cytokinetics Inc. CEO Robert Blum insisted that his firm is not mulling withdrawal of the marketing application for heart failure drug omecamtiv mecarbil, nor is the company now considering another study, after an unfavorable vote on the drug Dec. 13 by the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee.
As largely expected, Mirati Therapeutics Inc.’s adagrasib gained U.S. FDA accelerated approval ahead of its Dec. 14 PDUFA date, cleared for second-line use in patients with non-small-cell lung cancer (NSCLC) harboring the KRAS G12C mutation, in which it will go up ahead Amgen Inc.’s Lumakras (sotorasib), which has the advantage of a year and a half head start.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bittium, Quantumdx.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 1st, AB, Boehringer, Carina, Cytokinetics, Erasca, Eyenovia, Mersana, Mirati, Mirum, Myrtelle, NMD, Panbela, Pharmajet, Remegen, Virpax.
RSS
