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.
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.
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.
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.
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.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Novartis, TG.
The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bendit Technologies, Sonoscape Medical.
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