With the FDA’s blessing, Biohaven Pharmaceutical Holding Co. Ltd.’s Nurtec ODT (rimegepant) enters a massive market for treating migraine in adults. In the U.S. alone, more than 25 million people have been diagnosed and seek treatment.
SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.
HONG KONG – Singapore-based Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy (RMAT) designation by the U.S. FDA based on data from two independent phase I/II trials in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma.
The U.S. FDA has finalized two guidances dealing with class II tests that are subject to Medicare regulations, including the so-called dual CLIA waiver guidance. The agency said it will hold an April 14, 2020, webinar to go over both guidances, allocating 90 minutes to deal with questions about the two documents.
LONDON – It was third time lucky for Acacia Pharma Group plc, as the FDA finally gave approval to Barhemsys (amisulpride) as a rescue treatment for surgical patients suffering postoperative nausea and vomiting (PONV), despite standard-of-care treatment.
The second day of the FDA workshop on artificial intelligence (AI) in health care featured several interesting proposals, including that AI will be used in health care without the aid of a health care professional. John Martin, chief medical officer at Butterfly Network Inc., of Guildford, Conn., said the time is ripe for AI-assisted ultrasound in the home, which he claimed could reduce rehospitalizations in heart failure, one of the holy grails in U.S. government efforts to restrain health care spending growth.
Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.
While the staff at the U.S. Department of Health and Human Services (HHS) is currently all hands-on-deck in responding to the COVID-19 outbreak, some of the agencies in the department may have to divert resources to get sponsors of drug and device clinical trials to fill in nearly a decade-long data gap on Clinicaltrials.gov. That’s if a judge’s decision handed down this week stands.
Developers of artificial intelligence (AI) algorithms have their own nightmares to deal with, but the FDA is charged with employing a regulatory touch that steers clear of rocky shoals on one side and inescapable whirlpools on the other. The FDA’s Bakul Patel said during a Feb. 25 workshop that the FDA would quickly be swamped if the agency took a traditional regulatory approach to managing the super-iterative digital health space, but that the agency will keep a keen eye on the potential impact on patients as AI begins to move into clinical practice.
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