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Keryx does not meet primary endpoint in perifosine + capecitabine Phase 3 trial for colorectal cancer

Keryx Biopharmaceuticals, Inc. reported today that the Phase 3 "X-PECT" clinical trial evaluating perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

3 Apr 2012

Merck announces data from ZOSTAVAX Phase III study on shingles

Merck, known as MSD outside the United States and Canada, announced today that data from the pivotal Phase III study with ZOSTAVAX(Zoster Vaccine Live) in adults ages 50 to 59 were published in the April 1 issue of Clinical Infectious Diseases.

3 Apr 2012

AlloCure closes $25 million Series B venture financing

AlloCure, Inc., a clinical stage biotechnology company focused on the treatment of kidney disease, today announced the closing of a $25 million Series B venture financing.

2 Apr 2012

Ampio, Australian TGA reach agreement over Zertane submission plan

Ampio Pharmaceuticals, Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities, announced today that it reached agreement with the Therapeutic Goods Administration, Canberra, Australia, on a plan of drug manufacture and quality control for Zertane and the overall plan for the preparation of Common Technical Documents for the draft registration submission expected to be filed in June 2012.

2 Apr 2012

Enrollment complete in Oncolytics REOLYSIN combination trial for head and neck cancers

Oncolytics Biotech Inc. announced today that it has completed enrollment in the first, 80 patient stage of its Phase III clinical trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018).

2 Apr 2012

$Aeterna Zentaris X-PECT Phase 3 refractory advanced colorectal cancer trial fails to meet primary endpoint$

Aeterna Zentaris X-PECT Phase 3 refractory advanced colorectal cancer trial fails to meet primary endpoint

Aeterna Zentaris Inc. today announced that the Phase 3 "X-PECT" (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

2 Apr 2012

Clinical data for cabozantinib to be presented at ASCO annual meeting

Exelixis, Inc. announced today that its lead compound, cabozantinib, will be the subject of nine separate data presentations at the upcoming Annual Meeting of the American Society of Clinical Oncology.

2 Apr 2012

Novartis achieves primary endpoints in all three of QVA149 Phase III studies on COPD

Sosei Group Corporation, confirms the information released today by Novartis that the first three QVA149 Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints.

2 Apr 2012

New ACR guidelines recommend use of topical NSAIDs for older patients with knee OA

The American College of Rheumatology (ACR) Subcommittee on Osteoarthritis Guidelines has approved and issued several updates to clinical practice guidelines for the treatment of osteoarthritis (OA).

31 Mar 2012

CSL Behring initiates rVIIa-FP Phase I study in hemophilia A and B

CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in healthy volunteers the safety and pharmacokinetics of rVIIa-FP in comparison to placebo.

31 Mar 2012

Top-line results from Shire's SPD476 phase 3 trial on diverticulitis

Shire plc, the global specialty biopharmaceutical company, today announced top-line results of the PREVENT2 trial, a phase 3 investigational study of once-daily SPD476, MMX mesalamine in patients with a history of diverticulitis.

31 Mar 2012

Bionovo 2011 total revenues decrease to $0.3 million

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced financial results for the year ended December 31, 2011.

31 Mar 2012

Green Coffee beans - the new weight loss formula

Green coffee beans could be the newest weight-loss fad as a new study finds that the bean extract may help people lose weight. When roasted at 475 degrees, coffee beans are sometimes described as rich and full-bodied. Before that they are termed green.

29 Mar 2012

Lilly's ixekizumab Phase II trial on plaque psoriasis meets primary endpoint

New Phase II data, published today in the New England Journal of Medicine, showed that Eli Lilly and Company's ixekizumab, an anti-IL-17 monoclonal antibody, met its primary endpoint in patients with moderate-to-severe plaque psoriasis, with significantly more patients achieving at least a 75 percent improvement in Psoriasis Area and Severity Index (PASI) scores from baseline (PASI 75) compared with placebo at week 12.

29 Mar 2012

FDA extends review period for Almirall and Forest Labs' aclidinium bromide NDA

Forest Laboratories, Inc. and Almirall, S.A. announced today that the U.S. Food and Drug Administration (FDA) will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease.

29 Mar 2012

DSMB recommends Bionovo to continue Menerba Phase 3 trial for hot flashes

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced today that the Company's independent Data Safety Monitoring Board (DSMB) recommended that the Phase 3 trial of Menerba (MF101) could continue as designed after an initial review of its clinical safety and tolerability data.

29 Mar 2012

NEJM publishes results from Amgen's brodalumab Phase 2 trial on plaque psoriasis

Amgen announced today that results from a Phase 2 trial evaluating the safety and efficacy of brodalumab in 198 patients with moderate to severe plaque psoriasis were published in the New England Journal of Medicine.

29 Mar 2012

AHF calls on FDA Commissioner Hamburg to step down

AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS organization, today called on Food and Drug Administration (FDA) Commissioner Margaret Hamburg to step down in response to the agency's gross mismanagement of new product reviews and a lack of transparency.

29 Mar 2012

Positive results from Allergan's BOTOX Phase III trials on idiopathic overactive bladder

Allergan, Inc. today announced that two Phase III clinical trials of BOTOX (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints.

29 Mar 2012

Heart attack could be treated best with cheap mix of three injections: Study

When the shot was given early to patients with signs of a heart attack, the mixture of glucose, insulin and potassium (GIK), showed remarkable success in preventing full cardiac arrest - when the heart stops beating - and even death. And each shot cocktail costs only about $US50, according to the research presented at the American College of Cardiology's 61st annual scientific meeting in Chicago. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.

28 Mar 2012