Industry News

Multimodal Therapy for Sleep Disturbances

sleep - Wed, 2014-04-16 01:00
Status: Recruiting, Condition Summary: Advanced Cancers
Categories: Industry News

Arsenal Capital acquires Synchrogenix for regulatory writing, submission services, will merge it with Certara

Centerwatch - Tue, 2014-04-15 09:11
Arsenal Capital Partners, a private equity firm that acquired software and scientific consulting services provider Certara last December, now has purchased Synchrogenix, an independent regulatory-writing CRO, and will merge the two.
Categories: Industry News

Sleep Specialty Consultation: Improving Management of Sleep Disorders

sleep - Tue, 2014-04-15 01:00
Status: Completed, Condition Summary: Sleep Disorders
Categories: Industry News

Catalent, Zhejiang Hisun Pharma to collaborate on biosimilar development

Centerwatch - Mon, 2014-04-14 11:05
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.
Categories: Industry News

Scripps Research Institute launches drug discovery initiative Scripps Advance

Centerwatch - Mon, 2014-04-14 11:02
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.
Categories: Industry News

NeoStem to acquire California Stem Cell

Centerwatch - Mon, 2014-04-14 11:01
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.
Categories: Industry News

Ampio Pharmaceuticals' Vyrix inks agreement with Paladin Labs

Centerwatch - Mon, 2014-04-14 11:01
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.
Categories: Industry News

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

Centerwatch - Mon, 2014-04-14 10:54
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.
Categories: Industry News

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

Centerwatch - Mon, 2014-04-14 08:51
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.
Categories: Industry News

New therapy for advanced prostate cancer approved in Trinidad & Tobago

Centerwatch - Mon, 2014-04-14 06:40
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.
Categories: Industry News

Icon’s Firecrest training recognized by TransCelerate BioPharma

Centerwatch - Mon, 2014-04-14 06:13
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.
Categories: Industry News

The Pulse on Site Success <span>By Jeffrey Adelglass, M.D.</span>

Centerwatch - Mon, 2014-04-14 05:00
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.
Categories: Industry News

A Study of Gantenerumab in Patients With Mild Alzheimer Disease

Alzheimers - Mon, 2014-04-14 01:00
Status: Recruiting, Condition Summary: Alzheimer Disease
Categories: Industry News

HHS Secretary Sebelius, proponent of clinical research, resigns

Centerwatch - Fri, 2014-04-11 11:33
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.
Categories: Industry News

FDA approves expanded indication for certain pacemakers and defibrillators

Centerwatch - Fri, 2014-04-11 09:38
The FDA has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.
Categories: Industry News

Jon L. Hart named CEO of med fusion

Centerwatch - Fri, 2014-04-11 09:23
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.
Categories: Industry News

Pharmacyclics files sNDa for IMBRUVICA

Centerwatch - Fri, 2014-04-11 09:16
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.
Categories: Industry News

MEI Pharma adds David Urso as senior VP of Corporate Development, General Counsel

Centerwatch - Fri, 2014-04-11 09:12
MEI Pharma, an oncology company focused on the clinical development of novel therapies for cancer, has appointed David Urso senior vice president of Corporate Development and General Counsel. Urso joins MEI Pharma with more than two decades of experience in the life science industry, most recently as chief operating officer and general counsel at Tioga Pharmaceuticals, a company he co-founded in 2005 as a principal at Forward Ventures.
Categories: Industry News

Minomic to commence two trials of prostate cancer screening technology MiStat

Centerwatch - Fri, 2014-04-11 08:28
Private Australian biotechnology company Minomic International will launch two overseas trials of its MiStat prostate cancer screening test, following an agreement with CUSP Group, a uro-oncology trials management organization in the U.S.
Categories: Industry News
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