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.

The FDA’s attempts to thwart the use of electrostimulation devices for self-injurious and aggressive behavior came up short in an appeals court hearing of Rotenberg v. FDA, largely because the FDA’s approach suggested the agency would control the practice of medicine.

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.

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.