Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
The jury is still out on how much hydroxychloroquine and chloroquine actually help in the treatment or prevention of COVID-19, but desperate times have led desperate health care providers to use the antimalarial drugs to treat patients in desperate need of coronavirus cures.
PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
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.
To mitigate COVID-19-related drug shortages, the FDA issued new guidance reminding drug and biologic manufacturers of their legal obligations to notify the agency, in advance, of interruptions or the permanent discontinuance in the manufacturing of certain drugs. It also makes some new recommendations in light of the current emergency.
Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.
Not long after a morning earnings call on March 27 in which Intelgenx Corp. CEO Horst Zerbe said his team was still awaiting word from the FDA on its resubmitted 505(b)(2) application for its acute migraine candidate, Rizaport Versafilm, that news arrived in the form of a complete response letter (CRL), its third following earlier CRLs in February 2014 and April 2019.
Now that Rockwell Medical Inc.’s intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate) is FDA-approved, the nod coming a day before its PDUFA date of March 28, the company plans putting evaluation programs into action during the third quarter of this year. Only after those programs’ completion will the formulation be available commercially.
Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia. The win, a much-anticipated milestone precipitated by the company’s multibillion-dollar acquisition of ozanimod developer Celgene Corp. in November 2019, gives patients a new treatment option amid a growing field of therapies for MS.
Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
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