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 Machine cleans tanks efficiently
The HydroWhirl Orbitor tank-cleaning machine from BETE Fog Nozzle (Greenfield, MA) is designed for clean-in-place applications. The rotating device’s long-range cleaning jets enable it to wash tanks with diameters as large as 130 ft. Controlled rotation speed and concentrated spray jets help the device to clean many tanks in a single spray-pattern cycle. The machine’s rotor and stator maximize cleaning efficiency based on the client’s specific flow rate, operating pressure, and tank size.
The HydroWhirl unit’s simple design and small number of parts allow users to disassemble and reassemble it in 15 min or less. The device’s seals and bushings are made of 10% carbon-filled PTFE to resist wear and static buildup. Its gears and housing are made of 316 stainless steel to extend the machine’s service life. In addition, the product cleans itself, and its gearbox lubricates itself, thus reducing the possibility of process contamination.
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Management of Water/Cleaning Validation
From inspections of the water used in drug manufacture to cleaning validation, Shimadzu’s TOC analyzers are ideal for the management of the total amount of organic carbon in drug manufacturing processes. Multiple oxidation methods (combustion catalytic and wet chemical) can be, and they can also be used with the swab direct combustion method when combined with a solid sample combustion unit.
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| Biopharmaceutical company Ablynx (Ghent, Belgium) extended its development pact with Pfizer (New York) for one year. The company has a license agreement with Pfizer to develop Nanobody-based therapeutics against tumor necrosis factor alpha. This is the third extension of the collaboration.
In other Ablynx news, Boehringer Ingelheim (Ingelheim, Germany) has selected a Nanobody lead candidate for further development for the treatment of Alzheimer’s disease. This is the first lead candidate emerging from the Alzheimer’s disease collaboration between the two companies and will result in a €2 million ($2.5 million) milestone payment to Ablynx. AstraZeneca (London) reached a patent-litigation agreement with Teva Pharmaceuticals USA, regarding Teva’s proposed generic version of AstraZeneca’s Entocort EC (budesonide) capsules. AstraZeneca granted Teva a license to enter the US market with its generic version of oral budesonide on Feb. 15, 2012, subject to regulatory approval, or earlier in certain circumstances. Teva has conceded that both patents-in-suit in the litigation are valid and enforceable, and that both patents would be infringed by the manufacture or sale of Teva’s generic version of oral budesonide.
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Bayer Schering Pharma (Berlin), will establish a US innovation center in San Francisco, California, focused on expanding its global research network and building its specialty pharmaceutical pipeline. The company plans to use 49,000 ft2 leased laboratory and administrative space as a hub for collaborating with academic research scientists and small biotech firms to develop and commercialize products
Biogen Idec (Cambridge, MA) and Abbott (Abbott Park, IL) began a global Phase III study of daclizumab compared to interferon beta-1a (Avonex) in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). The trial investigates a subcutaneous formulation of daclizumab intended for monthly administration. Under the terms of the companies’ collaboration agreement, Biogen Idec will make a $30 million milestone payment to Abbott.
Contract Pharmaceuticals (Buffalo, NY), a manufacturer of liquids, creams, and ointments, will close its Buffalo plant at the end of 2011 and will consolidate its operations into its Mississauga, Ontario facility. The Buffalo plant employs 260 people. Displaced employees will be offered severance packages and outplacement programs, according to a press release.
Eisai Inc. (Woodcliff Lake, NJ), a US subsidiary of Eisai Co., Ltd. (Tokyo) opened a parenteral facility in Research Triangle Park, North Carolina. The 65,000-ft2 facility will serve as Eisai's global commercial manufacturing and drug-development site.
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Contract research firm ElexoPharm (Saabruecken, Germany) and Merck & Co. (Whitehouse Station, NJ) will develop and commercialize novel candidates targeting aldosterone synthase for the potential treatment of cardiovascular disease. Under the terms of the agreement, Merck will pay ElexoPharm an upfront payment of €1.5 million ($1.85 million) and up to €32.3 million ($40 million) in milestone payments.
KemPharm (North Liberty, IA) entered into a supply agreement with Johnson Matthey (West Deptford, NJ) for the manufacture of the active pharmaceutical ingredient (API) KP201, KemPharm's hydrocodone prodrug for acute pain. Under the agreement, KemPharm will be responsible for drug product, preclinical and clinical studies, and regulatory filings, while Johnson Matthey will be responsible for manufacturing the API for the development and commercialization of KP201.
MP Biomedicals (Santa Ana, CA), a provider of life-science, fine-chemical, and diagnostic products, and the Russian Corporation of Nanotechnologies (RUSNANO), a state-funded organization to advance nanotechnology (Moscow) will collaborate in the areas of nanotechnology research and development, in the creation of a research and development base, and in producing pharmaceuticals. The companies plan to jointly implement projects focused on anti-aging and increasing in life expectancy, according to a company press release.
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A partnership between New York City and the State University of New York’s Downstate Medical Center will create BioBAT, a 486,000-ft2 center for commercial bioscience at the Brooklyn Army Terminal. Construction on the first 56,000 ft2 of space will begin this year with completion expected in 2011. The project will create more than 1000 permanent jobs, according to a press release.
Roche (Basel) and Biogen Idec (Cambridge, MA) discontinued the development of the ocrelizumab clinical program in patients with rheumatoid arthritis (RA). After an analysis of the efficacy and safety results from Phase III studies, the companies concluded that the overall benefit-to-risk profile of ocrelizumab was not favorable for RA.
Sanofi-aventis (Paris) launched a public tender to acquire all outstanding shares of Nepentes (Warsaw), a Polish manufacturer of pharmaceuticals and
dermocosmetics. In 2009, Nepentes’s sales reached PLN 134.9 million ($40 million).
Shimadzu (Kyoto, Japan) and bioMérieux (Marcy l’Etoile, France) will collaborate to commercialize a mass spectrometry system for bacterial identification in microbiology laboratories. bioMérieux will work with Shimadzu and its subsidiary, Kratos Analytical, to adapt the linear MALDI-TOF (which stands for matrix-assisted laser desorption/ionization time-of-flight) mass spectrometry technology for integration into the microbiology laboratory workflow. The companies plan to commercialize the system in 2010.
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 and the National Institutes of Health launched a new website to provide a way for companies, researchers, and consumers to report pre- and postmarket safety data to the federal government. The site, called the Safety Reporting Portal (SRP), is currently used for reporting related problems with food. Once the site is fully developed, biomedical researchers involved in human gene-transfer clinical trials will be able to use it to report adverse events. Trial sponsors can use the portal to send investigational new drug reports to the agency as well. According to a press release on the site, FDA says the portal will “ultimately enhance the government’s systematic analysis of safety information, which will benefit public health.”
FDA also announced that Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection, is okay for continued use. Previously, 2009 H1N1 swine-flu tests were only available through Emergency Use Authorizations.
Delegates from India and Thailand attending the World Health Assembly (WHA) last week submitted a draft resolution requesting that, among other things, the World Health Organization (WHO) cease work on the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) because they believe it is being used to bolster intellectual property (IP) protection. WHO created the IMPACT task force in 2006 to seek global solutions to the problem of drug counterfeiting. The two members states requested WHO to create, instead, a non-conflict-of-interest program to address quality, safety, and efficacy. They feel that the latter is a public-health issue within WHO’s jurisdiction, unlike IP rights. The proposed resolution likely stemmed from recent increases in seizures of generic drug products manufactured in the two countries (see back story, “A New Patent Battleground has Formed over India's Drug Shipments through the European Union”). The WHA working group on counterfeit medical products will make specific recommendations on the draft resolution at the 64th assembly meeting in 2011.
Last week, ePT reported that FDA cleared the use of Rotarix (rotavirus vaccine, live, oral) to treat rotavirus in infants. This week, the European Medicines Agency has also stated that the presence of porcine circovirus (PCV) in the vaccine poses no risk to public health, according to a press release from GlaxoSmithKline (London).
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| Aastrom Biosciences (Ann Arbor, MI) appointed Sharon Watling vice-president of clinical and regulatory, and Ronnda L. Bartel, formerly vice-president of technical operations, as chief scientific officer. Elmar R. Burchardt, formerly vice-president of medical affairs, will leave the company's management team but will continue to serve as a company advisor.
Amarantus Therapeutics, a privately held biotechnology company, appointed Robert J. Zimmerman as a consulting chief development officer. Zimmerman will oversee the development of the company’s lead candidate, AMRS001, for the treatment of several apoptosis-related disorders.
Cleveland BioLabs (Buffalo, NY), a biotechnology company focused on programmed cell death technology, added two regulatory affairs executives to its development team. Donald Handley was appointed director of regulatory affairs, and Ann Hards was appointed vice-president of regulatory affairs.
Lukas Utiger, currently COO Lonza Life Science Ingredients (Basel), will become the new COO of Lonza Bioscience (Walkersville, MD), effective June 1, 2010. He will replace Anja Fiedler, who resigned for personal reasons. The company’s CEO, Stefan Borgas, assume leadership of the Life Science Ingredients business in addition to his current responsibilities until Fiedler’s successor is named.
Generic-drug manufacturer Qualitest Pharmaceuticals (Huntsville, AL), named Robert Mills president. Mills joins Qualitest from Columbia Laboratories (Livingston, NJ), where he was CEO and President.
Senesco Technologies (New Brunswick, NJ) named Leslie J. Browne president and CEO, effective May 25, 2010. Browne succeeds Jack van Hulst, who has served as the company’s CEO since November 2009 and remains a director of the company.
Takeda Pharmaceutical Company (Osaka, Japan) appointed Kiyohiko Tamura vice-president of its newly established office of the president and CEO, effective June 1, 2010. Tamura was previously director of division planning for the marketing planning and administration department in the pharmaceutical marketing division. |
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Anti-counterfeiting solutions
Which anticounterfeiting solution is your company currently using?
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