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Draft Guidance Issued on Capsule Bead Size
FDA issued a draft guidance for industry about the size of beads within drug products labeled for sprinkle. 
Avandia Costs GSK $3.4 Billion
GlaxoSmithKline is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products.
Sanofi Offer Set to Expire, Public Position Remains Unchanged
French daily Le Figaro reported that sanofi-aventis intended to reach an acquisition agreement with Genzyme that would value the latter company at roughly $76 per share, or a total of $20 billion.
EU Examines Patent Settlements
The EU Commission is on the lookout for “potentially problematic patent settlements” and has asked several pharmaceutical companies to submit copies of their patent settlement agreements made between originator and generic-drug companies.
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 Sensor provides speed and sensitivity
The Light-Induced Fluorescence (LIF) sensor from Natoli Engineering is designed to enable real-time monitoring of fluorescent analytes through intrinsic fluorescent sensing in the solid or liquid states. The sensitivity of fluorescence is roughly 1000 times greater than that of absorbance spectroscopy, and the sensor can detect residual active pharmaceutical ingredients (APIs) in rinse water and on surfaces.
The LIF sensor incorporates onboard control sensors, such as reference photodiodes, an accelerometer, a thermal monitor, and various diagnostic tools, that help to provide high-quality data. The device’s data output occurs every 100 ms, and this fast response time enables employees to make production decisions.
The LIF Sensor can verify tablets’ API content and is suitable for analyzing low-dose, high-potency drugs. Personnel also can use the device to monitor material during granulation, detect the end point of blending operations, and aid in cleaning verification. Because the device can monitor materials at any point in production, it can aid root-cause analysis.
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Allos Therapeutics, a biopharmaceutical company, will reduce its workforce by approximately 13%, primarily in research and development and general and administrative positions, according to the company’s fourth quarter report. The company will focus resources on its anticancer drug Folotyn (pralatrexate injection).
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FDA announced that the US District Court for the Southern District of Texas entered a consent decree of permanent injunction against contract manufacturer Deltex Pharmaceuticals, its president, Kabir Ahmed, and vice-president, Mohidur R. Khan. The consent decree permanently prohibits the company, Ahmed, and Khan from manufacturing and distributing drug products until Deltex's manufacturing operations and products are in compliance with federal law and the terms of the consent decree. Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing over-the-counter drug products, and failed to comply with current good manufacturing practice (CGMP) requirements.
Eisai Europe Limited, a subsidiary of the Tokyo-based pharmaceutical company Eisai Co., Ltd, established a sales and marketing operation in its wholly owned subsidiary in Amsterdam. The first Eisai product on the Dutch market is the epilepsy treatment Zonegran (zonisamide).
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Galbraith Laboratories, a provider of analytical services, added an Agilent GC/MS 5975C inert mass-spectroscopy detector (MSD) using EI ionization. The MSD system provides additional analytical capabilities and allows Galbraith to offer clients enhanced organic testing services.
ICON, a global provider of outsourced development services, expanded its late phase and outcomes research services through the acquisition of Oxford Outcomes, an international health-outcomes consultancy. Elizabeth Thiele, formerly ICON’s executive vice-president of business development, has been appointed president of the unit. Oxford Outcomes provides services in the areas of patient-reported outcomes, health economics, epidemiology, and translation and linguistic validation.
McNeil Consumer Healthcare, a division of Johnson & Johnson, announced a voluntary recall on Jan. 14, 2011, at the wholesale level, of certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol upper respiratory products, and certain lots of Benadryl, Sudafed PE, and Sinutab products distributed in the United States, the Caribbean, and Brazil. The company said in a statement that the products were manufactured at the McNeil plant in Fort Washington, Pennsylvania, prior to the April 2010 shut-down of the facility due to a previous recall of children and infants’ medications. After review of past production records, the company found instances where equipment-cleaning procedures were insufficient or that cleaning was not adequately documented. McNeil is also recalling of certain product lots of Rolaids Multi-Symptom Berry Tablets distributed in the United States, in order to fix a labeling issue—certain lots do not include the language “Does not meet USP” as required by regulation. The company said that these actions are not being undertaken on the basis of adverse events.
Merck entered into an alliance with Parexel International, a global biopharmaceutical services provider, under which Parexel will provide global clinical development services for designated biosimilar candidates to Merck BioVentures, a division of Merck focused on biosimilars. Parexel will provide a broad range of regulatory strategy and clinical development planning capabilities and will also establish a dedicated Merck BioVentures unit within its organization. Further details of the agreement were not disclosed.
RecipharmCobra Biologics, a biopharmaceuticals manufacturer, published the results of a study to develop an oral vaccine against tuberculosis in the journal Vaccine.
The study showed that the orally delivered ORT-VAC DNA vaccine produced higher immune responses in mice than the injected DNA vaccine. This resulted in a reduction in the lungs of the TB bacterium Mycobacterium tuberculosis in immunized mice. Previous studies using ORT-VAC to deliver protein vaccines have protected against bubonic plague and anthrax in mice. Research was conducted in collaboration with the Royal Holloway, University of London, and the Università Cattolica del Sacro Cuore, in Rome.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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ImmunoGen, a biotechnology company, appointed Theresa G. Wingrove vice-president of regulatory affairs. Wingrove reports to Daniel Junius, president and CEO.
Pharmaceutical company Orexo appointed Anders Lundström as its new CEO. Lundström joins Orexo from the biotechnology company Biogen Idec, where he was head of the company’s hemophilia division.
PharmAthene, a developer of medical countermeasures against biological and chemical weapons, made the following appointments: Susan Linna is vice-president of program management, Kevin Connolly is senior program director for rPA-based anthrax vaccines, Kimberly Taylor is senior program director for Valortim Anthrax antitoxin, and Thomas Fuerst is executive vice-president and CSO.
Erich Hunziker, CFO, chief information officer, and deputy head of the corporate executive committee, will retire from Roche at the end of March 2011 and plans to focus on several board memberships. Roche appointed Alan Hippe to succeed Hunziker as CFO. Hippe will join Roche as a member of the corporate executive committee as of April 2011.
Simcere Pharmaceutical Group, a pharmaceutical company, appointed Yushan Wan, the company’s corporate controller, as acting CFO. Frank Zhao resigned as CFO last week for personal reasons.
Peter Riehl retired as CEO, president, and director of Stellar Pharmaceuticals. Arnold Tenney, who has been chairman of the company since 2005, will serve as the interim CEO until a permanent replacement is found.
Jan Smilek, CFO and vice-president of finance for Sucampo Pharmaceuticals, has resigned. The company will initiate search for a new CFO.
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FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule, according to an agency release dated Jan. 13, 2011. Because of continued reports of liver injury, FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products with black boxes to warn of the potential risk for severe liver injury. The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years.
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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: Next month’s Viewpoint column discusses drug reimportation in the February issue of Pharmaceutical Technology. |
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FDA Recalls
FDA recently was granted the authority to issue recalls for food products. Should the agency have this power for pharmaceuticals as well?
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View the poll archive. |
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