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February 21, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE Merck Pays $688 Million To Resolve Vytorin Lawsuits Merck has agreed in principle to pay $688 million to settle two federal securities class-action lawsuits involving the company's anticholesterol drugs Vytorin and Zocor, thereby avoiding trial. Mylan, Biocon Form Pact to Develop and Commercialize Insulin Products Mylan has entered into a definitive agreement with Biocon Limited, an Indian biotechnology company, for an exclusive collaboration on the development and commercialization of generic versions of three insulin analog products. Sanofi Invests EUR 44 Million in Genzyme Campus Sanofi is investing EUR 44 million ($58.7 million) in Genzyme’s biotechnology campus in Waterford, Ireland. President Obama Plans for Healthcare Reform and Job Growth President Obama’s State of the Union Address on Feb. 12, 2013 touched on some issues that may directly impact the pharmaceutical industry: healthcare reform, innovation, and job creation. Modernization of USP Standards The US Pharmacopeial Convention contiues to make modernization of standards a top priority in 2013. Balancing Medicines Supply with Quality According to FDA, 75% of the products in shortage are generic sterile injectables; low-margin products that must be manufactured in specialized facilities and that must meet stringent quality metrics. EMA Seeks to Expand Collaboration on Orphan Medicines The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013. Daiichi Sankyo Faces Gender Discrimination Lawsuit Six current and former female pharmaceutical sales representatives have filed a $100-million gender discrimination lawsuit against Daiichi Sankyo in a US district court. Advertisement: Together:  It’s how we work.  It’s how we help Pharma Succeed. Look to Agilent for real world solutions that help pharmaceutical companies discover more rapidly and more efficiently. The Agilent RapidFire High-throughput System and 6550 iFunnel Q-TOF mass spec helped one lab reduce a week of work to 4.5 hours, transforming their productivity. Discover more, and request your free ADME Solutions Guide at our new pharma web page: www.agilent.com/chem/togetherADME 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 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 FDA has approved Novartis 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 Read More Industry Briefs

What do you think is the main challenge facing manufacturers seeking to launch a new biosimilar? Safety and interchangeability concerns 36%   Regulatory processes 28%       Legal challenges 9%       Complex manufacturing processes 27%       This week we would like to know... How do you think the reputation of the pharmaceutical industry has changed in recent years? Contact Us Click here to contact editorial. Click here to contact sales.

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