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CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

Solvay Pharmaceuticals, Inc. announced that Phase IIIb data published in the January issue of Clinical Therapeutics confirm that CREON® (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food.

5 Feb 2010

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

BioTime, Inc. today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.

5 Feb 2010

Research could help in developing protein-based vaccine against maternal malaria

Researchers at the University of Copenhagen have become the first in the world to synthesize the entire protein that is responsible for life-threatening malaria in pregnant women and their unborn children.

5 Feb 2010

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

ACCESS PHARMACEUTICALS, INC. announced today that it initiated an internal pre-licensing program to confirm the utility of its proprietary Cobalamin (vitamin B12) platform technology for targeted delivery of siRNA therapies. The program is considered important because, despite the widely publicized potential of RNA therapy, researchers up to now have been stymied in their efforts to design a pharmaceutical product that efficiently transports siRNA therapeutics into the cells they are designed to inhibit or kill.

5 Feb 2010

New report finds low adult vaccination rates in U.S.

A new report, Adult Immunization: Shots to Save Lives, released today by the Trust for America's Health (TFAH), the Infectious Diseases Society of America (IDSA), and the Robert Wood Johnson Foundation (RWJF) found that more than 30 percent of adults ages 65 and older had not been immunized against pneumonia in 36 states as of 2008.

5 Feb 2010

Medizone International's AsepticSure sterilization system eradicates all Super Bugs

Medizone International, Inc. announced today that every full scale test run completed thus far in its hospital room mock up facility has resulted in the total elimination of all bacteria present in the room.

5 Feb 2010

Anthem Blue Cross introduces DailyMed Pharmacy program for Medi-Cal members

Imagine having to face the daily struggle of taking six or more different medications a day to manage a chronic health condition; add to this the worry of missing or taking a dose incorrectly. For Anthem Blue Cross (Anthem) Medi-Cal members, that daily struggle will now be simplified to help increase medication adherence and reduce medication errors.

5 Feb 2010

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

Optimer Pharmaceuticals, Inc. today announced positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI). This study was conducted in approximately 100 clinical sites throughout North America and Europe. The Company plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010.

5 Feb 2010

New class of compound could become effective antidepressant with minimal side effects

Chemists at Oregon State University have discovered and synthesized a new compound that in laboratory and animal tests appears to be similar to, but may have advantages over one of the most important antidepressant medications in the world.

5 Feb 2010

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

Efficacy News and Research

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

Research could help in developing protein-based vaccine against maternal malaria

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

New report finds low adult vaccination rates in U.S.

Medizone International's AsepticSure sterilization system eradicates all Super Bugs

Anthem Blue Cross introduces DailyMed Pharmacy program for Medi-Cal members

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

New class of compound could become effective antidepressant with minimal side effects

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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