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J&J Voluntarily Recalls Rolaids Products
McNeil Consumer Healthcare, a division of McNEIL-PPC, part of Johnson & Johnson issued a voluntary recall on Dec. 9, 2010, for Rolaid products in the United States and Canada due to reports of possible product contamination. 
A Bad Year for Pharmaceutical R&D in Europe
Figures released by the European Medicines Agency regarding the evaluation of marketing-authorization applications show a significant decline in the number of approved products for 2010.
Abbott, B. Braun, and Roxane Pay $421.2 Million to Settle False-Claims Allegations
Abbott Laboratories, B. Braun Medical, and Roxane Laboratories, a subsidiary of Boehringer Ingelheim, agreed to pay the United States $421 million to settle False Claims Act allegations.
Pfizer's Thelin Withdrawn Due to Fatalities
Following two cases of fatal liver injury, Pfizer has voluntarily withdrawn Thelin (sitaxentan) from the worldwide market and discontinued all ongoing trials.
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 Control system eases access to information
Version R4.03 of Yokogawa’s (Sugar Land, TX) Centum VP production-control system incorporates an enhanced operator interface to batch software. Operators now can locate, deploy, and monitor recipes in fewer keystrokes than before. The interface also displays parameters such as elapsed time, unit status, and operation identification in one overview screen when a control recipe is running. Users thus do not have to seek information in several locations. In addition, the Centum VP software’s operator interface now uses frames and structured windows to simplify access to data and displays. Users can move between tabs with keystrokes to find information quickly, rather than calling up a new display or linking to a separate display. Yokogawa also has modified the software’s trend display system. A single screen now allows users to compare batches’ performance with that of a reference batch.
The software lets operators use Windows authentication or Yokogawa sign-ons for access to files. Personnel can set up user security attributes and restrict access easily for added data and access security.
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BioStorage Technologies (Indianapolis), a provider of management services, cold-chain logistics, and biomaterial storage, has expanded its service offerings to include a suite of global sample relocation services. The expanded capabilities allows the company to facilitate the transportation of entire sample inventories and associated equipment.
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Cephalon (Frazer, PA), a biopharmaceutical company, and Mesoblast (Melbourne, Australia), a developer of stem-cell therapies, formed a strategic alliance to develop Mesenchymal Precursor Stem Cell (MPC) therapeutics for degenerative conditions of the cardiovascular and central nervous systems. These conditions include congestive heart failure, acute myocardial infarction, Parkinson's disease, and Alzheimer's disease. The alliance also extends to products for augmenting hematopoietic stem-cell transplantation in cancer patients. In exchange for exclusive worldwide rights to commercialize specific products based on Mesoblast's proprietary adult stem-cell technology platform, Cephalon will make an upfront payment of $130 million and regulatory milestone payments of up to $1.7 billion.
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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.
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Dicerna Pharmaceuticals (Watertown, MA), an RNA interference (RNAi) company, and Kyowa Hakko Kirin (Tokyo), a biopharmaceutical company, expanded their ongoing research collaboration into the new therapeutic area of immunologic and inflammatory diseases. In January 2010, the companies announced a research collaboration and license agreement worth up to $1.4 billion for the research, development, and commercialization of DsiRNA pharmaceuticals and drug-delivery systems for therapeutic targets in oncology based on Dicerna’s proprietary Dicer Substrate Technology and Dicer Substrate siRNA (DsiRNA) molecules.
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DPT Laboratories (Lakewood, NJ), a pharmaceutical contract development and manufacturing organization, received US Food and Drug Administration approval to manufacture commercial supplies of a sterile ointment for wound care at its center of excellence for sterile and specialty products in Lakewood, NJ. Earlier this month, product began to ship from the site to North American customers.
Eli Lilly and Company (Indianapolis) has suspended its global Phase III study evaluating tasisulam, an investigational, small-molecule anticancer compound, as a second-line treatment for those with unresectable or metastatic melanoma. Lilly, in consultation with an independent data monitoring committee, recommended a "full clinical hold" because of safety concerns, meaning patients in the trial will not receive additional doses of the compound, allowing researchers the time to fully analyze existing data. Tasisulam was granted orphan drug status for stage 2b-IV melanoma by FDA in late 2009.
Forest Laboratories Ireland, a subsidiary of Forest Laboratories (New York), formed an agreement with Gruenenthal (Aachen, Germany) to develop an oral small-molecule analgesic, GRT 6005, and its follow-on compound GRT 6006. The agreement provides that Forest pay Gruenenthal an undisclosed upfront license payment in addition to development and commercialization milestones and royalties on net sales.
Contract manufacturer Inno Biologics (Nilai, Malaysia) delivered clinical-trial material to Avesthagen (Bangalore, India), a life-science company. The companies also signed a letter of intent for Inno Biologics to manufacture biosimilars for Avesthagen.
Johnson & Johnson (J&J, New Brunswick, NJ) made a public offer to acquire the biotechnology company Crucell (Leiden, The Netherlands). J&J, which owns 18% of Crucell, previously announced its intention to acquire the company. J&J’s offer of EUR 24.75 ($33) per share results in a total acquisition price of roughly EUR 1.75 billion ($2.3 billion).
Merck & Co. (Whitehouse Station, NJ) agreed to acquire SmartCells (Beverly, MA), a company developing a glucose-responsive insulin formulation for the treatment of diabetes mellitus. Merck will acquire all outstanding stock of SmartCells, whose shareholders will receive an upfront cash payment and be eligible to receive milestone payments for products resulting from the transaction of up to $500 million. SmartCells' board of directors has unanimously approved the transaction.
The PATH Malaria Vaccine Initiative, Merck & Co. (Whitehouse Station, NJ), and NYU Langone Medical Center are working together to evaluate an approach targeting a novel part of a major surface protein on the malaria parasite with the goal of developing a vaccine to prevent the malaria parasite from entering the human liver. The circumsporozoite protein (CSP) has been recognized as a potential target in the development of vaccines focused on the earlier stages of malaria infection, says a Merck press release, and the researchers are focusing on a new approach that targets a region of CSP important to a critical function of the protein.
Sartorius Stedim Systems, a subsidiary of Sartorius Stedim Biotech (Göttingen, Germany), will expand its production capacity with the construction of a new plant to be built in Guxhagen, Germany. Construction is scheduled to begin in the spring of 2011; Sartorius Stedim Systems plans to relocate in the first quarter of 2012. Thermo Fisher Scientific (Waltham, MA) agreed to acquire Dionex (Sunnyvale, CA), a manufacturer of chromatography systems, for $118.50 per share in cash, or a total purchase price of approximately $2.1 billion. The boards of directors have unanimously approved the transaction, which is expected to be completed in the first quarter of 2011.
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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Service provider Catalent Pharma Solutions (Somerset, NJ) appointed Scott Neilson vice-president of operations development, Elaine Dymond vice-president of quality, Ronald Overhiser vice-president of innovation operations, and Evjatar Cohen vice-president of portfolio management.
Chemsultants International (Mentor, OH), a provider of specialty polymer-based products and technologies, promoted Berry Decker to technical project manager and Cheryl Saqqa to testing project leader.
Merck KGaA (Darmstadt, Germany) appointed Stefan Oschmann as a member of the executive board and general partner of Merck KGaA. Oschmann succeeds Elmar Schnee, who leaves the company for personal reasons. Oschmann will be responsible for the company’s Merck Serono and Consumer Health Care divisions and will assume the lead of Merck Serono as of Jan. 1, 2011. In addition, Kai Beckmann was named a member of the executive board and general partner of Merck KGaA, effective Apr. 1, 2011. He will be responsible for the newly created executive board position of human resources.
Pfizer’s (New York) board of directors elected George A. Lorch, who has served as an independent director since 2000, as nonexecutive chairman of the board. Lorch has relinquished his positions on the Compensation and Science and Technology Committees to focus on his role as chairman. The board elected James Kilts chairman of the Compensation Committee effective today.
Joseph G. Acker, the former president and CEO of the Society of Chemical Manufacturers and Affiliates (SOCMA), died last week after battling pancreatic cancer. SOCMA is the US-based trade association representing batch and custom manufacturers, including contract manufacturers of active pharmaceutical ingredients and intermediates. Acker retired from SOCMA in December 2009 after 16 years with the organization.
Stephen A. Munk, president and CEO of Ash Stevens (Detroit, MI) was elected to the board of governors of the Society of Chemical Manufacturers and Affiliates, during the organization’s 89th annual membership meeting in New York on Dec. 6, 2010. |
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On Dec. 9, 2010, the US Food and Drug Administration issued a final guidance about how to comment during the agency's advisory committee meetings, including the process and timeframe. The guidance finalizes information contained in the 2005 draft document, titled The Open Public Hearing FDA Advisory Committee Meetings Draft Guidance. The new guidance takes effect with meetings held in March 2011.
On Dec. 14, 2010, the US Food and Drug Administration issued a draft guidance for industry on the development of combination drugs. The document provides recommendations for sponsor companies working to codevelop two or more novel drugs to be used in combination to treat a disease or condition. Comments are due within 60 days of the guidance's issue date. |
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Take the 8th Annual Global BioManufacturing Survey |
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Budget trends, new technologies, capacity, outsourcing and hiring issues, downstream processing, disposables, cost cutting, and quality initiatives, are just a few of the important topics covered in this year's 8th Annual Biopharmaceutical Manufacturing Report and Survey held by BioPlan Associates, Inc. Last year, more than 400 biomanufacturers and suppliers participated globally, and this year we're expecting even more. You will receive a free summary of the results from the study. In addition, for each completed survey, BioPlan Associates will donate $10 (up to $10,000) to the Global Alliance for Vaccine Initiative, or American Cancer Society.
Coming Soon: A peer-reviewed article focuses on analysis of root causes for recalls in the January issue of Pharmaceutical Technology. |
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Needleless devices
Do you believe that needleless devices will ever fully replace traditional syringes for patient self medication?
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View the poll archive. |
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