Medrhythms Inc., a digital therapeutics startup based in Portland, Maine, won an FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke.
The latest FDA report card on the quality of drugs being sold in the U.S. is nothing to brag about. On a grading scale where 90% to 100% is an “A” and anything below 60% is failing, the average manufacturing site inspection score for drugs marketed in the U.S. in fiscal 2019 would be a solid “C” – or 7.4 on the FDA’s 10-point grading scale. But at least 10 sites had failing marks with scores of 5.
Threads of hope and caution stitched together a wide-ranging appraisal of COVID-19 vaccines at June 9's BIO Digital plenary, "A Way Forward." The good news, delivered by one of the world's most sober participants in the pandemic response, mercifully came first.
As the FDA continues to shift its limited resources to the development and review of COVID-19 therapies and vaccines, other drugs in the pipeline may be delayed. In a question-and-answer guidance released late Tuesday, the agency acknowledged that, going forward, it may not be able to sustain its current performance level in meeting all its goal dates for new drugs and biologics.
Women, black and Hispanic/Latinx participants were underrepresented in pivotal clinical trials for drugs approved from 2007 to 2017, according to a new report by the Tufts Center for the Study of Drug Development. In the pivotal clinical trials, 44.9% of patients were women. Participants who identified as black or of African descent were the most underrepresented participant group, representing 5.4% of participants in clinical trials.
Nearly 40 years on, the generic drug market is often lauded as an American success story. But a closer inspection reveals such back-patting ignores the potential for serious public health risks caused by ongoing shortages in the generic drug supply. It also ignores quality issues and lingering physician and patient doubts about generics, especially those made in other countries.
In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials.
When it comes to guidance on interchangeables, the Pharmaceutical Research and Manufacturers of America (PhRMA) has some guidance for the FDA: Be more definite.
In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials. But patients still in the studies need to be followed for safety and efficacy, creating challenges for the industry.
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
