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Podcasts

Webcast: Protect and Legally Defend Your Scientific Intellectual Property: Digital Signatures Alone Aren't Enough
Mar. 31, 2011—Sponsored by Surety

Webcast: Critical Path Decisions for the 4 C’s in Life Sciences: Buy, Subscribe or Outsource Your “Order to Cash”, Contracts, Chargebacks and Compliance Systems
Apr. 14, 2011—Sponsored by CDC Software

Webcast: Risk Management for Pharmaceutical Manufacturing and Equipment: Meeting Regulatory Expectations and Preventing Contamination
On–Demand—Sponsored by Alfa Laval

Webcast: A Unique Workflow for Linearity Using Automated Sample Preparation and UHPLC
On–Demand—Sponsored by Dionex and Mettler Toledo

Podcast: A conversation with Jim Greenwood

Events

Selecting and Managing CROs
Mar. 28–29
King of Prussia, PA

IVT’s 2nd Annual Validation Week EU
Mar. 28–30
Amsterdam

Pharma & Biotech Supply Chain World Asia
Mar. 29–31
Singapore

Interphex 2011
Mar. 29–31
New York City

Drug Master Files (DMFs)—Understanding and Meeting Your Regulatory and Processing Responsibilities
Mar. 30–31
King of Prussia

WHCC 8th Annual Pharmaceutical, Biotech, and Medical Device Summit
Apr. 4–6
Washington DC

DIA/FDA Quantitative Structure-activity Relationship (Q)SAR Approaches to Assessing Genotoxic Impurities in Pharmaceuticals
Apr. 7
Rockville

More events


FindPharma Search
March 17, 2011 PharmTech.com

News

FDA Issues Draft Guidance on User-Fee Waivers, Reductions, and Refunds
FDA issued a draft guidance for industry on Mar. 11, 2011 that offers recommendations to applicants seeking to reduce their user-fee payments under the Federal Food, Drug, & Cosmetic Act.
Click Here to Read More

Senate Passes Patent-Reform Bill
Last Tuesday, the US Senate approved the “America Invents Act,” which is intended to reform the nation’s patent system. Click Here to Read More

FDA Files Consent Decree against Johnson & Johnson
FDA filed a consent decree of permanent injunction against McNeil for failing to comply with current good manufacturing practice requirements. Click Here to Read More

SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities
SOCMA’s Bulk Pharmaceutical Task Force and the European Fine Chemicals Group are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient manufacturing sites with the cost borne by those sites being inspected. Click Here to Read More


Product Spotlight

Probe enhances monitoring of cell-culture growth

FOSS NIRSystems’s Optimized BioProcess probes are available with a fixed or adjustable pathlength. The fixed-pathlength probe has a smooth surface and accumulates little debris, thereby facilitating cleaning in place. The adjustable-pathlength design enables users to adapt the probe for particular cultures or fermentations. FOSS can help clients optimize the pathlength for specific applications to allow sufficient flow through the gap and maximize sensitivity to low-level constituents.

The Optimized BioProcess probe, designed for use in bioreactors, has a small diameter that allows it to fit into standard bioreactor ports. Operators can use the smallest BioProcess Probe in a disposable bioreactor after it has been autoclaved with a proper aseptic-insertion device. The probes have several source and detector fibers that improve its ability to detect the light-scattering cells present in the bioreactor with a good signal-to-noise ratio. The number of fibers also allows the unit to measure low-level supernatant constituents.

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Company Notes

Eli Lilly and Company has made an irrevocable, unconditional offer to acquire the animal-health business of Janssen Pharmaceutica NV, a Johnson & Johnson company. According to the agreement, Elanco, Eli Lilly's animal-health division, would acquire products, manufacturing licenses, distribution rights, and the existing contract portfolio, as well as the related intellectual property and marketing authorizations. Janssen animal-health employees would transfer to Elanco.

Specialty-pharmaceutical company PROLOR Biotech is relocating its corporate office and research and development facility to a new, larger building located in the Weizmann Science Park in Nes Ziona, Israel. The move is expected to be completed by April 15.

Dendreon Corporation, a biopharmaceutical company, has received FDA approval for the remainder of its New Jersey manufacturing facility, thus allowing the company to significantly increase the availability of PROVENGE (sipuleucel-T) to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate-resistant (i.e., hormone-refractory) prostate cancer.

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Epizyme has formed a worldwide partnership with Eisai Tokyo to discover, develop, and commercialize therapeutics targeting EZH2, an epigenetic enzyme, for the treatment of lymphoma and other cancers in genetically-defined patients. Under the terms of the agreement, Epizyme will receive $6 million in upfront and initial milestone payments, and may earn more than $200 million in additional research, development, and sales milestones, and up to double-digit royalties. In addition, Eisai will fund 100% of research and development through human proof-of-concept, at which point Epizyme will have the right to opt into a profit share and cocommercialization arrangement for the United States.

FDA has accepted for review AstraZeneca and Bristol-Myers Squibb's New Drug Application for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus. A Marketing Authorization Application (MAA) for dapagliflozin has also been validated by the European Medicines Agency.

Amgen has signed an agreement with Pfizer to buy Pfizer’s manufacturing facility located at Dun Laoghaire, County Dublin, Ireland. The transaction is expected to close in the second quarter of this year.

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Grace Davison Discovery Sciences, a provider of separation services, opened a new technical-service knowledge center in southern India for customers in the pharmaceutical and biotechnology industries. The knowledge center will support Grace's customers in the areas of laboratory separations, bulk purification, excipients, and pharmaceutical intermediates.

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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 [email protected]

People Notes

Eli Lilly and Company has appointed Greg Plowman as the vice-president of oncology research and senior vice-president of ImClone Systems research. In this new role based at ImClone's research center at the Alexandria Center for Life Science, New York, Plowman will oversee the oncology research efforts of both Lilly and its subsidiary, ImClone.

Labopharm, a specialty-pharmaceutical company, has selected Mark D'Souza, formerly the chief financial officer, as its new president and chief executive officer and a member of the board of directors. D'Souza replaces James Howard-Tripp as president and chief executive officer and Howard-Tripp as board member.

Sanofi-aventis has named Richard Klausner chairman of the strategic development and scientific advisory council, where he will work directly with Elias Zerhouni, president of global research and development. Klausner also will act as special scientific and strategic advisor to Christopher A. Viehbacher, chief executive officer.

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Regulatory Roundup

FDA and EMA announced on Mar. 16, 2011, that they would carry out a joint pilot program for parallel assessment of quality-by-design-based new drug applications. The pilot applies to applications submitted to both agencies. According to a press release, the "parallel evaluation within this voluntary pilot program means that reviewers from both agencies will separately assess the quality/chemistry, manufacturing and control (CMC) section of the new drug applications (NDAs) submitted to the FDA and marketing authorization applications (MAAs) submitted to the EMA."

PharmTech, the magazine
Current Issue cover
Measuring Spending Levels
Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011. Read the full story in the March 2011 issue.
Click Here to Read More

Coming Soon: Be sure to look for PharmTech’s special April edition on solid dosage and excipients.

 

 
 
 
 
 
 
 
 
 

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