Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
When smart people make irrational choices, we often assume they are acting out of selfishness, stupidity or stubbornness.
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
Instead, the FDA granted Aduhelm a conditional approval, allowing it to be prescribed and used while Biogen conducts a post-marketing, phase 4 confirmatory study – which could take years to ...
It has also given accelerated approval for aducanumab (Aduhelm). While three drugs have been approved, the treatments didn't prove to be as effective as thought. Aduhelm was withdrawn from the market.
A government watchdog examining the FDA’s accelerated approval pathway has released a 32-page report (PDF) that concludes the agency’s controversial endorsement of Biogen’s failed Alzheimer ...
Roll Call reports that the newly finalized rule will allow for health care providers who have not seen a patient in person to prescribe six months’ worth of buprenorphine via telehealth. Also in ...
(Bloomberg) -- Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal ...
The report suggested that Aduhelm was more of an outlier, as investigators found only three troubling instances out of a sample of 24 accelerated approval drugs. But Ivan Troy, social science ...
The report highlights issues with the approvals of Biogen's Alzheimer treatment, Aduhelm; Serepta Therapeutics' Duchenne muscular dystrophy therapy, Exondys 51; and Covis Pharma's preterm birth ...
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The report focuses on drugs the FDA has greenlit through the accelerated approval pathway that have raised concerns, including Biogen's beta-amyloid-targeting Alzheimer's disease drug Aduhelm ...
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