Top Regulatory News Stories – Week Ending June 14, 2019

Genentech’s blood cancer drug Polivy earned an accelerated approval from the U.S. FDA due to the complete response rate shown during clinical trials.

The FDA approved Merk’s Keytruda as a frontline treatment for head and neck cancer.  Keytruda was initially approved in 2014 for advanced melanoma and has since received approvals as treatment for multiple other types of cancers.

AlloVir announced that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for Viralym-M (ALVR105), its lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, for the treatment of hemorrhagic cystitis (HC) caused by BK virus in adults and children following allogeneic hematopoietic stem cell transplantation (HSCT).

Epizyme, Inc. announced that it has submitted a NDA to the U.S. FDA for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

Global Blood Therapeutics poised to submit an application for accelerated approval this year for its sickle cell disease drug

In just its second enforcement letter this year, the FDA’s Office of Prescription Drug Promotion clamped down on Vivus for a webpage marketing its struggling obesity drug Qsymia.

Catalyst Pharmaceuticals is suing the FDA, seeking to vacate the recent approval of Jacobus Pharmaceutical’s drug

The FDA warned medical and scientific communities and other interested persons of the potential risk of transmitting multi-drug resistant organisms (MDROs) via poop transplants, otherwise known as fecal microbiota for transplantation (FMT).

In other news…

Biogen announced that it has completed its $800-million purchase of Nightstar Therapeutics, which focuses on adeno-associated virus (AAV) treatments for inherited retinal disorders.

Insys Therapeutics filed for bankruptcy following legal troubles.

New demands from the Federal Trade Commission demands could mean months-long delay for the Roche acquisition of Spark Therapeutics

Bluebird bio has sets a $1.8M price on its newly approved gene therapy

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