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FDA News - Fri, 2016-04-22 11:36
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FDA News - Fri, 2016-04-22 08:45
Categories: Industry News

Basilea awarded $100M BARDA contract for ceftobiprole program

Centerwatch - Thu, 2016-04-21 15:12

Basilea Pharmaceutica has announced that the Biomedical Advanced Research and Development Authority (BARDA), a division within the U.S. Department of Health and Human Services` Office of the Assistant Secretary for Preparedness and Response, has entered into a contract with Basilea Pharmaceutica International for the clinical phase III development aiming at regulatory approval of Basilea`s broad-spectrum […]

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Categories: Industry News

Juno reports positive data on two product candidates

Centerwatch - Thu, 2016-04-21 14:49

Juno Therapeutics, a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, has announced, in partnership with its collaborators, early clinical data from two product candidates. JCAR018 is a chimeric antigen receptor (CAR) T cell product candidate targeting CD22, and had data from a phase I trial in pediatric […]

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Categories: Industry News

DNAnexus, Solvebio partner to make genomic data more actionable

Centerwatch - Thu, 2016-04-21 14:35

DNAnexus, a cloud-based genome informatics and data management provider, has announced a partnership with SolveBio, a global provider of Genomics Intelligence, to integrate the two platforms and provide seamless access to SolveBio’s curated data and analysis services. Researchers globally will have the ability to move quickly from genomic data analysis to interpretation, freeing up time to […]

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Categories: Industry News

Medrio, Clinartis partner

Centerwatch - Thu, 2016-04-21 14:18

Medrio, a Software as a Service (SaaS) company providing cloud-based data management capabilities to clinical researchers, and Clinartis, a CRO providing clinical trial services in the U.S. and Europe, have announced a new partnership under Medrio’s Partner Program. Clinartis and Medrio have cultivated a business relationship through numerous phase I studies for which the CRO […]

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Novartis’s sIBM drug fails to hit primary goal in phase IIb/III trial

Centerwatch - Thu, 2016-04-21 13:48

MorphoSys partner Novartis has confirmed that a phase IIb/III study examining bimagrumab (BYM338) in sporadic Inclusion Body Myositis (sIBM) did not meet its primary endpoint. Data are currently being reviewed and will inform decisions on the bimagrumab development program. Ongoing clinical trials are not being discontinued at this time. “The outcome of the phase IIb/III […]

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Categories: Industry News

Bioclinica, ArisGlobal partner on pharmacovigilance model

Centerwatch - Wed, 2016-04-20 11:24

Bioclinica, a specialty clinical trials technology and services provider, has announced the selection of ArisGlobal‘s Safety Cloud as the preferred safety platform for its pharmacovigilance services. Under this partnership, Bioclinica becomes the preferred partner for ArisGlobal in business process consulting and change management as sponsors implement or upgrade ARISg. Together the partnership brings a flexible […]

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Categories: Industry News

The Ohio State University earns CEO Cancer Gold Standard accreditation

Centerwatch - Wed, 2016-04-20 11:17

The CEO Roundtable on Cancer has accredited The Ohio State University in Columbus, Ohio, with the CEO Cancer Gold Standard, recognizing its efforts to reduce the risk of cancer for its employees and covered family members. The CEO Roundtable on Cancer, a nonprofit organization of CEOs, founded by former President George H.W. Bush, developed and administers the Gold Standard, […]

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Categories: Industry News

CRF Health selected to support COPD trials involving 19,000+ patients

Centerwatch - Wed, 2016-04-20 11:09

CRF Health, a global provider of eCOA solutions for the life sciences industry, has announced that its TrialMax platform has been adopted by a developer of therapeutics for respiratory disease conditions to support one of the largest recorded phase III studies into chronic obstructive pulmonary disease (COPD). The trial, involving more than 19,000 patients, will […]

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Categories: Industry News

Hacene Mekerri to head PPD’s central laboratory

Centerwatch - Wed, 2016-04-20 11:06

Pharmaceutical Product Development (PPD) has announced that Hacene Mekerri has joined the global CRO to serve as vice president of its central laboratory organization. “Hacene has a unique combination of data management and systems expertise, as well as extensive global central laboratory management experience, which make him ideally suited to lead our central laboratory organization,” […]

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Categories: Industry News

Kinetiq adds executives, including Parrish, Riddle and Maeda

Centerwatch - Wed, 2016-04-20 11:00

Kinetiq, a new division of Quorum Review IRB with a focus on providing consulting and IT services, has completed its executive leadership team. “I’m thrilled with the addition of our new leadership,” said Cami Gearhart, CEO. “Each of our new executives brings the talent and experience needed to keep Kinetiq at the forefront of providing services to […]

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Categories: Industry News

GE Healthcare launches Turkish collaborative research scheme

Centerwatch - Wed, 2016-04-20 09:52

GE Healthcare’s life sciences business has officially launched a new research scheme to help foster Turkish bioprocessing development and manufacturing, through its latest Fast Trak Bioprocessing Technology and Training Laboratory in Istanbul. Based in GE’s Turkey Innovation Center, the R&D Laboratory is well-located to support the region’s rapidly growing biopharmaceutical and biotech industry, and help […]

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Categories: Industry News

Cancer Centers, biopharmaceuticals collaborate on precision medicines

Centerwatch - Wed, 2016-04-20 09:46

M2Gen, a healthcare informatics solutions company, has announced a collaboration with pharmaceutical companies and the Oncology Research Information Exchange Network (ORIEN), an alliance of cancer centers throughout the U.S. M2Gen also announced that Celgene will be the industry’s founding member of a network of participants joining in this new initiative. The launch of the ORIEN Avatar Research […]

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Categories: Industry News

Recipharm makes U.S., Sweden and India acquisitions

Centerwatch - Wed, 2016-04-20 09:34

Recipharm has signed two separate agreements to acquire Kemwell pharmaceutical’s contract development and manufacturing (CDMO) businesses. The first acquisition, comprising Kemwell’s U.S. and Swedish operations, is expected to close during the second quarter 2016, after review by the Swedish Competition Authority, while the second, comprising operations in India, is conditional on governmental approvals and expected to […]

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Categories: Industry News

La FDA actualiza las advertencias relativas al uso de la metformina, una medicina para la diabetes, en ciertos pacientes con una función renal deteriorada

FDA News - Wed, 2016-04-20 09:34
[4/8/2016] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) está exigiendo cambios al etiquetado con respecto a las recomendaciones para las medicinas para la diabetes que contienen metformina, a fin de ampliar el uso de este fármaco en ciertos pacientes con una función renal deteriorada.
Categories: Industry News

Study Evaluating RVT-101 in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil Treatment: MINDSET Study

Alzheimers - Tue, 2016-04-19 20:00
Status: Recruiting, Condition Summary: Alzheimer's Disease
Categories: Industry News

FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function

FDA News - Tue, 2016-04-19 12:37
[4-8-2016] The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function.
Categories: Industry News

Charles River Laboratories, BioMotiv partner

Centerwatch - Mon, 2016-04-18 15:43

Charles River Laboratories International has entered into a strategic partnership with BioMotiv, the therapeutic accelerator company associated with The Harrington Project for Discovery & Development. Charles River will provide discovery and preclinical development services that will enable BioMotiv to advance discoveries sourced from academic research and non-governmental organizations into novel medicines. Charles River has committed […]

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Categories: Industry News

Report: Pharmaceutical to accelerate investment in patient-centric capabilities

Centerwatch - Mon, 2016-04-18 15:37

The vast majority of large pharmaceutical companies plan to increase their investment in patient-centric capabilities such as treatment adherence programs, remote patient monitoring and medication delivery and support over the next two years, according to a new report from Accenture. The report, “The Patient is IN: Pharma’s Growing Opportunity in Patient Services,” is based on […]

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