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Company Notes
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Product Spotlight
People Notes

Regulatory Roundup


 
 

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Podcasts

Webcast: Metabolic Syndrome: Important Considerations in Trial Design
May 5, 2011 (Europe) and May 10, 2011 (North America)—Sponsored by SGS

Webcast: Quality by Design for Biologics: Biopharmaceutical Characterization
May 24, 2011 (Europe) and May 26, 2011 (North America)—Sponsored by SGS

Webcast: Learn How to Avoid Risk Contamination in Your Sterile Cleanroom
June 8, 2011—Sponsored by Kimberly-Clark Professional

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 Jim Greenwood

Events

ExcipientFest
May 10–May 11
Baltimore, MD

Interpack
May 12–May 18
Düsseldorf, Germany

2011 AAPS National Biotechnology Conference
May 16–May 18
San Francisco, CA

Cleanrooms — Standards & Technology
May 17
Edinburgh, United Kingdom

Cleaning Validation
May 17–May 19
Bethesda, MD

Sterile Pharmaceutical Dosage Forms: Basic Principles
June 1–June 2
Bethesda, MD

More events


FindPharma Search
May 5, 2011 PharmTech.com

News

FDA to Study Online Drug Marketing
FDA is collecting public comments on a series of studies that the agency plans to conduct on online direct-to-consumer promotion of prescription drug products, according to an announcement in the Federal Register.
Click Here to Read More

Teva Snatches Cephalon from Valeant
Israel-based Teva Industries seals deal to acquire Cephalon for $6.8 billion. Click Here to Read More

PhRMA Urges Congress to Reauthorize Legislation for Pediatric Drugs
PhRMA urged Congress to reauthorize two pieces of legislation relating to pediatric studies and exclusivity, the Best Pharmaceuticals for Children Act, and the Pediatric Research Equity Act. Click Here to Read More

Excipient-Certification Standards Presented for Comment
IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients. Click Here to Read More

Federal Appeals Court Lifts Ban on Funding for Embryonic Stem Cell Research
A federal appeals court has lifted a ban on federal funding for embryonic stem cell research. Click Here to Read More


Product Spotlight

Lift tables incorporate protected hydraulic packages

The David Round Company’s 304 stainless-steel lift tables are designed for bulk-material applications in controlled pharmaceutical manufacturing environments (e.g., cleanrooms). The machines’ hydraulic packages are laid out flat on the bottom of the tables, and the cylinders are in a horizontal position. This design enables the hydraulic components to be covered, thus protecting them and reducing opportunities for contamination.

Personnel can operate the tables’ hydraulic packages with pushbutton controls. The tables can be raised from 18 in. to as high as 42 in., which is within the appropriate ergonomic range. The tables’ reinforced scissors-type lift capacity is rated at 2000 lbs.

The tables are mounted on wheels for portability, and personnel can collapse them to the floor. In addition, the tables’ highly polished finish, smooth welds, and few crevices enable easy wash down.

Advertisement:
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Company Notes

GE Healthcare has agreed to acquire Applied Precision, a supplier of cellular imaging technologies for the cell-biology and biomedical research sectors. The acquisition, which is subject to customary closing conditions, including regulatory approvals, is expected to close in the second quarter of 2011.

Advertisement:
Reports from the Waters Bioanalysis World Tour:
Our recent special event series has been creating a lot of buzz among bioanalysts, with engaging discussions on topics from microsampling to peptide bioanalysis. Read reports written by the Bioanalysis Journal, watch our on-demand webinars, and look for future symposia dates at www.waters.com/biotour

 

The biopharmaceutical companies Talceris Biotherapeutics and Griflos have reached a consent agreement with the Federal Trade Commission (FTC) that outlines the conditions necessary for Grifols' acquisition of Talecris to proceed. The consent agreement remains subject to approval by FTC before the transaction can be completed. To meet the terms of the agreement, Grifols has agreed to sell select assets and has entered into certain commercial, lease, and manufacturing agreements with the Italian biopharmaceutical company Kedrion for up to seven years. Under the agreement, Kedrion and Grifols will enter into a contract-manufacturing agreement to fractionate and purify Kedrion's plasma and to deliver intravenous immunoglobulin and albumin under Kedrion's private label, and Factor VIII under the trade name Koate, all of them for sale only in the US. Also, Grifols will sell its Melville, New York, fractionation facility to Kedrion and will manage the facility for up to a four-year lease agreement with Kedrion. Grifolos also will sell to to Kedrion Talecris' US FVIII business and two Talecris plasma-collection centers.

Advertisement:
Webcast Auction: May 24 at 11 AM ET.
Featuring processing & packaging equipment from Teva! Lot catalog includes PK 'V' 100 Cubic Foot Blender, Elanco Shionogi Semi Automatic Capsule Filler, Kikusui Libra 36 Station Tablet Press, Marion 30 Cubic Foot Paddle Blender, AMF 340 qt Planetary Mixer and much more. Register & Bid Online at http://www.equipnet.com/auctions

 

The contract development firm Velesco has partnered with Vindonwestech, a stability-storage provider and manufacturer of controlled environment rooms, to expand its formulation-development services.

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

Catalent Pharma Solutions has reportedly named Rao Tatapudy vice-president of Scientific Affairs, Innovation & Growth. He will be responsible for strategic research and development and technology programs. Tatapudy is coming fromPfizer, where he served as New Product Leader and director of New Product and Process Development.

Advertisement:
Optimum FTIR Performance, Sensitivity, and Reliability
Shimadzu’s IRAffinity-1 FTIR is ideal for high-precision infrared analysis in a multitude of pharmaceutical applications, from identification of foreign matter to analysis of contaminants. It features best-in-class sensitivity, long-term stability, increased reliability with self-diagnosis and continuous monitoring during operation, protection from humidity with a triple protection interferometer, and analysis support programs . Learn more

Acura Pharmaceuticals announced the passing of Andrew Reddick on Apr. 28, 2011, following an eight-year tenure as president and CEO; he was 58. Robert Jones has been named as Reddick’s interim replacement.

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NO, we don’t know why some outsourcing labs can’t handle chemical analysis in your timeframe. But, YES, we can!  Compendial, non-compendial or custom methods. Raw material and API analysis to container and finished product testing. We have HPLC, LC-MS/MS, GC, IC, dissolution, AA and more, plus experts who know their stuff. Microbiology and stability testing, too. Get a quote or more information now.celsis.com/GetAnswers

Gilead Sciences appointed Muzammil M. Mansuri as senior vice-president of research and development strategy and corporate development.

Advertisement:
Effective Pharmaceutical Audits and Self-Inspections
Le Meridien Cambridge, Boston, MA
May 16-18, 2011
Course Fee: $2675 USD
Pharmaceutical auditors take decisions and make assessments which are critical to the competitiveness of pharmaceutical companies…

  • Approval of suppliers
  • Approval of contractors
  • Acceptability of in-house practices and procedures
  • Overall regulatory compliance status
Often, auditors are working alone or in small teams in very challenging circumstances. It follows, therefore, that pharmaceutical auditors must be selected with care and, most importantly, given the best possible training! This course is designed to do just that. At NSF-DBA, we will provide practical guidance on how to maximize audit effectiveness through thorough preparation and attention to the human side of auditor/auditee encounter.

NeurogesX, a biopharmaceutical company, announced CEO Anthony DiTonno will retire by the end of 2011. DiTonno has been CEO of NeurogesX since March 2003.

Advertisement:
Reduce Tablet Punch Sticking With Precision Coatings. http://pharmtech.findpharma.com/pharmtech/Article/ ArticleStandard/Article/detail/693992

Savient Pharmaceuticals, a specialty biopharmaceutical company, named Richard Crowley executive vice-president of biopharmaceutical operations. Crowley formerly served as senior vice-president of biopharmaceutical operations for ImClone Systems.

Advertisement:
CBI’s 9th Product Complaints for Bio/Pharmaceuticals and Medical Devices — June 14–16, 2011, Arlington, VA
Create your own agenda at the QA/QC event of the year. Hear from the FDA and quality leaders from Abbott, Alcon Labs, American Medical Systems, Baxter Healthcare Corp., Becton Dickinson, GE Healthcare, Janssen Supply Group, LLC, Merck & Co., Inc. Philips Healthcare, Shire and more. Be the next to benefit.
Register today at www.cbinet.com/productcomplaints

 
Regulatory Roundup

FDA announced on its Transparency Blog last week that it is calling on industry to provide feedback on existing regulations and whether any of them need improvement. The initiative is based on an executive order from President Obama issued this past January to improve regulation and regulatory review. Industry can provide comments through the Federal eRulemaking Portal.

PharmTech, the magazine
Current Issue cover
Experts Ponder Ways to Fill Pharma Pipeline
FDA, NIH and industry seek new strategies to spur drug development and promote access to therapies.
Click Here to Read More

View this and other articles from our special issue on Solid dosage and Excipients
Click Here to Read More

Coming soon: This week, the May issue of Pharmaceutical Technology goes live online, including special reports on over-the-counter drug regulation and developments in inhalables.

 

 

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On Our Blog PharmTech Talk

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