Top Regulatory News Stories – Week Ending November 2, 2018

The US FDA has approved Novartis/Sandoz’s Hyrimoz, a biosimilar of Abbvie’s Humira, the world’s bestselling prescription medicine. https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoztm-adalimumab-adaz

TherapeuticsMD announced that the FDA has approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women. https://www.businesswire.com/news/home/20181029005251/en/TherapeuticsMD-Announces-FDA-Approval-TX-001HR-BIJUVA%E2%84%A2-Estradiol

Merck’s immunotherapy Keytruda has received broader approval from the FDA for previously untreated squamous non-small cell lung cancer:  https://www.biopharmadive.com/news/merck-keytruda-secures-broader-lung-cancer-approval/541050/

Amneal’s ANDA for Carmustine for injection was the first ANDA to win a priority review – a new designation for generic drugs thanks to the FDA Reauthorization Act of 2017 (FDARA). https://www.raps.org/news-and-articles/news-articles/2018/10/amneal-wins-first-priority-review-anda-approval?feed=Regulatory-Focus

Cerecor Inc. announced that it has submitted to the FDA three Orphan Drug Designation Requests for substrate replacement therapies to treat ultra-rare inherited metabolic disorders known as Congenital Disorders of Glycosylation (CDGs). https://www.firstwordpharma.com/node/1601322

Taiho Oncology said the FDA has accepted and granted priority review for the sNDA for Lonsurf (trifluridine/tipiracil, TAS-102) for previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction. https://cancerletter.com/articles/20181026_7/

The FDA granted priority review to Incyte’s ruxolitinib for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids. https://www.healio.com/hematology-oncology/bone-marrow-transplantation/news/online/%7Bd8b1f8de-8731-427d-a35e-8ae43cae92c5%7D/fda-grants-priority-review-to-jakafi-for-acute-graft-versus-host-disease

An FDA advisory panel voted 21-2 against recommending approval of Alkermes’ depression drug: https://www.biopharmadive.com/news/alkermes-depression-5461-chances-slim-negative-panel-vote/541257/

The FDA’s Office of Prescription Drug Promotion (OPDP) last week sent a warning letter to Vanda Pharmaceuticals for failing to list risk information on a webpage for two of its drugs. https://www.raps.org/news-and-articles/news-articles/2018/10/vanda-lands-opdp-warning-letter-over-risk-info-on?feed=Regulatory-Focus

In other news…

Novartis has scrapped 20% of its drug programs in order to focus on potentially transformative therapies that fit with the company’s ambitions. https://www.fiercebiotech.com/biotech/novartis-dumps-20-programs-following-pipeline-review

Takeda is ready to auction off a PhIII inflammatory bowel disease drug at Shire to clear the last hurdles to a $62B buyout https://endpts.com/takeda-is-ready-to-auction-off-a-phiii-favorite-at-shire-to-clear-the-last-hurdles-to-a-62b-buyout/?utm

Eli Lilly has struck a licensing agreement to use Dicerna’s GalXC RNAi technology platform for up to 10 cardio-metabolic, neurodegeneration, and pain targets:  https://www.biospace.com/article/eli-lilly-makes-a-big-bet-on-rnai-therapies-with-dicerna-deal/

Astellas is jumping into gene and cell therapy production with $255M investment https://www.fiercepharma.com/manufacturing/astellas-jumps-into-gene-and-cell-therapy-production-255-million-investment

Novo Nordisk says it will cut about 1,300 employees by the end of 2018: https://www.fiercepharma.com/pharma/novo-nordisk-expands-job-cuts-to-1-300-as-executives-play-down-lilly-s-glp-1-threat

 

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/

 

 

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