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Home » Topics » Regulatory

Regulatory
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Makena

Covis makes second offer to withdraw Makena

March 8, 2023
By Mari Serebrov
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.
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CFIUS finally clears merger with F-star and Invox

March 8, 2023
By Tamra Sami
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.
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Regulatory actions for March 8, 2023

March 8, 2023
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.
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Freestyle Libre 3 sensor with smartphone app

Abbott’s Libre 2 and 3 gain clearance for AID integration

March 7, 2023
By Annette Boyle
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.
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US budget preview puts more Medicare burden on biopharma

March 7, 2023
By Mari Serebrov
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.
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Gilead antiviral IPR win upheld on appeal

March 7, 2023
By Mari Serebrov
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.
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Lungs

Affibody in $637M respiratory disease deal with Chiesi

March 7, 2023
By Caroline Richards
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.
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Regulatory actions for March 7, 2023

March 7, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Coherus, Neuromod Devices, X-Bolt.
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Regulatory actions for March 7, 2023

March 7, 2023
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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Regulatory actions for March 6, 2023

March 6, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Sooma.
Read More
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