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March 2016

 

 

academics

 

Clinical research courses

Albumedix announced that its albumin-based VELTIS® half-life extension technology is being used by CSL Behring in IDELVION®, a  therapy recently authorized for the treatment of haemophilia B in the U.S. The application of Albumedix’s VELTIS technology in the drug delivers an extended half-life which will improve the lives of patients living with the condition by reducing the frequency of injections up to once every 14 days. The U.S. Centers for Disease Control and Prevention, report that the condition affects approximately one in 25,000 male births.

Anacor Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review Anacor's New Drug Application (NDA) seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

Aratana Therapeutics, Inc., a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, announced the Food and Drug Administration's Center for Veterinary Medicine (CVM) approved GALLIPRANT® (grapiprant tablets) for the control of pain and inflammation associated with osteoarthritis in dogs.

EOS imaging announced that the Company has received approval from the China Food and Drug Administration (CFDA) to market the EOS system in China, further expanding the Company’s commercial opportunities in the fast growing Asia Pacific market. The EOS system can now be marketed in 51 countries.

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Amgen and UCB announced positive top-line results for romosozumab from the pivotal Phase 3 placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis (BRIDGE). These data showed the BRIDGE study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine (as assessed by dual energy x-ray absorptiometry) in men with osteoporosis treated with romosozumab compared with placebo at 12 months.

LEO Pharma announced that it received scientific approval of Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g)  for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar® is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.

The cost of treating Hepatitis C virus (HCV) could be reduced by half if doctors are trained to predict when a patient can safely stop taking the expensive but effective direct-acting antiviral (DAA) medication, suggests new research.