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. https://www.biospace.com/article/genentech-s-blood-cancer-drug-approved-two-months-ahead-of-pdufa-date/?s=61
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. https://endpts.com/merck-grows-keytruda-indications-with-head-and-neck-cancer-approval/
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). https://www.biospace.com/article/releases/allovir-announces-viralym-m-granted-regenerative-medicine-advanced-therapy-rmat-designation-for-the-treatment-of-hemorrhagic-cystitis-caused-by-bk-virus-in-adults-and-children-following-allogeneic-hsct/?s=61
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. https://www.drugs.com/nda/tazemetostat_190530.html?utm_source=ddc&utm_medium=rss&utm
Global Blood Therapeutics poised to submit an application for accelerated approval this year for its sickle cell disease drug https://endpts.com/global-blood-therapeutics-poised-to-submit-application-for-accelerated-approval-with-new-pivotal-data-on-its-sickle-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. https://www.fiercepharma.com/marketing/prescription-drug-police-ding-vivus-for-misleading-qsymia-obesity-treatment-webpage?mkt_tok=eyJpIjoiT0dRMVpXSm1NemN6TmpnMSIsInQiOiJjc1NLRUlxVzFiaklWVCtuWCtXb3FuNWt5STQycDFEOFdTXC9CbWR3VXAxXC8rdjZHNmVHdU14VFIwOG1DOW01dzJ5ZjJZa3g2TXY3V0owOGV3bDZ4QVwvV3RtS2xrU2dWUFhOQ0RuM1psaG50UkxCWHNQSGw4UTF1cVpYb085VmlhQyJ9&mrkid=944305
Catalyst Pharmaceuticals is suing the FDA, seeking to vacate the recent approval of Jacobus Pharmaceutical’s drug https://www.biopharmadive.com/news/catalyst-sues-fda-seeks-to-vacate-approval-of-a-competitors-drug/556733/
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). https://www.raps.org/news-and-articles/news-articles/2019/6/fda-warns-of-one-death-linked-to-fecal-transplants?feed=Regulatory-Focus
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. https://www.firstwordpharma.com/node/1646009
Insys Therapeutics filed for bankruptcy following legal troubles. https://www.biospace.com/article/insys-therapeutics-files-for-bankruptcy/?utm
New demands from the Federal Trade Commission demands could mean months-long delay for the Roche acquisition of Spark Therapeutics https://www.biopharmadive.com/news/ftc-demands-roche-spark-deal-delay/556747/
Bluebird bio has sets a $1.8M price on its newly approved gene therapy https://endpts.com/as-bluebird-keeps-analysts-waiting-for-a-price-researchers-outline-efficacy-standards-on-its-gene-therapy/
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