Selected first quarter product approvals.



Alexza Pharmaceuticals Inc. (NASDAQ:ALXA)

EC approves Adasuve Staccato loxapine to treat mild to moderate agitation in adults with schizophrenia or bipolar disorder

Bayer AG (Xetra:BAYN)/Onyx Pharmaceuticals Inc. (NASDAQ:ONXX)

FDA approves Stivarga regorafenib to treat locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST) in patients who have previously been treated with Gleevec imatinib and Sutent sunitinib; Japan approves Stivarga to treat unresectable, advanced/recurrent colorectal cancer


India approves Alzumab itolizumab to treat chronic plaque psoriasis

Biogen Idec Inc. (NASDAQ:BIIB)

FDA approves Tecfidera dimethyl fumarate (formerly BG-12) to treat adults with relapsing forms of multiple sclerosis (MS)

Biotie Therapies Corp. (HSE:BTH1V)/H. Lundbeck A/S (CSE:LUN)

EC approves Selincro nalmefene to reduce alcohol consumption in adults with alcohol dependence

Cangene Corp. (TSX:CNJ)

FDA approves botulism antitoxin heptavalent (BAT) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin

Celgene Corp. (NASDAQ:CELG)

FDA grants accelerated approval to Pomalyst pomalidomide to treat patients with multiple myeloma (MM)

Celgene Corp. (NASDAQ:CELG)

China approves Revlimid lenalidomide in combination with dexamethasone to treat relapsed or refractory MM in patients who have received at least one prior therapy

Cosmo Pharmaceuticals S.p.A. (SIX:COPN)/Santarus Inc. (NASDAQ:SNTS)

FDA approves Uceris budesonide to induce remission of mild to moderate active ulcerative colitis (UC)

Eli Lilly and Co. (NYSE:LLY)

EC approves Amyvid florbetapir as a PET imaging agent to estimate beta amyloid neuritic plaque density in patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline

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

FDA approves Avastin bevacizumab as second-line treatment in combination with an irinotecan-or oxaliplatin-based chemotherapy regimen in patients with metastatic colorectal cancer (mCRC) who have progressed after first-line treatment with Avastin

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

EC approves Perjeta pertuzumab in combination with Herceptin trastuzumab and docetaxel to treat adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy

Genmab A/S (CSE:GEN)/GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Japan approves Arzerra ofatumumab to treat relapsed/refractory CD20-positive chronic lymphocytic leukemia (CLL)

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

FDA approves Kynamro mipomersen as an addition to lipid-lowering medications and diet to treat homozygous familial hypercholesterolemia (hoFH)

Hyperion Therapeutics Inc. (NASDAQ:HPTX)/ Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX)

FDA approves Ravicti glycerol phenylbutyrate for the management of chronic urea cycle disorders in patients 2 years of age and older

Japan Tobacco Inc. (Tokyo:2914; Osaka:2914)/Gilead Sciences Inc. (NASDAQ:GILD)

Japan approves Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate to treat HIV-1 infection

Johnson & Johnson (NYSE:JNJ)

EC approves Zytiga abiraterone acetate for use in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC)

Johnson & Johnson (NYSE:JNJ)

FDA grants accelerated approval to Sirturo bedaquiline (TMC207) to treat adults with multi-drug resistant pulmonary tuberculosis (TB) as part of a combination therapy when other alternatives are not available

Johnson & Johnson (NYSE:JNJ)/Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508)

FDA approves Invokana canagliflozin to improve glycemic control in adults with Type II diabetes

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)

Japan approves Nouriast istradefylline to improve the "wearing-off" phenomena in Parkinson's disease (PD) patients receiving levodopa-containing therapy

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)/Otsuka Pharmaceutical Co. Ltd./Bristol-Myers Squibb Co. (NYSE:BMY)

Japan approves Onglyza saxagliptin to treat Type II diabetes