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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Novartis, TG.
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.
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Astellas, Coherus, Innovent, Inxmed, Merck, PTC, Regeneron.
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.
It’s been one thing after another for rusfertide from Protagonist Therapeutics Inc. for the past year. Now the U.S. FDA has told the company it wants to rescind the breakthrough designation, a relatively rare occurrence, based on observed malignancies in a follow-up to September’s clinical hold.
The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Atyr, Biogen, Boehringer, Briacell, Direct, Eli Lilly, Novavax, Recbio.
Pharma CEOs have pushed back strongly against intellectual property (IP) waivers for COVID-19 vaccines and therapies, saying that pricing is not the reason why middle- and low-income countries have not received pharmaceutical countermeasures against the pandemic. Senior execs from Pfizer Inc., Eli Lilly and Co., and Roche Holding AG, also expressed concerns about the latest funding package from the U.S. government, which at $10 billion is less than half that originally requested by the White House.
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