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FDA revokes 5 COVID test EUAs at request of sponsors

April 19, 2022
By Mark McCarty
The U.S. FDA’s device center reported April 18 that it has revoked the emergency use authorizations (EUAs) for five tests for the SARS-CoV-2 virus, a seemingly significant reduction in the inventory of tests for the COVID-19 pandemic. However, the sponsor of the test in each of these revocations requested that the EUA be revoked, an indication that the market for some types of these tests is saturated.
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Varicose veins concept art

Acotec wins NMPA nod for radiofrequency ablation to treat varicose veins

April 19, 2022
By Doris Yu
Acotec Scientific Holdings Ltd. has received marketing approval for its radiofrequency ablation system from China’s NMPA to treat varicose veins. The radiofrequency ablation system consists of an endovenous radiofrequency catheter and a radiofrequency generator.
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U.S. flag and money

MDMA’s Leahey says quality of reviews more important than speed in user fee programs

April 19, 2022
By Mark McCarty
The U.S. FDA’s draft device user fee agreement was months late in arriving on Capitol Hill, a fact which also delayed the public meeting on the draft, an event that finally took place April 19. The meeting kicked off with an acknowledgement by second-time FDA commissioner Robert Califf of the growing role of user fees in FDA finances, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said that the quality of FDA reviews was at least as important as the timeliness of those reviews even though the user fee deals include many deadline-based metrics.
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Markups on cancer drug prices shoot for the moon

April 19, 2022
By Mari Serebrov
With renewed focus on the U.S. Cancer Moonshot, the price of oncology drugs is more than a satellite issue, especially as new drugs launch with ever-increasing prices and other cancer drugs continue to see price hikes.
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Regulatory actions for April 19, 2022

April 19, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bendit Technologies, Cosara, Genetron, Ihealthscreen, Microgem, Smart Medical Systems.
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J&J goes for the sure bet with $99M opioid settlement

April 19, 2022
By Mari Serebrov
Deciding not to roll the dice this time, Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. removed themselves April 18 from an ongoing opioid trial in West Virginia by agreeing to a $99 million settlement with the state.
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Drug capsule and dollar sign

Potential biosimilar savings subdued in US

April 19, 2022
By Mari Serebrov
Although broader use of biosimilars in the U.S. would reduce Medicare Part D spending and save beneficiaries nearly $2 million in out-of-pocket costs, plan formularies continue to discourage the use of the more affordable follow-ons, according to a recent report from the Department of Health and Human Services’ Office of Inspector General.
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DNA illustration

China clarifies regulations on sharing human genetic resources

April 19, 2022
By Tamra Sami
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
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Japanese money and medicine

Japan’s annual drug price reforms result in less predictability for pharma market

April 19, 2022
By Tamra Sami
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
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Regulatory actions for April 19, 2022

April 19, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Novartis, TG.
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