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Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).

29 Apr 2010

Albireo to present study results of A3309 in patients with chronic constipation at 2010 DDW annual meeting

Albireo today announced that additional clinical data will be reported from a recent study assessing the safety, tolerability and efficacy of A3309 in patients with chronic constipation. A3309 is a first-in-class investigational compound for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The results will be presented during the 2010 Digestive Disease Week (DDW) annual meeting being held in New Orleans, US.

29 Apr 2010

Pain Therapeutics reports net loss of $1.0 million for first-quarter 2010

Pain Therapeutics, Inc., a biopharmaceutical company, today reported first quarter 2010 financial results. Net loss for Q1 2010 was $1.0 million, or $0.02 per share, compared to a net loss of $1.8 million, or $0.04 per share, for Q1 2009.

29 Apr 2010

Experts discuss recent advancements in personalized medicine for treating childhood disorders

Many of the world's leading experts in pediatric pharmacogenomics and personalized medicine are gathering today at a first-of-its-kind conference in Kansas City to change the way childhood diseases and illnesses are treated.

29 Apr 2010

Talecris Biotherapeutics first-quarter net income increases 35.6% to $45.3 million

Talecris Biotherapeutics Holdings Corp. today announced its financial results for the three months ended March 31, 2010, and filed its first quarter 2010 Form 10-Q with the U.S. Securities and Exchange Commission (SEC).

29 Apr 2010

Combination of antibiotics can cure Chlamydia-induced ReA: Study

Researchers from University of South Florida College of Medicine found a combination of antibiotics to be an effective treatment for Chlamydia-induced reactive arthritis, a major step forward in the management, and possibly cure, of this disease. Results of this study are published in the May issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.

29 Apr 2010

Celladon's first Phase II trial of MYDICAR for advanced heart failure meets primary endpoint

Targeted Genetics Corporation announced today that its licensing partner, Celladon Corporation, has reported today that Celladon's first Phase II trial with MYDICAR® for the treatment of advanced heart failure has met its primary safety and efficacy endpoints, as prospectively defined in the Phase II trial protocol.

29 Apr 2010

Lycera to advance discovery, development efforts with second tranche of $11 million Series A financing

Lycera Corporation, a biopharmaceutical company pioneering an innovative approach to developing novel oral medicines to treat autoimmune diseases, today announced that the company has made important progress, triggering a second tranche of $11 million in its Series A financing. Proceeds from the second tranche will be used to continue to advance Lycera's discovery and development efforts and further support the growth of the company.

29 Apr 2010

Neurocrine Biosciences reports net loss of $8.6M in first quarter 2010

Neurocrine Biosciences, Inc. today announced its financial results for the quarter ended March 31, 2010. For the first quarter of 2010, the Company reported a net loss of $8.6 million, or $0.19 per share compared with a net loss of $19.7 million, or $0.51 per share, for the same period in 2009.

29 Apr 2010

Phase 1B/2 clinical study to evaluate efficacy of PMX-60056 in reversing heparin levels initiated

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 1B/2 dose-ranging clinical study with its anticoagulant reversing agent, PMX-60056. The study is intended to demonstrate the safety and efficacy of PMX-60056 in reversing varying heparin levels, including the highest levels commonly used in surgical settings.

29 Apr 2010

Positive results from interim analysis of ongoing Phase 2a study of BCX4208

BioCryst Pharmaceuticals, Inc. announced positive top-line results from a planned interim analysis of its ongoing Phase 2a, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered BCX4208 in patients with gout.

28 Apr 2010

Research reveals therapeutic benefit of ACTH in treatment of osteonecrosis

Researchers at Mount Sinai School of Medicine have found a potential new treatment for osteonecrosis, or the death of bone tissue, in people who are treated with steroids for several common medical conditions. There are currently no treatment options for people with this debilitating disease. The research is published in the April 27 issue of Proceedings of the National Academy of Sciences.

28 Apr 2010

Potential new treatment for osteonecrosis

28 Apr 2010

Update on ICA-105665 clinical development plans for treatment of epilepsy and pain

Icagen, Inc. today provided an update on clinical development plans for ICA-105665, the Company's novel drug candidate for the treatment of epilepsy and pain.

28 Apr 2010

NCCTG to conduct Phase II study of brostallicin in combination with cisplatin for mTNBC cancer

Cell Therapeutics, Inc. today announced that the North Central Cancer Treatment Group ("NCCTG") plans to conduct a Phase II study of brostallicin in combination with cisplatin in patients with metastatic triple-negative breast ("mTNBC") cancer, defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2. Additionally, the majority of breast cancers that are associated with the susceptibility mutation (BRCA1) are of the triple-negative type.

28 Apr 2010

Phase II clinical trial to test safety and efficacy of transplanted encapsulated islets

The Juvenile Diabetes Research Foundation announced today that it is partnering with Living Cell Technologies, a New Zealand-based biotechnology company focused on developing cell based therapeutics, in a Phase II clinical trial to study the safety and effectiveness of transplanting encapsulated insulin-producing cells from pigs as a treatment for type 1 diabetes with significant hypoglycemia unawareness.

28 Apr 2010

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension. Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

28 Apr 2010

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

Cardiovascular Systems, Inc., has received Food and Drug Administration unconditional Investigational Device Exemption (IDE) approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI's Diamondback 360® System in the coronary arteries. CSI received conditional IDE approval for the ORBIT II study in January 2010.

28 Apr 2010

Biostar receives Shaanxi SFDA approval to market Xin Aoxing Oleanolic Acid Capsules

Biostar Pharmaceuticals, Inc., the Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsule, and other pharmaceutical products, announced today it has received new advertising approval from Shaanxi State Food and Drug Administration for marketing Xin Aoxing Oleanolic Acid Capsules.

27 Apr 2010

Interim results from Phase I clinical trial of PLX-PAD for treatment of CLI

Pluristem Therapeutics Inc. today announced interim top-line results from its Phase I clinical trials utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia, the end-stage of peripheral artery disease. The interim data demonstrated that PLX-PAD is safe, well tolerated and effective.

27 Apr 2010

Efficacy News and Research

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Albireo to present study results of A3309 in patients with chronic constipation at 2010 DDW annual meeting

Pain Therapeutics reports net loss of $1.0 million for first-quarter 2010

Experts discuss recent advancements in personalized medicine for treating childhood disorders

Talecris Biotherapeutics first-quarter net income increases 35.6% to $45.3 million

Combination of antibiotics can cure Chlamydia-induced ReA: Study

Celladon's first Phase II trial of MYDICAR for advanced heart failure meets primary endpoint

Lycera to advance discovery, development efforts with second tranche of $11 million Series A financing

Neurocrine Biosciences reports net loss of $8.6M in first quarter 2010

Phase 1B/2 clinical study to evaluate efficacy of PMX-60056 in reversing heparin levels initiated

Positive results from interim analysis of ongoing Phase 2a study of BCX4208

Research reveals therapeutic benefit of ACTH in treatment of osteonecrosis

Potential new treatment for osteonecrosis

Update on ICA-105665 clinical development plans for treatment of epilepsy and pain

NCCTG to conduct Phase II study of brostallicin in combination with cisplatin for mTNBC cancer

Phase II clinical trial to test safety and efficacy of transplanted encapsulated islets

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

Biostar receives Shaanxi SFDA approval to market Xin Aoxing Oleanolic Acid Capsules

Interim results from Phase I clinical trial of PLX-PAD for treatment of CLI

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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