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 Software improves data retrieval
The updated version of Deacom’s (Wayne, PA) enterprise resource-planning (ERP) software contains features designed to help users retrieve information quickly. The software’s menu is now presented as a collapsible menu tree to make room for a section of frequently used documents. Users can grab items from the menu and move them to this new section. This feature makes the software easier to navigate and enables users to configure the system according to their own preferences.
The new version of the ERP also allows users to access dashboard reports more easily. These reports can be set up to retrieve data automatically from a particular week, month, or year, according to the user’s requirements.
The company also improved the software’s forecasting algorithms. Users can create forecasts based on historical data or data provided by customers. Operators also can adjust a forecast to reflect anticipated changes in operations. |
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Abbott Laboratories (Abbott Park, IL) and Pierre Fabre (Castres, France), an independent French pharmaceutical company, agreed to collaborate on the development and commercialization of h224G11, a preclinical monoclonal antibody that targets the cMet receptor, for the treatment of cancer. The companies will also collaborate on research to explore next-generation cMet antibodies.
Catalent Pharma Solutions (Somerset, NJ), which provides outsourced dose-form manufacturing and packaging to the global pharmaceutical industry, expanded its Schorndorf, Germany, site to include a new potent-products area. The expansion will allow Catalent’s Schorndorf facility to provide complex and innovative dose-form production, overencapsulation, and packaging solutions for potent products.
International biopharmaceutical company Cephalon (Frazer, PA) agreed to purchase Mepha (Switzerland), a privately held pharmaceutical company, for $590 million. Mepha specializes in dosage formulations and markets both generic and branded-generic products. The acquisition wlll diversify Cephalon’s business mix and double the size of its international business. Mepha manufactures and markets more than 120 products in 50 countries and reported 2009 sales of $380 million.
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analytica, March 23 – 26, 2010 in Munich, Germany
The world’s leading trade fair for Laboratory Technology, Analysis and Biotechnology. More than 1,000 exhibitors and 33,000 trade visitors attended analytica 2008. The 2010 show promises to be the most international analytica to date - there has been a 13% increase in international exhibitors so far. More information at
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Biopharmaceutical company Enzon Pharmaceuticals (Bridgewater, NJ) sold its specialty-pharmaceutical business to a US subsidiary of Sigma-Tau Pharmaceuticals (Gaithersburg MD). Enzon received $300 million in cash and may receive as much as $27 million more, based on the achievement of success milestones and specified royalties.
Daiichi Sankyo (Tokyo) filed a new drug application in Japan for the influenza drug CS-8958, which is delivered using Hovione’s (Loures, Portugal) TwinCaps inhaler. CS-8958 is a laninamivir prodrug, a long-acting neuraminidase inhibitor developed as an inhaled drug by Daiichi Sankyo for the Japanese market. Hovione has licensed its inhalation device patents to Daiichi Sankyo and Biota Holdings (Victoria, Australia) and collaborated on the formulation development.
The contract manufacturing organization Lonza (Basel) reported 2009 sales of CHF 2.69 billion ($2.55 billion), down from sales of CHF 2.94 billion ($2.77 billion). The company attributed the sales reduction to lower demand across all businesses, including order reductions in large-scale biopharmaceutical projects in custom manufacturing and recession-related lower demand in life-science ingredients.
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Merck KGaA (Darmstadt, Germany) started construction on a production plant that will manufacture inorganic salts at its Darmstadt, Germany, site. The new plant will increase Merck’s inorganic-salts capacity by about 50%. The company is investing around EUR 30 million ($42 million) in planning, developing, and constructing the plant, which will produce active ingredients and excipients for use in biopharmaceutical production processes, additives for the food industry, and laboratory reagents. The plant is scheduled to begin operation in mid 2011.
Penwest Pharmaceuticals (Patterson, NY), a drug-development company, signed a research and development agreement with Otsuka Pharmaceutical (Japan), a global-healthcare company, to develop a formulation of an undisclosed Otsuka compound utilizing Penwest's drug-delivery technology. Terms of the agreement were not disclosed.
Regis Technologies (Morton Grove, IL), a provider of synthesis and separation services for active pharmaceutical ingredients and intermediates, passed FDA’s preapproval inspection (PAI) for its manufacture of 4-aminopyridine, the active ingredient in Ampyra. Ampyra is produced by the biopharmaceutical company Acorda Therapeutics (Hawthorne, NY) and was approved by FDA in January 2010 as a treatment to improve walking in patients with multiple sclerosis. Regis Technologies also passed its general inspection by FDA, which was conducted during the same period as the PAI.
Sartorius Stedim Biotech (Aubagne, France) and Corning (Corning, NY), both suppliers to the pharmaceutical and biotechnology industries, will jointly market cell-culture products through a combined product catalogue. The companies will also work together on other marketing and sales initiatives and joint product development.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com
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FDA released its annual guidance agenda. The list of draft guidances the agency plans to develop and issue in 2010 is noted on the agency website. Noteworthy are draft guidances covering comparative claims in prescription-drug promotion, direct-to-consumer advertisements, drug-product promotion using social-media tools, chemistry, manufacturing, and control (CMC) postmarketing plans, CMC postapproval changes reportable in an annual report, residual drug in transdermal drug-delivery systems, combination-drug development, pediatric-drug labeling, electronic regulatory submissions, current good manufacturing practice for highly potent compounds, and importation of active pharmaceutical ingredients for human drugs.
President Obama issued a memorandum to executive-department heads and agencies one year ago calling for a revision to the principles guiding the federal regulatory process, according to OMB Watch, a nonprofit government watchdog organization. The memo required federal agencies (including FDA) to submit recommendations for a new executive order within 100 days. Public comments were also requested. Now that the president has completed his first year in office, OMB Watch has called on Obama to complete this process by issuing a revised executive order. OMB Watch would like to see greater flexibility for agencies as well as “a more streamlined process for engaging in rulemaking and seeking White House review…. Currently, agencies are required to perform any number of analyses before writing new standards, including the notoriously unreliable cost−benefit analysis,” says the OMB Watch press release. The nonprofit noted the president’s commitment to transparency, an initiative which FDA is pursuing through its Transparency Initiative. OMB Watch's detailed recommendations for reforming the regulatory process are online, including specific recommendations for FDA.
According to a Jan. 29, 2010 Reuters article, the number of Warning Letters FDA sent in 2009 (41) was nearly double the number of letters sent in 2008 (21). Thomas Abrams, head of FDA's Division of Drug Marketing, Advertising, and Communication, told Reuters that the agency had already sent nine letters in 2010. "We're trying to get the point across to industry that we want them to comply with the law because it affects public health," he told Reuters. "If you don't comply with the law, we are going to take action."
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Bioanalytical Systems (West Lafayette, IN) announced that Richard M. Shepperd,
its president and chief executive officer, has retired as president and intends to retire from his other positions later this month. Anthony S. Chilton, BASi's chief operating officer, Scientific Services, was appointed interim president.
Catalent Pharma Solutions (Somerset, NJ) appointed Kurt Nielsen chief technology officer and senior vice-president, innovation and growth, effective immediately. Nielsen will be responsible for innovation activities and investments across Catalent’s advanced dose forms and packaging technologies.
Cephalon (Frazer, PA) named Kevin Buchi chief operating officer; Wilco Groenhuysen executive vice-president and chief financial officer; and Alain Aragues executive vice-president and president of Cephalon Europe. |
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CMO Market
What factor do you think will be most significant in 2010 for determining the health of the market for contract manufacturing of active pharmaceutical ingredients?
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