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Amgen Receives CHMP Positive Opinion For IMLYGIC™ (Talimogene Laherparepvec)

R&DAmgen2015-10-26 17:40 Read   631

 THOUSAND OAKS, CA, USA I October 23, 2015 I Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.

Reviva Pharmaceuticals Reports RP5063 Positive Efficacy Results for Memory Deficits

R&DReviva2015-10-26 17:18 Read   812

 Reviva Pharmaceuticals, Inc., a privately held drug discovery and development company, today presented new positive preclinical efficacy data for memory deficits at the Society for Neuroscience annual meeting in Chicago. RP5063 reverses and prevents subchronic phencyclidine-induced declarative memory deficits and increases cortical dopamine efflux in C57BL/6J mice.

Roche's Kadcyla fails in gastric cancer trial

R&DPmlive2015-10-25 19:59 Read   317

Kadcyla (trastuzumab emtansine) - an antibody-drug conjugate (ADC) that links the antibody in Roche's Herceptin to a cytotoxic molecule - was unable to show a benefit as a second-line treatment for HER2-positive advanced gastric cancer in the study.

Xenon Announces Its Partner Genentech Has Advanced GDC-0310, a Second Nav1.7 Inhibitor for Pain, Into Clinical Development

R&Dpeplinereview2015-10-23 10:46 Read   393

Xenon Pharmaceuticals Inc. announced that the Company's partner Genentech, a member of the Roche Group, has advanced a second Nav1.7 inhibitor into clinical development.

OXiGENE Announces Initiation of Phase 1b/2 Clinical Trial of OXi4503 in Acute Myeloid Leukemia

R&DOXiGENE 2015-10-23 10:33 Read   241

October 21, 2015, OXiGENE, Inc. (OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced that it has initiated a phase 1b/2 clinical trial (Study OX1222) of its investigational drug OXi4503 for treatment of acute myeloid leukemia (AML).

Advanced Radioactive Iodine Refractory Differentiated Thyroid Cancer

R&D VBL2015-10-23 10:07 Read   269

VBL Therapeutics Presents Positive Data on VB-111 in Advanced Radioactive Iodine Refractory Differentiated Thyroid Cancer at the ITC 2015 Conference

Oncodesign Presents Novel LRRK2 Inhibitor Jointly Discovered with Ipsen at the 2015 Neurosciences Meeting in Chicago

R&DOncodesign2015-10-23 09:51 Read   335

ONCODESIGN presented with Ipsen (Euronext: IPN, ADR: IPSEY), a global specialty-driven pharmaceutical company, the discovery and characterization of ODS2005294, a novel LRRK2 inhibitor they jointly discovered in a research collaboration started in January 2012.

Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV

R&DGilead2015-10-23 09:39 Read   1123

Gilead Sciences announced 96-week results from two Phase 3 studies (Studies 104 and 111) evaluating its investigational once-daily single tablet regimen (STR), Genvoya (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg or E/C/F/TAF), for the treatment of HIV-1 infection in treatment-naïve adults.

Ember Therapeutics Announce Initial Positive Results From a Phase 2 Trial of BMP-7 in Patients with Moderate Osteoarthritis of the Knee

R&DEmber2015-10-21 18:03 Read   392

Ember said that an initial analysis of 78 of the 320 total patients enrolled in the Phase 2 trial provided evidence that even a single local dose of BMP-7 could prevent cartilage loss and had potential anabolic effects.

Neurocrine Announces Initiation of Phase II Clinical Study of VMAT2 Inhibitor NBI-98854 in Adults with Tourette Syndrome

R&DNeurocrine2015-10-21 17:44 Read   276

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has expanded the clinical efforts for NBI-98854 (Valbenazine), a highly selective small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, by initiating a Phase II clinical trial in adults with Tourette syndrome.  

Cancer Patients Treated with Lexicon’s Telotristat Etiprate Report Improved Function and Well-Being

R&DLexicon2015-10-20 17:42 Read   171

The first oral therapy in development for the treatment of carcinoid syndrome (CS), was associated with patient-reported improvements in social and physical function and emotional well-being according to new exit interview data from the Phase 3 TELESTAR study presented at the 2015 Neuroendocrine Tumor Society Annual Symposium in Austin, Texas.

Tarsa Therapeutics’ NDA for TBRIA(TM), the First Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis, Accepted for Filing

R&DTarsa Therapeutics2015-10-20 17:13 Read   300

October 19, 2015 — TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM(calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016.