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Regulatory actions for Jan. 12, 2023

Jan. 12, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Avillion, Eisai, Intellia, SFA, Takeda, Union.
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U.S. FDA headquarters

FDA warns Olympus and a subsidiary over medical device reporting procedures

Jan. 11, 2023
By Mark McCarty
The U.S. FDA’s surveillance of endoscopes related to reprocessing issues has yielded two more warning letters, one each for Tokyo-based Olympus Medical and its Aizu Olympus subsidiary, both of which were cited for inadequate procedures for medical device reports (MDRs).
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Moderna vaccine vial and syringe on tray

No US price increases for COVID-19 vaccine, new HELP chair tells Moderna

Jan. 11, 2023
By Mari Serebrov
Sen. Bernie Sanders (I-Vt.), the incoming chair of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, penned a blistering letter that takes Moderna Inc. CEO Stéphane Bancel to task over the company’s plans to more than quadruple the U.S. list price of its COVID-19 vaccine once the government’s supply is depleted.
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Paxlovid

China drops Paxlovid coverage despite rising COVID cases

Jan. 11, 2023
By David Ho
China's National Healthcare Security Administration will not be adding Pfizer Inc.'s COVID-19 treatment Paxlovid to its list of medicines covered by basic medical insurance schemes in the country, due to its high prices.
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CFIUS singles out mergers with Chinese companies as potential national security threats

Jan. 11, 2023
By Tamra Sami
Proposed mergers with Chinese companies will likely be subject to increased scrutiny from the Committee on Foreign Investment in the United States (CFIUS) as evidenced by the temporary hold placed on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd. that was announced in June 2022.
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Regulatory actions for Jan. 11, 2023

Jan. 11, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medmira, MTD.
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Regulatory actions for Jan. 11, 2023

Jan. 11, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Can-Fite, Dizal, Minerva, Qualigen, Renexxion, Treadwell.
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Person using COVID-19 antigen test at home

FDA hits COVID test maker for lack of marketing authorization, quality management lapses

Jan. 10, 2023
By Mark McCarty
U.S. FDA warning letters for medical devices are relatively rare these days, and the Oct. 6, 2022, warning to Empowered Diagnostics LLC of Pompano Beach, Fla., suggests that COVID tests are still front and center where FDA enforcement is concerned.
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Opticyte technology

Opticyte snags FDA breakthrough nod for organ failure monitor

Jan. 10, 2023
By Meg Bryant
The U.S. FDA has granted Opticyte Inc. a breakthrough device designation for its Cell O2 patient monitor, a noninvasive technology for monitoring patients at risk of organ failure. The device could help to reduce serious illness and deaths by alerting clinicians to patients experiencing organ failure before irreversible damage occurs.
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Agilent overcomes Thermo Fisher’s Dionex unit in scrum over chromatography patents

Jan. 10, 2023
By Mark McCarty
Some patent litigation cases don’t require a deep effort to interpret claims, but the litigation between Agilent Technologies Inc., and Dionex Softron GmbH, forced the Court of Appeals for the Federal Circuit to determine whether a written description adequately captures the use of a piston in a liquid chromatograph to avoid nullification of the claim.
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