DIA Biosimilars 2013

Vertex Pharmaceuticals

Vertex, GSK partner on phase II all-oral study of VX-135, GSK2336805 for Hep C

Friday, November 2, 2012 11:23 AM

Vertex Pharmaceuticals, a global biotechnology company based in Cambridge, Mass., has entered into a non-exclusive agreement with GlaxoSmithKline (GSK) to conduct a phase II proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing Vertex's nucleotide analogue HCV polymerase inhibitor VX-135 and GSK's NS5A inhibitor GSK2336805.

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Cenduit: Now with Patient Reminders

Vertex corrects, provides additional data on cystic fibrosis study

Wednesday, May 30, 2012 10:44 AM

Vertex Pharmaceuticals of Cambridge, Mass., has released a correction to the previously reported responder analysis, as well as additional data from, its recent interim analysis of an ongoing phase II combination study of VX-809 and Kalydeco (ivacaftor) that showed significant improvements in lung function (forced expiratory volume in one second, FEV1) among adults with cystic fibrosis who have two copies of the most common mutation in the cystic fibrosis transmembrane conductance regulator gene, F508del.

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CRF Health – eCOA Forum

FDA approves Kalydeco to treat rare form of cystic fibrosis

Friday, February 3, 2012 01:46 PM

The FDA has approved Kalydeco (ivacaftor), manufactured by Vertex Pharmaceuticals, for the treatment of a rare form of cystic fibrosis in patients ages six and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

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Icon boosts its presence in Asia with acquisition of Chinese CRO BeijingWits Medical Consulting

Monday, December 19, 2011 10:13 AM

Now that many mid-tier CROs have been acquired by either equity investment firms or other CROs and the trend has slowed, a new form of consolidation is emerging. Robust CROs are rounding out their offerings with small but strategic acquisitions to make them bigger, stronger and more complete. The ultimate goal: to continue winning lucrative strategic outsourcing agreements from sponsors.  

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Gilead Sciences acquires Pharmasset, looks to duplicate its HIV success in hepatitis C

Monday, November 28, 2011 08:02 AM

Consolidation among drug sponsors continues. 

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Cubist Pharmaceuticals names senior VP

Tuesday, October 18, 2011 10:06 AM

Cubist Pharmaceuticals has named Jennifer Jackson, Ph.D., senior vice president of regulatory affairs. Jackson will oversee all facets of Cubist’s regulatory affairs, providing oversight for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities. Jackson will report to Steve Gilman, Ph.D., Cubist’s executive vice president of research and development and chief scientific officer.

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FDA approval spurs Vertex move to Boston waterfront

Wednesday, May 25, 2011 11:51 AM

The approval of Vertex’s Pharmaceutical’s hepatitis C treatment triggered one the biggest real estate deals in Boston’s history and is expected to spur the economic turnaround of the waterfront’s industrial area, according to a report in The Boston Globe.

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FDA finds Vertex’s HVC drug effective

Wednesday, April 27, 2011 01:48 PM

The FDA has indicated that Vertex Pharmaceuticals’ experimental drug telaprevir cures more patients of hepatitis C than any current therapies, according to a Bloomberg report. 

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Phase III study of VX-770 for cystic fibrosis shows positive results

Friday, April 1, 2011 11:01 AM

Massachusetts-based Vertex Pharmaceuticals announced positive results from a 24-week analysis of the ongoing phase III ENVISION study of VX-770, an oral medicine in development that targets the defective protein that causes cystic fibrosis (CF). ENVISION (n=52) was designed to evaluate VX-770 among children ages 6 to 11 with the G551D mutation in the CFTR gene.

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Pharmasset presents early-stage data

Thursday, March 17, 2011 01:40 PM

Pharmasset’s experimental hepatitis C therapies may pose a challenge to treatments from Vertex Pharmaceuticals, based on trial results to be released in late March, BMO Capital Markets Corp. analysts said, according to a Bloomberg report.

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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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