Clinical Intelligence

Shire’s VPRIV shows significant improvement in Gaucher-related bone disease

Friday, June 29, 2012 12:38 PM

Shire, a global specialty biopharmaceutical company based in Dublin, released new data that show VPRIV (velaglucerase alfa for injection), the company’s enzyme replacement therapy for type 1 Gaucher disease, significantly improved selected markers of Gaucher-related bone disease in patients.

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Yakult initiates phase I trial in multiple myeloma with perifosine in Japan

Friday, June 29, 2012 12:12 PM

Aeterna Zentaris’ Japanese partner Yakult Honsha has initiated a phase I trial in multiple myeloma with perifosine, the company's oral Akt/PI3K inhibitor drug.

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FDA approves Myrbetriq for overactive bladder

Friday, June 29, 2012 12:04 PM

The FDA has approved Astellas Pharma’s Myrbetriq (mirabegron) to treat adults with overactive bladder.

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Lexicon touts significant results for LX4211 phase IIb trial in T2D

Monday, June 25, 2012 03:50 PM

Lexicon Pharmaceuticals of The Woodlands, Texas, has reported that LX4211, an investigational, oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), showed substantial, dose-dependent, statistically-significant reductions in hemoglobin A1c (HbA1c) in a phase IIb trial in patients diagnosed with poorly-controlled type 2 diabetes who were concurrently treated with metformin, an established diabetes therapy.

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First artificial pancreas trial testing in patients' homes at night

Friday, June 22, 2012 02:59 PM

For the first time ever, two patients with diabetes were successfully treated overnight in their own homes with the MD-Logic Artificial Pancreas (MD-Logic) system, developed by specialists at Schneider Children's Medical Center of Israel. The test is a major step towards the development of a commercial device for night-time automatic control of a patient's blood glucose levels at home.

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CytoPharm, Amarillo report positive results in phase II HCV

Friday, June 22, 2012 02:24 PM

Taiwan-based pharmaceutical company CytoPharm and Texas-based biotech Amarillo Biosciences released positive clinical findings from a dose-ranging, phase II clinical trial of patients infected with hepatitis C virus (HCV) in Taiwan.

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Teva reports top-line results from phase III MS trial

Monday, June 18, 2012 03:30 PM

Teva Pharmaceutical, an Israel-based global pharmaceutical company, released positive top-line results from the GALA (Glatiramer Acetate Low-Frequency Administration) phase III trial showing that 40mg/1ml glatiramer acetate injection (GA) significantly reduced multiple sclerosis (MS) disease activity, while maintaining a favorable safety and tolerability profile.

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GSK receives FDA approval for MenHibrix

Monday, June 18, 2012 12:33 PM

The FDA has approved GlaxoSmithKline’s vaccine MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b in children aged six weeks through 18 months.

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Altheus Therapeutics completes Zoenasa phase I trial in ulcerative colitis

Friday, June 15, 2012 11:34 AM

Altheus Therapeutics of Oklahoma City, Okla., has completed a two dose, double-blind, active-controlled phase I trial of the safety and tolerability of Zoenasa rectal suspension in adult patients with left-sided, or distal, ulcerative colitis.

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Selexys Pharmaceuticals concludes phase I study in sickle cell disease

Thursday, June 14, 2012 11:54 AM

Selexys Pharmaceuticals, a privately held biopharmaceutical company based in Oklahoma City, Okla., has completed a phase I clinical study of its lead compound SelG1, an antibody specific for the pro-inflammatory cell adhesion molecule P-selectin.

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December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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