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Podcasts

Webcast: Formulation Development Strategies
September 28, 2011—Sponsored by BASF

Webcast: Preventing Costly Out-of-Specification Investigations
September 20, 2011—Sponsored by Mettler-Toledo

Webcast: Winning Regulatory Strategies and Opportunities in Dermatology
July 20, 2011—Sponsored by Dow Pharmaceutical Sciences

Webcast: Quality Control: Preventing Cross-Contamination in a Pharmaceutical Manufacturing Environment
June 21, 2011 (North America) and June 23, 2011 (Europe)—Sponsored by SGS

Podcast: A Conversation with NIH Director Francis Collins

Events

World Drug Delivery Congress 2011
September 5, 2011–September 7, 2011
Singapore

Advances in Pharmaceutical Process Design
September 6, 2011–September 8, 2011
Dublin, Ireland

3-Day MBA in Generics
September 6, 2011–September 8, 2011
Singapore

19th Annual European Chemicals Policy
September 7, 2011–September 8, 2011
Barcelona, Spain

Pharma Chem Outsourcing
September 12, 2011–September 15, 2011
Long Branch, New Jersey

IVT's 2nd Annual West Coast Forum on Supplier Audits
September 13, 2011–September 15, 2011
San Diego, California

More events


FindPharma Search
September 1, 2011 PharmTech.com



News

FDA Publishes Draft Guidance on Tablet Scoring
FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.
Click Here to Read More

EMA to Apply New Electronic Submission Validation Criteria
EMA announced that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011. Click Here to Read More

USP and Brazil Partner on Public Health Education
USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.
Click Here to Read More


Product Spotlight

Process-control interface integrates plant operations

Yokogawa’s Centum VP Release 5 incorporates field digital information that complies with various wireless specifications. The software includes diagnostics; integrates data, alarms, and events from subsystems; and disseminates the information to the operator. It allows normal process displays and trending. In addition, the product lets users integrate alarms from multiple software systems, integrate asset-management information from devices, access modular procedural automation, and link to electronic standard operating procedures.

The Centum VP contains a new Field Control System that offers four times the processing performance, twice the application-storage capacity, and five times the control–network throughput than previous versions of the software. It supports most types of pharmaceutical manufacturing operations, including main manufacturing plants and pilot plants, that use the Centum VP software package for recipe and batch management. The software’s unified gateway station integrates with other software solutions, thus allowing the interface to control and monitor all the systems at the plant, including programmable logic controls.

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Company Notes

Bend Research, a CDMO, and the CRO Xcelience have formed a collaboration to provide oral solid-solubilization formulation solutions and expedited clinical-supply manufacturing in combined programs.

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Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications. Spress®; Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction. PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required.Learn more.

EMD Millipore, the life sciences division of Merck KGaA, has acquired the CDMO Amnis. The transaction is subject to regulatory approvals and closing is expected to occur in the fourth quarter of 2011. The terms of the transaction were not disclosed.

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The biopharmaceutcial company Icagen sent a letter to shareholders on Aug. 29, 2011, reaffirming the board of directors’ unanimous recommendation to accept the $6-per-share bid from Pfizer. The board received a letter from Pfizer on Aug. 26, 2011, that their proposal of $6 per share was their best and final offer, and that the offer was scheduled to expire at the end of Aug. 31, 2011.

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The Silverson Verso In-Line Laboratory mixer is the result of 60+ years of mixing experience and untold hours of scale-up research. This bench top In-Line mixer bridges the gap between laboratory and full-scale pharmaceutical production, providing proven, predictable accuracy. The Verso allows reliable forecasting of the performance of larger Silverson In-Line mixers under full-scale conditions. For a free on-site trial call 413-525-4825.

 

Novo Nordisk has announced plans to build a new corporate center in Bagsværd, Denmark. The EUR 134-million ($193.4 million) project will feature two office buildings and house 1100 administrative employees. Groundbreaking will begin in October 2011, and completion is scheduled for the end of 2013.

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Covance, one of the world's largest and most comprehensive drug development services companies, now offers a comprehensive and integrated set of CMC Pharmaceutical Development Services, including API development and supply, preformulation and formulation, analytical and stability, and regulatory documentation services. This offering is built on the combination of top-five pharma expertise, facilities, and decades of excellent client service record. Covance is committed to helping you reduce the time required to development milestones and improve your molecule hit rate.http://www.covance.com/cmcpds

Virginia Governor Bob McDonnell announced that Pfizer is selling its Henrico County, Virginia, manufacturing plant to the CMO Fareva, according to reports from various news sources. Fareva plans to invest $42 million into the facility, according to the reports.

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Valeant Pharmaceuticals International, a specialty pharmaceutical company, has agreed to acquire the health-sciences company Afexa Life Sciences for approximately CAN 76 million ($77.6 million). Under the agreement, Afexa’s shareholders will receive CAN 0.71 per share in cash, and the company’s board of directors unanimously approved the offer. The deal is subject to customary closing conditions and regulatory approval.

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At Solvay Chemicals, we manufacture BICAR® Sodium Bicarbonate and Soda Ash IPH to meet the exacting specifications of the US and EP Pharmacopeias and National Formulary. Produced according to cGMP, these are the products of choice for API or excipient applications requiring effervescent or desiccant properties. Solvay Chemicals, Inc. is part of the Solvay Group, the leading global producer of sodium bicarbonate and soda ash.http://www.solvaychemicals.us/marketsapplications/marketshidden/0,,40615-2-0,00.htm


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

The American Association of Pharmaceutical Scientists (AAPS) has elected Dr. Anthony J. DeStefano, vice-president of General Chapters at the US Pharmacopeia, as the organization’s new president-elect. DeStefano will begin his three-year term in October at the 2011 AAPS Annual Meeting and Exposition in Washington, D.C.

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C.W. Brabender® Instruments, Inc. introduces the Stainless Steel 12mm Clamshell Segmented Twin-Screw Compounder with application to the pharmaceutical industry for hot melt extrusion, new product development, compounding, pilot-scale & nanocomposites applications. The clamshell barrel allows visual assessment of processing steps, ease of screw mounting and quick cleaning. The modular segmented screws offer various individual processing possibilities. C.W. Brabender® Instruments, Inc. is… where quality is measured.

Merck KGaA has named Robert Yates president of its Merck Millipore division, effective Sept. 1, 2011. He will report to Bernd Reckmann of Merck’s executive board, and will be responsible for the chemicals business sector, which includes the Merck Millipore and performance materials divisions.

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5th Annual Pharma/Biotech Collaboration Accounting and Transaction Strategy
On September 21st, join your industry colleagues in Philadelphia, PA to hear accounting best practices and financial due diligence for strategic R&D deals, transactions, licensing and revenue arrangements.http://www.cbinet.com/collaboration | 800-817-8601 | [email protected]

Regulatory Roundup

The East African Community (EAC) has joined the International Conference on Harmonization’s (ICH) steering committee as the sixth Regional Harmonization Initiative (RHI) member of the ICH Global Cooperation Group (GCG), according to an ICH press release. EAC represents the Republics of Kenya, Uganda, the United Republic of Tanzania, Republic of Rwanda and Republic of Burundi with its headquarters in Arusha, Tanzania. GCC currently includes APEC, ASEAN, EAC, GCC, PANDRH, and SADC, as well as Australia, Brazil, China, Chinese Taipei, India, the Republic of Korea, Russia and Singapore. GCC members participate in harmonization discussions but are not part of the original three harmonization regions: the United States, Europe, and Japan.

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PharmTech, the magazine
Current Issue cover
Offshoring Biomanufacturing
By Eric Langer
China rises to the top as a destination for international outsourcing.
Click Here to Read More

Coming soon: Our October issue will contain a special feature on solid-dosage formulation.

Strategies for Innovation in Pharmaceutical Sourcing and Procurement
By Patricia Van Arnum
Pharmaceutical companies and their suppliers share approaches for innovation in sourcing and procurement.Click Here to Read More
 

 

 

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