Following battles over its price and accelerated approval, Biogen Inc. and Eisai Co. Ltd.’s Aduhelm (aducanumab) now has newly approved prescribing information from the FDA that limits the patient population and sales along with it. The updated Indications and usage now reads that the anti-amyloid beta monoclonal antibody should be used only in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. That’s the patient population in which treatment was initiated in clinical trials that led to approval. The company said the new wording “clarifies the indication.” The original FDA-approved language cleared the drug for much broader use in Alzheimer’s.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus. Bold, Eucure, Jazz, Replicel, Scisparc, Sorrento.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Athenex, Immutep, Janssen-Cilag, Levo, Merck, Opthea, Orgenesis, Sciclone, Y-Mabs.
The U.S. Federal Trade Commission (FTC) reported a series of moves recently that promise more scrutiny of companies in the life sciences industry, such as the more routine use of subpoenas and other compulsory processes during investigations. However, the FTC has also announced a broader revamp of the agency’s rulemaking authorities that some critics argue would allow the commission to promulgate rules that are in defiance of standing FTC practice.
The U.S. Supreme Court has agreed to take up one piece of the 340B conundrum that’s pitting biopharma against hospitals and catching the Department of Health and Human Services in between. The case the court agreed to hear, the American Hospital Association (AHA) v. Becerra, focuses on whether HHS has the authority to cut Medicare reimbursement rates to reflect the steep discounts 340B hospitals get on certain prescription drugs.
Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Agenus, Bristol Myers Squibb, Cytodyn, Diurnal, Hangzhou Chance, Iterum, Moderna, Recipharm, Zydus Cadila.
An ongoing FDA review of Iterum Therapeutics plc's NDA for a bilayer tablet containing sulopenem etzadroxil and probenecid for uncomplicated urinary tract infections (uUTI) has uncovered "deficiencies that preclude the continuation" of talks on labeling and postmarketing requirements, the company said. The revelation, less than four weeks before the NDA's July 25 PDUFA date, "throws an on-time approval into serious doubt," making Iterum's receipt of a complete response letter "a reasonably likely scenario," H.C. Wainwright analyst Ed Arce wrote.
Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adlon, Alzamend Neuro, Hutchmed, Ildong, Immunic, Jazz, Lupin, Mesoblast, Puma, Prometic, Scpharmaceuticals.
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