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GSK launches Medivir's Xerclear for OTC use in Europe

Medivir AB, the research-based specialty pharmaceutical company focused on infectious diseases, announces that its unique cold sore product Xerclear, which Medivir developed in-house, is now being launched for over-the-counter (OTC) use by its partner GlaxoSmithKline (GSK) in Europe.

8 Feb 2012

FDA accepts Genentech's pertuzumab BLA and grants Priority Review

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application for pertuzumab and granted Priority Review.

8 Feb 2012

Forum for Collaborative HIV Research suggests new approach for conducting Phase 3 HIV clinical trials

As the war on HIV/AIDS begins its fourth decade, medical researchers, pharmaceutical manufacturers, patient advocates and government regulators face a new and unexpected scientific challenge: how to demonstrate the safety and efficacy of promising new antiretroviral drugs when the two traditional study designs – the superiority trial and the non-inferiority trial – are no longer useful in showing improvements in both "treatment experienced" patients and those who have never received drug therapy (treatment-naive patients).

7 Feb 2012

FDA approves ivermectin lotion for treatment of head lice

Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. Effective and well-tolerated, Sklice Lotion treats lice in most patients with a single 10-minute application of the lotion, without nit combing.

7 Feb 2012

FDA reviews Amgen’s prostate cancer drug Xgeva

U.S. Food and Drug Administration (FDA) researchers say that an Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side effects.

7 Feb 2012

Merck completes two suvorexant Phase III trials on insomnia

Merck, known as MSD outside the United States and Canada, today provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia.

7 Feb 2012

EpiCept seeks FDA Fast Track designation for AmiKet to treat CIPN

EpiCept Corporation today announced that it has filed for Fast Track designation for AmiKet(amitriptyline 4%, ketamine 2% cream) for the treatment for chemotherapy-induced peripheral neuropathy (CIPN) with the U.S. Food and Drug Administration.

7 Feb 2012

Positive data from Chimerix CMX001 Phase 2 study on CMV disease

Chimerix, Inc., a biotechnology company developing novel antiviral therapeutics, today announced positive results from CMX001 Study 201, a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV) disease in hematopoietic stem cell transplant (HCT) recipients.

6 Feb 2012

Combination of ICS and LABA appears to reduce severe asthma attacks

A Henry Ford Hospital study has found that using two types of common asthma medications in combination reduces severe asthma attacks.

6 Feb 2012

Positive results from Chimerix CMX001 study for CMV in hematopoietic stem cell transplant recipients

6 Feb 2012

Orexigen reaches SPA agreement for Contrave outcomes trial with FDA

Orexigen Therapeutics, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for the Contrave outcomes trial.

6 Feb 2012

Takeda launches EDARBYCLOR in the U.S. for treatment of hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., announced EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is now available by prescription in U.S. pharmacies for the treatment of hypertension to lower blood pressure in adults.

6 Feb 2012

Aspirin plus clopidogrel unlikely to prevent recurrent strokes and may increase risk of death, bleeding

The anti-blood clot regimen that adds the drug clopidogrel (Plavix) to aspirin treatment is unlikely to prevent recurrent strokes and may increase the risk of bleeding and death in patients with subcortical stroke according to late-breaking research presented at the American Stroke Association's International Stroke Conference 2012.

4 Feb 2012

G-CSF's AX200 does not improve stroke-related disability

A new drug that showed promise in animal studies and an early clinical trial didn't improve disability among stroke patients, according to late-breaking research presented at the American Stroke Association's International Stroke Conference 2012.

4 Feb 2012

Soy isoflavone supplements do not reduce breast cancer cell proliferation

Soy isoflavone supplements did not decrease breast cancer cell proliferation in a randomized clinical trial, according to a study published in Cancer Prevention Research, a journal of the American Association for Cancer Research.

4 Feb 2012

Study to evaluate vitaminD3, omega3 and home exercise in preventing age-related chronic diseases

In Europe, the number of seniors aged 70 and over will increase by 40% in the next 20 years, while those aged 80 and over will more than double. Health authorities and the medical community expect a corresponding increase in the number of people suffering costly and debilitating age-related chronic diseases such as osteoporosis, arthritis, heart and lung diseases and dementia.

3 Feb 2012

Merck receives FDA approval for JANUMET XR to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration approved JANUMET XR (sitagliptin and metformin hydrochloride extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA (sitagliptin), with extended-release metformin.

3 Feb 2012

New England Journal of Medicine publishes Diamyd Medical's antigen-based diabetes therapy study

An article with the results of Diamyd Medical's European Phase III study of the antigen-based diabetes therapy Diamyd® has been published in the scientific journal the New England Journal of Medicine. The now published results were previously presented at the American Diabetes Association's 71st Scientific Sessions in San Diego, California, USA, on June 28, 2011.

3 Feb 2012

Takeda, SPI announce that lubiprostone phase 3 trial on OBD meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced today that lubiprostone met the primary endpoint in a phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.

2 Feb 2012

ImmunoCellular receives U.S. patent allowance for cancer stem cell treatment

ImmunoCellular Therapeutics, Ltd., a biotechnology company focused on the development of novel immune-based cancer therapies, announced the allowance of U.S. patent claims related to the Company's method of treating glioblastoma multiforme (GBM) in a patient by targeting cancer stem cells.

2 Feb 2012