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2nd European Conference on Pharmaceutical Excipients
November 26, 2012–November 27, 2012
Berlin, Germany
World Drug Manufacturing Summit
November 26, 2012–November 28, 2012
Dusseldorf, Germany
Pharma Integrates 2012
November 28, 2012–November 29, 2012
London, United Kingdom
PDA/FDA Vaccines Conference
December 3, 2012–December 4, 2012
Bethesda, Maryland
IVT's 3rd Annual Stability Programs Forum
December 4, 2012–December 6, 2012
San Diego, California
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The Federal Patent Court in Germany has found the formulation patent protecting AstraZeneca’s Seroquel XR (quetiapine fumarate) prolonged-release tablets–marketed as Seroquel Prolong in Germany–to be invalid. The patent was challenged by Accord Healthcare, Hexal, and Teva Deutschland. The Federal Patent Court decision is limited to Germany and is not binding in other countries. AstraZeneca is engaged in numerous other proceedings regarding Seroquel XR-related patents and regulatory exclusivity for Seroquel XR. Further updates will be provided on a quarterly basis as part of the company’s earnings report. Total sales of Seroquel XR in Germany for the ten months, ending on Oct., 31 2012, were $82 million. Read More
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Free Technical Posters for Tablet Manufacturers
The latest edition to Natoli's extensive collection of free technical resources, the Technical Poster Series features 3 large-format posters packed with helpful tips, charts, terminology, and more. For a limited time, all 3 posters are available at no charge — shipping included — so order yours now!  http://www.natoli.com/Posters-PT.html |
GlaxoSmithKline (GSK) announced FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously 14–0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine candidate supports its licensure for the active immunization for the prevention of disease in persons 18 years of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. Read More
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Vindon Scientific (USA) provide outsourced storage to clients in our stability storage suite in Atlanta, encompassing walk in rooms and chambers, a complete range of World Climatic ICH conditions as well as unique conditions.
In addition Vindon Scientific manufacture and distribute stability storage walk in rooms, reach in rooms and chambers for the pharmaceutical and chemical industry.  www.vindonscientific.com |
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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The United States Pharmacopeial Convention (USP) has announced a new drug naming policy to take affect May 1, 2013. USP worked on the new policy with FDA and industry stakeholders to clarify naming practices for medicines and make them more consistent. According to USP, “the policy will apply prospectively to drug product and compounded preparation monographs that appear in USP’s compendia of public quality standards—the United States Pharmacopeia and National Formulary (USP–NF).” For more information, visit USP’s website at http://uspgo.to/monograph-naming.
USP has also announced its “Fifth Bioassay Workshop,” which will be held on Dec. 4-5, 2012 at USP headquarters in Rockville, MD. The workshop will focus on the development, monitoring, and validation of bioassays. Visit USP's website for more information.
FDA has made available, Guidance on Q11 Development and Manufacture of Drug Substances. FDA intends the guidance to “harmonize the scientific and technical principals relating to the description and justification of the development and manufacturing process of drug substances….”
Also released by FDA on November 19, 2012 is Guidance for Industry, Electronic Source Data in Clinical Investigations.
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| Protecting the Public |
by: Hallie Forcinio
Overt and covert packaging technologies evolve to authenticate drugs and fight counterfeits.
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Coming soon:Pharm Tech’s December issue will examine leading innovation strategies with Pfizer, Merck, Novartis, Sanofi, and Roche. |
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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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Fluid-bed system provides optimized granulation and drying
