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FDA issues complete response letter for roflumilast NDA

Forest Laboratories, Inc. and Nycomed today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast. Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.

18 May 2010

Early CPAP as effective for preemies as ventilator, with fewer complications: Study

Two findings from an NIH research network study provide new information on how much oxygen very preterm infants should receive starting on the first day of life and the most effective means to deliver it to them.

17 May 2010

Female sex hormones may work with estrogen in reducing airway constriction: Research

Female sex hormones may work with beta-agonists in reducing airway constriction, according to new bench research from the Mayo Clinic.

17 May 2010

Trubion Pharmaceuticals to present promising data from Phase 1 studies of SBI-087, SBI-087

Trubion Pharmaceuticals, Inc. today announced the acceptance of two Phase 1 data presentations on SBI-087 (PF-05230895) at the 2010 annual congress of the European League Against Rheumatism (EULAR) in Rome, Italy. Presentations will include promising data from a Phase 1 study of SBI-087 for the treatment of rheumatoid arthritis (RA) and a Phase 1 study of SBI-087 for the treatment of systemic lupus erythematosus (SLE). Copies of both abstracts are available at http://www.eular.org. SBI-087 is Trubion's next-generation CD20-directed small modular immunopharmaceutical (SMIP™) product candidate and is being developed in collaboration with Pfizer.

13 May 2010

Harbor BioSciences reports encouraging results from Triolex Phase IIa trials

Harbor Biosciences, a biopharmaceutical company developing novel therapeutics for the treatment of cancer, metabolic and inflammatory diseases, today released an update to its development program for Triolex to treat obesity-induced insulin resistance and type-2 diabetes mellitus (T2DM).

10 May 2010

European patent strengthens Soligenix' topically active steroid intellectual property portfolio

Soligenix, Inc., a late-stage biotechnology company, announced today that the European Patent Office granted patent EP 1392321 "Method of Treating Inflammatory Disorders of the Gastrointestinal Tract using Topically Active Corticosteroids." The new patent's main claims cover the use of topically active corticosteroids in orally administered dosage forms that act concurrently in the upper and lower gastrointestinal tract.

10 May 2010

Forest, Nycomed to present data from six roflumilast posters at ATS International Conference

Forest Laboratories, Inc. and Nycomed today announced that they will present data from six roflumilast posters during the American Thoracic Society (ATS) International Conference being held in New Orleans, LA, May 14 through May 19, 2010. Roflumilast is an investigational anti-inflammatory, oral medication for the treatment of Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in patients at risk of exacerbations.

10 May 2010

Steroids can raise cardiovascular risks in post-transplant patients

Post-transplant patients who have been removed from a corticosteroid regimen have fewer cardiovascular events than those patients on steroids, increasing their graft survival rates and reducing early mortality, according to study results being presented this week by University of Cincinnati (UC) transplantation researchers.

10 May 2010

Osiris Therapeutics reports net income of $2.4M for first-quarter 2010

Osiris Therapeutics, Inc., the leading stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, cardiovascular and orthopedic areas, announced today its results for the first quarter of fiscal 2010.

7 May 2010

Study reveals benefits of X-ray guided steroid injections for treatment of hamstring tendonitis

Fluoroscopic (X-ray) guided steroid injections offer a safe and effective alternative to the conventional treatment of hamstring tendonitis, according to a study to be presented at the ARRS 2010 Annual Meeting in San Diego, CA. Conventional treatment includes rest, anti-inflammatory drugs, and physical therapy.

7 May 2010

OSIR reports net income of $15.7M for fourth-quarter 2009 compared to net loss of $7.8M in 2008: MicroStockProfit.com

MicroStockProfit.com announces an investment report featuring Osiris Therapeutics Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

6 May 2010

Osiris Therapeutics resumes enrollment in Prochymal trial for treatment-resistant Crohn's disease

Osiris Therapeutics, Inc. today announced that it is resuming enrollment in its clinical trial evaluating Prochymal for patients with treatment-resistant Crohn's disease. The findings of an interim analysis showed that for the primary endpoint of disease remission, Prochymal is approaching statistical significance in the intent to treat (ITT) population, and has reached significance in the per protocol population.

6 May 2010

Natural plant extract could help treat COPD and inflammatory disorders

A widely and safely used plant extract acts as a novel anti-inflammatory agent that may one day be used for the treatment of chronic obstructive pulmonary disease, or COPD, as well as other inflammatory conditions.

4 May 2010

Genetic test to predict newborns requiring hospital readmission shortly after birth

The results of two separate research studies taking place at Children's Mercy Hospitals and Clinics will help physicians use genetic testing to prevent complications, and ease the worry of new parents by predicting in advance which newborns may require readmission to the hospital shortly after birth. The studies also will help physicians identify which of their young patients are likely to respond well - or not - to steroid therapy for asthma.

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

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

Prevention and nonsurgical treatment options to prevent low back pain and protect spine

Back and neck problems can be caused by a herniated disc, spinal stenosis, injury, strain or osteoarthritis. "Although more than 75 percent of Americans will experience some back pain during their lifetime, about 90 percent of cases are resolved without surgery," stated John K. Ratliff, MD, FACS, a Philadelphia spine surgeon and American Association of Neurological Surgeons spokesperson.

24 Apr 2010

Children born very early have abnormal lung function: U.K. researchers

More than half of children who were born very early—at 25 weeks or less (normal gestation is around 40 weeks)— have abnormal lung function and are twice as likely as their full-term peers to have a diagnosis of asthma, according to U.K. researchers, who followed a national cohort of extremely preterm infants to age 11.

22 Apr 2010

Positive results from pivotal Phase 3 trials of BENLYSTA in SLE patients

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced topline secondary endpoints from BLISS-76, the second of two pivotal Phase 3 trials of BENLYSTA™ (belimumab) in seropositive patients with systemic lupus erythematosus.

20 Apr 2010

Steroid News and Research

FDA issues complete response letter for roflumilast NDA

Early CPAP as effective for preemies as ventilator, with fewer complications: Study

Female sex hormones may work with estrogen in reducing airway constriction: Research

Trubion Pharmaceuticals to present promising data from Phase 1 studies of SBI-087, SBI-087

Harbor BioSciences reports encouraging results from Triolex Phase IIa trials

European patent strengthens Soligenix' topically active steroid intellectual property portfolio

Forest, Nycomed to present data from six roflumilast posters at ATS International Conference

Steroids can raise cardiovascular risks in post-transplant patients

Osiris Therapeutics reports net income of $2.4M for first-quarter 2010

Study reveals benefits of X-ray guided steroid injections for treatment of hamstring tendonitis

OSIR reports net income of $15.7M for fourth-quarter 2009 compared to net loss of $7.8M in 2008: MicroStockProfit.com

Osiris Therapeutics resumes enrollment in Prochymal trial for treatment-resistant Crohn's disease

Natural plant extract could help treat COPD and inflammatory disorders

Genetic test to predict newborns requiring hospital readmission shortly after birth

Experts discuss recent advancements in personalized medicine for treating childhood disorders

Research reveals therapeutic benefit of ACTH in treatment of osteonecrosis

Potential new treatment for osteonecrosis

Prevention and nonsurgical treatment options to prevent low back pain and protect spine

Children born very early have abnormal lung function: U.K. researchers

Positive results from pivotal Phase 3 trials of BENLYSTA in SLE patients

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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