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On Demand Webcast: ACQUITY UPLC I-Class System Strategies for Exploiting Sensitivity of Modern MS Detection
October 25, 2011—Sponsored by Waters Corporation (On Demand)
Webcast: Cell-Line Development for Biomanufacturing: Considerations for Optimizing Mammalian Cell Lines
October 27, 2011—Sponsored by Mirus Bio (On Demand)
Webcast: Industry Experts on the Design and Performance of Oral Osmotic Technology
November 15, 2011—Sponsored by Colorcon
Webcast: Optimizing Topical Drug Development and Manufacturing
December 7, 2011–Sponsored by DPT
Podcast: Pfizer Outlines its Supply Strategy
Podcast: Perspectives from CPhI Worldwide Patricia Van Arnum, senior editor of Pharmaceutical Technology, discusses strategies in optimizing API syntheses and manufacturing. Participants include Jan-Olav Henck, PhD, chief scientific officer at Aptuit, Fred Fleitz, senior manager of process R&D with Cambridge Major Laboratories, and Roger McDonald, director of business development with Cambridge Major Laboratories. Also, Annemieke Timmers, CPhI brand director with UBM, discusses CPhI Worldwide, which was held in Frankfurt in October 2011 and other CPhI events.
Podcast: US Pharmacopeia Leaders Discuss the Future of Biologics and Biosimilars
Featuring USP's Tina Morris and Matthew van Hook, and Engel & Novitt's Gillian Woollett
Podcast: Vetter's Chicago Facility Fully Operational (Vetter)
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The Digital Pharma Marketing Course
November 27, 2011–November 28, 2011
Brussels, Belgium
CPhI India
November 30, 2011–December 2, 2011
Mumbai, India
BioManufacturing World China 2011
November 30, 2011–December 1, 2011
Shanghai, China
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
November 30, 2011–December 2, 2011
King-of-Prussia, Pennsylvania
4th West Coast Forum on Clinical Supply Chain Management
December 6, 2011–December 7, 2011
Burlingame, California

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FDA Approves 35 Novel Medicines in Fiscal Year 2011
At a press conference held Nov. 10, 2011, FDA Commissioner Margaret Hamburg said the agency had approved 35 novel medicines in fiscal year 2011. Among the approved products were two drugs for late-stage metastatic melanoma and the first drug to treat Hodgkins lymphoma in 30 years. 
Merck & Co. Outlines Progress in Its Late-Stage Pipeline
Merck & Co. highlighted the key developments in its late-stage pipeline and its near-term plans for regulatory filings. The company has 19 candidates in Phase III clinical trials and plans to submit eight new US regulatory filings in 2012–2013, including five new drug candidates. 
GSK Announces $50-Million Innovation Fund in Canada
GlaxoSmithKline is looking to advance the commercialization of scientific innovation in Canada with its launch of the GSK Canada Life Sciences Innovation Fund, which was announced at a GSK-hosted event in Toronto last week. The $50-million national fund will identify strategic investment opportunities in Canada’s life-sciences industry, including academic and health institutions, translational research centers, and start-up companies. 
Alliance Between Pharma and Nonprofits to Speed Development of Tuberculosis Therapies
AstraZeneca, Bayer, Sanofi, Tibotec, TB Alliance, and the World Health Organization agreed to share information on tuberculosis compounds within their respective drug pipelines, according to the Critical Path to TB Drug Regimens. The purpose of the agreement is to promote information sharing around scientific and clinical studies so that partners can identify opportunities to test compounds in combination. 
EMA Addresses Globalized Supply Chain Issues With Annex 16 Revisions
The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation. 
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Cation exchanger offers direct capture of recombinant proteins
EMD Millipore’s Eshmuno chromatography resins are ion exchangers designed for fast and efficient purification of antibodies. The new multimode cation exchanger Eshmuno HCX media was specifically designed for the direct capture of recombinant proteins at high salt concentrations. Eshmuno’s tentacle technology creates a multipoint interaction with the biopharmaceutical, thus resulting in increased binding capacities. The hydrophilic polyvinyl ether base allows for high flow rates and expedited processing.
PharmPrep P sorbent, part of the company’s portfolio of chromatography media, features particles that have a perfect spherical shape. These particles are designed to pack columns more efficiently and with more stable results than sorbents with irregular materials. The two sizes (i.e., 10 and 20 μm) of the PharmPrep P sorbent enable the user to change to larger particles to increase productivity by operating preparative columns by increased flow rates. The sorbent has a pore diameter of 100 Å (10 nm) and can fit perfectly into the polishing step of small peptides like insulin and other biopharmaceutical and pharmaceutical APIs such as antibiotics and hormones.
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Ab Sciex, a provider of life-sciences analytical technologies, has acquired the mass spectrometry business of Labindia Instruments, a life-sciences service provider.
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Ablynx, a biopharmaceutical company, has expanded its osteoarthritis partnership with Merck Serono, and entered into a third agreement to codiscover and codevelop Nanobodies against two targets in osteoarthritis. The companies plan to develop multispecific products, which are designed to extended half-lives. Under the terms of the agreement, Ablynx will receive an upfront payment of EUR 20 million ($27 million) payable in two tranches over the next three months and will be fully responsible for all activities and costs for each program, excluding manufacturing costs and costs relating to certain in vivo models, up to the delivery of the preclinical package that will form the basis of an investigational new drug (IND) filing or IND-equivalent filing. Ablynx is entitled to receive a further EUR 15 million ($20.3 million) for each program if the preclinical packages are accepted by Merck Serono. Ablynx has the option to continue with Merck Serono on a 50:50 codevelopment basis and share the resulting profits or to convert this collaboration into an exclusive, worldwide licensing deal with milestone payments and tiered royalties.
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The Silverson Verso In-Line Laboratory mixer is the result of 60+ years of mixing experience and untold hours of scale-up research. This bench top In-Line mixer bridges the gap between laboratory and full-scale pharmaceutical production, providing proven, predictable accuracy. The Verso allows reliable forecasting of the performance of larger Silverson In-Line mixers under full-scale conditions.
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Baxter International has completed its acqusition of Baxa Corporation for a cash consideration of $380 million. Baxa develops pharmacy technology that enhances the efficiency and safety of oral and intravenous dose preparation and delivery.
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From performance to price, Shimadzu’s new compact, research-grade spectrophotometers outclass the competition. With an absorbance level to 8 Abs, measurement range to 1400 nm, ultra-low stray light (0.00005 %T at 220 nm), integrated validation software, they are ideal for a wide range of applications.
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The CDMO Bend Research has entered into a licensing agreement with Merck & Co. Under the terms of the agreement, Bend Research will provide Merck access to its proprietary spray-dried dispersion technology. Depending on Merck’s additional needs, Bend may also provide Merck with access under the license agreement to additional drug-delivery platforms and intellectual property, including modified-release technologies and drug-discovery formulation tools.
The biotechnology company ArQule and Daiichi Sankyo have entered into a license agreement for the development of a new AKT inhibitor called ARQ 092, the first compound to emerge from the companies’ November 2008 agreement to collaborate on research using the AKIP (ArQule Kinase Inhibitor Platform) technology to generate selective and potent small-molecule kinase inhibitors. Under the license agreement, Daiichi Sankyo will obtain exclusive rights for development, manufacturing, and marketing of ARQ 092 on a worldwide basis.
FEI, an instrumentation company providing imaging and analysis systems for research and industry, has acquired TILL Photonics, a provider of high-speed imaging systems for live cell fluorescence microscopy. The purchase price for the acquisition was EUR 14.5 million ($20 million), plus an earn-out payable in two years based on attainment of specified milestones.
Laboratoires Thissen, the Belgian subsidiary of the CDMO NextPharma Technologies, will file a petition for bankruptcy with the commercial court of Nivelles in Belgium. No other companies in the NextPharma group are affected by this decision. After the bankruptcy filing, it is anticipated that the court will appoint a receiver for the site who will review the potential options for its future. The principal activity at Laboratoires Thissen SA is the commercial-scale manufacturing of sterile cytotoxic products. The site currently employs a staff of approximately 300 employees.
Metrics has added neat API capsule-filling to its potent and cytotoxic facility. The company secured for its potent facility a Capsugel Xcelodose system, a powder microdoser and automated encapsulator that places API directly into capsules with a high level of accuracy. Metrics also installed a custom-built isolation system for the equipment, achieving total containment at levels approximating 30 nanograms per cubic meter of room air.
Mylan has entered into an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture, and commercialize Pfizer’s generic equivalent to GlaxoSmithKline’s Advair Diskus (fluticasone propionate, salmeterol xinafoate) and Seretide Diskus, which uses Pfizer’s dry-powder inhaler delivery platform, for treating asthma and chronic obstructive pulmonary disorder. Pfizer will grant Mylan rights to its dry-powder delivery platform to develop and commercialize additional brand and generic pharmaceutical products, including rights of negotiation for certain existing Pfizer compounds currently in various stages of development. In connection with the transaction, Mylan will employ select key members of the former Pfizer respiratory inhalation development team based at Discovery Park in Sandwich, United Kingdom (UK), where Mylan will establish a respiratory development division. Some employees also will be based in Cambridge, UK. As part of the agreement, Mylan will pay for remaining development and capital expenditures to bring products to market. Pfizer will be due a payment of $17.5 million at closing of the transaction and will be eligible for additional payments, contingent upon regulatory and commercial success, including profit-sharing. Mylan will have exclusive commercialization rights for the generic equivalent to GlaxoSmithKline’s Advair Diskus and Seretide Diskus in the United States, Canada, Australia, New Zealand, and in the European Union and European Free Trade Association countries. In the rest of the world, Mylan and Pfizer will have copromotion rights to the product. The transaction is subject to regulatory approval and is expected to close by year-end.
The CRO Quintiles has completed its acquisition of Advion BioServices, a bioanalytical laboratory. The new subsidiary has been renamed Advion Bioanalytical Labs as a result of the transaction.
In other news, Quintilies has sold its minority interest in Invida, an Asia–Pacific commercial solutions joint venture, to the Italy-based Menarini Group, which is acquiring Invida in its entirety. Invida was formed in 2006 by Quintiles, the Zuellig Group, and TLS Beta, an Asian investment company.
Sartorius, a process- and laboratory-technology provider, has agreed to acquire the liquid-handling business of the Finnish laboratory supplier Biohit Oyj.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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BioStorage Technologies, a provider of biomaterial storage and cold-chain logistics for the bioscience industry, has appointed Barb Dunn as director of resource management. Dunn will direct and conduct all activities for BioStorage Technologies’ biorepository facilities including space management, network infrastructure, and communication services.
The CDMO Catalent Pharma Solutions has appointed Jonathan Arnold as vice-president and general manager of sterile technologies, effective immediately.
Genzyme, a subsidiary of Sanofi, has named William Sibold head of the multiple sclerosis division, and Rogério Vivaldi as head of the rare-diseases division. Both appointees will report to David Meeker, president and CEO of Genzyme, and will join Genzyme’s executive team.
Merck KGaA has named Joachim Christ head of corporate controlling, effective Jan. 1, 2012. He will report to Matthias Zachert, a member of the executive board of Merck and chief financial officer.
Novartis has appointed Timothy Wright as global head of development, effective immediately. Wright joined Novartis in 2004 and most recently served as senior vice-president and global head of translational sciences at Novartis Institutes for BioMedical Research.
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The International Conference on Harmonization (ICH) steering committee and working groups met in Seville, Spain, earlier this month. The groups meet twice annually to discuss, revise, and approve various harmonization guidelines. At the latest meeting, the steering committee approved a revised ICH S2(R1) guideline for genotoxicity testing and data interpretation for medicines intended for human use. The Quality Implementation Working Group (IWG) completed three points-to-consider documents on process validation/process verification, the role of modeling in QbD, and design space. All documents will soon be accessable on the ICH website. The next meeting will be held in Fukuoka, Japan, in June 2012.
The US Pharmacopeia has developed a memorandum of understanding with the Chilean Pharmacopeia Foundation to help provide the quality and safety of medicines in Chile and the United States. USP has recently established similar partnerships with Russia and the Ukraine.
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Using Simulation to Improve Drug-Delivery Effectiveness |
by: Marc Horner, Ralf Kroeger
Pharmaceutical companies are responding to the high cost of introducing new drugs to market in different ways.
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Coming soon: Don't miss Pharm Tech's special coverage on Process Validation and Compliance in the upcoming December issue. |
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Solid-Dosage Innovation
What is driving manufacturers to reformulate or reinvent currently marketed solid dose pharmaceutical products?
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View the poll archive. |
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