Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.
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.
DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches.
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.
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.
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.
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