United States

QPS Holdings, Hepregen partner

Monday, June 3, 2013 11:29 AM

QPS Holdings, a U.S.-based CRO, and Hepregen, developer of HepatoPac and HepatoMune "liver-in-a-dish" products, have partnered to provide QPS a license to offer drug metabolism and pharmacokinetic (DMPK) services to its clients using Hepregen's products, in both the U.S. and Europe. The partnership also includes marketing and sales, providing co-promotion of the HepatoPac-associated DMPK services. This arrangement is the first such partnership in the field for both companies.

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TransCelerate reveals collaborative methodology for risk-based monitoring

Monday, June 3, 2013 11:25 AM

TransCelerate BioPharma, an independent nonprofit focused on accelerating the development of new medicines, has released a position paper outlining a methodology for risk-based site monitoring (RBM) that could modernize and streamline the way studies are conducted and monitored.  The RBM position paper reflects TransCelerate's collaborative approach to improve speed, efficiency and capabilities in bringing new therapeutics to patients. 

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Indiana Biosciences Research Institute opens doors

Friday, May 31, 2013 11:18 AM

The new Indiana Biosciences Research Institute opened its doors as the first industry-led collaborative life sciences research institute in the U.S.

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Biogen Idec, WPI to develop programs for BETC

Friday, May 31, 2013 10:50 AM

Global biotechnology company Biogen Idec has signed a collaboration agreement with Worcester Polytechnic Institute (WPI) to develop and deliver programs at the university’s Biomanufacturing Education and Training Center (BETC) of Worcester, Mass.

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FDA lifts clinical hold on anthrax vaccine program

Thursday, May 30, 2013 03:24 PM

PharmAthene, a biodefense company developing medical countermeasures against biological and chemical threats, said the FDA has lifted the clinical hold previously placed on a proposed phase II study of SparVax, a next generation recombinant anthrax vaccine.

"Anthrax has been identified as one of the foremost potential biological threats to the nation,” said Eric I. Richman, president and CEO.  “The U.S. government's requirement for a recombinant anthrax vaccine for the civilian Strategic National Stockpile is an important national security imperative that remains unfilled. Next-generation anthrax vaccines like SparVax, which employ modern vaccine technology, offer the potential for improved convenience, cost-effectiveness, more rapid immunity, and the ability for large scale rapid delivery.”

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GenVec, Naval Medical Research Center enter $3.5 million contract

Thursday, May 30, 2013 03:19 PM

GenVec, a biopharmaceutical company focused on therapeutics and vaccines, has signed an agreement worth approximately $3.5 million with the Naval Medical Research Center (NMRC) to support malaria vaccine development. 

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OncoGenex initiates trial in advanced squamous cell lung cancer

Thursday, May 30, 2013 01:21 PM

OncoGenex Pharmaceuticals plans initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label phase II trial evaluating OGX-427 in previously untreated patients with advanced squamous cell lung cancer.

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Targacept initiates phase IIb study of TC-5214

Thursday, May 30, 2013 01:14 PM

Targacept, a clinical-stage biopharmaceutical company developing novel neuronal nicotinic receptors (NNR) therapeutics, plans the initiation of a phase IIb clinical study of TC-5214 as a treatment for overactive bladder (OAB). TC-5214 acts potently on alpha3beta4 and other NNRs located in or around the bladder  believed to play a key role in bladder contraction and signaling of the urge to urinate.

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FDA grants Breakthrough Therapy status to asfotase alfa for HPP

Wednesday, May 29, 2013 12:33 PM

The FDA has granted Breakthrough Therapy designation to asfotase alfa for the treatment of patients with hypophosphatasia (HPP), according to Alexion Pharma International, a global pharmaceutical company based in Cheshire, Conn.

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Avoca Group holds Quality Summit

Tuesday, May 28, 2013 02:11 PM

The Avoca Group, a Princeton, N.J.-based consulting and research organization specializing in clinical outsourcing and alliance management, held its second annual Avoca Quality Consortium Summit May 8 and 9. Last year, Avoca formed the industry‐wide Avoca Quality Consortium, bringing together quality, outsourcing and operational professionals from member pharma, biotech and CROs to accelerate the development of a best practice approach to quality management and oversight of outsourced clinical research.

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