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UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

UCB announced today results from the PRECiSE 3 7-year open label extension clinical trial of Cimzia (certolizumab pegol), the longest continuous trial of an anti-TNF therapy evaluating long-term safety in Crohn's disease.

6 May 2014

Covagen begins COVA322 Phase Ib/IIa study to treat patients with rheumatoid and psoriatic arthritis

Covagen today announced it has initiated a Phase Ib/IIa study with COVA322, a bispecific TNF/IL-17A inhibitor.

6 May 2014

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) providing regular approval for Soliris® (eculizumab) for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

6 May 2014

UH biomedical engineer receives ALR grant to study cause of lupus nephritis

In the U.S. alone, more than 1.5 million people have lupus, a chronic autoimmune disease in which the immune system turns against itself, attacking a person's healthy tissue, cells and organs. The symptoms can range from debilitating pain and fatigue to organ failure.

6 May 2014

New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

New two-year data from the Phase 3 ADVANCE clinical trial for peginterferon beta-1a in adults with relapsing forms of multiple sclerosis (RMS) has been presented at the 66th American Academy of Neurology (AAN) annual meeting.

5 May 2014

Research provides definitive evidence of safety of Tdap immunization during pregnancy

A preliminary study finds that receipt of the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in the third trimester of pregnancy did not increase the risk of adverse events for the mother or infant, according to a study in the May 7 issue of JAMA, a theme issue on child health.

5 May 2014

Vibrating oral capsule for chronic constipation shows positive results

An oral capsule that vibrates as it moves through the digestive tract has shown notable promise as a non-pharmacological treatment for constipation, according to new research presented today at Digestive Disease Week- (DDW).

5 May 2014

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

Ruthigen, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, today announced that the Company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for its lead drug candidate RUT58-60.

2 May 2014

New computational model rapidly assess therapy outcomes in prostate cancer patients with bone metastasis

A new computational model that simulates bone metastasis of prostate cancer has the potential to rapidly assess experimental therapy outcomes and help develop personalized medicine for patients with this disease, according to data published in Cancer Research, a journal of the American Association for Cancer Research.

2 May 2014

UT Southwestern docs receive grants for innovative studies on lung cancer pathways, drug therapy

Two UT Southwestern doctors have received more than a half-million dollars in grants from the Department of Defense for innovative studies on lung cancer pathways and to test the effectiveness of a potentially less expensive drug therapy.

2 May 2014

Biotech to the rescue

MIT professor Ram Sasisekharan's three biotech companies — Momenta Pharmaceuticals, Cerulean Pharma, and Visterra — share a similar goal.

1 May 2014

Ranibizumab trial gets promising results for CNV

Patients with visual impairment due to myopic choroidal neovascularisation achieve better visual acuity after 3 months of individualised treatment with ranibizumab than with verteporfin photodynamic therapy, show the results of a phase III randomised controlled trial.

1 May 2014

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Teva Pharmaceutical Industries Ltd. today announced positive results from a pivotal Phase III study of hydrocodone bitartrate extended-release tablets designed with Teva's proprietary technology providing potential abuse-deterrent properties (CEP-33237).

30 Apr 2014

Purdue Pharma seeks FDA authorization to market once-daily hydrocodone bitartrate tablet

Purdue Pharma L.P. announced that it has filed a New Drug Application (NDA) with the U.S. Food & Drug Administration seeking authorization to market a once-daily, single-entity hydrocodone bitartrate tablet (HYD).

30 Apr 2014

Synergy reports positive top-line results from plecanatide phase 2b study in patients with IBS-C

Synergy Pharmaceuticals Inc. today announced positive top-line results from a phase 2b dose-ranging study assessing plecanatide's safety and efficacy in 424 patients with irritable bowel syndrome with constipation (IBS-C).

30 Apr 2014

New study explores methods for improving resilience of health system

According to a new study by the American Meteorological Society Policy Program, a risk management framework can improve the resilience of healthcare facilities and services to high-impact weather such as tornadoes and hurricanes. The report is based on a recent AMS Policy Program workshop, A Prescription for the 21st Century: Improving Resilience to High-Impact Weather for Healthcare Facilities and Services, held in Washington, DC in October 2013.

30 Apr 2014

Otsuka's Deltyba gets EC marketing authorization for MDR-TB treatment

Otsuka Pharmaceutical Co., Ltd. today announced that the European Commission has granted a marketing authorization for Deltyba (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

30 Apr 2014

Can-Fite BioPharma submits study protocol to FDA for CF102 Phase II trial for advanced liver cancer

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it has submitted a study protocol to the U.S. Food and Drug Administration for its Phase II clinical trial of CF102 for the treatment of advanced liver cancer.

29 Apr 2014

Report focuses on behavioral issues linked with patients' self-management of type 2 diabetes

Clinical Therapeutics features a special report in its April issue focusing primarily on the behavioral issues associated with patients' self-management of type 2 diabetes.

29 Apr 2014

AAN review finds certain forms of medical marijuana can help treat some symptoms of MS

A review by the American Academy of Neurology of available scientific research on the use of medical marijuana in brain diseases finds certain forms of medical marijuana can help treat some symptoms of multiple sclerosis (MS), but do not appear to be helpful in treating drug-induced (levodopa) movements in Parkinson's disease.

29 Apr 2014

Efficacy News and Research

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

Covagen begins COVA322 Phase Ib/IIa study to treat patients with rheumatoid and psoriatic arthritis

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

UH biomedical engineer receives ALR grant to study cause of lupus nephritis

New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

Research provides definitive evidence of safety of Tdap immunization during pregnancy

Vibrating oral capsule for chronic constipation shows positive results

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

New computational model rapidly assess therapy outcomes in prostate cancer patients with bone metastasis

UT Southwestern docs receive grants for innovative studies on lung cancer pathways, drug therapy

Biotech to the rescue

Ranibizumab trial gets promising results for CNV

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Purdue Pharma seeks FDA authorization to market once-daily hydrocodone bitartrate tablet

Synergy reports positive top-line results from plecanatide phase 2b study in patients with IBS-C

New study explores methods for improving resilience of health system

Otsuka's Deltyba gets EC marketing authorization for MDR-TB treatment

Can-Fite BioPharma submits study protocol to FDA for CF102 Phase II trial for advanced liver cancer

Report focuses on behavioral issues linked with patients' self-management of type 2 diabetes

AAN review finds certain forms of medical marijuana can help treat some symptoms of MS

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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