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Global News

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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CRF Health eCOA webinar series

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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Jon L. Hart named CEO of med fusion

Friday, April 11, 2014 01:23 PM

med fusion, an integrated, advanced laboratory and clinical trials service organization, has appointed Jon L. Hart CEO, effective March 31. This appointment is the next step in the organization’s continued drive towards becoming the clear leader in providing lab and clinical trial support to healthcare providers and biotech/pharmaceutical companies through a patient-centric support model.

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Pharmacyclics files sNDa for IMBRUVICA

Friday, April 11, 2014 01:16 PM

Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the FDA, based on data from the randomized, multi-center, open-label phase III RESONATE study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.

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April 21

Healthcare IPOs soar in first quarter

Survey compares 'push/pull' tactics in patient recruitment

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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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