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Also, Oxford BioMedica forms collaboration with sanofi-aventis; FDA requires labeling changes for botulinum toxin producs; C. Richter King joins IAVI; more...
Althea Technologies (San Diego, CA), a provider of services for biopharmaceutical development and manufacturing, opened its commercial-scale current good manufacturing practices (CGMP) manufacturing facility in San Diego, California. The new facility complies with Unites States and European manufacturing regulations and its building management system ensures a sterile manufacturing environment.
Amylin Pharmaceuticals (San Diego, CA), announced changes to its sales strategy within the diabetes market. Amylin's existing primary care and specialty sales forces will merge into a single organization, and the total number of sales representatives will be reduced by approximately 35%, or 200 employees. Amylin expects the changes to be implemented in the next several weeks.
Analytical Bio-Chemistry Laboratories (ABC, Columbia, MO), merged with Morse Laboratories (Sacramento, CA), a good laboratory practices-compliant analytical laboratory. The merger adds to ABC's pesticide residue chemistry services.
BASi (West Lafayette, IN), a contract research organization, expanded its bioanalytical services in the area of large-molecule bioanalysis and protein-based and oligonucleotide-based therapeutics. BASi offers ligand-binding assays, which are used in macromolecular drug therapeutics, immunogenicity screening, and biomarkers in biological matrices. The company uses enzyme immunoassays or enzyme-linked immunosorbent assay-based applications for these services.
Jubilant Biosys (Bangalore, Karnataka, India), a subsidiary of Jubilant Organosys (Noida, Uttar Pradesh, India), signed a research collaboration agreement with AstraZeneca (London) focused on providing preclinical drug candidates to AstraZeneca’s pipeline. The collaboration will initially focus on the neuroscience area. AstraZeneca will own the compounds developed under the collaboration with worldwide development and commercialization rights. Jubilant will be eligible to receive research funding spanning an initial five-year period, in addition to success-based development milestones and royalties.
Lancaster Laboratories (Lancaster, PA), a provider of laboratory services and part of Thermo Fisher Scientific, was awarded the 2009 Eli Lilly Global Supplier Award. Lancaster Laboratories was one of a few companies selected among Lilly’s 6500 global suppliers.
Oxford BioMedica (Oxford, UK) entered into a collaboration with sanofi-aventis (Paris) to develop gene-based medicines using the company’s LentiVector gene delivery technology for the treatment of ocular diseases. Oxford BioMedica will receive an upfront payment of $26 million and up to $24 million over three years. In addition, sanofi-aventis has an exclusive option for a worldwide license to develop and commercialize four ocular products, and, if successful, Oxford BioMedica will receive further license fees, milestone payments, and royalties.
On April 30, 2009, the US Food and Drug Administration required safety label changes, a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS) for all botulinum toxin products. The affected products include Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm. The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. These symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses, according to FDA’s press release.
A proposed rulepublished in the Federal Register on May 5, 2009, states that 21 CFR Part 601 would be amended to clarify the procedures for FDA to notify the public about the revocation of a biologics license. The rule proposes the new language to read, “The Commissioner, following revocation of a biologics license under 21 CFR 601.5(b), will publish a notice in the Federal Register with a statement of the specific grounds for the revocation.”
Last week, US Food and Drug Administration’s Risk Communication Advisory Committee held a meeting to discuss its risk communication strategic plan and risk communication research needs. The committee published its recommendations to FDA, which include the expansion of efforts to create partnerships with other public and private organizations that produce and use studies relevant to the effectiveness of FDA’s communications and that FDA develop a work-flow system for ensuring that communication needs are integrated into its operations.
The European Medicines Agency appointed Fergus Sweeney head of its inspections sector, effective May 1, 2009. The position was vacated in January 2009 when the former head, Emer Cooke, was named as the agency’s international liaison officer.
C. Richter (Rick) King, former senior vice-president of research at GenVec (Gaithersburg, MD) joined the International AIDS Vaccine Initiative (IAVI, New York) as vice-president of vaccine discovery. “One of the biggest challenges of any vaccine discovery effort is determining the vaccine candidates that are worth pursuing and those that are not,” King said in a press release. “My job at IAVI will be to work together with IAVI scientists and partners to do just that. There are several innovative vaccine candidates currently in pre-clinical development at IAVI, and I hope to help bring the most promising ones into human testing over the next few years.”
The NanoFabrication Systems Division of NanoInk (Skokie, IL ), an emerging growth technology company specializing in nanometer-scale manufacturing and applications development, appointed Tom Warwick as general manager for Europe and the Middle East. Warwick brings more than 20 years of experience in the sales and marketing of high-technology products in Europe. He will provide support to the existing distributor, LOT-Oriel, as NanoInk expands its offerings with new products in the nanofabrication tools market.
Pfizer (New York) appointed Freda Lewis-Hall chief medical officer and senior vice-president of Pfizer. Lewis-Hall will be the senior physician in the company and will report to Jeffrey B. Kindler, Pfizer’s chairman and CEO. Lewis-Hall was previously with Vertex Pharmaceuticals (Cambridge, MA).
Takeda Global Research & Development Center, Inc., US (Lake Forest, IL) named Azmi Nabulsi president. Nabulsi will direct all aspects of Takeda's US drug-development activities and will report to Nancy Joseph-Ridge, general manager of the pharmaceutical development division of Takeda Pharmaceuticals International, Inc.
Vertex Pharmaceuticals (Cambridge, MA), a biotechnology company, announced that Peter Mueller, the company’s executive vice-president of drug innovation and realization and chief scientific officer, will expand his responsibilities to cover global research and development in light of Freda Lewis-Hall’s departure. Effective May 15, 2009, he will become Vertex’s executive vice-president of global research and development and chief scientific officer.
WuXi PharmaTech (Shanghai) appointed Hao Zhou vice-president of finance. Zhou's responsibilities include financial planning and analysis, ERP system implementation, tax, and treasury. Christine Lu-Wong is named vice-president and chief accounting officer and is responsible for financial reporting and accounting operations. Zhou and Lu-Wong will report to Edward Hu, chief operating officer and acting chief financial officer.