Top Regulatory News Stories – Week Ending June 15, 2018

The FDA granted accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced, PD-L1–positive cervical cancer with disease progression on or after chemotherapy. Keytruda was previously approved for several other oncology indications including metastatic non-small cell lung cancer, advanced melanoma, recurrent or metastatic head and neck squamous cell carcinoma, metastatic urothelial carcinoma, and advanced gastric cancer. https://www.curetoday.com/articles/fda-approves-keytruda-for-cervical-cancer-treatment-

The FDA approved Roche’s Avastin (bevacizumab) plus chemotherapy as a treatment for women with advanced ovarian cancer following initial surgery. Avastin is now approved for ten distinct uses across six different types of cancer in the United States: https://www.roche.com/media/releases/med-cor-2018-06-13.htm?utm_source=LI&utm_medium=E&utm_campaign=RO_DA_Onco_Ovar

The FDA announced the approval of the first generic versions of Indivior's Suboxone Film (buprenorphine/naloxone), with both Dr. Reddy's Laboratories and Mylan gaining clearance to market the opioid dependence treatment in multiple strengths. https://www.firstwordpharma.com/node/1572781

Bristol-Myers Squibb announced that the China National Drug Administration (CNDA) approved Opdivo (nivolumab) for the treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC), making the product the first PD-1 inhibitor authorized in China. https://www.firstwordpharma.com/node/1572832?tsid=28&region_id=4

Insmed announced that the FDA Division of Antimicrobial Products will have an advisory committee meeting this summer to review data supporting Insmed's NDA for ALIS (Amikacin Liposome Inhalation Suspension) for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).  https://www.firstwordpharma.com/node/1572836?tsid=28&region_id=4

Ironwood Pharmaceuticals announced the FDA has granted its olinciguat (IW-1701) Orphan Drug Designation for sickle cell disease.  https://www.biospace.com/article/ironwood-pharma-s-sickle-cell-drug-gets-orphan-drug-designation/?utm

Sage Therapeutics announced that the FDA will let it run a shorter study so that it may gain a quicker path to approval for its depression drug SAGE-217. https://seekingalpha.com/article/4181229-sages-depression-drug-skips-line-shorter-trial-duration-fda-approval

Curis, Inc. announced that the FDA has granted Fast Track designation for the development of fimepinostat (formerly CUDC-907) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. https://www.drugs.com/clinical_trials/curis-announces-fda-fast-track-designation-fimepinostat-cudc-907-development-patients-relapsed-17832.html

AMO Pharma announced that the FDA has granted Orphan Drug Designation to its investigational therapy AMO-04 for the treatment of Rett syndrome, a rare childhood neurodevelopmental disorder. https://www.firstwordpharma.com/node/1572362

Samus Therapeutics reported that the FDA has granted orphan drug designation to PU-H71 for the treatment of myelofibrosis. https://www.firstwordpharma.com/node/1572307

Sunovion Pharmaceuticals announced that the FDA has accepted its NDA for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is January 29, 2019. https://www.drugs.com/nda/apl_130277_180612.html

ContraVir Pharmaceuticals announced the approval of the IND and initiation of the clinical development program of CRV431 in the United States https://www.firstwordpharma.com/node/1572621?tsid=2

Hoping to pave the way for greater adoption of value-based contracts, the FDA published final guidance that clarifies how drugmakers can share product information with payers while remaining compliant with FDA rules on communication. https://www.biopharmadive.com/news/fda-guidance-drugmakers-payers-communication-value-based-contracts/525547/

In other news…

Advaxis will lay off about a quarter of its workforce, cutting costs amid a restructuring that seeks to reduce spending on the company's lead candidate in favor of three earlier compounds. https://www.biopharmadive.com/news/advaxis-lays-off-staff-refocuses-cancer-pipeline/525286/

Melinta Therapeutics raised $123 million in a public offering of 22,000,000 shares of its common stock last week. The company said it will use the funds to advance its pipeline of novel antibiotics to treat serious bacterial infections, as well as expand its sales staff. https://www.biospace.com/article/melinta-therapeutics-snags-123-million-in-a-public-offering/?utm

Eagle Pharmaceuticals announced that the U.S. District Court for the District of Columbia issued a decision requiring the FDA to grant seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI). https://www.firstwordpharma.com/node/1571780

Eisai is building a new research center in Cambridge with a $100 million plan to tackle Alzheimer’s: https://endpts.com/eisai-is-building-a-bespoke-cambridge-research-center-with-a-100m-plus-plan-to-find-new-ways-to-tackle-alzheimers/?utm

Flex Pharma is cutting 60% of its staff after halting a clinical trial due to safety concerns: https://www.biopharmadive.com/news/flex-calling-it-quits-after-trial-stop/525620/  

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/