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Status: Recruiting, Condition Summary: Advanced Cancers
Arsenal Capital acquires Synchrogenix for regulatory writing, submission services, will merge it with Certara
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.
Status: Completed, Condition Summary: Sleep Disorders
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.
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.
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.
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.
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.
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.
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.
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.
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.
MAyflOwer RoAD Study: A Study of RO4602522 in Patients With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy
Status: Recruiting, Condition Summary: Alzheimer Disease
Status: Recruiting, Condition Summary: Alzheimer Disease
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.
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.
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.
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.
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.
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.