Industry News

Cytori Therapeutics receives Frost & Sullivan 2016 Technology Innovation Award

Centerwatch - Tue, 2016-08-23 08:47

Cytori Therapeutics has received the Frost & Sullivan 2016 Technology Innovation Award in recognition of advancements made in the field of regenerative medicine for over a decade. Frost & Sullivan’s industry research and benchmarking analysis report that Cytori’s pioneering technology platform has become the leading technology to enable the research and practice of cellular therapies […]

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FDA finds U.S. drugs related to French BIA 10-2474 do not pose similar safety risks

Centerwatch - Tue, 2016-08-23 08:44

The FDA, with information received from the EMA and the French national medicines agency (ANSM), has completed a comprehensive review of safety information relevant to the investigational new drug BIA 10-2474 and the potential implications for related drugs under investigation in the U.S. The Agency has found, based on the available information, that BIA 10-2474 […]

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BioPharma Services acquires Bioanalytical Laboratory Services (BLS)

Centerwatch - Tue, 2016-08-23 08:40

BioPharma Services has acquired key human resource assets along with a list of validated assays from Bioanalytical Laboratory Services (BLS). Over the past three years, BLS, led by Lab director, Nicola Hughes, Ph.D., has built a leading bioanalytical research center specializing in complex method development, method validation and the analysis of biological samples for preclinical […]

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Report: In vivo CRO market projected to reach $4.9B by 2024

Centerwatch - Tue, 2016-08-23 08:34

The global in vivo CRO market is expected to reach $4.9 billion by 2024, according to a new report by Grand View Research. Economic efficiency and focus on core competencies by pharmaceutical giants are anticipated to be the primary market promoters.  The use of CRO services helps manufacturers/ sponsors to provide complete attention on the production capacity […]

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PPD’s clinical research technology portfolio recognized for innovation

Centerwatch - Tue, 2016-08-23 08:26

Pharmaceutical Product Development (PPD) has announced its selection as one of the most innovative organizations using information technology at IDG’s CIO magazine’s 29th annual CIO 100 Awards. PPD’s technology features innovations, including utilizing wearable or mHealth technology, and Preclarus, PPD’s portfolio of solutions that provides clients transparent, real-time access to clinical trial operations and patient data to bring life-saving […]

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FDA acceptance of Xenetic’s phase II endometrial cancer IND

Centerwatch - Tue, 2016-08-23 08:23

Xenetic Biosciences, a biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics, has announced that an Investigational New Drug (IND) application for the company’s product candidate, Virexxa (sodium cridanimod), has been allowed to proceed by the FDA. This enables Xenetic to initiate a phase II clinical study of Virexxa in conjunction with progestin therapy […]

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Casebia Therapeutics establishes operations in Cambridge, Massachusetts

Centerwatch - Tue, 2016-08-23 08:16

Casebia Therapeutics, the joint venture founded by Bayer and CRISPR Therapeutics, started its operations in Cambridge, Massachusetts. In December, 2015 Bayer and CRISPR Therapeutics agreed to create a joint venture to discover, develop and commercialize new breakthrough therapeutics to cure blood disorders, blindness and congenital heart disease. The two parties formally closed the transaction in the […]

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Institute of Human Virology awarded $14.4M for HIV vaccine research

Centerwatch - Tue, 2016-08-23 07:49

The Institute of Human Virology (IHV) at the University of Maryland School of Medicine has been awarded a $14.4 million grant from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) to tackle a significant scientific global challenge in HIV vaccine research—the inability to produce long-lasting antibodies to protect against HIV infection. “Since our group co-discovered […]

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Pfizer to acquire Medivation for $14B

Centerwatch - Mon, 2016-08-22 08:31

Pfizer and Medivation have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion. The Boards of Directors of both companies have unanimously approved the merger, […]

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The CenterWatch Weekly, August 22, 2016

Centerwatch - Mon, 2016-08-22 08:00

As necessity for real-world evidence rises, PPD acquires of Evidera Pharmaceutical Product Development (PPD) has agreed to buy Evidera, a Maryland-based company that provides evidence-based solutions for the healthcare industry, as demand rises for research that shows the effectiveness and value of new medicines in real world settings. Charles River Laboratories is first CRO to join U.K.-based research consortium Charles River Laboratories is […]

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The many roles that contribute to patient recruitment

Centerwatch - Mon, 2016-08-22 08:00

Recruiting patients into a clinical trial takes careful planning and flawless execution from multiple sources. Although the site is often responsible for contributing the majority of patients needed to meet enrollment targets, there is not one single person or role that is ultimately responsible for patient recruitment. Principal investigators, study coordinators, clinical research associates (CRAs), […]

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Cerulean announces relapsed renal cell carcinoma trial results

Centerwatch - Fri, 2016-08-19 09:48

Cerulean Pharma, a clinical-stage company developing nanoparticle-drug conjugates (NDCs), has announced top-line results from the company’s phase II, randomized, multicenter clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) in the treatment of patients with advanced renal cell carcinoma (RCC). The trial was conducted at 43 sites in the U.S. and South Korea, and […]

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Cerulean reduces workforce

Centerwatch - Fri, 2016-08-19 09:33

Cerulean Pharma, a clinical-stage company developing nanoparticle-drug conjugates (NDCs), is reducing its workforce by approximately 48%, to a total of 23 full-time equivalent employees, under a plan expected to be substantially completed by the end of 2016. This workforce reduction is designed to reduce operating expenses while the company refocuses its clinical strategy for CRLX101. […]

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CTI to relocate to Kentucky, create 500 jobs

Centerwatch - Fri, 2016-08-19 09:30

Gov. Matt Bevin has announced CTI Clinical Trial and Consulting Services, a global, privately held company providing therapeutic expertise to the pharmaceutical and biotechnology industries, will relocate its headquarters to Covington with a $36.4 million investment projected to create up to 500 Kentucky-resident jobs. CTI plans to move its headquarters from the Cincinnati suburb of Blue […]

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FDA grants Soligenix’s Dusquetide Orphan designation for Macrophage Activation Syndrome

Centerwatch - Fri, 2016-08-19 09:23

Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, has announced that the Office of Orphan Products Development of the FDA has granted Orphan drug designation to the active ingredient dusquetide for treatment of macrophage activation syndrome (MAS). Dusquetide has previously received […]

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Safe Use Initiative - Extramural Research

FDA News - Thu, 2016-08-18 15:51
Part of the Safe Use Initiative (updated)
Categories: Industry News

10 Tips for Enabling Better CRO-Sponsor Collaborations

Centerwatch - Thu, 2016-08-18 08:00

By Craig Morgan, brand development director at goBalto Inc. By 2020[1] 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors […]

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