Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that its investigational product candidate MYDICAR® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the...
Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for the fixed-dose combination therapy...
The U.S. Food and Drug Administration today issued a draft guidance aimed at fostering early-stage development of medical devices within the United States. Doing early-stage development is important to help stimulate U.S.-based innovation and contribute to medical research. The guidance...
Results add to data suggesting that SVR can be achieved with the combination of daclatasvir (BMS-790052) and asunaprevir (BMS-650032) in HCV genotype 1b patients Study expanded to include alfa/RBV ineligible or intolerant patients Bristol-Myers Squibb Company (NYSE: BMY) announced results from...
Bayer HealthCare Pharmaceuticals announced that the investigational drug radium-223 chloride showed positive data in the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. The study met its primary endpoint by significantly improving overall survival by 44% (p=0.00185...
Sanofi (EURONEXT: SAN and NYSE: SNY) announced today results of the pivotal SAVE-ONCO study which demonstrated that, in cancer patients initiating a chemotherapy regimen, investigational semuloparin significantly reduced the risk of the composite of symptomatic-deep vein thromboembolism (DVT)...
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE, 4502), announced that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug...
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced that updated clinical data from a fully enrolled Phase 1 trial of its investigational, pan-BCR-ABL inhibitor, ponatinib, will be presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) being held in Orlando, Florida...
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced results from a randomized, double-blind Phase 3 clinical study in adults with type 2 diabetes inadequately controlled on metformin therapy alone. The study demonstrated dapagliflozin was non-inferior compared to...
Tibotec Pharmaceuticals announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed...
Nanotherapeutics, Inc., announced that it has filed an Investigational New Drug (IND) Application with the Food and Drug Administration (FDA) for NanoDTPA™ an orally administered capsule that is a less invasive treatment alternative to the FDA approved injectable Zn-DTPA (diethylenetriamine...
Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010...
In a new Phase III study, BRINAVESSTM (vernakalant) intravenous, an investigational compound being developed in the European Union by Merck (known as MSD outside the USA and Canada) (NYSE: MRK) and Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) to treat atrial fibrillation, showed that...
Pfizer Inc. (Pfizer) and Debiopharm Group™ (Debiopharm) announced today that they have entered into a co-development agreement to conduct a Phase 3 trial of tremelimumab (CP675,206), a fully human anti-CTLA4 monoclonal antibody for the treatment of patients with unresectable, Stage IV melanoma...
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced Merck and Co., Inc.'s decision (through an affiliate) to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis being developed under its research collaboration with Arena. Merck also informed...