Top Regulatory News Stories – Week Ending July 13, 2018

Eagle Pharmaceuticals announced that the U.S. FDA has granted seven years of orphan drug exclusivity in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine hydrochloride. https://www.biospace.com/article/releases/fda-grants-eagle-seven-year-orphan-drug-exclusivity-for-bendeka-bendamustine-hydrochloride-injection-/?s=95

OBI Pharma, Inc. announced that the FDA has granted Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC).   https://www.firstwordpharma.com/node/1577396?tsid=28&region_id=4

Enzyvant announced that it has initiated its rolling submission of a BLA for RVT-802 to the FDA. The company expects to complete its BLA submission by the end of 2018.  https://www.biospace.com/article/releases/enzyvant-announces-initiation-of-rvt-802-rolling-bla-submission-for-the-treatment-of-complete-digeorge-anomaly/?s=95

Recursion announced that the FDA has cleared an IND application for a Phase 1 clinical trial of REC-994 in the treatment of cerebral cavernous malformation (CCM).  https://www.prnewswire.com/news-releases/recursion-receives-fda-clearance-of-investigational-new-drug-application-to-initiate-first-clinical-trial-of-rec-994-in-cerebral-cavernous-malformation-300678055.html

Emmaus Life Sciences announced that the FDA has accepted its IND application for L-glutamine as a treatment for diverticulosis. https://www.biospace.com/article/releases/emmaus-life-sciences-announces-fda-acceptance-of-ind-application-for-clinical-study-of-l-glutamine-for-treatment-of-diverticulosis/

Adagene, Inc. has received notification from the FDA to proceed on its IND application to study its lead product (ADG-106) in patients with advanced solid tumors and non-Hodgkin lymphoma. https://www.biospace.com/article/releases/us-fda-approves-adagene-io-program-ind-for-solid-tumor-and-non-hodgkin-lympoma-ph1-trial/

Acceleron Pharma announced that the FDA has granted orphan drug designation for ACE-083, the Company’s locally acting “Myostatin+” muscle agent, for the treatment of patients with facioscapulohumeral muscular dystrophy. https://www.biospace.com/article/releases/acceleron-receives-fda-orphan-drug-designation-for-ace-083-in-facioscapulohumeral-muscular-dystrophy/

The FDA has granted Priority Review to Merck’s sBLA for KEYTRUDA® (pembrolizumab) for the treatment of patients with advanced hepatocellular carcinoma. https://www.biospace.com/article/releases/fda-grants-priority-review-to-merck-s-supplemental-biologics-license-application-for-keytruda-pembrolizumab-for-the-treatment-of-patients-with-advanced-hepatocellular-carcinoma/

Dicerna Pharmaceuticals announced that the EMA’s Committee for Orphan Medicinal Products (COMP) has recommended designating DCR-PHXC, the Company’s lead GalXC™ product candidate, as an orphan medicinal product for the treatment of primary hyperoxaluria (PH) in the European Union.  https://www.businesswire.com/news/home/20180711005135/en

Roche Canada announced today that Health Canada has approved GAZYVA® (obinutuzumab), in combination with chemotherapy, followed by GAZYVA monotherapy in patients achieving a response, for the treatment of patients with previously untreated stage II bulky (>7cm), III or IV follicular lymphoma. https://www.firstwordpharma.com/node/1577423

Bristol-Myers Squibb Canada announced that immuno-oncology (I-O) combination therapy OPDIVO (nivolumab) 3mg/kg plus YERVOY (ipilimumab) 1mg/kg for intravenous injections, was approved by Health Canada for the treatment of adult patients with intermediate/poor-risk advanced or metastatic renal cell carcinoma. http://news.morningstar.com/all/canada-news-wire/20180709C1600/only-immuno-oncology-combination-therapy-approved-by-health-canada-as-first-line-treatment-for-advanced-or-metastatic-renal-cell-carcinoma.aspx

FDA Commissioner Scott Gottlieb released a statement on the misuse of opioids and the need to balance access to treatment: https://www.biospace.com/article/releases/statement-by-fda-commissioner-scott-gottlieb-m-d-on-balancing-access-to-appropriate-treatment-for-patients-with-chronic-and-end-of-life-pain-with-need-to-take-steps-to-stem-misuse-and-abuse-of-opioids/

FDA Commissioner Scott Gottlieb also outlined a regulatory framework for the development of gene therapies. https://www.firstwordpharma.com/node/1578253

The FDA on Friday warned consumers of a potential international extortion scam, saying criminals forged FDA warning letters targeting those purchasing medicines online or via the phone. https://www.raps.org/news-and-articles/news-articles/2018/7/fake-warning-letters-fda-cautions-over-potential?feed=Regulatory-Focus

In other news…

Takeda announced that it has received unconditional clearance from the United States Federal Trade Commission for the proposed acquisition of Shire plc announced on May 8, 2018 https://www.businesswire.com/news/home/20180709005909/en

Regulus Therapeutics is putting its two clinical programs on hold — and axing 60% of its remaining staff.  https://endpts.com/cash-strapped-regulus-braces-for-drastic-downsizing-while-hitting-the-brakes-on-lead-programs/

Due to failure of its lead drug, Aquinox announced a restructuring which will cut 53% of its workforce: https://endpts.com/aquinox-discards-lead-drug-chops-half-of-its-staff-in-wake-of-phiii-disaster/

Pfizer Inc said on Wednesday it would reorganize its business into three units: biosimilars & hospital business, branded & generic medicines, and consumer healthcare.  https://www.firstwordpharma.com/node/1578080

BioCryst Pharmaceuticals and Idera Pharmaceuticals announced that the companies are calling off their planned merger after BioCryst shareholders voted down the agreement at a special meeting on Tuesday.  https://www.firstwordpharma.com/node/1578030

Otsuka Pharmaceutical agreed to acquire Visterra for approximately $430 million in cash. https://www.firstwordpharma.com/node/1578083?tsid=28&region_id=4

The Novartis Institutes for BioMedical Research is ending its early-stage anti-infectives research programs located in Emeryville, California. As a result, the company expects to lay off about 140 employees.  https://www.biospace.com/article/novartis-to-drop-anti-infectives-research-programs-and-lay-off-140/

 

This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com   You can also visit us on LinkedIn at https://www.linkedin.com/company/dennis-partners/