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Bio-Europe 2012
November 12, 2012–November 14, 2012
Hamberg, Germany
PDA FDA Pharmaceutical Supply Chain Conference
November 13, 2012–November 14, 2012
Bethesda, Maryland
2012 Pharmaceutical Cold Chain & Good Distribution Practice Conference
November 15, 2012–November 16, 2012
Bethesda, Maryland
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
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Novartis has announced the construction of a new biotechnology facility in Singapore with an investment of over $500 million. The new facility will focus on drug-substance manufacturing based on cell-culture technology, and will be colocated with the pharmaceutical production site in Tuas, Singapore. Read More
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Life Sciences Guidebook: Best Practices for FDA Compliance Solutions
As Life Science organizations evolve, product lifecycles are speeding up to accommodate market demand and keep up with competing products. As a result, quality benchmarks need to evolve as well. Read this guide on FDA Compliance Systems and learn how your company can save time, increase your ROI and more. Learn how to select a solution, best practices for FDA compliance and Quality solutions, and tips for implementation success.  Read More |
The CDMO Patheon has agreed to acquire Banner Pharmacaps, a specialty pharmaceutical business dedicated to the research, development, and manufacturing of gelatin-based dosage forms. The acquisition will be structured as a purchase of all of the shares of the entities through which Banner conducts its operations, for $255 million, subject to working capital and other adjustments. The acquisition is subject to applicable regulatory approvals and other customary terms and conditions, and is expected to close by the end of 2012. 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 |
Pfenex has awarded Althea Technologies a contract for the cGMP manufacturing of circumsporozoite protein from plasmodium falciparum, a malaria antigen. Althea Technologies will implement the cGMP-ready Pfenex Expression Technology-based production process that was developed at Pfenex over the past several months. Processes for several additional malaria antigens are currently being developed at Pfenex. Read More
Advertisement:
 Catalogs of Innovative Lab and Clean Room Equipment
– technical resources and competitive pricing on popular lines of laboratory products from Terra Universal. Streaming eCatalogs contain application tutorials and instructional video on controlled-temperature systems, sample preparation equipment, and analytical instrumentation. Terra also manufactures complete lines of critical environment enclosures, including hoods, isolation chambers, desiccators, modular clean rooms and pass-through chambers. |
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
Advertisement:
Overcoming Formulation Challenges of Parenteral Drugs
Live Webcast: Tuesday, December 11, 2012 at 11:00 AM EST
Register Free at  www.pharmtech.com/parenteral |
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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FDA has pushed back goals in relation to the Prescription Drug User Fee Act, the Biosimilar User Fee Act, and Medical Device User Fee Act as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due Oct. 31, 2012, and extend them as needed. The extensions will be no more than the number of business days the agency was closed. FDA said in a press release that it does not anticipate the need to extend goals for all applications under review and it anticipates that many applications will not require an extension. Certain applications sent that would have been received during the agency’s closure may “present issues regarding calculation of applicable review or regulatory clocks.” FDA asks that sponsors contact the review division or office responsible regarding submissions filed on Oct. 29 or 30, 2012.
The European Medicines Agency (EMA) has released meeting highlights from the Pharmacovigilance Risk Assessment Committee, held Oct. 29–31, 2012.
EMA has announced changes to Variation Regulations. The amendments affect the provisions governing centrally authorized medicines and will go into effect Nov. 2, 2012.
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| Determining Potency of Preclinical Dose Formulations |
by: Ashley Sanchez, Melissa Whitsel, Amy Smith
Multiple factors arising during sample preparation can affect potency measurements.
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Coming soon: Pharm Tech’s December issue will contain results from our annual employment survey; including job satisfaction, salaries, company status, and more. |
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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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Web-based system provides real-time management of processes
