Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Bristol Myers Squibb, Daiichi Sankyo, Incyte, Xortx.
The U.S. Supreme Court has handed down a broadly unanimous decision that allows the targets of Federal Trade Commission (FTC) enforcement action to appeal that action to federal district court prior to the conclusion of the agency’s review or enforcement process. The outcome could prove a boon to life science companies that may now challenge FTC actions against mergers and acquisitions prior to the conclusion of that action, a point at which the company’s options have narrowed drastically.
Following up on a bipartisan effort to keep down the costs of insulin, U.S. Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) reintroduced a bill on April 20 to ensure patients with diabetes can access the life-saving medicine without the excess costs associated with drug rebates and stymied competition.
The European Commission is bringing out rules designed to further simplify and streamline procedures for pharmaceutical companies planning on merging under EU Merger Regulation rules. The commission assesses mergers and acquisitions of companies whose turnover exceeds certain thresholds to prevent concentrations that would significantly impede effective competition in the European Economic Area or in a substantial part of it.
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies. No additional efficacy or safety data has been requested.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apex, Aquestive, Cantargia, Carsgen, DBV, Dermata, Genentech, Innocare, Regeneron, Sanofi, Sensei, Therapeutic Solutions, Tiziana.
The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GE Healthcare, Meridian Bioscience, Noctrix Health.
While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward.
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