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
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