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DrugDev named Best Place to Work by the Philadelphia Business Journal

Friday, September 5, 2014 10:12 AM

The Philadelphia Business Journal has named DrugDev one of its Best Places to Work in the Philadelphia region. The recognition continues the tradition established by CFS Clinical, a provider of global investigator payment, contracting and regulatory services, which had been named to the prestigious list each of the previous two years until it was acquired by DrugDev in October 2013.

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Oncolytics Biotech completes patient enrollment in phase II ovarian cancer study

Friday, September 5, 2014 09:53 AM

Oncolytics Biotech has completed patient enrollment in a randomized, phase II study of paclitaxel plus reolysin versus paclitaxel alone in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG186H).

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Debiopharm Group's antibiotic Debio 1450 receives QIDP designation from the FDA

Friday, September 5, 2014 09:40 AM

Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs including anti-infective and oncology therapeutics as well as companion diagnostics, has announced that the FDA has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

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Tracy Tsuetaki joins Parexel as senior vice president

Friday, September 5, 2014 09:34 AM

Parexel International, a global biopharmaceutical services provider, has appointed Dr. Tracy Tsuetaki as senior vice president for peri/post-approval services and Parexel consulting. He will oversee the strategy and operational management for both businesses. He also will be on Parexel's business review committee.

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AbbVie, Calico launch R&D collaboration for age-related diseases

Thursday, September 4, 2014 12:35 PM

Chicago-based AbbVie and Calico, a California-based Google-founded R&D company, have announced a novel R&D collaboration intended to help the two companies discover, develop and bring to market new therapies for patients with age-related diseases, including for neurodegeneration and cancer.

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Redx Pharma, AstraZeneca collaborate

Thursday, September 4, 2014 12:34 PM

Redx Pharma, a U.K.-based group focused on early stage drug discovery and development, has entered into a research collaboration with AstraZeneca to discover and develop new molecules targeting a genetic driver of tumor growth and survival.

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Johnson & Johnson to accelerate Ebola vaccine program in collaboration with NIH

Thursday, September 4, 2014 12:29 PM

Johnson & Johnson has committed to accelerate its Ebola vaccine program in collaboration with the NIH. J&J will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate to deliver immediate relief aid to address the current Ebola outbreak.

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Infinity, AbbVie partner to develop, commercialize oncology drug duvelisib

Thursday, September 4, 2014 12:28 PM

Infinity Pharmaceuticals, based in Cambridge, Mass., and AbbVie have entered into a global collaboration to develop and commercialize duvelisib (IPI-145), Infinity's oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, to treat cancer.

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HHS contracts with Mapp Biopharmaceutical to develop ZMapp for Ebola

Thursday, September 4, 2014 12:22 PM

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

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DPT Laboratories acquires Meda Pharmaceuticals’ facility, retains employees

Thursday, September 4, 2014 12:21 PM

DPT Laboratories, a Texas-based contract development and manufacturing organization (CDMO) with a specialized focus on semi-solid and liquid dosage forms, has acquired Meda Pharmaceuticals’ Lakewood, N.J., facilities.

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September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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