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Lilly, Zymeworks expand collaboration agreement

Friday, October 24, 2014 01:10 PM

Eli Lilly and Zymeworks, a Vancouver-based, privately held biotherapeutics company, are expanding an existing licensing and collaboration agreement. Originally announced in January, the global strategic collaboration is focused on the development of an undisclosed number of novel bi-specific antibody therapeutics using Zymeworks' proprietary Azymetric platform.

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Celgene collaborates with Sutro Biopharma, inks option to acquire

Friday, October 24, 2014 01:09 PM

Sutro Biopharma, located in South San Francisco, has entered into a strategic collaboration and option agreement with Celgene to discover and develop multispecific antibodies and antibody drug conjugates (ADCs). This new agreement follows the December 2012 collaboration between the two companies and focuses on the field of immuno-oncology, while further broadening the Sutro platform for discovery, development and manufacture of best-in-class biotherapeutics.

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J&J Innovation adds J-Labs incubator at Texas Medical Center

Friday, October 24, 2014 01:07 PM

Johnson & Johnson Innovation plans to expand J-Labs (formerly Janssen Labs) to include a new incubator located within Texas Medical Center's new Innovation Institute. The 30,000-square-foot J-Labs facility will accommodate up to 50 life science startups.

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Xiaflex approved for concurrent treatment in Dupuytren's contracture patients

Friday, October 24, 2014 12:48 PM

Auxilium Pharmaceuticals has announced that the FDA has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.

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Treasury’s tax inversion changes scuttle some big biopharma mergers, modify others, prompting calls for Congressional corporate tax reform

Thursday, October 23, 2014 03:50 PM

The widely-discussed $54.6 billion acquisition of Dublin-based Shire by AbbVie is officially canceled, having crumbled after a notice by the U.S. Treasury Department to tighten tax rules that deter U.S. companies from moving their legal headquarters to countries with lower business taxes.

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Cubist Pharmaceuticals names Robert J. Perez CEO

Thursday, October 23, 2014 03:47 PM

Cubist Pharmaceuticals has selected Robert J. Perez as the company's CEO, effective January, 2015. Perez, who currently is Cubist's president and chief operating officer, will succeed Michael W. Bonney who is retiring from his current role as CEO on Dec. 31, and will become non-executive chair of Cubist's board of directors. Current board chair Kenneth M. Bate will become lead independent director.

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TWi Biotechnology receives Orphan Drug designation for AC-201

Thursday, October 23, 2014 03:29 PM

TWi Biotechnology has received the designation of Orphan Drug from the FDA for using AC-201 to treat epidermolysis bullosa (EB). TWi Biotechnology has developed proprietary formulations to be used topically for the indication of EB.

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ProNAi Therapeutics adds five to senior management team

Thursday, October 23, 2014 03:17 PM

ProNAi Therapeutics, a private company dedicated to developing and commercializing a new class of therapies based on its proprietary DNAi platform, has added five seasoned executives to its senior management team.

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Adheris Health, Behavioral Insights Group launch ethnographic study

Thursday, October 23, 2014 01:51 PM

Adheris Health, an inVentiv Health company and a provider of medication adherence programs, has announced the start of the next phase of an ethnographic study into how Americans make healthcare decisions and the role of American culture in influencing health behaviors.

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aTyr Pharma appoints John C. McKew vice president, research

Thursday, October 23, 2014 01:45 PM

aTyr Pharma, an innovative rare disease therapeutics enterprise, has announced that John C. McKew, Ph.D., has joined the company as vice president, research. McKew brings more than two decades of experience in translational research, including key leadership positions at the NIHWyeth Research and Genetics Institute (prior to its acquisition by Wyeth). McKew will lead aTyr's efforts to expand and translate its novel Physiocrine biology into meaningful therapeutics to treat rare, grave immune-driven disorders.

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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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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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