Industry Briefs: February 18, 2013

Company News

Almac and DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, reported the successful transfer of enzymes for enzyme screening, process development and scale-up manufacture, as part of an October 2012 agreement in biocatalysis. The agreement grants both parties access to their enzyme platform technologies and services for the manufacturing of APIs. The collaboration also enables Almac to offer its customers a preferred partner for large-scale production. Read More

AstraZeneca announced that, on Feb. 14, 2013, the United States Court of Appeals for the Federal Circuit summarily upheld a lower court ruling that had found the formulation patent protecting Seroquel XR (quetiapine fumarate) extended-release tablets in the US to be valid and infringed. Read More

The Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services, will continue to support the Protein Sciences’s influenza vaccines program. BARDA held an internal review of the Protein Sciences program and made a decision to modify its contract with the company to support certain activities associated with scaling up manufacturing to meet the capacity metrics in the contract and to be able to expand the age indication of Flublok and Panblok influenza vaccines. Read More

DSM Pharmaceutical Products has signed a collaboration agreement with Chemtrix in the field of continuous flow chemistry. The collaboration is intended to provide equipment, development, and manufacturing services to the pharmaceutical industry. Read More

Guerbet, a contrast agent specialty company for medical imaging, has announced that the Medical Imaging Drugs Advisory Committee to FDA has voted unanimously to recommend that FDA approve the new drug application (NDA) for Dotarem (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The committee also voted not to recommend at this time approval of the indication for children under two years of age. Read More

FDA has approved Novartis’s Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant. Zortress is the first mammalian target of rapamycin inhibitor approved for use following liver transplantation. It is also the first immunosuppressant approved by the FDA in over a decade for use following liver transplantation. Read More