|
|
 |
 |
|
Report: Pharma Supply Chain Underused, Inefficient, Ill-Equipped
Pharma’s manufacturing and supply chain needs a “radical overhaul” to cope with new products coming to market, according to a PricewaterhouseCoopers report. 
 Control of chromatography systems facilitates data integration
Shimadzu has enabled its GC-2010 Plus and GC-2014 gas-chromatography systems to be controlled with Waters’s Empower 2 software. This modification permits clients to integrate data from various chromatographs into one networked solution. Controlling chromatography systems through the data system also provides full documentation of instrument parameters.
Empower 2 software is designed to integrate fully with companies’ policies for electronic-signature compliance, audit trails, and system logs. The product’s Method Validation Manager helps users ensure that the validation of chromatographic methods is consistent. The software’s ApexTrack Integration feature automatically detects the peaks in a chromatogram with minimal operator intervention.
|
|
|
 |
|
Forest Laboratories, agreed to acquire Clinical Data, a specialty pharmaceutical company, for $1.2 billion. The transaction reflects a price of $30 per share in cash plus contingent consideration of up to $6 per share that may be paid upon achievement of certain commercial milestones related to its depression treatment Viibryd (vilazodone hydrochloride). Forest will finance the transaction with existing cash. The transaction was approved by the boards of both companies and is expected to be completed in the second quarter of 2011, subject to customary closing conditions.
Advertisement:
Contract Manufacturing and Packaging for Solid Oral Dosage
Ropack, a leader in packaging solutions for the pharmaceutical, biopharmaceutical and nutraceutical industries, now provides the technology and expertise for stickpack packaging of solid oral dosage in a low relative humidity and temperature-controlled environment. Stickpacks – slim, tube-shaped packets the size of a stick of gum – offer impressive benefits: fill accuracy, portability, product differentiation, reduction in paper and foil usage, product differentiation and ideal sample option.
 http://www.ropack.com/en/service/primary-packaging/stick-pack |
Gilead Sciences, a biotechnology company, agreed to acquire the biotechnology company Calistoga for $375 million. Calistoga could earn up to an additional $225 million in milestone payments. Gilead anticipates that the deal will close in the second quarter of 2011, subject to the satisfaction of certain closing conditions.
Advertisement:
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.
 Read more...
|
Johnson & Johnson has completed its tender offer for Crucell, the biopharmaceutical company, and has declared the offer unconditional. As a result, Crucell will now operate as the center for vaccines within the Johnson & Johnson pharmaceuticals group.?The companies reported that the share acceptance level is 95.24% of the issued and outstanding share capital of Crucell, and expect that the settlement of the offer will take place on Feb. 25, 2011.
Advertisement:
It’s all about the science that distinguishes Aptuit as the most complete global API provider. It’s about getting the API right the first time, every time and recognizing the critical impact the API has on everything needed to launch breakthrough drug products. Come to Informex Booth 1242 to speak to Aptuit professionals. Visit
 www.aptuit.com to learn more. |
Japanese pharmaceutical company Kyowa Hakko Kirin agreed to buy the UK-based specialty pharmaceutical company ProStrakan Group for £292 million ($472 million) in cash. The deal was approved by the ProStrakan board. A company press announcement said that the transaction would provide Kyowa with an established European and US marketing and sales platform, together with a portfolio of proprietary products.
Advertisement:
Single-use filling solutions designed to grow with your product. Systems are available for lab through high-speed production. PreVAS is the most complete solution available including bags, tubing, connectors, pumps and filling needles preassembled, presterilized and ready to use. Systems are now available with both peristaltic and rolling diaphragm pumps.
 Click for more information...
|
In a 6–2 decision, the US Supreme Court affirmed the ruling of the US Court of Appeals for the Third Circuit in favor of Pfizer’s subsidiary Wyeth, in Bruesewitz v. Wyeth. The Third Circuit determined that the National Childhood Vaccine Injury Act prevents civil suits against manufacturers of FDA-approved childhood vaccines based on a claim that a particular vaccine should have been designed differently.
Advertisement:
World’s Only No Compromise UHPLC
At 19,000 psi, Shimadzu’s modular Nexera meets all analysis requirements: conventional, ultra-high speed, high resolution, high temperature, green, multidimensional, etc. with no compromise in data integrity. Features include the world’s fastest injection (10-second cycle time), near-zero carryover (0.0015% without rinsing), maximum resolution with the widest pressure/flow range (130MPa up to 3mL/min), and excellent injection reproducibility (0.25% area %RSD).
 Learn more...
|
Upsher-Smith Laboratories is voluntarily expanding its previously announced recall of Jantoven (warfarin sodium), USP, 3 mg tablets to include additional products that were packaged on the same packaging line between May 17, 2010, and Nov. 17, 2010. The company is initiating the recall as a precautionary measure after a single bottle labeled as Jantoven (warfarin sodium), USP, 3 mg tablets was found by a retail pharmacy to contain tablets at a higher, 10 mg strength. For more information about the recall, see the company’s Q&A web page.
Advertisement:
Feel the empowerment that comes from knowing that SAFC is ready to meet your contract manufacturing needs with quality products, innovative ideas and superior service. We stand ready to work with you every step of the way, anticipating your needs and offering keen insight. If you missed us at Informex, please visit our website and discover for yourself the SAFC difference.
 www.safcglobal.com |
Advertisement:
Reports from the Waters Bioanalysis World Tour
At APA and AAPS last year, Waters gathered some of the brightest minds in bioanalysis to discuss the impact and opportunities made available with recent advances in LC/MS technologies. Read reports from these special events written by the Bioanalysis Journal and look for future symposia dates.
 waters.com/biotour |
Advertisement:
Spirax Sarco Presents a Solution for the Prevention of Reverse Flow and Cross Contamination The CVS10 provides a solution to protect any item of equipment from pressure surges associated with hydraulic forces such as waterhammer.
Additional features include: full traceability of wetted materials
throughout the valve, .507psi (35mbar) opening pressure as standard, high kv value with minimal pressure loss, and a choice of surface finish to maintain sterility and reduce risk of microbial growth.
 http://www.spiraxsarco.com/us/about/news-article.asp?news_id=48 |
Advertisement:
Thousands of pharmaceutical, biologic, generic, and contract services professionals gather annually at INTERPHEX (March 29-31, 2011, Javits Convention Center, New York City) to see new products, network, and learn about emerging trends surrounding drug manufacturing. At INTERPHEX 2011, you’ll find the solutions and education you need to ensure quality, improve efficiency, and solve your manufacturing and supply chain problems. Register for a free exhibit hall pass at
 www.INTERPHEX.com |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
|
|
|
Bayer HealthCare appointed Erica L. Mann as the new president of its consumer-care division and as a member of the Bayer HealthCare executive committee, effective Mar. 14, 2011. Mann most recently served as president and general manager of Pfizer Nutritional Health and was a member of the Pfizer senior-management team.
Paul A. Grayson, who has been president and CEO of the biotechnology company Fate Therapeutics since April 2008, is leaving to form a new company.
Gelest, a provider of silicone-based products, promoted Edward Kimble to product manager of silicones, and appointed Barbara Tsuie product manager of silanes and metal-organics. Both employees will report to Joel Zazyczny, vice-president of silanes, silicones and metal-organics. In its research and development (R&D) and technical-services areas, the company appointed Janis Matisons senior technical manager, reporting to Jerry Larson, vice-president of R&D. In addition, Jonathan Goff was appointed manager of Silicones R&D, and Yun Mi Kim was appointed technical service manager.
Hemispherx Biopharma, a specialty pharmaceutical company, appointed Ronald Ritz as senior director of manufacturing. Ritz previously served as senior director of technical operations at Enzon Pharmaceuticals.
Neogenix Oncology, a biotechnology company, appointed Albine Martin as COO. Martin was previously a partner at Adjuvant Global Advisors, a commercial strategy and business-development consulting firm, and a consultant to Neogenix for the past six months.
Savient Pharmaceuticals made three executive appointments in conjunction with the commercial launch of Krystexxa (pegloticase). Louis Ferrari was appointed senior vice-president of North America commercial, Christine Mikail was appointed senior vice-president of corporate development, and Stephen Davies was appointed chief information officer and group vice-president. All three will report to Savient CEO John H. Johnson.
Selcia, a provider of contract research services, appointed Simon Saxby as its CEO. He will assume his position in April 2011 and replace Hans Fliri, who will retain his role as chairman of the board. Selcia also appointed Andreas Rummelt as a nonexecutive director.
|
|
 | |
| |
|
The US Department of Health and Human Services released a new National Vaccine Plan on Feb. 16, 2011, to enhance coordination of all aspects of federal vaccine and immunization activities. The new plan, the first update to the system since 1994, is meant to ensure that all Americans can access the preventive benefits of vaccines. According to a press announcement on the HHS website, next steps include regional stakeholder meetings to discuss how to implement the strategies laid out in the plan. The final implementation is to be completed by the end of 2011.
|
|
|
|
|
| |
|
|
Tableting Equipment
From which region do you buy the majority of your tablet manufacturing equipment?
|
View the poll archive. |
|
|
|
