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INDUSTRY NEWS
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developing these products to address a wide range of unmet healthcare needs,” said Eric Borin, Vice President and General Manager – Americas, BD Medical – Pharmaceutical Systems. “The availability of the BD Neopak™ Glass Prefillable Syringe system through the BD AccelerateSM program demonstrates BD’s understanding of its pharmaceutical partners’ current challenges when bringing drugs to market for patients.”
Building on more than 100 years of industry expertise, BD selected products suited to specifi c market needs with attributes to reduce regulatory and drug compatibility risks intended to enable pharmaceutical companies to expedite drug products through the development stages. The current syringe systems off ered through the program include BD Neopak™ Glass Prefi llable Syringes, BD Hypak™ Glass Prefi llable Syringes and BD Hypak™ Glass Prefi llable Syringes for Biotech. As of January 2013, more than 40 BD pharmaceutical partners have participated in the BD AccelerateSM program.
Thermo Fisher Scientific Receives Clearance from the European Commission for its Acquisition of Life Technologies
Thermo Fisher Scientific, the world leader in serving science, today announced that it has received approval from the European Commission (EC) for its pending acquisition of Life Technologies Corporation.
To expedite the approval, Thermo Fisher has committed to divest of its cell culture (sera and media), gene modulation and magnetic beads businesses. Combined, these businesses had 2012 revenue of approximately $225 million.
The acquisition remains subject to additional regulatory approvals, including the U.S. Federal Trade Commission (FTC). Based on its discussions with the FTC, Thermo Fisher does not believe any additional divestures will be required in order to receive U.S. approval. The company is working with the regulatory agencies to complete the transaction as soon as possible, and still expects to close in early 2014.
Orphan Drug Model to be Debated by Catalent Expert at FDA/CMS Summit
Carolyn Finkle, Catalent Pharma Solutions’ Vice President of Global Regulatory Affairs, participates in a panel discussion, “A Rare Opportunity: Orphan Drugs,” at the FDA/CMS Summit for biopharma executives, which took place on the 11th and 12th of December in Washington DC. The session explored how well the Orphan Drug model is operating in a world of evolving science and business, including an update from the FDA’s Orphan Products Office, and perspectives from industry and patients on the interplay
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of regulation, reimbursement and unmet need for patients with rare diseases. Joining Ms. Finkle in the discussion were senior experts from the biopharmaceutical industry and the FDA.
Carolyn Finkle has over 27 years of scientific and industry experience including 19 years in management of drug and biologic development, quality and regulatory affairs for companies in the U.S. and Canada.
She has co-authored 1 book chapter on First-in-Man global regulatory requirements, over 18 abstracts and 12 papers for industry associations and scientific publications, chaired DIA sessions (global regulatory), AAPS workshops at the annual meetings, and currently serves as a faculty member of the Pharmaceutical Education and Research Institute (PERI). Ms. Finkle is also a contributor to the UCSF American Course of Drug Development and Regulatory Sciences (ACDRS), and co-Director of the Georgetown University Master’s Program in Clinical and Translational Research.
The global leader in development solutions and advanced delivery technologies for drug, biologic and consumer health products, Catalent recently announced several new clinical and commercial supply contracts focused around its Kansas City, MO, facility, including for Pharmacyclics’ oncology drug IMBRUVICA™, Aegerion’s lipid-lowering treatment JUXTAPID™, and Exelixis’ COMETRIQ® for the treatment of progressive, metastatic medullary thyroid cancer.
Lonza and BioWa Sign License Agreements with Pfi zer, Inc. Allowing Use of T eir POTELLIGENT® CHOK1SV Cell Line for T erapeutic Antibody Research and Development
BioWa, Inc. and Lonza today announced that they have entered into research agreements with Pfizer Inc. allowing the use of the POTELLIGENT® CHOK1SV Cell Line in the research and development of multiple proprietary antibodies in Pfizer’s pipeline.
POTELLIGENT® CHOK1SV is a host cell line for manufacturing recombinant antibodies that combines the power of BioWa’s engineered glycosylation POTELLIGENT® Technology with the advantages of Lonza’s industry leading GS Gene Expression System™. The GS System™ includes Lonza’s pre-eminent host cell line, CHOK1SV.
“We are pleased that the core value of POTELLIGENT® Technology has been recognized by a global pharmaceutical company such as Pfizer, and are excited to work together with Pfizer on their innovative antibody research pipelines,” said Yasunori Yamaguchi, PhD, President and CEO of BioWa.
The POTELLIGENT® CHOK1SV Cell Line retains the desirable features of a high-producing cell line (robust, high-yielding, scalable), with the advantage of a proven bioprocess platform for the CHOK1SV Cell Line. Antibodies produced by this cell line exhibit enhanced
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