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.
DUBLIN – Novartis AG, Bristol Myers Squibb Co. and Sanofi SA were among firms that secured positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP) on marketing authorization applications for new therapies, which will progress to formal approvals 67 days from now. Because of the COVID-19 pandemic, the committee’s March meeting was held virtually.
Aegea Medical Inc., of Menlo Park, Calif., has received U.S. FDA approval for its next-generation Mara water vapor ablation system, the only endometrial ablation treatment that uses vapor to treat heavy menstrual bleeding. The first commercial procedure was performed by Kirk Brody, an obstetrician-gynecologist in Chattanooga, Tenn.
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.
The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.