Pfizer has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for crizotinib to treat adults with previously treated anaplastic lymphoma kinase (ALK)-positive ...
Tags: Pfizer, CHMP, anaplastic lymphoma kinase
Auxilium Pharmaceuticals and Actelion Pharmaceuticals Canada have announced Health Canada notice of compliance (approval) for Xiaflex (collagenase clostridium histolyticum or CCH) to treat Dupuytren's contracture in adults with a palpable ...
Janssen Research & Development has submitted a new drug application (NDA) to the FDA for canagliflozin to treat adult patients with type 2 diabetes. The filing is based on a global Phase III clinical development program, including nine ...
Tags: Janssen Research&Development, SGLT2, cardiovascular study
Pfizer has received positive opinion from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency for the marketing authorization of axitinib to treat patients with advanced renal cell carcinoma. The European ...
The United States Patent and Trademark Office (USPTO) has issued notice of allowance for Avanir Pharmaceuticals' patent application covering Nuedexta. The patent application entitled, Pharmaceutical Compositions Comprising ...
Tags: USPTO, patent application, nuedexta, pseudobulbar affect
Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval. Bedaquiline,an investigational drug administered orally,is used as part of ...
Tags: FDA, new drug application, investigational drug, pulmonary
CytoDyn has entered into an agreement to purchase Progenics Pharmaceuticals' proprietary humanized monoclonal antibody HIV viral-entry inhibitor drug candidate, PRO 140, for $3.5m. Upon successful continued clinical development of PRO ...
Tags: CytoDyn, HIV viral-entry inhibitor drug, humanized monoclonal antibody
Sygnis Pharma will join forces with X-Pol Biotech to secure sustainable business model. The company believes that the changes are essential after the termination of clinical development activities in December 2011. Sygnis' new business ...
Ventana Medical Systems has received FDA approval for the application of its INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) on the BenchMark ULTRA automated slide staining platform. The BenchMark XT instrument, the HER2 ...
The cancer genetic testing services provider, NeoGenomics has launched the first molecular assay, NeoType CLL for clinical use in the US, which detects mutations in the SF3B1 gene (splicing factor 3b, subunit 1). The assay will offer ...
Tags: molecular assay, clinical research, clinical development
Merck Serono, a division of Merck, and Auxogyn have partnered to develop Early Embryo Viability Assessment (Eeva) test. Pursuant to the deal, Merck Serono will provide strategic, scientific and medical support for the development of ...
Tags: Early Embryo Viability Assessment test, eeva test, clinical development
CeeTox and Cellular Dynamics International (CDI) have introduced a new predictive cardiac safety screening service, Cardiac Arrhythmia Assessment Screen (CAAS), which uses human induced pluripotent stem (iPS) cell-derived cardiomyocytes. ...
Biotechnology company Avaxia Biologics has received AVX-470 investigational new drug (IND) application clearance for the treatment of ulcerative colitis from the FDA. The bovine anti-tumor necrosis factor polyclonal antibody is based on ...
Tags: Avaxia, Ulcerative Colitis Therapy, IND
PDS Biotechnology has entered into a licensing agreement with Merck KgaA, Germany, for use of PDS Biotechnology's Versamune nanotechnology platform. Under the terms of the agreement, Merck will obtain the rights to use the technology ...
Tags: Versamune nanotechnology platform, company cooperation
INC Research, a clinical research organization, has selected Trial Interactive as its global electronic Trial Master File (eTMF) solution. Trial Interactive offers access to global project documentation, get rid of much of the travel ...
Tags: company cooperation, clinical solution, web-based clinical platform