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Home » Topics » Regulatory

Regulatory
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Regulatory actions for April 24, 2023

April 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Route 92 Medical, Yourbio Health.
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Regulatory actions for April 24, 2023

April 24, 2023
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.
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U.S. Supreme Court

Axon prevails at US Supreme Court in a decision that opens challenges to FTC

April 21, 2023
By Mark McCarty
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.
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Regulatory actions for April 21, 2023

April 21, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Uromems.
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Insulin vials and syringe

Insulin pricing bill in US requires PBMs to pass through rebates

April 21, 2023
By Karen Carey
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.
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EC to 'cut red tape' for merging pharma firms

April 21, 2023
By Caroline Richards
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.
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Postponed stamp on calendar

FDA pushes back PDUFA date for Daiichi Sankyo’s quizartinib

April 21, 2023
By Tamra Sami
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.
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Regulatory actions for April 21, 2023

April 21, 2023
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.
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Pills on a spoon

FDA’s Califf says big pharma has ‘let us down’ in failing to develop non-addictive analgesics

April 20, 2023
By Mark McCarty
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.
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Regulatory actions for April 20, 2023

April 20, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GE Healthcare, Meridian Bioscience, Noctrix Health.
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