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11th Winter Conference on Medicinal & Bioorganic Chemistry
January 20, 2013–January 24, 2013
Steamboat Springs, Colorado
Quality by Design
January 23, 2013–January 24, 2013
London, United Kingdom Social Media in the Pharmaceutical Industry
January 23, 2013–January 24, 2013
London, United Kingdom Pre-Filled Syringes
January 28, 2013–January 29, 2013
London, United Kingdom CBI's 4th Annual Effective Preparation for FDA Advisory Committee Meetings
February 5, 2013–February 6, 2013
Washington, DC
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US Supreme Court to Hear Pay-for-Delay Case
The US Supreme Court accepted an appeal by the Federal Trade Commission of a decision that upheld an arrangement of payments by Solvay Pharmaceuticals to generic drug companies to postpone introduction of generic versions of its branded testosterone-replacement drug.
Biogen Idec and Isis Pharmaceuticals to Collaborate on Antisense Programs
Biogen Idec and Isis Pharmaceuticals announced that they have entered into a global collaboration agreement to discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders.
EU Court Dismisses AstraZeneca Appeal
The Court of Justice of the European Union has dismissed an appeal by AstraZeneca concerning a 2005 decision that found the company guilty of abusing its dominant position in the marketplace.
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 Capsule filler with multiple dosing units is designed for small runs
MG America’s FlexaLAB capsule filler, which can produce up to 3000 capsules per hour, is designed for research and development, clinical trials, and small-batch production. The FlexaLAB can function with either continuous or intermittent motion. Installing multiple dosing units allows the FlexaLAB to manufacture capsules with combinations of products. The machine can fill powders, pellets, microtablets, tablets, liquids, and certain low-dosage powder inhalants and can perform capsule-into-capsule functions. The machine includes a touch-screen panel and PLC for machine-functions control. Machine speed can be adjusted from the monitor.
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Amgen has agreed to acquire the Reykjavik, Iceland-based, human-genetics R&D company deCODE Genetics. The all-cash transaction values deCODE Genetics at $415 million, subject to customary closing adjustments, and was unanimously approved by Amgen’s board of directors. Read More
Featured White Paper: Pharmaceutical Compliance that Spans the Supply Chain
Today's rise in globalization means that the pharmaceutical market is operating on a grander scale than ever before. Pharmaceutical organizations typically extend manufacturing to suppliers, which are often located around the world. For suppliers to effectively operate within this global environment, harmonization is needed. Learn why global harmonization is important in the Pharmaceutical industry, best practices of extending the quality system to the supplier, and how suppliers will benefit from being included in harmonization initiatives.  Read More |
Baxter International has agreed to acquire Gambro, a privately held dialysis-product company based in Lund, Sweden, for total consideration of SEK 26.5 billion (USD 4 billion). The transaction will be financed through a combination of cash generated from overseas operations and debt. Baxter expects to maintain its current dividend payout ratio of approximately 40%. The closing of the transaction is subject to regulatory approvals and other customary closing conditions and is expected to occur in the first half of 2013. Read More
VitalDose® Excipients for Customizable Delivery
Learn more about VitalDose® EVA excipients on the VitalDose website and blog. Learn how EVA polymers have been used for years in controlled release pharmaceutical and medical device applications. VitalDose EVA can assist in the tailored dosing and delivery of your API and offers manufacturing process versatility and multiple routes of administration. VitalDose@Celanese.com or  www.VitalDose.com/blog. |
Following a five-year partnership with Exelixis during which Catalent Pharma Solutions has provided analytical, clinical-trial supply, and manufacturing support for Cometriq (cabozantinib), FDA has approved Exelixis’ aforementioned treatment of progressive, metastatic medullary thyroid cancer. Catalent will now continue to be the exclusive commercial drug-supply partner for the 20- and 80-mg capsule dose packs in the US. All US Cometriq capsule manufacturing and packaging operations will be undertaken at Catalent’s 450,000-ft2 facility in Kansas City, Missouri. Read More
The University of Texas MD Anderson Cancer Center and GlaxoSmithKline (GSK) have signed a research collaboration and license agreement to develop new therapeutic antibodies that promote an immune system attack against cancer. Under the agreement, MD Anderson grants GSK exclusive worldwide rights to develop and commercialize the antibodies, which activate OX40 (secondary receptor proteins) on the surface of T cells. MD Anderson, through its new Institute for Applied Cancer Science, will collaborate with GSK to conduct preclinical research on the antibodies. Read More
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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| An Industry Perspective on Harmonization and Implementation of ICH and USP Requirements |
by: Katherine Ulman, Neil Schwarzwalder, Andrew Teasdale, David Schoneker, and Priscilla Zawislak
The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012, and are to be implemented by industry by May 2014.
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Coming soon: Pharm Tech’s January issue features a cutting-edge forum on solid-dosage drug products. |
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Participate in the bio-industry's most in-depth, global study: 10th Annual Biopharmaceutical Manufacturing Report and Survey.
Your input is more important than ever, as we benchmark global and re gional trends affecting our industry. You will receive a summary of the results of this important global study. AND for each completed survey we’ll donate a select amount to global health charities. Takes between 10–25 minutes, depending on your areas of expertise.
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Know Before You Go—2012 Conference Previews
Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.
Find company backgrounds, new product releases, booth materials, and more.
PharmTech's online
Gateway is your guide to the season's leading shows.
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