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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 FT Global Pharmaceutical & Biotechnology Conference
December 4, 2012–December 5, 2012
London, United Kingdom 5th Annual Contract Manufacturing
December 7, 2012–December 8, 2012
London, United Kingdom New York Pharma Forum 23rd Annual General Assembly
December 7, 2012
New York, New York
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 Filter dryer agitator aids production processes
API manufacturers can perform efficient cake drying during filtration and separation processes with PSL’s agitated nutsche filter dryers. The systems feature a series of sharp curved blades with spaces at different specific points of each arm. When being moved and lifted between the gaps within the filter dryer agitator, the product moves at a lower velocity and is swept by the second arm of the blade to achieve efficient mixing at different velocities. The curved blades can also penetrate difficult cakes without undue product stress. For high containment, glovebox isolators can be mounted on the side to provide safe product offloading, contained sampling, and total heel recovery for maximum product yield.
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Takeda Pharmaceutical has established a new organization (Global Medical Affairs Japan Department) in Takeda Development Center Japan, Pharmaceutical Development Division, with appointment of its senior leadership, effective Dec. 1, 2012. Along with this, the company’s Strategic Medical Research Planning Division, currently under Takeda Development Center Japan, will be positioned under Global Medical Affairs Japan Department. Koki Nakamura has been named general manager of the new department. Read More
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Handheld Raman Accelerates Raw Material Release
Enwave Optronics introduces the NEW ASSUPx Handheld Raman Analyzer for raw material verification. Most materials are measured and evaluated within 15 seconds. The ASSUPx is fully 21 CFR Part 11 compliant for GMP requirements. It is an ideal choice for pharmaceutical, industrial chemicals and applications requiring high speed, reliable Raman analysis.
Enwave Optronics, Inc.
 http://www.enwaveopt.com/EZRaman-H.htm |
The biopharmaceutical company UCB has announced that Exemed Pharmaceuticals, a manufacturer of APIs, will acquire UCB’s production facility in Vapi, India. The deal includes a multiyear supply agreement between UCB and Exemed as well as the transfer of UCB Vapi’s staff of approximately 80 members to Exemed. 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 |
In a separate deal, UCB and NewBridge Pharmaceuticals, a specialty therapeutics company have agreed to make UCB’s core products Cimzia (PEGylated anti-tumor necrosis factor), Vimpat (lacosamide), and Neupro (rotigotine), available in several Middle East and African countries. Under the agreement, NewBridge acquires the rights to Cimzia, Vimpat, and Neupro from the RX Group, UCB’s previous partner in the region. UCB will operate with its new partner for the region and will supply NewBridge with the three products on an exclusive basis. NewBridge will also be responsible for managing the local regulatory approval process, future commercialization, and pharmacovigilance in each of the relevant countries. Read More
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Accelerate the Development of Challenging Drug Candidates via Crystal Engineering
Live Webcast: Thursday, December 6, 2012 from 10:00 AM -11:15 AM EST
Register Free at  www.pharmtech.com/engineering |
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
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Microbial Control & Monitoring of Cleanrooms: Understanding New Regulatory Requirements
Monday, December 3, 2012 from 11:00 AM to Noon EST
Register Free at  www.pharmtech.com/microbial |
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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The European Medicines Agency (EMA) has announced a plan to address drug supply shortages following manufacturing problems. The plan was developed in collaboration with the European regulatory authorities in the EU member states.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has provided an update from the Pharmacopoeial Discussion Group (European Pharmacopoeia, Japanese Pharmacopoeia, and the US Pharmacopeia) meeting that took place on Nov. 6–7, 2012 in Rockville, Maryland. According to EDQM, 28 of the 35 General Chapters and 43 of the 62 excipient monographs have been harmonized.
The International Conference on Harmonization (ICH) has released an update from the Steering Committee and its Expert Working Groups meeting in San Diego, California, on Nov. 10–15, 2012. The meeting addressed reform to include the involvement of global regulators and reassure ICH’s commitment to harmonization.
FDA has released the following guidance documents and guidelines:
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| EU Sets Guidelines for Biosimilar Monoclonal Antibodies |
by: Sean Milmo
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies.
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Coming soon: Pharm Tech’s December issue highlights a technical forum on anticounterfeiting. |
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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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