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FDA Testifies to Congress Regarding J&J Recalls, Quality Concerns
About one month after the announcement of McNeil Consumer Healthcare’s recall of children’s liquid pain and allergy medications, the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue. 
FDA Partners with Drugs.com
The US Food and Drug Administration began a partnership with the website Drugs.com to expand access to the agency's consumer-health information.
Congress Holds Hearings on the Benefits and Risks of Synthetic Biology
The US House of Representatives held hearings last week to gain testimony on the potential benefits and risks associated with synthetic biology and synthetic genomics.
EMA Database Aids Safety Monitoring
A study conducted by the European Medicines Agency showed that statistical methods using the agency’s EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues “significantly earlier” compared with routine pharmacovigilance. |
 Column oven reproducibly controls temperature
The Thermo Scientific (Waltham, MA) Column Oven efficiently and reproducibly controls the temperature of high-performance liquid chromatography (HPLC) columns within 0.1 °C. Probes read the temperature
of a heated plate within the column and transmit the data to the controller to maintain a constant temperature. The unit is insulated to minimize heat loss.
The Column Oven is available in models that accommodate four 150- or 250-mm analytical HPLC columns. The device’s controller uses a touch screen to enable easy and fast manual temperature control. A user-determined default temperature is applied at startup.
Operators can press the appropriate spot on the screen to adjust the oven’s temperature. The Column Oven incorporates holding adapters that allow the unit to fit into existing systems easily. The product is appropriate for applications in which it is desirable to place a column close to the ion source of a mass spectrometer.
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| AAIPharma Services (Wilmington, NC), a contract development and manufacturing organization (CDMO), has opened new laboratory facilities in Durham, North Carolina, consolidating its former Chapel Hill, North Carolina, laboratories into one site. The new 180,000-ft2 laboratories provide good manufacturing practice (GMP) analytical testing.
AMRI (Albany, NY), a contract manufacturer of active pharmaceutical ingredients (APIs) and intermediates, is reducing its US workforce by 10%, or approximately 80 jobs. The company also is suspending operations of its research facilities in Rensselaer, New York. As part of a planned investment in 2009 and 2010, the company is spending $30 million on international facility and capability expansions and estimates it will increase its non-US workforce by 180 positions.
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AstraZeneca (London) has received a complete response letter (CRL) from the US Food and Drug Administration for its new drug application for Axanum (aspirin/esomeprazole magnesium) tablets. The company also received a CRL for its supplemental new drug for Nexium (esomeprazole magnesium). AstraZeneca is evaluating the CRLs and will continue discussions with FDA, according to a company press release.
Biocon (Bangalore, Karnataka, India), a CDMO, has signed a long-term agreement with the biopharmaceutical company Optimer Pharmaceuticals (San Diego) for commercially manufacturing the API fidaxomicin, a macrocyclic antibiotic.
Celsis (Chicago), a provider of rapid microbial detection products and services, recently updated its drug master file with FDA to include information on testing nonsterile and sterile raw materials, in-process solutions, and finished goods on the Celsis system.
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Centocor Ortho Biotech (Horsham, PA), part of Johnson & Johnson (New Brunswick, NJ) has acquired RespiVert (London), a drug-discovery company focused on developing small-molecule, inhaled therapies for treating pulmonary diseases.
Claris Life Sciences (Ahmedabad, Gujarat, India) has initiated a recall of all lots of the intravenous (i.v.) medications, metronidazole, ciprofloxacin, and ondansetron. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals (Schaumburg, IL), Pfizer (New York), and West-Ward Pharmaceuticals (Eatontown, NJ) labels. FDA has advised healthcare professionals not to use these products because of potential contamination. According to an FDA notice, FDA received reports of floating material in i.v. bags of metronidazole and ondansetron.
Covidien (Dublin), a provider of healthcare products, has agreed to sell its specialty chemicals business to an affiliate of New Mountain Capital for $280 million. The business, based in Phillipsburg, New Jersey, manufactures and markets high-purity chemicals and related products under the J.T. Baker and Mallinckrodt Laboratory Chemicals brand names. The products are used in the pharmaceutical, biotechnology, and other industrial markets.
DPT Laboratories (San Antonio, TX), a CDMO, has completed a $15-million investment at its 450,000-ft2 center of excellence for semisolids and liquids in San Antonio. The expansion includes two bulk manufacturing areas, the addition of three manufacturing filling lines, clinical-scale manufacturing for pressurized metered dose inhalers, lighting options for light-sensitive materials, and advanced air filtration and handling.
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Expansion of Vetter Development Service (VDS)
The North American market is critical to Vetter’s strategic global growth as nearly half of its client base is already located here. In order to maximize on this opportunity, Vetter has decided to create a facility, its first outside of Germany, at the Illinois Science + Technology Park in suburban Chicago. The facility, which focuses on preclinical to phase II clinical batch projects, is an expansion of Vetter Development Service. With significant progress already having been made, the facility is scheduled to be operational by beginning of the fourth quarter 2010.
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Genzyme (Cambridge, MA) has received US marketing approval from FDA for Lumizyme (alglucosidase alfa), produced at the 4000-L bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is a lysosomal glycogen-specific enzyme for treating Pompe disease.
ISP Pharmaceuticals (Wayne, NJ) has added new equipment at its Sao Paulo, Brazil, laboratory for developing pharmaceutical pellets and evaluating excipient and coatings in pharmaceutical pellets prepared by extrusion spheronization.
Lubrizol (Cleveland, OH) plans to invest $40 million in its Calvert City, Kentucky, facility, which manufactures Carbopol polymers, which are used in the pharmaceutical, personal care, and home care markets.
Siegfried USA (Pennsville, NJ), part of the Siegfried Group (Zofingen, Switzerland), a contract API manufacturer, has formed a supply pact with Jazz Pharmaceuticals (Palo Alto, CA). Under the agreement, Siegfried will supply at least 60% of Jazz’s requirements for sodium oxybate, the API in Xyrem, a drug to treat sleeping disorders.
Thermo Fisher Scientific (Waltham, MA), an analytical instrumentation and science services company, has agreed to acquire Fermentas International (Burlington, Ontario, Canada), a distributor of enzymes, reagents, and kits for molecular and cellular biology research, for $260 million in cash subject to a post-closing adjustment. The deal is expected to close in the third quarter of 2010. Fermentas will become part of Thermo Fisher’s analytical technologies segment.
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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| The US Pharmacopeia (USP) and Russia’s Roszdravnadzor, the federation’s regulatory healthcare agency, signed a memorandum of understanding in April 2009 to work toward protecting and improving the quality of medicines. As part of the agreement, USP announced on June 1, 2010, that it has completed a series of eight drug quality courses at Moscow’s Scientific Center for Expertise of Medical Products. Approximately 100 Russian laboratory specialists attended the workshops. |
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| Amylin Pharmaceuticals (San Diego) appointed Christian Weyer senior vice-president, research & development (R&D). Orville Kolterman was named senior vice-president, chief medical officer. These changes will help the company focus on preparations for a new product launch and the advancement of its late-stage development programs, according to a company press release.
AstraZeneca (London) appointed Martin Mackay to the newly created position of president of R&D, effective July 1, 2010. Mackay joins AstraZeneca from Pfizer (New York) led the pharmatherapeutics R&D group.
Ikaria (Clinton, NJ), a biotherapeutics company, appointed Douglas Greene, executive vice-president of R&D. Greene succeeds Ralf Rosskamp, who held the position since 2007.
Pfizer (New York) named Mikael Dolsten president of Pfizer worldwide R&D. Dolsten previously led Wyeth’s R&D organization from May 2008, and after the close of the Wyeth acquisition was named president of Pfizer’s biotherapeutics R&D.
Specialty pharmaceutical company Xanodyne Pharmaceuticals (Newport, KY), named Natasha Giordano president, CEO, and as a member of the board of directors, succeeding Michael J. Valentino. Giordano most recently served as the company's chief operating officer. |
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Anticounterfeiting solutions
Which anticounterfeiting solution is your company currently using?
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