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Bio-Europe 2012
November 12, 2012–November 14, 2012
Hamburg, 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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Baxter International has announced an exclusive 20-year partnership with Hemobrás, a Brazilian biotechnology company, to provide hemophilia patients in Brazil greater access to recombinant Factor VIII (rFVIII) therapy for treating hemophilia A. Under the agreement, Baxter will be the exclusive provider of Brazil’s rFVIII treatment over the next 10 years while the companies collaborate on the technology transfer to support development of local manufacturing capacity by Hemobrás. Baxter will receive cash payments for product it supplies to Hemobrás and, following completion of the technology transfer and royalties on rFVIII produced by Hemobrás. Baxter expects peak annual sales to exceed $200 million. Read More
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Life Sciences Guidebook: Best Practices for FDA Compliance Solutions
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Merck & Co. settled an agreement with plaintiffs to resolve Plubell v. Merck, an economic class-action lawsuit pending in Missouri state court. The class consists of Missouri consumers who purchased Vioxx (rofecoxib), but do not claim any physical injury, and who seek to recover damages under the Missouri Merchandising Practices Act. Under the agreement, Merck will pay to resolve all validated claims submitted by class members, approved attorneys’ fees and expenses, and settlement notice costs and administrative expenses. The company recorded a charge for this settlement in the third quarter of 2012. The agreement is subject to court approval and certain conditions related to participation. 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 |
Takeda Pharmaceutical has agreed to acquire Envoy Therapeutics. Under the agreement, Takeda America Holdings will acquire 100% of the equity in Envoy for total consideration of up to $140 million, which includes an up-front payment and progress-dependent, preclinical milestone payments. Read More
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 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.
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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
