Top Regulatory News Stories – Week Ending May 3, 2019

The U.S. FDA gave Sanofi’s dengue vaccine Dengvaxia a very narrow approval on Wedneday.  The company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people.

Finch Therapeutics Group announced that the FDA has granted Fast Track designation to its Full-Spectrum Microbiota® (FSM®) therapy for the treatment of children with Autism Spectrum Disorder (ASD).

AVROBIO, Inc. announced that the FDA has cleared their IND application for AVR-RD-01, its gene therapy candidate for the treatment of Fabry disease.

Emtora Biosciences, a biotech startup formerly known as Rapamycin Holdings received Orphan Drug Designation from the FDA for a treatment for a rare genetic disease known as Familial Adenomatous Polyposis (FAP).

Heron Therapeutics disclosed that the FDA has rejected HTX-011, a non-opioid painkiller for postoperative pain. According to Heron, the FDA wants additional information on chemistry, manufacturing and controls to proceed, along with more non-clinical data.

In other news…

If all goes as planned, the first clinical trial in the United States testing CRISPR against cancer by altering the DNA of tumor cells inside patients could begin recruiting participants next year.

Celgene and bluebird bio published interim data from CRB-401, their Phase I trial of bb2121, their CAR-T therapy in patients with relapsed and refractory multiple myeloma.

Magenta Therapeutics announced the pricing of its public offering of 4,250,000 shares of its common stock at a price to the public of $13.25 per share, for total gross proceeds of approximately $56.3 million.

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