Top Regulatory News Stories – Week Ending July 20, 2018

Agios Pharmaceuticals said the US FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year. https://www.biospace.com/article/agios-pharmaceuticals-scores-fda-approval-for-tibsovo-second-aml-drug-win-in-less-than-a-year/

SIGA Technologies announced that the FDA approved its filing for oral TPOXX (tecovirimat) as the first therapy with an indication specifically for the treatment of smallpox “to mitigate the impact of a potential outbreak.” https://www.firstwordpharma.com/node/1578847

Astellas Pharma and Pfizer announced the FDA approved a sNDA for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. This FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. https://www.businesswire.com/news/home/20180713005429/en/U.S.-FDA-Approves-XTANDI%C2%AE-enzalutamide-Treatment-Men#.W0oVFb5Ap18.linkedin

Ocular Therapeutix announced that it has received acknowledgement from the FDA that the NDA for DEXTENZA® for ocular pain has been accepted.  https://www.businesswire.com/news/home/20180719005161/en

An FDA Advisory Committee has backed GSK’s 1-shot P. vivax malaria therapy with a 13-0 vote: https://www.fiercebiotech.com/biotech/fda-adcomm-backs-gsk-s-one-shot-p-vivax-malaria-therapy

Nohla Therapeutics announced that the FDA has granted Nohla’s lead product candidate dilanubicel (NLA101) Orphan Drug Designation for reduction of morbidity and mortality associated with hematopoietic stem cell transplant (HSCT). https://www.firstwordpharma.com/node/1579101?tsid=1

Inozyme Pharma announced that both the FDA Office of Orphan Products Development and the EMA Committee for Orphan Medical Products granted Orphan Drug Designation to INZ-701 for the treatment of ENPP1 Deficiency. https://www.businesswire.com/news/home/20180717005194/en

Gamida Cell announced that the FDA has granted orphan drug designation for NiCord as a treatment for hematopoietic stem cell transplantation (HSCT).  https://www.businesswire.com/news/home/20180717005112/en

MaxCyte announced that it has received IND clearance from the FDA to begin a clinical study in the United States with its first wholly-owned chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11.  https://www.firstwordpharma.com/node/1578907?tsid=2

Braeburn announced that the FDA has assigned a PDUFA goal date of December 26, 2018 for its NDA for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults with opioid use disorder. CAM2038 was previously granted Fast Track and Priority Review designations.  https://www.firstwordpharma.com/node/1579011?tsid=2

FDA Commissioner Scott Gottlieb shared a plan for making more prescription drugs available over the counter. The process would use digital health technologies to help patients self-select a treatment and could lower healthcare costs for patients with common conditions or chronic conditions.  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm

In other news…

PTC Therapeutics acquired gene therapy startup Agilis for $200M in cash and stock https://endpts.com/nabbing-late-stage-drug-ptc-acquires-gene-therapy-startup-agilis-for-200m-in-cash-stock/?utm

Shares in Indivior jumped on news that a US district court granted a preliminary injunction preventing Dr. Reddy’s Laboratories from selling or importing its generic version of Suboxone Film (buprenorphine/naloxone).  https://www.firstwordpharma.com/node/1578901

Several biotech companies have IPOs this week including Allakos, Constellation Pharma, Crinetics Pharmaceuticals, Replimune, and Rubius Therapeutics:   https://endpts.com/a-unicorn-joins-this-weeks-stampede-of-biotechs-into-the-red-hot-nasdaq-casino/?utm

 

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