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Webcast: Improving Cell Culture Productivity: Best Practices for Automation and Control Sponsored by Parker Hannifan (On Demand) Webcast: Overcoming Formulation Challenges of Parenteral Drugs Sponsored by Croda (On Demand) MORE WEBCASTS DCAT Week 2013 March 11–14, 2013 Washington, USA Pittcon Conference & Expo March 17–21, 2013 Philadelphia, USA Advertisement: Accelerate Sterile and Non-Sterile Clinical Trial Manufacturing with Single-Use Technologies Live Webcast: Wednesday, March 6, 2013 at 11:00 AM ET Register Free at http://www.pharmtech.com/ accelerate

February 28, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE Roche/Genentech Win FDA Approval for Antibody-Drug Conjugate FDA approved Roche’s antibody-drug conjugate, Kadcyla (trastuzumab emtansine or T-DM1), for the treatment of people with HER2-positive metastatic breast cancer. Affymax and Takeda Recall All Lots of OMONTYS (peginesatide) Injection Affymax and Takeda Pharmaceutical Company Limited have decided to voluntarily recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions. Report Explores Future of Opioid Abuse-Resistant Formulations The ongoing economic crisis in Europe has accelerated healthcare cost-containment measures targeting the price of pharmaceuticals, but the pharma industry is not giving in without a fight. Merck and Samsung Bioepis Form Biosimilars Development and Commercialization Agreement Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates. 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. Ablynx and Spirogen Collaborate on Novel Toxin-Nanobody Drug Conjugates Belgium drug developer Ablynx and UK-based Spirogen have entered into a research collaboration to discover and develop novel anticancer drug conjugates combining Spirogen’s proprietary cytotoxic drugs, pyrrolobenzodiazepines (PBDs), and the company's associated linker technology, with nanobodies generated using Ablynx's proprietary technology platform. Rare Disease Day: Progress and Potential For the past six years, the last day in February has been designated Rare Disease Day. First observed in Europe in 2008 by the European Rare Disease Organization, the initiative expanded to the US in 2009. In 2012, more than 60 countries participated. This year, events will be held worldwide on Feb. 28, 2013, to bring the cause of rare diseases to the attention of patients, the public, the medical profession, and policy makers. 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 Althea Technologies and Profectus BioSciences have formed a manufacturing supply agreement for plasmid DNA production. Covance has entered into an exclusive alliance and services agreement with M2Gen, a subsidiary of the Moffitt Cancer Center. MediciNova has received Fast Track designation from FDA for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Merck announced that the Phase III Centric trial of the investigational integrin inhibitor cilengitide did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy). Viropro and Oncobiologics have formed a biosimilar collaboration agreement under which Viropro will have the rights to manufacture six monoclonal antibody products being developed by Oncobiologics for commercialization in more than 70 emerging market countries (excluding China). 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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