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World Companion Diagnostics Summit Europe
March 26, 2012—March 29, 2012
Frankfurt, Germany
9th Annual Controlled Release
March 28, 2012—March 29, 2012
London, United Kingdom
ICH Q3D Metal Impurities Workshop
April 4, 2012—April 5, 2012
Bethesda, Maryland
Pharmaceutical Strategic Outlook
April 11, 2012—April 13, 2012
New York, New York
2012 PDA Annual Meeting
April 16, 2012—April 18, 2012
Phoenix, Arizona
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FDA Updates Sentinel Initiative Status
In a presentation published on FDA’s website on Mar. 15, 2012, Janet Woodcock, director of CDER, outlined the current status and future plans for FDA’s Sentinel Initiative, an electronic drug safety tracking system established as part of the FDA Amendments Act of 2007.
FDA Warns Teva Pharmaceuticals About Improper Promotional Materials
Teva Pharmaceuticals received a Warning Letter from FDA informing them that promotional materials as well as an associated webpage for Copaxone (glatiramer acetate injection) solution for subcutaneous injection were found to be false and misleading.
EMA Says Ben Venue's Anticancer Drugs Should be Manufactured in Another Facility
The European Medicines Agency has recommended that manufacturing processes for two anticancer medicines be transferred from Ben Venue Laboratories to alternative facilities. The decision follows GMP shortcomings identified at the US-based manufacturer in late 2011, and marks the end of the EMA’s review of all fourteen centrally authorized medicines that were produced at the site.
UK Union to Fight Closure of Sanofi UK Manufacturing Facility
Unite, Britain and Ireland’s largest trade union with 1.5 million members, said it will fight the closure of Sanofi’s pharmaceutical manufacturing facility in Newcastle-upon-Tyne in northeast England. Last week, Sanofi announced the closure of the facility, which employs 450 people and makes solid-dose oral drugs mainly for the UK and European markets.
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 Tubing assemblies for high-volume flow rates
Meissner’s BioFlex tubing assemblies provide secure and convenient fluid paths for use within single-use systems and are designed to accommodate flow rates in excess of 100 L/min. The assemblies can also be used in conventional or hybrid facilities to connect single-use and stainless-steel processing equipment. BioFlex assemblies are easily customizable to end-user requirements and can integrate sterilizing- through clarification-grade capsule filters.
BioFlex assemblies are provided sterile and ready for immediate use, incorporating the end-user’s required tubing material, connectors, filters, pinch clamps, and other specified components, thus eliminating the cost and concern of on-site assembly. Pre- and post-use integrity testing procedures can be accommodated for applications that require sterile filtration.
BioFlex can be specified with capsule filters for processing volumes from 10 mL to over 10,000 L in sterilizing grades of SteriLUX PVDF, STyLUX PES, or EverLUX PES membranes. Its fluid path assemblies are supplied gamma irradiated at a sterilizing dosage in accordance with ANSI/AAMI/ISO 11137-2:2006 methodology. |
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FDA issued a Warning Letter to the specialty-pharmaceutical company Warner Chilcott for GMP violations determined from a June 22–July 29, 2011 inspection of the company's Fajardo, Puerto Rico, manufacturing facility. FDA cited Warner Chilcott for the following specific violations, which were determined as inadequately addressed from an Aug. 18, 2011, company response:
- "Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 CFR § 211.192]."
- "Your firm has failed to ensure that your quality control unit fulfills its responsibilities as required by [21 CFR § 211.22(a)]." Read More
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8 Ways to Reduce Tablet Manufacturing Costs
Are you working with a reduced budget for 2012? Want to learn how to get more and spend less? In an effort to help our customers get the most from their budgets, we put together this valuable list complete with tips, products, and video.  Click here now for access to the exclusive details! |
GlaxoSmithKline (GSK) has agreed to divest its noncore OTC brands in Europe to the Belgian healthcare company Omega Pharma for EUR 470 million ($621.9 million) in cash. The brands being divested include Lactacyd, Abtei, Solpadeine, Zantac, Nytol, and Beconase, and generated sales of approximately £185 million in 2011 ($293.3 million).
It is expected the divestment will be completed in the second quarter of 2012, subject to regulatory approvals. The net cash proceeds from the transaction are expected to be approximately £310 million ($491.5 million), which will be returned to shareholders during 2012. As part of the agreement, Omega will be acquiring the Herrenberg, Germany, manufacturing site which employs approximately 110 people. A number of the brands that are being divested are manufactured at Herrenberg, and it is anticipated that existing employees will transfer with the site to Omega Pharma under the provisions of German employment law. Read More
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Podcast -  Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation. |
Merck & Co. has agreed to create the California Institute for Biomedical Research (Calibr). Calibr, an independent, nonprofit organization to be led by Peter G. Schultz, will offer academic scientists a streamlined, efficient, and flexible path for translating biomedical research into medicines. Merck will provide funding to Calibr of up to $90 million during a period of seven years and has an option to obtain an exclusive commercial license to any proteins or small-molecule therapeutic candidates derived from work conducted by Calibr. Read More
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Overcoming Challenges in Complex Formulation Development: Bilayer Tablets & Beads-in-Capsules
Live Webcast: Tuesday, April 3, 2012 at 11:00 am EDT, 16:00 GMT
Register Free at  http://www.pharmtech.com/bilayer
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Sigma-Aldrich has opened a new facility in Wuxi, China, which will provide localized packaging, analytical services, and quality control for high-quality products to support the company's research and industrial customers in the region. The new facility sits on approximately 20 acres of land and includes a dedicated quality control center, an analytical application laboratory, and a packaging building. Read More
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Risk Management in Sterile Manufacturing
LIVE WEBCAST:Thursday, April 12, 2012 from 2:00 PM - 3:00 PM EDT
Register Free at  http://www.pharmtech.com/dpt |
Sigma-Aldrich has also recently completed a 57,000-ft2 expansion of its Bangalore, India, campus. The new addition features approximately 49,000 ft2 of distribution space and 8000-ft2 of packaging space. The existing 10-acre campus will continue to house the administrative offices, sales, marketing, and distribution functions, as well as manufacturing. Read More
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What's the matter with Sample Prep? - Novel approaches and solutions
Live Webcast: Tuesday, April 24, 2012 at 11:00 AM EDT
Register Free at  http://www.pharmtech.com/sample |
Industry Briefs:
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 [email protected] |
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