As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved Biogen, Inc.'s Aduhelm (aducanumab) to treat Alzheimer's disease through the FDA Accelerated Approval Program in a landmark decision. The FDA's approval...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more