Publication: Drug Discovery and Development

First reported 2 hours ago - Updated 2 hours ago - 1 reports

Glenmark's TRPA1 Antagonist Excels in Phase 2a

Glenmark Pharmaceuticals announced that its first-in-class Transient Receptor Potential Ankyrin 1 (TRPA1) antagonist, GRC 17536, has shown positive data in a Phase 2a double blind, placebo controlled, multi-center, proof of concept study conducted on ... [Published Drug Discovery and Development - 2 hours ago]
First reported Sep 16 2014 - Updated 15 hours ago - 1 reports

Bayer, Orion Initiate Phase 3 Prostate Cancer Trial

Bayer HealthCare and Orion Corp., a pharmaceutical company based in Espoo, Finland, have begun to enroll patients in a Phase 3 trial with ODM-201, an investigational novel oral androgen receptor (AR) inhibitor in clinical development for the treatment ... [Published Drug Discovery and Development - Sep 16 2014]
First reported Sep 16 2014 - Updated 22 hours ago - 1 reports

Relmada in MOA Agreement With MSKCC

Relmada Therapeutics Inc., a clinical-stage company developing novel therapies for the treatment of chronic pain, announced that it has entered into an agreement with Memorial Sloan Kettering Cancer Center (MSKCC) in a series of animal studies for levorphanol, ... [Published Drug Discovery and Development - Sep 16 2014]
First reported Sep 16 2014 - Updated Sep 16 2014 - 1 reports

TapImmune Releases Interim Data on Phase 1 Cancer Trial

TapImmune Inc. reported that analysis of the interim data from the first 13 patients in a Phase 1 clinical trial show that each of the patients treated have raised specific T-cell immune responses against a set of five naturally processed folate receptor ... [Published Drug Discovery and Development - Sep 16 2014]
First reported Sep 15 2014 - Updated Sep 16 2014 - 1 reports

FDA Accepts Shire's sNDA for Vyvanse

Shire plc, the global specialty biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with priority review a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules ... [Published Drug Discovery and Development - Sep 15 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

Amgen Heart Study Shows Positive Ivabradine Results

Amgen announced data from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study evaluating ivabradine in patients with chronic heart failure (HF) were presented at the 18th Annual Scientific Meeting of the Heart ... [Published Drug Discovery and Development - Sep 15 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

Lilly Colorectal Cancer Drug Hits OS Endpoint

Eli Lilly and Co. announced that the RAISE trial, a Phase 3 study of ramucirumab (Cyramza) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. The global, randomized, double-blind ... [Published Drug Discovery and Development - Sep 15 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

Cardio3 BioSciences to Continue Phase 3 Heart Therapy Trial

Cardio3 BioSciences SA (C3BS) announced it has received the recommendation of the Data Safety and Monitoring Board (DSMB) to continue the CHART-1 clinical trial according to the original protocol. The recommendation is based on a planned analysis performed ... [Published Drug Discovery and Development - Sep 15 2014]
First reported Sep 11 2014 - Updated Sep 12 2014 - 1 reports

Biogen's Phase 3 Tecfidera Trial Shows Positive 5-Year MS Data

Biogen Idec announced that five-year results from the ENDORSE Phase 3 extension study show Tecfidera (dimethyl fumarate) provides strong and sustained efficacy in a broad range of people living with relapsing-remitting multiple sclerosis (RRMS). These ... [Published Drug Discovery and Development - Sep 11 2014]
First reported Sep 11 2014 - Updated Sep 11 2014 - 1 reports

University Working Toward Long-Acting HIV Drugs

HIV drugs that only need to be taken once a month are to be developed at the University of Liverpool in a bid to overcome the problem of "pill fatigue."Currently, it is not uncommon for people to miss doses of the antiretroviral drugs that are used to ... [Published Drug Discovery and Development - Sep 11 2014]
First reported Sep 11 2014 - Updated Sep 11 2014 - 1 reports

SEM for 3-D Volume Imaging of Cells and Tissues

The Teneo VS scanning electron microscope (SEM) from FEI offers a VolumeScope capability for life science applications. The Teneo platform tightly integrates FEI’s latest-generation SEM with VolumeScope, an in-chamber microtome and proprietary analytical ... [Published Drug Discovery and Development - Sep 11 2014]
First reported Sep 11 2014 - Updated Sep 11 2014 - 1 reports

Two Anti-Ebola Vaccines in Historic Race

One of the most rapidly fast-tracked vaccines in history— an anti-Ebola “ChAd3” vaccine— just started clinical trial in humans, and may be done in November. In non-human primates, it offered five weeks of protection— 10 months when followed by a booster ... [Published Drug Discovery and Development - Sep 11 2014]

Quotes

Patrick Keohane, chief medical officer, Glenmark, stated: "Diabetic neuropathy remains a difficult to manage chronic clinical condition with limited therapeutic options. These initial efficacy and safety data with GRC 17536, a peripherally acting novel therapeutic, are encouraging, and Glenmark intends to be ready to file for a Phase 2b dose range finding study in patients with neuropathic pain before the end of this financial year. This announcement also reaffirms our position globally in the development of novel pain therapies."
...with a poor prognosis for patients at risk for hospitalization," said Sean Harper, executive vice president of Research and Development at Amgen. "Analyses from the pivotal SHIFT study complement the main trial findings that form the basis of our U S submission package for ivabradine. We recently received a priority review designation for ivabradine from the FDA and are working with the agency to potentially bring this important treatment option to certain patients with chronic heart failure in the U SS as soon as possible."
...treatment options that improve survival," said Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology. "We are pleased that the RAISE study demonstrated a survival benefit and are hopeful that ramucirumab will become a new anti-angiogenic treatment option after first-line bevacizumab-containing therapy for metastatic colorectal cancer patients."
...Thorsten Eickenhorst, senior vice president and chief medical officer, EMD Serono. "This study underscores our company's dedication to furthering breakthrough scientific research that can advance treatment options for those living with multiple sclerosis."

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Glenmark's TRPA1 Antagonist Excels in Phase 2a [Published Drug Discovery and Development - 2 hours ago]
Relmada in MOA Agreement With MSKCC [Published Drug Discovery and Development - Sep 16 2014]
TapImmune Releases Interim Data on Phase 1 Canc... [Published Drug Discovery and Development - Sep 16 2014]
Bayer, Orion Initiate Phase 3 Prostate Cancer T... [Published Drug Discovery and Development - Sep 16 2014]
FDA Accepts Shire's sNDA for Vyvanse [Published Drug Discovery and Development - Sep 15 2014]
Amgen Heart Study Shows Positive Ivabradine Res... [Published Drug Discovery and Development - Sep 15 2014]
Lilly Colorectal Cancer Drug Hits OS Endpoint [Published Drug Discovery and Development - Sep 15 2014]
Cardio3 BioSciences to Continue Phase 3 Heart T... [Published Drug Discovery and Development - Sep 15 2014]
University Working Toward Long-Acting HIV Drugs [Published Drug Discovery and Development - Sep 11 2014]
SEM for 3-D Volume Imaging of Cells and Tissues [Published Drug Discovery and Development - Sep 11 2014]
Biogen's Phase 3 Tecfidera Trial Shows Positive... [Published Drug Discovery and Development - Sep 11 2014]
Two Anti-Ebola Vaccines in Historic Race [Published Drug Discovery and Development - Sep 11 2014]
Sanofi Posts Promising Trial Results for MS Drug [Published Drug Discovery and Development - Sep 11 2014]
The "New Normal" In Laboratory Efficiency: Lean... [Published Drug Discovery and Development - Sep 11 2014]
EMD Serono, Accelerated Cure Project Launch MS ... [Published Drug Discovery and Development - Sep 10 2014]
Drug Safety Report Details 49,000 Undisclosed S... [Published Drug Discovery and Development - Sep 10 2014]
EC Grants Marketing Authorization for Lilly-BI ... [Published Drug Discovery and Development - Sep 10 2014]
BI COPD Combo Excels in Phase 3 [Published Drug Discovery and Development - Sep 09 2014]
Novartis Ultibro Breezhaler Superior in Reducin... [Published Drug Discovery and Development - Sep 09 2014]
J&J, Janssen Partner with University of Toronto... [Published Drug Discovery and Development - Sep 08 2014]
Soligenix Acquires Phase-3-Ready Oncology Program [Published Drug Discovery and Development - Sep 05 2014]
Ascendia Advances Nano-Emulsion Technology Plat... [Published Drug Discovery and Development - Sep 05 2014]
Actavis Antibiotic NDA Accepted, Deemed QIDP [Published Drug Discovery and Development - Sep 05 2014]
Antisense Acromegaly Drug Shows Efficacy in Pha... [Published Drug Discovery and Development - Sep 05 2014]
NeuroDerm Starts Phase 2a Study of Parkinson’s ... [Published Drug Discovery and Development - Sep 05 2014]
Mallinckrodt's Pain Drug Shows Efficacy in Phase 3 [Published Drug Discovery and Development - Sep 04 2014]
Bayer Submits App in Japan for New Eylea Indica... [Published Drug Discovery and Development - Sep 04 2014]
Flexion Advances OA Drug Development Plan by On... [Published Drug Discovery and Development - Sep 04 2014]
How Outsourcing Can Accelerate the Drug Develop... [Published Drug Discovery and Development - Sep 04 2014]
Amgen Submits Cholesterol Drug for EMA Approval [Published Drug Discovery and Development - Sep 03 2014]
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