I am posting a bit early this week due to the long holiday weekend. Here are the top regulatory news stories to follow this week:
- FDA’s biosimilars lead Leah Christl said last week at DIA’s annual conference in Chicago that she expects interchangeable biosimilars will come to market within the next two years: http://raps.org/Regulatory-Focus/News/2017/06/26/27969/FDA-Interchangeable-Biosimilar-Approvals-Expected-Within-2-Years/
- The FDA took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of ANDAs for which there are fewer than three ANDAs approved for the reference listed drug. Both moves seek to increase generic drug competition and lower the cost of pharmaceuticals in the US. http://raps.org/Regulatory-Focus/News/2017/06/27/27979/FDA-to-Speed-Reviews-of-More-Generic-Drugs-Offers-Lists-of-Those-With-Limited-Competition/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails
- The FDA approved a new oral blood-thinner made by Portola Pharmaceuticals to prevent deep vein thrombosis and pulmonary embolisms in acutely ill patients who are not undergoing surgery. The drug, BevyxXa, known also as betrixaban, is the first oral treatment and first extended duration treatment for this patient population. https://www.reuters.com/article/us-portola-pharma-fda-approval-idUSKBN19E1WS
- The FDA has accepted Icon Bioscience’s recently submitted NDA for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery. Tthe agency has established a PDUFA date of February 12, 2018 http://processandproduction.pharmaceutical-business-review.com/news/fda-accepts-nda-filing-for-icons-dexycu-270617-5853274
- The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis’ Imraldi for approval. Imraldi is a biosimilar candidate referencing Humira (adalimumab) for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis. The CHMP’s positive opinion will be reviewed by the European Commission (EC) to grant a marketing authorization for Imraldi. http://regulatoryaffairs.pharmaceutical-business-review.com/news/emas-chmp-recommends-samsung-bioepis-imraldi-for-ec-approval-260617-5852469
- Sanofi and Regeneron Pharmaceuticals have secured approval from the EC for Kevzara (sarilumab) in combination with methotrexate (MTX) to treat adult patients with moderately to severely active rheumatoid arthritis (RA) in adult patients. http://regulatoryaffairs.pharmaceutical-business-review.com/news/sanofi-regeneron-secure-ec-approval-for-kevzara-to-treat-rheumatoid-arthritis-280617-5854119
- The EC has approved Novartis’ Erelzi, the biosimilar of Amgen and Pfizer’s Enbrel (etanercept), for the treatment of multiple inflammatory diseases. http://regulatoryaffairs.pharmaceutical-business-review.com/news/novartis-etanercept-biosimilar-approved-in-europe-to-treat-inflammatory-diseases-280617-5854460
- Puma Biotechnology announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 – 4 to recommend approval of PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable. https://www.drugs.com/nda/neratinib_170524.html
- Epizyme, Inc. announced that the FDA has granted Orphan Drug designation to tazemetostat, the company’s first-in-class EZH2 inhibitor, for the treatment of patients with soft tissue sarcoma (STS). https://www.firstwordpharma.com/node/1481941
- The FDA has granted Orphan Drug Designation to Conatus’ drug candidate IDN-7314 for the treatment of primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver which can lead to cirrhosis and liver failure. https://www.drugs.com/clinical_trials/fda-grants-conatus-orphan-designation-idn-7314-psc-17483.html
In other industry news…
Kala Pharmaceuticals has filed to sell up to $86.25 million in common stock in an IPO. The company has achieved highly positive Phase 3 trial results for its nanoparticle-based drug delivery treatment for ocular surgery post-operative inflammation and pain. https://seekingalpha.com/article/4084292-kala-pharmaceuticals-files-86-million-ipo
bluebird bio has released topline interim data from the initial cohort of 17 patients in the ongoing Phase 2/3 Starbeam Study (ALD-102) evaluating its investigational gene therapy Lenti-D in under-18 boys with cerebral adrenoleukodystrophy (CALD). http://clinicaltrials.pharmaceutical-business-review.com/news/bluebird-bios-phase-23-study-of-lenti-d-gene-therapy-yields-positive-results-270617-5853282
Bavarian Nordic reported results from a Phase 2 study which showed that a single shot of its universal respiratory syncytial virus (RSV) candidate can elicit a significant immune response shortly after vaccination. http://www.fiercepharma.com/vaccines/bavarian-nordic-reports-positive-rsv-vaccine-top-line-phase-2-data
Coherus BioSciences disclosed that it will cut its staff by 51 employees, roughly 30% of its total workforce. The layoffs come after the FDA’s June 12 rejection of its BLA for CHS-1701, a biosimilar of Amgen’s Neulasta (pegfilgrastim). http://www.biopharmadive.com/news/coherus-staff-layoff-restructure-biosimilar-rejection/446082/
Sarepta Therapeutics has appointed Douglas Ingram as its new President and CEO. Ingram previously served as the president of Allergan until it merged with Actavis in 2015. Former CEO Ed Kaye will stay on in an advisory capacity. http://www.biopharmadive.com/news/sarepta-new-ceo-allergan-ingram-kaye-dmd/446160/
Best wishes for a great holiday weekend!
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