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.
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data presented by Bellerophon Therapeutics Inc. to grant it expanded access approval for its iNOpulse system for pulmonary delivery of NO.
With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic.
DBV Technologies SA officials took pains to reassure investors that data wanted by the FDA with regard to the BLA for Viaskin Peanut allergy therapy are already in hand and need only be turned over to the agency, but that didn’t stop shares (NASDAQ:DBVT) from sliding 55.7%, or $2.93, to close March 17 at $2.33.
“For those of us who believe in a free market, it is really important that the market works well,” FDA Commissioner Stephen Hahn said March 9 at a public workshop on ensuring a U.S. biologic marketplace that includes sustainable biosimilar and interchangeable competition.
With deeming day a little more than a month away, the FDA is taking final steps to ease the transition of simple proteins approved as new drug applications (NDAs) to biologic license applications (BLAs). The March 23 change will open drugs such as insulin and various hormones to new competition, likely bringing in the next wave of biosimilars. And this time, interchangeability could be riding the crest.
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
