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Catalent, Zhejiang Hisun Pharma to collaborate on biosimilar development

Monday, April 14, 2014 03:05 PM

Catalent Pharma Solutions, a global provider of development solutions and advanced delivery technologies for drug, biologic and consumer health products, has signed an agreement with Zhejiang HISUN Pharmaceuticals to provide HISUN with a broad range of biosimilar cell lines, using Catalent's proprietary GPEx technology for the Chinese market. The development and manufacturing programs will benefit from the GPEx technology's proven capability to produce very stable and high-yielding cell lines.

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Scripps Research Institute launches drug discovery initiative Scripps Advance

Monday, April 14, 2014 03:02 PM

The Scripps Research Institute (TSRI) has announced the formation of Scripps Advance, a new drug discovery initiative to translate early-stage biomedical research projects, both internal and external to TSRI, into clinical development candidates. Scripps Advance's first collaborator in this new endeavor is the Johnson & Johnson Innovation Center in California.

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NeoStem to acquire California Stem Cell

Monday, April 14, 2014 03:01 PM

NeoStem, a provider of emerging cellular therapy, has entered into a definitive agreement to acquire California Stem Cell (CSC), an Irvine, Calif.-based stem cell biotechnology company. NeoStem plans to initiate a pivotal phase III trial of Melapuldencel-T, an autologous melanoma initiating (stem) cell immune-based therapy intended to eliminate the tumor cells capable of causing disease recurrence.

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Ampio Pharmaceuticals' Vyrix inks agreement with Paladin Labs

Monday, April 14, 2014 03:01 PM

Ampio Pharmaceuticals’ wholly-owned subsidiary Vyrix Pharmaceuticals, a specialty pharma company focused on developing and commercializing late-stage prescription pharmaceuticals to improve men's sexual health, has signed an agreement with Paladin Labs, a Canadian specialty pharma company, to provide exclusive rights to market, sell and distribute Zertane in Canada, the Republic of South Africa, Sub-Saharan Africa and Latin America.

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Domain Therapeutics receives $230K grant from Michael J. Fox Foundation

Monday, April 14, 2014 02:54 PM

Domain Therapeutics, a biopharmaceutical company specializing in the R&D of new drug candidates targeting G protein-coupled receptors (GPCRs), has received a second grant of $230,000from the Michael J. Fox Foundation(MJFF) for Parkinson’s research to support its metabotropic glutamate receptor type III (mGluR3) positive allosteric modulators (PAM) program. The MJFF first supported the initial stages of this program in 2012 with a $300,000 grant.

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Trial results for AbbVie’s Hepatitis C candidate heat up race for effective treatment

Monday, April 14, 2014 12:51 PM

The race to replace interferon with a far more effective treatment for hepatitis C has become one of the most promising and lucrative battles in drug development, as AbbVie, Gilead Sciences, Merck and Bristol-Myers Squibb vie for the finish line.

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New therapy for advanced prostate cancer approved in Trinidad & Tobago

Monday, April 14, 2014 10:40 AM

The Chemistry, Food and Drugs Division of the Trinidad & Tobago Ministry of Health approved the introduction of Janssen's Abiraterone Acetate, the first orally administered androgen synthesis inhibitor (testosterone) medication for the treatment of patients with metastatic castration-resistant prostate cancer.

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Icon’s Firecrest training recognized by TransCelerate BioPharma

Monday, April 14, 2014 10:13 AM

Icon,a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that its Firecrest training meets TransCelerate BioPharma’s minimum criteria for International Conference on Harmonization Good Clinical Practice (ICH/GCP) training.

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The Pulse on Site Success By Jeffrey Adelglass, M.D.

Monday, April 14, 2014 09:00 AM

Throughout the evolution of clinical trials, patient enrollment has remained the most confounding element of timely trial completion. From the site perspective, the challenges are many. It is critical to mobilize strategies that minimize cost, maximize recruitment and avert patient attrition.

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HHS Secretary Sebelius, proponent of clinical research, resigns

Friday, April 11, 2014 03:33 PM

Health and Human Services Secretary Kathleen Sebelius—whose agenda included keeping clinical research a priority—has resigned on the heels of the Affordable Care Act (ACA) web site turmoil last October, even though more recently she had achieved the goal of 7.5 million registrations for coverage.

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CWWeekly

April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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