The FDA’s device center just released three performance reports related to the fourth and fifth device user fee agreements, including a financial report that shows the agency collected far more in user fees than it spent for fiscal year 2022, yielding a carryover amount of more than $142 million. One of the more interesting aspects of the report is that because the taxpayer dollars used for FDA’s device inspections did not meet a pre-specified amount for two consecutive years, third-party inspections for FDA compliance purposes have been disallowed for fiscal year 2023, making hash of a program sought by domestic manufacturers who distribute their products to other nations as well as in the U.S.
Noting that the FDA had rejected its previous proposal last year to voluntarily withdraw Makena from the U.S. market, Covis Pharma BV is again offering to voluntarily withdraw the drug, which is the only drug approved to reduce the risk of preterm birth. Along with its offer, the company asked the agency “to allow for an orderly wind-down that would best serve the interests of the patients,” according to a March 6 letter from Covis’ attorney to FDA Commissioner Robert Califf and Namandjé Bumpus, the agency’s chief scientist.
After placing a temporary hold on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd., citing “unresolved national security risks,” the Committee on Foreign Investment in the United States (CFIUS) has finally cleared the merger to proceed.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Genethon, Ionis, Novan, Regeneron, Sanofi, Shorla, Siga, Takeda.
Abbott Laboratories received U.S. FDA clearance for the Freestyle Libre 2 and Freestyle Libre 3 continuous glucose monitoring (CGM) sensors for integration with automated insulin delivery (AID) systems. AID systems automatically adjust and administer insulin via a pump based on blood glucose levels determined by the sensors. Abbott said it was partnering with multiple AID manufacturers in the U.S. and Europe.
The Biden administration offered a sneak peek March 7 at its fiscal 2024 budget by outlining ways it proposes extending the life of the U.S. Medicare Hospital Insurance Trust Fund by at least 25 years.
The U.S. Court of Appeals for the Federal Circuit once again delved into genus claims as it affirmed Gilead Sciences Inc.’s win in its inter partes review (IPR) challenge of several claims in a patent held by the University of Minnesota.
Chiesi Farmaceutici SpA has agreed to pay Affibody AB up to $214 million in a collaboration and licensing agreement to develop an inhaled treatment for respiratory diseases, with a further $423 million also in the cards if the deal is extended to two more programs. The fees consist of up front and milestone payments, based on certain development, regulatory and commercial achievements, with additional mid-single to low double-digit royalties on sales.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Coherus, Neuromod Devices, X-Bolt.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioarctic, Cantex, Coherus, Eli Lilly, Ikena, Merck, Milestone.
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