2015

Zafgen’s Beloranib IND gets complete clinical hold after second death

Monday, December 7, 2015

Zafgen, a Boston-based biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, has received verbal notice from the FDA that its beloranib investigational new drug (IND) application has been placed on complete clinical hold, affecting the ongoing open label extension (OLE) portion of the pivotal phase III ZAF-311 bestPWS clinical trial in patients with Prader-Willi syndrome (PWS). A complete clinical hold is an order that the FDA issues to a sponsor to suspend all clinical work requested under the company’s IND application.

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INC named ‘Best CRO’ at 11th Annual Scrip Awards

Monday, December 7, 2015

INC Research Holdings, a global phase I to IV CRO, was named Best Contract Research Organization at the 11th Annual Scrip Awards. INC was selected from among several global CROs by a panel of life science industry executives. The Best CRO ranking from Scrip follows INC Research’s recognition earlier in the year as Top CRO to Work With among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey.

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Study: CROs increase pay in the face of escalating employee turnover

Friday, December 4, 2015

Turnover in the U.S. for clinical monitoring jobs (the function that monitors participants’ health during a clinical trial) at CROs jumped up to 25.4% from the previous year’s reported low of 16.4%, according to the 17th annual CRO Industry Global Compensation and Turnover Survey, conducted by HR+Survey Solutions, a specialty compensation consulting and research firm. While that number is below the four-year high of 29.4%, it is significantly higher than estimates of overall U.S. professional turnover of 15.7%.

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Cummings criticizes Turing’s fake price cut

Friday, December 4, 2015

Rep. Elijah Cummings (D-Md.), ranking member of the House Committee on Oversight and Government Reform, has sent a letter to former hedge fund manager Martin Shkreli, CEO of Turing Pharmaceuticals, condemning his company’s efforts to tout a 50% “price cut” for Daraprim after the company increased the price of the drug in August by 5,000%.

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Baxalta opens Global Innovation Center

Friday, December 4, 2015

Baxalta, a global biopharmaceutical provider dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, has announced the official opening of its Global Innovation Center in Cambridge, Mass.

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