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Positive results from Alkermes’ ALKS 5461 phase 1/2 study on MDD

Alkermes plc today presented positive results from the phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, in an oral session at the 52nd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Phoenix.

30 May 2012

FDA accepts CSL Behring’s 4-factor PCC BLA for standard review

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (i.e., warfarin) in patients with acute major bleeding. If approved by the FDA, the CSL Behring 4-factor PCC would be the first agent of its kind available in the United States.

30 May 2012

EPO issues patent to Cytune’s CYP0150 for treatment of cancer

Cytune Pharma, an emerging leader in innovative immunomodulatory agents against cancer and infectious diseases, announced today that it will attend the BIO2012 to present its major achievements over the last 12 months and to foster partnering discussions.

30 May 2012

Lung in Oncology models for drug discovery launched by PRECOS

Preclinical Oncology Services Limited (PRECOS), a leading pre-clinical research and development service provider with a specific focus on oncology, has launched its Lung In ONcology model atlas (LION).

29 May 2012

Oncos Therapeutics commences clinical study with oncolytic viruses

Oncos Therapeutics today announced the successful initiation of its Phase I clinical study of CGTG-102, an oncolytic adenovirus suggested as a potential new treatment for many types of solid tumors.

29 May 2012

Abbott to highlight latest investigational research findings on HUMIRA at EULAR 2012

Abbott scientists and independent researchers will highlight the latest investigational research findings on HUMIRA (adalimumab) at the European League Against Rheumatism (EULAR) Congress in Berlin, Germany, from 6-9 June, 2012.

29 May 2012

EMA CHMP issues positive opinion to Eisai’s Fycompa for treatment of partial-onset seizures

Eisai announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.

29 May 2012

Scientists develop super-sensitive test that could detect diseases earlier

Scientists have developed an ultra-sensitive test that should enable them to detect signs of a disease in its earliest stages, in research published today in the journal Nature Materials.

28 May 2012

Ultra-sensitive test can diagnose diseases in their earliest stages

Scientists have developed an ultra-sensitive test that should enable them to detect signs of a disease in its earliest stages, in research published today in the journal Nature Materials.

28 May 2012

Sihuan's Roxatidine passes Chinese SFDA on-site inspection

Sihuan Pharmaceutical Holdings Group Ltd., a leading pharmaceutical company with the largest cardio-cerebral vascular drug franchise in China's prescription market, announced that Roxatidine Acetate Hydrochloride for Injection, Sihuan Pharmaceutical's first-to-market generic drug, recently passed on-site inspection for drug registration conducted by the Chinese State Food and Drug Administration.

25 May 2012

Merck welcomes launch of ROTATEQ in Rwanda of Africa’s rotavirus vaccination program

Merck, known as MSD outside the United States and Canada, welcomes today's launch in Rwanda of Africa's first national rotavirus vaccination program with ROTATEQ (rotavirus vaccine, live, oral, pentavalent), Merck's vaccine for the prevention of rotavirus disease.

25 May 2012

Gene therapy can effectively treat ADA-deficient severe combined immunodeficiency

Severe combined immunodeficiency is defect in the immune system that results in a loss of the adaptive immune cells known as B cells and T cells. Mutations in several different genes can lead to the development of severe combined immunodeficiency, including mutation of the adenosine deaminase (ADA) gene. Traditional treatment options, such as enzyme replacement therapy, are of limited efficacy, but bone marrow transplant from a compatible donor leads to a better response.

25 May 2012

ITM in Antwerp receives Gates Foundation grant for malaria research

The Antwerp Institute of Tropical Medicine has received a $3m grant from the Bill & Melinda Gates Foundation for malaria research. They will use it to attack malaria mosquitoes from a new angle.

25 May 2012

FDA advisory committee votes in favor of Pfizer's tafamidis meglumine

Pfizer Inc. announced today that the United States Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on Pfizer's clinical data package for tafamidis meglumine.

25 May 2012

Linagliptin safe and effective for African American patients with type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced Phase 3 study results for linagliptin 5 mg once-daily, which showed significant hemoglobin A1c (HbA1c or A1C) reduction of 0.88 percent compared to 0.24 percent in the placebo group (p=0.0002) at 24 weeks in black or African American adult patients with type 2 diabetes whose blood sugar was not adequately controlled.

25 May 2012

Insmed initiates patient screening for ARIKACE phase 2 NTM lung disease trial

Insmed Incorporated, a biopharmaceutical company, today announced that it has begun screening patients for its U.S. phase 2 clinical trial, Treatment with ARIKACE to Realize Greater Efficacy Trial (TARGET-NTM), of ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease.

24 May 2012

LVRC safe and effective choice for patients with severe heterogeneous emphysema

A tiny, resilient metal wire designed to gather and compress diseased lung tissue may offer relief to patients with severe heterogeneous emphysema, a subtype of the disease that involves specific, usually isolated areas of the lungs, according to the results of a multicenter international trial conducted in the Netherlands, Germany and France. The wire, called a lung volume reduction coil (LVRC), can be easily implanted and is designed to take the place of more invasive procedures used to improve the lung function of emphysema patients.

24 May 2012

Positive Results for Pulsar Stent in Clinical Study – BIOTRONIK announces

The six-month results from the prospective, multicenter, single-arm 4EVER study demonstrate efficacy and safety of BIOTRONIK's Pulsar Stent System in 120 superficial femoral artery (SFA) patients. Analysis of the 120 patients showed excellent device performance, very promising patency rates and convincing evidence of the benefits of lower limb intervention on a 4F platform. Although only the interim results were presented at the Leipzig Interventional Course (LINC 2012) in Leipzig, Germany, analysis of the full cohort has recently been made available.

24 May 2012

Results from several studies related to ACT’s TEMPASURE cardiac ablation catheter

Advanced Cardiac Therapeutics, Inc., a developer of innovative temperature-sensing cardiac ablation systems, today announced results of several studies related to the company's TEMPASURE cardiac ablation catheter.

24 May 2012

Nevro to initiate Senza HF-SCS System study for chronic pain

Nevro Corp., a medical device company focused on achieving improved pain relief for patients suffering from debilitating chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro's high-frequency spinal cord stimulation system for the treatment of chronic pain.

24 May 2012