Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).
India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices.
China is the latest country mixing things up when it comes to COVID-19 boosters. Since boosters were implemented in China in October, adults have been given a third dose of their primary vaccine regimen, which has consisted of one of three inactivated vaccines produced by Sinopharm Group Co. Ltd. and Sinovac Biotech Ltd.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Biomarin, Dizal, Novavax, Ose, Transthera, UCB, Veloxis.
The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.
LONDON – Two years into the pandemic and the number of new drugs approved by the EMA fell from 97 approvals in 2020 to 92 in 2021. But both years are still well up on pre-COVID-19 times in 2019 when 66 products got the nod, according to the EMA’s annual human medicines report.
The FDA’s approval of Agios Therapeutics Inc.’s Pyrukynd (mitapivat) for treating hemolytic anemia marks a turnaround from nearly a year ago. That’s when Agios sold its commercial, clinical and research-stage oncology portfolio to privately held Servier Pharmaceuticals LLC to concentrate on rare diseases.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Medtronic, Ra Medical Systems.
As part of its ongoing effort to speed drug pricing competition in the U.S. through the development of generics, the FDA is releasing another batch of draft and revised draft product-specific guidances on the design of bioequivalence studies to support abbreviated new drug applications. Among the 30 new draft guidances is one specific to remdesivir, which was approved in October 2020 as a COVID-19 treatment.
In the latest chapter in an ongoing contract dispute between AOP Orphan Pharmaceuticals GmbH and Pharmaessentia Corp., the German Federal Court of Justice this week set aside the €143 million (US$162.8 million) in damages awarded to AOP, citing procedural flaws in quantifying the product supply and damages.
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