Efficacy News and Research

RSS

BioMarin announces update on BMN 110 Phase I/II trial for Morquio A Syndrome

BioMarin Pharmaceutical Inc. today announced an update on the Phase I/II trial for BMN 110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. Preliminary clinical data from the first 24 weeks of the study (12 weeks at 0.1mg/kg and 12 weeks at 1.0 mg/kg) have been evaluated, and BioMarin plans to announce top-line results for the full 36-week study after completion of dosing at 2.0 mg/kg in the second quarter of 2010.

5 Feb 2010

Paloma Pharmaceuticals receives FDA approval to enter Phase I studies with P529

Paloma Pharmaceuticals, Inc. announced today that it has received acceptance of its IND to enter Phase I studies with Palomid 529 (P529) in patients with age-related macular degeneration (AMD).

5 Feb 2010

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug LUVENIQ™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

5 Feb 2010

Alkermes develops proprietary LinkeRx technology platform to create injectable antipsychotics

Alkermes, Inc. today announced that it has developed a novel, proprietary LinkeRx™ technology platform to enable the creation of injectable extended-release versions of antipsychotics and other central nervous system (CNS) therapies.

4 Feb 2010

BioCryst Pharmaceuticals announces fourth-quarter and full-year 2009 financial results

BioCryst Pharmaceuticals, Inc. today announced financial results for the fourth quarter and year ended December 31, 2009.

4 Feb 2010

February issue of Chest releases latest medical news

Inhaled corticosteroids (ICS) are widely used for the treatment of chronic obstructive pulmonary disease (COPD). However, new research suggests that ICS may only provide a modest benefit in reducing exacerbations in patients with COPD.

4 Feb 2010

NovaBone Products relocates operations division to expanded and upgraded facilities

NovaBone Products, LLC has announced the relocation of its operations division to expanded and upgraded facilities where it will meet increasing demands of higher sales to a more geographically diverse distributor network.

4 Feb 2010

Shire's clinical study results for treatment of Gaucher disease to be presented at LDN World Symposium

Shire plc, the global specialty biopharmaceutical company, today announced that data from one of three Phase III clinical trials for velaglucerase alfa, the company's enzyme replacement therapy (ERT) in development for the treatment of Type 1 Gaucher disease, will be presented at the Lysosomal Disease Network (LDN) World Symposium, February 10-12, 2010 in Miami, Florida.

4 Feb 2010

Study: Generic nifedipine product not bioequivalent to Adalat XL

An extended release generic nifedipine product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) is not bioequivalent to the Canadian originator product, Adalat(R) XL(R), according to the results of a study recently published in the International Journal of Clinical Pharmacology and Therapeutics.

4 Feb 2010

St. Jude Medical to commence enrollment in IRASE AF trial

St. Jude Medical, Inc. today announced it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment in the IRASE AF (IRrigated Ablation System Evaluation for AF) trial, a multicenter, randomized, single-blind study evaluating the safety and efficacy of the company’s Duo 12 port open irrigated catheter ablation system for treatment of Atrial Fibrillation (AF). AF is the most common cardiac arrhythmia (abnormal heartbeat), affecting an estimated 3.3 million Americans and millions more worldwide.

4 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010

Study shows Cymbalta reduces chronic low back pain

In a new study, 60 mg of Cymbalta® (duloxetine HCl) taken once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) average pain rating, compared with placebo.

3 Feb 2010

FDA approves Labopharm's OLEPTRO antidepressant for MDD

Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.

3 Feb 2010

Daiichi Sankyo initiates Phase III trial of edoxaban in reducing recurrent VTE complications

Daiichi Sankyo Company, Limited, announced today that it has initiated a new large-scale pivotal Phase III trial for edoxaban, its investigational oral Factor Xa inhibitor. This new study, called HOKUSAI (pronounced hoe·koo·sigh) VTE, is evaluating the safety and efficacy of edoxaban in reducing recurrent venous thromboembolic (VTE) complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

3 Feb 2010

Public policy implications in abstinence-only programs

Study focused on young African American preteens in an urban area: This is a legitimate public health study and it did show that a certain type of abstinence only program can help some very young adolescents (average age 12) delay sexual initiation for up to 24 months.

3 Feb 2010

LExICon study evaluating laser assisted lead removal using Spectranetics laser sheath published

Spectranetics Corporation today announced publication of the four-year, retrospective LExICon (Lead Extraction in Contemporary Settings) study in the February 9th issue of the Journal of American College of Cardiology.

3 Feb 2010

Iodoprovidone exhibits safety and efficiency in management of malignant pleural effusion

In the USA each year, 200,000 cancer patients suffer from a malignant pleural effusion - development of excessive fluid (pleural effusion) in the chest. Several litres of such fluid can accumulate, and many patients suffer from significant breathlessness and distress. One in four patients with lung cancer, one in every three with breast cancer and most of the patients with mesothelioma will develop a malignant effusion.

3 Feb 2010

Efficacy News and Research

BioMarin announces update on BMN 110 Phase I/II trial for Morquio A Syndrome

Paloma Pharmaceuticals receives FDA approval to enter Phase I studies with P529

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Alkermes develops proprietary LinkeRx technology platform to create injectable antipsychotics

BioCryst Pharmaceuticals announces fourth-quarter and full-year 2009 financial results

February issue of Chest releases latest medical news

NovaBone Products relocates operations division to expanded and upgraded facilities

Shire's clinical study results for treatment of Gaucher disease to be presented at LDN World Symposium

Study: Generic nifedipine product not bioequivalent to Adalat XL

St. Jude Medical to commence enrollment in IRASE AF trial

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Study shows Cymbalta reduces chronic low back pain

FDA approves Labopharm's OLEPTRO antidepressant for MDD

Daiichi Sankyo initiates Phase III trial of edoxaban in reducing recurrent VTE complications

Public policy implications in abstinence-only programs

LExICon study evaluating laser assisted lead removal using Spectranetics laser sheath published

Iodoprovidone exhibits safety and efficiency in management of malignant pleural effusion

Research retraction underscores the safety and efficacy of MMR vaccines

Baker's yeast promising against cancer

NanoBio awarded sixth U.S. patent covering its novel nanoemulsion technology

Discover how SciY empowers scientists

Why use light scattering to analyze proteins and viral vectors?

Changing the landscape of R&D to build clinical success from the ground up

Latest News