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Tohoku University, Thomson Reuters team up to restore Tohoku’s medical system

The Intellectual Property & Science business of Thomson Reuters, the world's leading source of intelligent information for businesses and professionals, today announced a collaboration with Tohoku University Tohoku Medical Megabank Organization (ToMMo) to help restore Tohoku's medical system to its pre-earthquake state and help its medical community further develop its research efforts.

12 Dec 2013

FDA Advisory Committee recommends metreleptin for treatment of generalized lipodystrophy

AstraZeneca and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommends the investigational medicine metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD).

12 Dec 2013

AP, Kaiser Permanente initiate clinical trial to evaluate the efficacy of Promescent lidocaine spray

Absorption Pharmaceuticals LLC in collaboration with Kaiser Permanente announced today the initiation of a clinical trial to evaluate the efficacy of Promescent lidocaine spray for men with premature ejaculation. This Phase III, double blind, placebo-controlled, randomized study will measure the intravaginal ejaculatory latency time for subjects aged 18 and older.

11 Dec 2013

FDA advisory committee votes in favor of WATCHMAN Left Atrial Appendage Closure device

The U.S. Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably by a majority, Yes: 13, No: 1, that the benefits of the WATCHMAN Left Atrial Appendage Closure device outweigh the risks.

11 Dec 2013

Early tumor shrinkage predicts targeted therapy efficacy in RCC

Early tumor shrinkage in patients with metastatic renal cell carcinoma following vascular endothelial growth factor-targeted therapy may herald good long-term survival, research shows.

11 Dec 2013

First patient enrolled in Otonomy's pivotal Phase 2b study of OTO-104 for Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced enrollment of the first patient in its pivotal Phase 2b study of OTO-104 for the reduction of vertigo in patients with unilateral Meniere's disease.

11 Dec 2013

Daiichi Sankyo presents subgroup analysis of Hokusai-VTE study at ASH annual meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced results of a prespecified subgroup analysis of 771 cancer patients enrolled in the phase 3 Hokusai-VTE study.

11 Dec 2013

New research reveals novel way to develop anti-diarrhoeal drugs

New gastroenterology research carried out by the RCSI in conjunction with Trinity College Dublin and Johns Hopkins University in Baltimore, Maryland has uncovered a new route for the development of anti-diarrhoeal drugs.

11 Dec 2013

Study shows children with ALL can safely receive intravenous infusions of chemotherapy

Children with acute lymphoblastic leukemia (ALL), the most common form of pediatric cancer, can safely receive intravenous infusions of a reformulated mainstay of chemotherapy that has been delivered via painful intramuscular injection for more than 40 years, research suggests.

11 Dec 2013

Experimental compound reduces joint inflammation in animal models of rheumatoid arthritis

An experimental compound synthesized and developed by scientists from the Florida campus of The Scripps Research Institute has the capacity to significantly reduce joint inflammation in animal models of rheumatoid arthritis, an autoimmune disease that affects more than two million Americans.

11 Dec 2013

Budget cuts, years-long flat funding can delay research into effective treatments for cancer

Research advances that have come to fruition over the past year demonstrate extraordinary progress in the fight against cancer, according to a new report released today by the American Society of Clinical Oncology. The report stresses, however, that recent budget cuts and years-long flat funding can only delay efforts to translate research into effective treatments for millions of individuals with cancer.

11 Dec 2013

Pronai Therapeutics reports positive results from PNT2258 Phase II study on lymphoma

ProNAi Therapeutics, Inc., a leader in developing nucleic acid therapeutics, presented safety and efficacy data from its ongoing Phase II study yesterday at the 55th Annual Meeting of the American Society for Hematology (ASH) in New Orleans, Louisiana.

11 Dec 2013

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Pharmacyclics, Inc. today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55TH Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013.

11 Dec 2013

Genzyme granted Priority Review for Cerdelga investigational oral therapy for Gaucher disease

Genzyme, a Sanofi company, announced today that the Food and Drug Administration (FDA) has granted a six-month Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1.

11 Dec 2013

Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A.

From Baxter International Inc. 11 Dec 2013

Avanir Pharmaceuticals' AVP-923 phase II trial fails to meet primary efficacy endpoint

Avanir Pharmaceuticals, Inc. today announced that PRIME, its phase II clinical trial of the investigational drug AVP-923 (dextromethorphan / quinidine) for the treatment of central neuropathic pain in patients with multiple sclerosis did not meet the primary efficacy endpoint.

10 Dec 2013

Pemetrexed, paclitaxel regimens equally effective in NSCLC

PointBreak trial results suggest that pemetrexed- and paclitaxel-based chemotherapy offer comparable survival outcomes and tolerability for patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) but with differing toxicity profiles.

10 Dec 2013

Biosimulation and epilepsy treatments: an interview with Dr. Serge Bischoff, CEO of Rhenovia and RHENEPI program director

The need for biosimulation is primarily to do with the very high attrition rate in drug development and especially in the development of drugs for the central nervous system.

10 Dec 2013

FoundationOne Heme identifies clinically actionable genomic alterations in multiple myeloma cases

Foundation Medicine today announced new data from a pilot study demonstrating that its fully informative genomic profile for hematologic malignancies, FoundationOne Heme, identified both novel and previously reported clinically actionable genomic alterations in multiple myeloma cases. These data were presented in an oral presentation titled Pilot Study To Evaluate The Prevalence Of Actionable Oncogenic Mutations In Patients With Relapsed Refractory Multiple Myeloma (abstract number 755) by Alexander Lesokhin, M.D., medical oncologist, Memorial Sloan-Kettering Cancer Center, at the 55th American Society of Hematology Annual Meeting in New Orleans.

10 Dec 2013

Epilepsy experts discuss on new NTI definition, bioequivalence guidelines at AES annual meeting

For several years, epilepsy practitioners have questioned the U.S. Food and Drug Administration's definition of bioequivalence as it applies to narrow therapeutic index drugs, such as those used for epilepsy. In response to these concerns, the FDA has sponsored 3 studies of antiepileptic drugs and also convened an advisory board to help determine which drugs are NTI.

10 Dec 2013

Efficacy News and Research

Tohoku University, Thomson Reuters team up to restore Tohoku’s medical system

FDA Advisory Committee recommends metreleptin for treatment of generalized lipodystrophy

AP, Kaiser Permanente initiate clinical trial to evaluate the efficacy of Promescent lidocaine spray

FDA advisory committee votes in favor of WATCHMAN Left Atrial Appendage Closure device

Early tumor shrinkage predicts targeted therapy efficacy in RCC

First patient enrolled in Otonomy's pivotal Phase 2b study of OTO-104 for Meniere's disease

Daiichi Sankyo presents subgroup analysis of Hokusai-VTE study at ASH annual meeting

New research reveals novel way to develop anti-diarrhoeal drugs

Study shows children with ALL can safely receive intravenous infusions of chemotherapy

Experimental compound reduces joint inflammation in animal models of rheumatoid arthritis

Budget cuts, years-long flat funding can delay research into effective treatments for cancer

Pronai Therapeutics reports positive results from PNT2258 Phase II study on lymphoma

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Genzyme granted Priority Review for Cerdelga investigational oral therapy for Gaucher disease

Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Avanir Pharmaceuticals' AVP-923 phase II trial fails to meet primary efficacy endpoint

Pemetrexed, paclitaxel regimens equally effective in NSCLC

Biosimulation and epilepsy treatments: an interview with Dr. Serge Bischoff, CEO of Rhenovia and RHENEPI program director

FoundationOne Heme identifies clinically actionable genomic alterations in multiple myeloma cases

Epilepsy experts discuss on new NTI definition, bioequivalence guidelines at AES annual meeting

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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