December 2011

Delcath’s Ireland location achieves ISO 13485 Certification

Wednesday, December 28, 2011

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

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

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

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

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

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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