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House Committee Passes IST Requirements in Chemical Facility Security Bill
The House Energy and Commerce Committee approved H.R. 2868, the “Chemical Facility Anti-Terrorism Act of 2009,” a measure to modify and codify existing requirements of the Chemical Facility Anti-Terrorism Standards program. 
GAO Report Calls Out FDA's Poor Oversight of Accelerated Drug Approvals
The US Food and Drug Administration needs to enhance its oversight of drugs approved on the basis of surrogate endpoints, according to a September report from the Government Accountability Office that was released this week.
Generic APIs Outstrip Innovation
The global API market has expanded from $69 billion in 2004 to more than $90 billion in 2008, according to a report from the Italian Chemical Pharmaceutical Association. In particular, the report noted a rapid growth rate for generic APIs.
FDA Tracks Influenza A Treatment with Prescription Data
The US Food and Drug Administration is using prescription data from Wolters Kluwer Pharma Solutions to track the treatment of influenza A (H1N1) and other influenza viruses, according to a statement that the company released last week. |
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 Enhanced interface facilitates visual inspection
Cognex (Natick, MA) has introduced version 1.2 of its VisionView operator interface application software, which gives users a greater ability to customize their displays and capture application data. Users now have the option to run the operator-interface software on a personal computer (PC) without losing any functionality. This option lets users connect monitors of various sizes to the PC.
The new software version also lets operators pan, zoom, rotate images, and focus accurately for close examination of defective parts. The interface provides password-protected user control and lets users change regions of interest. Users can save high-resolution images of failed parts automatically to an external storage device. Application-parameter changes can be saved directly to an existing job or renamed and saved as a new job.
The VisionView touch-screen interface and the VisionView PC version work with Cognex In-Sight vision systems, which enable the monitoring and control of vision systems on a production line.
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AnC Bio Inc. (Seoul, South Korea), announced its new subsidiary, AnC Bio VT, LLC, is currently raising money for a new $50-million facility in Orleans County, Vermont, that will create more than 200 new jobs. The facility will manufacture portable dialysis machines, cell-therapy machines, vaccines, and other biomedical supplies, as well as conduct research and development. The company expects the facility to open in 2011.
Astellas Pharma (Tokyo, Japan) and Medivation (San Francisco, CA) agreed to develop and commercialize MDV3100, Medivation's investigational drug for the treatment of prostate cancer. Medivation will receive an up-front cash payment of $110 million, and is eligible to receive payments of up to $655 million in milestone payments. The companies will jointly commercialize MDV3100 in the US and will share all US development and commercialization costs as well as profits.
BioStorage Technologies (Indianapolis, IN), a provider of biomaterials storage, management, and cold-chain logistics, will open a new 16,140-ft2 biorepository in Frankfurt, Germany. The facility will offer worldwide, industry-compliant logistics, supply-chain management, and will meet international customs and transportation and documentation regulations, according to a company press release.
Cephalon (Frazer, PA) and BioAssets Development Corporation (BDC, Wellesley, MA), a privately held biopharmaceutical company, signed an agreement that will provide Cephalon with an option to acquire BDC. Cephalon will pay BDC an upfront payment of $30 million and, assuming exercise of the option, an additional payment on the closing of the acquisition. Additional future regulatory and sales milestone payments could be made to BDC stockholders. The agreement is subject to customary regulatory approvals, as well as BDC stockholder approvals.
Hovione (Loures, Portugal) acquired an aseptic spray-drying production line, vial filling, and backup utilities from the specialty pharmaceutical company Acusphere (Boston, MA). The equipment includes sterile filtration, aseptic spray drying, secondary drying and vial filling, as well as terminal sterilization systems, lyophilization, water for injection and clean-steam production utilities.
Laureate Pharma (Princeton, NJ), a biopharmaceutical development and protein production company, signed a biopharmaceutical development and manufacturing agreement with an undisclosed client. Laureate will develop the process to manufacture a unique Fc fusion protein and produce this product under current good manufacturing practice conditions for use in clinical trials. Terms were not disclosed.
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Malvern Instruments (Malvern, UK), a materials-characterization company, and Kaiser Optical Systems (Ann Arbor, MI), a supplier of Raman analyzers and components for spectroscopy, formed a development collaboration in which the companies will seek the involvement of potential customers at the final stages of product development and for beta evaluations later this year.
Malvern will integrate Kaiser’s RamanRxn System analyzers and probes into its Morphologi platform, and the initial focus will be on pharmaceutical, life science, and forensic applications.
Micromeritics (Atlanta, GA) opened its new European headquarters located in the Avantis Science Park near Aachen, Germany. The new building features more than 500 m2 of floor space, and the company’s European materials analysis laboratory will operate from the facility.
Novavax (Rockville, MD) and Xcellerex (Marlborough, MA) signed a vaccine-manufacturing deal designed to speed the development of Novavax’s manufacturing process to commercial scale and begin immediate production of its 2009 H1N1 influenza vaccine for potential commercial sale. Earlier this week, Novavax launched a two-stage, 4,000-patient clinical study of its H1N1 flu vaccine in Mexico to support registration in that
country. The companies will use Novavax’s unique virus-like particle vaccine technology to produce initial commercial quantities of H1N1 vaccine with Xcellerex’s FlexFactory biomanufacturing platform.
OXiGENE (South San Francisco, CA), a biopharmaceutical company focused on cancer and eye diseases, will acquire the biopharmaceutical company VaxGen (South San Francisco, California) for $33 million. The agreement has been approved unanimously by the boards of directors of both companies, and is subject to customary closing conditions. The companies expect the transaction to be completed in early 2010.
The European Commission approved the proposed acquisition of Schering-Plough (Kenilworth, NJ) by Merck (Whitehouse Station, NJ). After its investigation, the Commission concluded that the proposed transaction would not significantly impede effective competition in the European Economic Area or any substantial part of it.
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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The US Food and Drug Administration authorized the emergency use of the investigational antiviral drug peramivir intravenous (IV) for 2009 H1N1 influenza in certain adult and pediatric patients who are admitted to a hospital. Certain conditions must be met in order to use IV peramivir in these populations and situations, according to an agency press release. FDA took this action in response to a request from the US Centers for Disease Control and Prevention.
FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) sent a Warning Letter to King Pharmaceuticals (Bristol, TN) over two video news releases for its painkiller Embeda (morphine sulfate and naltrexone hydrochloride). The letter calls the videos false or misleading because they “omit and minimize the risks associated with EMBEDA, fail to present the limitations to its approved indication, and present misleading claims” and violate sections (e)(5) and (e)(6)(i) of 21 CFR 202.1, Prescription-drug advertisements.
FDA released this week a draft guidance for industry—SPL Standard for Content of Labeling Technical Qs & As. The guidance provides information to applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup language (XML). This is revision 1 of a guidance of the same name that was issued in December 2005. The guidance has been revised to reflect changes in the technology since 2005 and to harmonize the submission of SPL in the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. The Q&A document provides answers to common questions about preparation and submission of SPL standards and content-labeling documentation. FDA said it anticipates that additional guidance will be provided as new questions arise about the use of SPL. |
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Advaxis (North Brunswick, NJ), a biotechnology company developing proprietary Listeria monocytogenes cancer vaccines, appointed Christopher Duignan senior vice president of finance. Duignan will work with Fredrick Cobb, CFO of Advaxis.
Cephalon (Frazer, PA) named Bob Repella senior vice-president of US pharmaceutical operations. Repella previously served as executive vice-president and general manager of the Biopharma Business Unit for Wyeth Pharmaceuticals (Madison, NJ).
Jiangbo Pharmaceuticals (Laiyang, China) announced the resignation of Haibo Xu, the company's chief operating officer, for health reasons. Jiangbo initiated a search for a replacement candidate for COO. Xu will remain a member of the board of directors.
Lightlake Therapeutics (London), a drug-discovery company focused on obesity, appointed Roger Crystal as its CEO. Crystal will be based in the company’s London headquarters.
Medivation (San Francisco, CA) appointed Hank Mansbach vice-president of medical affairs. Mansbach will lead the company’s medical-affairs activities for dimebon (latrepirdine), a Phase III candidate for the treatment of Alzheimer's and Huntington diseases, and MDV3100, which is in Phase III clinical development for the treatment of advanced prostate cancer.
Telormedix (Bioggio, Switzerland), a biopharmaceutical company, appointed Johanna Holldack as its CEO. Holldack previously held positions at Borean Pharma (Aarhus, Denmark), MediGene (Munich, Germany), and Chiron (Emeryville, CA).
Warner Chilcott (Adree, Ireland) appointed Mahdi Fawzi president of global research and development. Fawzi previously held a position at Wyeth Pharmaceuticals (Madison, NJ), where he was responsible for directing global preclinical development activities.
WuXi PharmaTech (Shanghai, China) appointed Hui Cai vice-president of business development. Cai will report directly to Richard M. Soll, senior vice-president of integrated services.
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Aseptic Techniques
Are current aseptic techniques/technologies adequate to ensure patient/personnel safety?
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