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Podcasts

Webcast: Highlighting the Characterization of Irregularly Shaped Particles Using Dynamic Image Analysis
April 23, 2010 (9 am and 11 AM ET)

Webcast: Topical Formulation Development and Screening
April 28, 2010 (1 PM ET) Sponsored by Dow Pharmaceutical Sciences

Webcast: The Impact of Harmonizing Microbial Testing
On-Demand

Sponsored By Celsis

Webcast: Protect IP and Reduce the "Sign and Witness" Burden in Lab Informatics Systems
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Sponsored by Surety

Webcast: Complex Documents in the Pharmaceutical Industry Made Easy
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Sponsored by SCHEMA and JustSystems

Podcast: Pfizer’s Maddaluna on Integrating Wyeth’s Manufacturing Organization

Events

BIO 2010
May 3–6
Chicago

ExcipientFest Americas
May 5–6
San Juan

Basics of Tablet Manufacturing and Troubleshooting
May 18–19
St. Charles, MO

12th Annual C21 BioVentures
May 25–27
Nape, CA

Chemspec Europe 2010
June 9–10
Berlin, Germany

Pharmaceutical Tablet Technology
August 9–11
St. Charles, MO

More events


FindPharma Search
April 22, 2010 PharmTech.com

News

INTERPHEX Comes to New York
INTERPHEX 2010 will take place this week at the Jacob K. Javits Center in New York.
Click Here to Read More

FDA Removes Last CFC Inhalers from the Market
After several years of debate and review, the US Food and Drug Administration called for metered-dose inhalers to be removed from the market. Click Here to Read More

SOCMA Raises Concerns about Toxic-Substances Reform Bill
The Society of Chemical Manufacturers and Affiliates raises concerns over a recently introduced bill in the US Senate, which seeks to reform the Toxic Substances Control Act. Click Here to Read More



Product Spotlight

Software provides scalable serialization solution
Cognex’s (Natick, MA) In-Sight Track and Trace software package is a data-capture and -verification solution designed to help pharmaceutical manufacturers achieve unit-level product traceability. Together with Cognex’s In-Sight vision systems, the software can read 2D and 1D barcodes and verify identification-code contents. The product also evaluates data-matrix codes during production to detect changes in print quality. In addition, the software confirms the accuracy of printed text and detects label misalignment.

Users can configure and operate the software through a touchscreen interface. Developers can integrate the Track and Trace interface into a computer-based human–machine interface or into a custom application. Users also can combine the software with third-party products. This feature enables users to customize and scale their serialization solutions according to their needs. The software complies with 21 CFR Part 11, and is provided with the technical controls needed for validation.

Company Notes

Abbott Laboratories (Abbott Park, IL) announced that the Utah Department of Health is one of five US agencies participating in its PLEX-ID Biopreparedness Evaluation Program. The program involves Abbott, the Association of Public Health Laboratories, and five state public-health laboratories. Its goal is to assist public-health authorities in identifying and characterizing a wide range of microorganisms in surveillance activities for infectious diseases, food safety analysis, and biodefense readiness.

The US Food and Drug Administration sent warning letters to Astellas Pharma (Tokyo), GlaxoSmithKline (GSK, London), and Novartis (Basel) for allegedly using misleading promotions for cancer, pain, and bladder drugs. FDA officials said that a GSK advertisement omitted important information about the safety and effectiveness of the cancer drug Arzerra. FDA also alleged that a promotional webpage overstated the effectiveness of GSK’s and Astellas overactive-bladder drug Vesicare. FDA warned Novartis about misleading claims about its pain reliever Voltaren gel.

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Celgene (Summit, NJ) and the biopharmaceutical company Agios Pharmaceuticals (Cambridge, MA) agreed to a collaboration targeting cancer metabolism. Under the terms of the agreement, Agios will receive a $130-million upfront payment, including an equity investment. In return, Celgene receives an initial period of exclusivity during which it has the option to develop any drugs resulting from the Agios cancer-metabolism research platform.

Charles River Laboratories International (Wilmington, MA), a contract-research organization, received a Certificate of Good Laboratory Practice compliance from Belgian’s Organization for Economic Cooperation and Development.

Advertisement:
Enwave Optronics, Inc. is the innovative leader in affordable Raman spectroscopy solutions. Enwave offer portable Raman instruments with best performances and prices in the industry. Raman microscopes and high sensitivity Raman instruments with the best performance-to-price ratios are also available. Click here to read more.

The contract manufacturer DPT Laboratories (San Antonio, TX) expanded its aseptic manufacturing and development capabilities at its Center of Excellence for Sterile and Specialty Products in Lakewood, New Jersey. DPT’s sterile center will focus on aseptic production of sterile dosage forms, including small-volume parenterals, ophthalmic preparations, preservative-free nasal sprays, and sterile ointments.

Pfizer (New York) and Stemgent (Boston, MA), which provides research tools and services to institutions, companies, and universities, agreed to a research and licensing agreement through which certain research reagents developed or discovered by Pfizer will be made available to the global research community through Stemgent.

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The pharmaceutical company Perrigo (Allegan, MI) was named an authorized generic partner by Ferndale Laboratories (Ferndale, MI), a provider of products for the relief of dermal pain or anorectal discomfort due to hemorrhoids and anogenital pruritus. Perrigo launched an authorized generic of Analpram HC Cream and will have future opportunities to launch other Ferndale products as its authorized generic distributor.  

PRA International (Raleigh, NC), a clinical-research organization, established operations in New Zealand, which is a research hub for studies in skin cancer, multiple sclerosis, asthma and several other conditions.

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Live Webcast: Protect IP and Reduce the "Sign and Witness" Burden in Lab Informatics Systems.

Sandoz (Holzkirchen, Germany) signed a definitive agreement to acquire Oriel Therapeutics (Research Triangle Park, NC), a specialty pharmaceutical company focused on respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease. Terms of the deal were not disclosed.

Thermo Fisher Scientific (Waltham, MA), a provider of equipment, software, and services for research, analysis, discovery, and diagnostics, announced that the Nigerian National Agency for Food and Drug Administration and Control successfully field-deployed several Thermo Scientific TruScan hand-held Raman instruments for the rapid identification of counterfeit and substandard drugs.

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com


PharmTech Talk blog
People Notes

Bristol-Myers Squibb (New York) appointed Charles Bancroft as its chief financial officer effective Apr. 8, 2010.

Patheon (Research Triangle Park, NC), a provider of contract development and manufacturing services, appointed Mark Kontny as its president of global pharmaceutical development services and as its chief scientific officer.

PharmTech, the magazine
Current Issue cover
ISPE Raises the Bar for Baseline Guides
By Susan J. Schniepp
New information improves an organization's guide to building manufacturing facilities.
Click Here to Read More

Coming Soon: The May 2010 cover story of Pharmaceutical Technology will address modular contract manufacturing

Is Hot Melt Extrusion an Untapped Resource?
By Erik Greb

HME has not been a common way of manufacturing drugs, and many industry employees don’t understand the principles of HME or the advantages that the technique offers. Click Here to Read More


 

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