DIA Biosimilars 2013

Clinical Intelligence

GSK, Theravance report positive results from four phase III COPD studies

Monday, July 2, 2012 03:09 PM

GlaxoSmithKline and Theravance, a biopharmaceutical company based in San Francisco, issued results from four pivotal phase III studies of investigational LAMA/LABA involving over 4,000 patients with chronic obstructive pulmonary disease (COPD).

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Cenduit: Now with Patient Reminders

The CenterWatch Monthly, July 2012

Sunday, July 1, 2012 07:30 AM

Patient-driven drug development goes prime time

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CRF Health – eCOA Forum

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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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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