Selected third quarter product approvals.



Almirall S.A(Madrid:ALM)/Forest

EC approves Bretaris/Eklira Genuair aclidinium bromide as maintenance treatment for patients

Laboratories Inc. (NYSE:FRX)/Menarini Group

with chronic obstructive pulmonary disease (COPD); FDA approves it as Tudorza Pressair

Amarin Corp. plc (NASDAQ:AMRN)

FDA approves Vascepa icosapent ethyl as an adjunct to diet to reduce triglycerides in adults with severe hypertriglyceridemia

Amgen Inc. (NASDAQ:AMGN)

FDA approves Prolia denosumab to include treatment to increase bone mass in men with osteoporosis at high risk for fracture

Astex Pharmaceuticals Inc. (NASDAQ:ASTX)/

EC approves Dacogen decitabine to treat newly diagnosed de novo or secondary acute

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)/ Johnson & Johnson (NYSE:JNJ)

myelogenous leukemia (AML) in patients 65 years and older

Bayer AG (Xetra:BAYN)

FDA approves Stivarga regorafenib to treat previously treated metastatic colorectal cancer (mCRC)

Boehringer Ingelheim GmbH/Eli Lilly and Co. (NYSE:LLY)

EC approves Jentadueto linagliptin/metformin to treat Type II diabetes

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)

EC approves Fycompa perampanel as an adjunctive therapy for partial-onset seizures in epilepsy patients

Eli Lilly and Co. (NYSE:LLY)/ Bristol-Myers Squibb Co(NYSE:BMY)

FDA approves Erbitux cetuximab as first-line therapy for mCRC

Forest Laboratories Inc. (NYSE:FRX)/ AstraZeneca plc (LSE:AZN; NYSE:AZN)

EC approves Zinforo ceftaroline to treat complicated skin and soft tissue infections (cSSTI) and community-acquired bacterial pneumonia (CABP)

Genentech Inc./Roche (SIX:ROG; OTCQX:RHHBY)

FDA approves Lucentis ranibizumab to treat diabetic macular edema (DME)

Genzyme Corp./Sanofi (Euronext:SAN; NYSE:SNY)

FDA approves once-daily oral Aubagio teriflunomide to treat relapsing forms of multiple sclerosis (MS)

Gilead Sciences Inc. (NASDAQ:GILD)

FDA approves Stribild elvitegravir/cobicistat/emtricitabine/tenofovir to treat HIV-1 infection in treatment-naive adults

Gilead Sciences Inc. (NASDAQ:GILD)

FDA approves once-daily Truvada emtricitabine/tenofovir for pre-exposure prophylaxis (PrEP) to reduce risk of HIV-1 infection in uninfected adults

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

EC approves Votrient pazopanib to treat advanced soft tissue sarcoma in patients who received prior chemotherapy or who have progressed in the last 12 months after neo-adjuvant therapy

Horizon Pharma Inc. (NASDAQ:HZNP)/ SkyePharma plc (LSE:SKP)

FDA approves Rayos prednisone delayed-release tablets to treat a broad range of diseases, including rheumatoid arthritis (RA), polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and COPD

Incyte Corp. (NASDAQ:INCY)/Novartis AG (NYSE:NVS; SIX:NOVN)

EC approves Jakavi ruxolitinib to treat chronic idiopathic myelofibrosis, post-polycythemia vera or essential thrombocythemia myelofibrosis

Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD)/Forest Laboratories Inc. (NYSE:FRX)

FDA approves Linzess linaclotide to treat chronic constipation and irritable bowel syndrome with constipation (IBS-C)

Medivation Inc. (NASDAQ:MDVN)/Astellas Pharma Inc. (Tokyo:4503)

FDA approves Xtandi enzalutamide to treat metastatic castration-resistant prostate cancer (CRPC) in patients previously treated with docetaxel


FDA and EC approve Afinitor everolimus in combination with Aromasin exemestane from Pfizer Inc. (NYSE:PFE) to treat postmenopausal women with hormone receptor-positive, HER2-negative breast cancer

Novo Nordisk A/S (CSE:NVO; NYSE:NVO)

Japan approves Tresiba insulin degludec to treat Type I and Type II diabetes

NPS Pharmaceuticals Inc. (NASDAQ:NPSP)/ Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

EC approves Revestive teduglutide to treat short bowel syndrome (SBS)

Onyx Pharmaceuticals Inc(NASDAQ:ONXX)

FDA grants accelerated approval to Kyprolis carfilzomib to treat patients with multiple myeloma (MM) who have received at least two prior lines of therapy