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FDA Recommends Reducing Residual Drug in Transdermal Delivery Systems
In a draft guidance, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use “an appropriate scientific approach” during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products’ labeled use periods. 
Senate Committee Passes Measures Restricting Patent Settlements
The US Senate Appropriations Committee approved a measure that would restrict certain patent settlements under which innovator-drug companies pay generic-drug companies to delay the entry of a generic product.
SOCMA Raises Concern over TSCA Reform
Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 that involve chemical safety and reporting requirements are drawing criticism from the chemical industry.
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 Monitoring system safeguards data
Testo’s (Sparta, NJ) Saveris system monitors temperature, humidity, and pressure through wireless or Ethernet probes. The system’s external temperature probes provide measurements accurate to within 0.4 °F, and its external humidity probe provides measurements accurate to within 1%. The system’s internal and external probes fit any custom configuration and integrate with Testo’s industrial transmitters.
The Saveris system’s software provides automatic operation and recordkeeping. Users can program the system to send email or text alarm notifications to several responders automatically. In addition, the software creates daily or weekly graphic reports and automatically saves them to a storage location or mails them to chosen recipients.
The system’s base can store 40,000 readings per channel if the computer connection is lost. The probe pooling is timed, and data are sent in short bursts. If external interference prevents pooling or affects the transmission, data are stored internally in each probe until communication is re-established to prevent data loss. |
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The US Food and Drug Administration approved an inhalation product by 3M (St. Paul, MN) using the 3M Integrated Dose by Dose Counter. The product, which also incorporates 3M’s fluorinated ethylene polymer coating, received FDA approval after a one-cycle review of the new drug application. The counter is designed to helps prevent patients from running out of medication in their metered-dose inhalers by providing an accurate count of how much medication remains.
Contract manufacturing organization Aptuit (Greenwich, CT), and Siena Biotech (Siena, Italy), a drug-discovery company, formed a partnership in which Siena Biotech will take a minority stake in Aptuit's Italian operations in Verona, Italy, and Aptuit will become a “provider of choice” for Siena Biotech. Under the agreement, the companies will focus on developing Siena Biotech's pipeline of compounds, involving three therapeutic areas: Alzheimer's disease, Huntington's disease, and oncology. Financial terms were not disclosed.
Almac (Craigavon, UK) launched its biomarker service, Biomarkers for Biopharma, designed for biopharmaceutical companies to use for pharmacodynamic solutions, patient-selection markers, assay development, and bioinformatics/biostatistics.
Bilcare (Pune, India), a provider of packaging, will acquire the global films business of the Ineos Group (Lyndhurst, UK) for approximately €100 million ($132.3 million). The company’s films business produces materials for pharmaceutical blister packaging. The deal comprises the business, assets, and personnel related to Ineos’s films operations located in North America, Europe, and Asia.
The global charity Cancer Research UK recently opened its manufacturing hub and marked the launch of its Biotherapeutics Development Unit. The new £18-million ($28.7-million) drug-manufacturing facility is part of Cancer Research UK's Drug Development Office and is based at its Clare Hall site in Hertfordshire. The organization’s first product is an antibody for treating a range of cancers, called Chi Lob 7/4, and is currently being tested in a Phase I clinical trial to treat cancer patients who are no longer responding to conventional treatment.
Charles River Laboratories International (Wilmington, MA), a contract research organization, mutually agreed with WuXi PharmaTech (Cayman) Inc. (Shanghai) to terminate the previously announced acquisition agreement. Under the termination agreement, Charles River will pay WuXi a $30-million breakup fee. Charles River’s board of directors also authorized a new $500-million stock repurchase program.
DiTEBA Research Laboratories (Mississauga, Canada), a provider of analytical testing services, and Thesis Chemistry (Cambridge, Canada), a provider of contract chemistry services, will collaborate to expand their offerings to the pharmaceutical and biopharmaceutical industries.
Biopharmaceutical company Emergent BioSolutions (Rockville, MD) opened a biomanufacturing unit in Baltimore, Maryland. The new facility consists of 56,000 ft2 of manufacturing and office space and includes multiple manufacturing suites designed to support clinical and commercial manufacture of the company's rPA, anthrax monoclonal, and tuberculosis product candidates.
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Chemical manufacturer Gelest (Morrisville, PA) appointed Gautavik International (Mumbai) the exclusive distributor of Gelest’s complete line of silane, metal-organic, and silicone products in India. Targeted life-science sectors include pharmaceuticals, biosciences, dental, and medical devices.
Merrion Pharmaceuticals (Dublin), a pharmaceutical development company, announced that its new facility in Citywest, Ireland, has been licensed under the European Union’s Clinical Directive for Investigational Medicinal Products. Inspections conducted by the Irish Medicines Board confirmed the quality, safety, and efficacy of medicines developed at the facility. The 30,000-ft2 facility was acquired by Merrion in July 2009 and is designed to develop new drug products and manufacture products for clinical development.
Novartis Vaccines (Cambridge, MA) started shipping seasonal influenza vaccine to US customers for the 2010–2011 season. The company plans to supply approximately 40 million doses of Fluvirin (influenza virus vaccine), which has been approved by the US Food and Drug Administration for patients age 4 and older, according to a company press release. The Influenza A (H1N1) strain is included in this year’s seasonal influenza vaccine.
Contract research organization PPD (Wilmington, NC) expanded its current good manufacturing practice (CGMP) laboratory-testing services in Wayne, Pennsylvania. The 5000-ft2 facility will provide small- and large-molecule testing for a range of product-development programs including vaccines and biologics. The facility can be expanded to include an additional 10,000-ft2 of laboratory space.
Sensient Technologies (Milwaukee, MN) plans to expand its pharmaceutical coating capabilities at its Color Group headquarters site in St. Louis, Missouri. With the expansion, Sensient will increase the square footage dedicated to pharmaceutical coatings by more than 50% and raise its batch size significantly to accommodate larger orders, according to a company press release.
Teva Canada, part of Teva Pharmaceutical Industries (Jerusalem), reached an agreement with Canada’s Competition Bureau on its acquisition of ratiopharm (Ulm, Germany). The Bureau said Teva and ratiopharm are free to close the transaction without competition-related risk.
The US Food and Drug Administration has approved vaccines for the 2010–2011 influenza season in the United States. The vaccine is made up of three strains of influenza, including the 2009 Influenza A H1N1 virus. The following manufacturers will produce this season’s vaccines: CSL Limited (Melbourne, Australia), Novartis Vaccines and Diagnostics (Cambridge, MA), GlaxoSmithKline Biologicals (Brussels, Belgium), ID Biomedical (Seattle), MedImmune Vaccines (Gaithersburg, MD), Novartis Vaccines and Diagnostics (New York), Sanofi Pasteur (Lyon, France).
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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Generic-drug producer Caraco Pharmaceutical Laboratories (Detroit) named G.P. Singh Sachdeva COO of the company. Previously, Singh served as senior vice-president of business strategies of the company from July 2007 to July 2010, vice-president of sales and marketing from September 2003 to July 2007, and national sales and marketing manager from September 2000 to September 2003.
CT Atlantic (Schlieren, Switzerland), a biotechnology company focused on cancer treatment by human-derived antibodies, appointed Michael Höcker as its CEO. In addition, Cara Lerner was appointed to COO.
Cytomedix (Rockville, MD), a developer of biologically active regenerative therapies for wound care, appointed Patrick P. Vanek to the newly created position of vice-president of operations.
Biopharmaceutical company Dynavax Technologies (Berkeley, CA) promoted J. Tyler Martin to the newly created position of president and appointed Martin to the company's board of directors. Martin joined Dynavax as chief medical officer in February 2009.
Global Research Services (Rockville, MD), a cardiovascular clinical-research organization, named Benoît Martin as its European general manager and executive vice-president of global development. Martin will be based at the company’s Langenfeld, Germany, office.
Lupin Ltd. (Mumbai) appointed Paul McGarty president of its US subsidiary, Lupin Pharmaceuticals, Inc., which is headquartered in Baltimore, Maryland. McGarty previously served as CEO of Nycomed (Zurich).
Quintiles (Research Triangle Park, NC), a biopharmaceutical services company, appointed Kevin K. Gordon as its CFO. Gordon succeeds current CFO Mike Troullis, an 18-year veteran of Quintiles. |
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Pay-to-Delay
Do you agree with the US Federal Trade Commission that pay-to-delay deals are anticompetitive?
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View the poll archive. |
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