It’s all systems “go” for Travere Therapeutics Inc. and its sparsentan after meetings with the FDA paved the way for filings and potential accelerated approvals in the rare kidney disease IgA nephropathy and the kidney scarring condition focal segmental glomerulosclerosis.
In an effort to advance a fiscal 2022 spending package through a divided Congress, U.S. President Joe Biden released the framework for his Build Back Better agenda Oct. 28 – minus provisions that would allow Medicare to directly negotiate at least some prescription drug prices.
The EMA and the EU Heads of Medicines Agencies are launching a pilot project to support not-for-profit organizations and academia in the repurposing of an authorized drug for a new indication in an area of public health interest.
The U.S. Department of Health and Human Services is proposing to withdraw or repeal a Trump-era rule imposing expiration dates on most of the rules implemented by the department and its agencies, including the FDA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Axial, Bharat, Biontech, Bio-Path, Eli Lilly, Medicenna, Novartis, Novavax, Ocugen, Pfizer, Quell, Vitti.
As part of its ongoing research into drug advertising, the FDA’s Office of Prescription Drug Promotion (OPDP) is proposing a study to understand how “targeted mechanism of action” (MoA) claims influence patients and health care providers when they’re used in drug ads and other promotional materials.
To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.
The U.S. Federal Trade Commission (FTC) has restored a rule that requires prior authorization for any mergers that affect a market that was the subject of previous allegations of attempted anticompetitive behavior. The agency’s press release on the change seems to respond to the decision by Illumina Inc. to complete its acquisition of Grail Inc. and its multicancer screening test, as indicated by the statement that the policy would address the behavior of companies that see little risk to their long-term market strategies despite FTC opposition to an acquisition.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angel, Atamyo, Axcella, Biovie, Corvus, Emmaus, Geron, Mereo, Moderna, Nova Mentis, Precigen, Seagen.
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