Global News

ERT completes acquisition of PHT

Monday, May 11, 2015 03:14 PM

ERT, a global solutions provider for patient safety and efficacy endpoint data collection headquartered in Philadelphia, Pa., has completed the acquisition of Boston, Mass.-based PHT, an eClinical innovator focused on the adoption of patient-driven mobile apps for improved clinical research. Financial terms of the transaction have not been disclosed.

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Quest Diagnostics

UNC-Chapel Hill, GSK partner for HIV cure, launch Qura Therapeutics

Monday, May 11, 2015 02:06 PM

The University of North Carolina at Chapel Hill, a global public research university with experience in HIV basic and clinical research, and GlaxoSmithKline have created the dedicated HIV Cure Center and a jointly owned new company that will focus on discovering a cure for HIV/AIDS. This unique public-private partnership will redefine the traditional way of conducting research and create a new model to seek the breakthroughs needed to tackle a global health issue.

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FDA lifts clinical hold on NeuroDerm’s ND0612 for Parkinson's

Monday, May 11, 2015 10:30 AM

The FDA has lifted the clinical hold on U.S. clinical studies of ND0612H and ND0612L, primary product candidates based on proprietary, subcutaneously-delivered Levodopa/Carbidopa (LD/CD) liquid formulation for the treatment of Parkinson's disease, owned by NeuroDerm, a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases. The hold was lifted after the FDA reviewed additional information related to the product candidates' delivery devices. U.S. clinical development of these product candidates is therefore cleared to proceed in the second half of 2015.

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Surface Oncology appoints Detlev Biniszkiewicz CEO

Monday, May 11, 2015 09:09 AM

Surface Oncology, a Cambridge, Mass.-based provider of next-generation cancer immunotherapies, has appointed Detlev Biniszkiewicz, Ph.D., president and CEO, effective immediately. Biniszkiewicz brings over 15 years of industry leadership and experience building a transformative pipeline of novel cancer therapies, most recently as the head of the oncology strategy at AstraZeneca.

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Assessing past performances

Monday, May 11, 2015 08:00 AM

The adage “Keep the past in the past” does not apply to clinical research best practices.

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Plasmatech Biopharmaceuticals to acquire Abeona Therapeutics

Friday, May 8, 2015 12:24 PM

PlasmaTech Biopharmaceuticals, a Texas-based biopharmaceutical company advancing protein biologic therapies and oncology supportive care products, has entered into a definitive agreement to acquire Abeona Therapeutics, a company engaged in the development and commercialization of therapies for patients with lysosomal storage diseases. The company will issue to Abeona Therapeutic members a total of 3,979,761 common shares upon closing of the transaction, and up to an additional $9 million in performance milestones, in common stock or cash, at the company’s option.

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ViiV Healthcare begins phase III dolutegravir/rilpivirine program for HIV maintenance therapy

Thursday, May 7, 2015 01:03 PM

ViiV Healthcare has started a phase III clinical trial program to evaluate the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV. The phase III program comprises two replicate studies evaluating 48 week viral suppression with a two drug regimen combining an integrase inhibitor (dolutegravir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine) in patients with HIV who already have achieved viral suppression with a three drug regimen.

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AbbVie’s Venetoclax receives FDA Breakthrough Therapy designation for CLL

Thursday, May 7, 2015 12:54 PM

AbbVie has announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

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Clinipace Worldwide co-founders named E&Y Entrepreneur of the Year finalists

Thursday, May 7, 2015 12:44 PM

Clinipace Worldwide, a global digital CRO, has announced Jeff Williams, CEO and co-founder, and Chris Porter, president and co-founder, have been named one of three finalists in the Health Care & Life Sciences category of the Ernst & Young Entrepreneur Of The Year 2015 Southeast Program, which includes Alabama, Georgia, North Carolina, South Carolina and Tennessee. The awards program recognizes entrepreneurs who demonstrate excellence and extraordinary success in areas such as innovation, financial performance and personal commitment to their businesses and communities.

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Quintiles establishes bioanalytical laboratory in Europe

Thursday, May 7, 2015 12:27 PM

Global CRO Quintiles has expanded its bioanalytical laboratory services with the establishment of a GLP-compliant bioanalytical liquid chromatography-mass spectrometry (LC-MS) lab. The lab, located in the Netherlands, will have extensive bioanalytical testing capabilities and will provide a European facility for Quintiles customers to conduct pharmacokinetics studies. 

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May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

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Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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