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Moderna, Karolinska Institute to collaborate on messenger RNA therapeutics

Thursday, October 16, 2014 02:30 PM

Moderna Therapeutics, a Cambridge, Mass.-based pharma, has formed a strategic, long-term collaboration with Karolinska Institute (KI) and Karolinska University Hospital (KUH), both in Sweden, for the discovery and development of innovative drugs using Moderna's messenger RNA (mRNA) Therapeutics technology. mRNA Therapeutics enable the in vivo production of both intracellular proteins and secreted proteins.

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West Pharmaceutical Services, HealthPrize Technologies to reward patient adherence

Thursday, October 16, 2014 02:26 PM

West Pharmaceutical Services and HealthPrize Technologies are teaming up to reward patients for taking their medications.

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Inversion rule change prompts AbbVie to halt Shire takeover

Thursday, October 16, 2014 02:21 PM

In what could have been a major pharmaceutical acquisition and one of the biggest tax inversion deals, Chicago-based AbbVie has recommended its shareholders vote against its proposed $54 billion takeover of Shire, a Dublin-headquartered pharmaceutical company specializing in medications to treat attention deficit disorder and rare diseases

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Synthetic Biologics fills irritable bowel syndrome Clinical Advisory Board

Thursday, October 16, 2014 12:29 PM

Synthetic Biologics, a biotechnology company developing novel anti-infective biologics and drugs targeting specific pathogens that cause serious infections and diseases, has expanded its Clinical Advisory Board (CAB) created to support development of SYN-010, the company's statin-class candidate intended to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS).

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CytRx appoints Steven A. Kriegsman as chairman of the board

Thursday, October 16, 2014 12:21 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has appointed Steven A. Kriegsman, president, CEO and a director of the company, as chairman of the board, effective Oct. 15. He replaces Max E. Link, Ph.D., whose unexpected passing was announced on Oct. 7.

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Genspera hires Melanie Thomas as medical advisor

Thursday, October 16, 2014 12:08 PM

GenSpera, a developer of prodrug therapeutics for the treatment of cancer, has hired Melanie Thomas, M.D., MS, as medical advisor.

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Immatics, BioNTech advance personalized cancer vaccines into clinical trials

Thursday, October 16, 2014 12:00 PM

BioNTech and immatics biotechnologies are moving a novel concept of fully personalized therapeutic cancer vaccines, Glioma Actively Personalized VAccine Consortium (GAPVAC), into the clinic. The German national authority, the Paul-Ehrlich-Institute (PEI), has approved the start of a phase I/II study, GAPVAC-101, which applies for the first time the concept of treating glioblastoma patients based on drugs designed and manufactured for each patient individually according to specific characteristics of their tumor and immune system.

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WILEX subsidiary Heidelberg Pharma, Roche extend collaboration

Thursday, October 16, 2014 09:00 AM

Wilex’s Germany-based subsidiary Heidelberg Pharma and Roche have extended an existing 2013 license agreement to apply the antibody drug conjugate (ADC) technology for the further development of Roche antibodies. The aim is to identify and develop novel Antibody Targeted Amanitin Conjugates (ATACs) based on Heidelberg Pharma's patented technology to couple α-Amanitin to antibodies.

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CytRx launches discovery laboratory to develop anti-cancer drug platform

Thursday, October 16, 2014 08:31 AM

CytRx, a Los Angeles-Calif.-based biopharmaceutical R&D company specializing in oncology, has commenced operations at its new discovery laboratory in Freiburg, Germany. The new laboratory will conduct discovery and translational research to create drug candidates that utilize novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors.

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MHRA sets up ‘one-stop shop’ for advice on regenerative medicine

Thursday, October 16, 2014 08:00 AM

The U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovation Office has set up a portal for all regulatory queries concerning regenerative medicines, the Regenerative Medicines Regulatory Advice Service. A “one-stop shop” service, it will provide a single point of access from the four regulators in the field: the Human Tissue Authority (HTA), the Human Fertilization and Embryology Authority (HFEA), Health Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), which will provide a coordinated single response service for free regulatory advice.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

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CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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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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