Cromos Pharma, where the patients are

Articles Published in 2011

Ambry Genetics launches Illumina MiSeq Next-Gen sequencing services

Wednesday, December 28, 2011 01:22 PM

Ambry Genetics has launched Illumina MiSeq Next-Gen sequencing services. Ambry Genetics has been an early adapter of Illumina sequencing systems since 2007 and has experience as a Certified Service Provider processing thousands of samples.

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CRF Health eCOA webinar series

Provenance closes an $8 million financing agreement

Wednesday, December 28, 2011 01:11 PM

Provenance Biopharmaceuticals has closed an $8 million financing arrangement with Alopexx Enterprises for the continued development of anti-cancer therapeutic, DI-Leu16-IL2.

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Delcath's Ireland location achieves ISO 13485 Certification

Wednesday, December 28, 2011 10:26 AM

Delcath Systems has reported that the company's Galway, Ireland location has achieved ISO 13485:2003 Certification--an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). ISO 13485 Certification is a regulatory requirement of the EU's Medical Device Directive, and represents an important step toward commercialization of the Delcath Hepatic CHEMOSATR Delivery System following its European CE Mark approval in April 2011.

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Eisai resubmits Perampanel NDA to FDA

Tuesday, December 27, 2011 01:28 PM

Eisai has resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the FDA. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. The application was originally submitted in May 2011.

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Cetero Research expands senior management team

Tuesday, December 27, 2011 11:49 AM

Cetero Research has reported two new appointments to its senior management team. Michael C. Fillios was named chief administrative officer, with leadership responsibility and oversight of human resources, information technology, project management, marketing and client services. David Coggin was named vice president, biometrics. He will oversee the operational management of PK/PD, data management, miostatistics and medical writing services.

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FDA reviews NDA for VIVUS' Qnexa

Tuesday, December 27, 2011 11:11 AM

VIVUS has reported that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on seeking approval to market Qnexa in the United States. The FDA has accepted the NDA for review. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

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Baxter, Momenta enter $33 million biosimilar development agreement

Friday, December 23, 2011 12:29 PM

Baxter International and Momenta Pharmaceuticals have entered into a global collaboration to develop and commercialize follow-on biologic products, also known as biosimilars. Biosimilars replicate existing, branded biologics used in the treatment of a variety of diseases including cancer, autoimmune disorders and other chronic conditions. With this collaboration, Baxter will leverage its leading clinical development and biologic manufacturing expertise, global leadership in sterile injectables and global commercial capabilities, while Momenta will provide its expertise in high-resolution analytics, characterization, and product and process development.

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AstraZeneca, Chi-Med collaborate to develop novel cancer therapy

Friday, December 23, 2011 11:47 AM

AstraZeneca and Hutchison MediPharma, an R&D company majority owned by Chi-Med, have entered into a global licensing, co-development, and commercialization agreement for Volitinib (HMPL-504), a novel targeted therapy and a highly selective inhibitor of the c-Met receptor tyrosine kinase for the treatment of cancer. Volitinib, which will imminently enter phase I testing, has been discovered and developed in China by HMP.

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Chelsea Therapeutics' phase II Droxidopa trial meets primary endpoint

Friday, December 23, 2011 11:01 AM

Chelsea Therapeutics International has reported results of a phase II dose-finding study designed to evaluate the safety and determine the potential therapeutic dose range of droxidopa, alone or in combination with carbidopa, that might be effective for the treatment of fibromyalgia.

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PTC Therapeutics receives $5 million award from the Wellcome Trust

Friday, December 23, 2011 10:45 AM

PTC Therapeutics has received a $5 million Seeding Drug Discovery (SDD) award from the Wellcome Trust to support the development of small-molecule drugs that target life-threatening infections caused by multidrug-resistant (MDR) Gram-negative bacteria. PTC previously received a $5.4 million SDD Award from the Wellcome Trust to support its BMI1 oncology program.

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Make way for mobile health in clinical trials
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