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FDA Joins Chemical-Screening Collaboration
The US Food and Drug Administration has joined the Tox21 collaboration, which aims to develop ways to more effectively predict how chemicals will affect the body and environment. 
Merck KGaA Acquires Millipore and Founds New Divisions
Merck KGaA, a global pharmaceutical and chemical company, completed its acquisition of Millipore, a life-science company, for roughly EUR 5.2 billion ($6.7 billion).
SOCMA Voices Concern over Chemical-Site Security Bill
The Society of Chemical Manufacturers and Affiliates expressed “strong concern” over legislation introduced in the US Senate regarding chemical-site security.
Nycomed and Pfizer Sue Generic Firms
Teva and Sun Pharmaceuticals’ motion to overturn a verdict issued against them in April 2010 for patent infringement has been denied by a US court, leaving the companies at the mercy of pharma giants Pfizer and Nycomed, who have said they will “vigorously” pursue damage claims. |
 Laboratory system facilitates testing
Freeslate’s (Sunnyvale, CA) Core Module-3 (CM3) analytical system is designed to automate laboratory processes. The system includes Freeslate’s Lab Execution and Analysis software, which is compatible with third-party instruments and enables scientists to design, execute, analyze, and report on experiments in one environment on their desktops.
The CM3 system’s configurable design is based on a standard base platform and various arm and deck elements that dispense materials, mix, control temperature, and perform analytical measurements. Scientists can reconfigure the system for new applications easily, says John Senaldi, the company’s CEO.
The unit's balance precisely quantifies powders and liquids and provides feedback to a dispensing algorithm to ensure that the correct amount of material is being dispensed. An imaging module allows scientists to see materials at various points during an experiment, thus providing indications of sample stability. The CM3 system is suitable for large-molecule drug formulation stability testing and small-molecule drug polymorph studies. |
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AVI BioPharma (Bothell, WA), a developer of RNA-based therapeutics, was awarded a new contract with the United States Department of Defense for the development of the company's hemorrhagic fever virus therapeutic candidates, AVI-6002 and AVI-6003, for Ebola and Marburg viruses, respectively. AVI will receive an initial payment of $80 million and up to $291 million if the products are approved by FDA.
CSL (Melbourne, Australia) will build a biotechnology facility at its manufacturing site in Broadmeadows, Australia. The new facility will focus on the late-stage development of therapies for cancer, bleeding disorders, inflammation,and infection.
Encorium Group (Wayne, PA), a clinical research organization (CRO), acquired Progenitor Holdings (Zurich), a CRO providing services in emerging market regions. Encorium acquired Progenitor for cash and stock valued at EUR 1.7 million ($2.2 million), plus earn-out consideration of cash and stock with a value of up to EUR 1.5 million ($1.9 million).
GlaxoSmithKline (GSK, London) said it expects to record a legal charge for the second quarter of 2010 of £1.57 billion ($2.36 billion) (equating to an after-tax cost of £1.35 billion). The charge includes settlements, agreements in principle to settle, and other provisioning for long-standing legal cases involving an investigation by the US government into the company’s former manufacturing site at Cidra, Puerto Rico; product-liability and antitrust litigation relating to Paxil (paroxetine); and product-liability cases regarding Avandia (rosiglitazone) and other products.
Johnson & Johnson (J&J, New Brunswick, NJ) said on the company’s blog that it would eliminate 300 of the 400 jobs at the Fort Washington, Pennsylvania, plant that manufactured the recently recalled children’s and infants’ medications. Reuters reported early this week that J&J and Merck (Whitehouse Station, NJ) received a Form 483 letter from the US Food and Drug Administration after an inspection of a Lancaster, Pennsylvania, plant owned by a joint venture between the two companies called Johnson & Johnson–Merck Consumer Pharmaceuticals. Reuters said that an FDA spokeswoman confirmed the agency had issued the inspection report.
LyoTechnica (Carlsbad, CA) was launched to provide contract drug development services for injectable pharmaceuticals. The company offers analytical and formulation development, manufacturing of sterile stability batches, stability testing services, and regulatory support services.
Mylan (Pittsburgh, PA), a generic-drug company, agreed to acquire Bioniche Pharma (Galway, Ireland), a pharmaceutical company focused on injectables, for $550 million in cash. Mylan will gain entry into the North American injectables market through the acquisition.
Pfizer (New York) suspended its chronic low back pain and painful diabetic peripheral neuropathy clinical program for the investigational compound tanezumab. Pfizer previously announced the suspension of tanezumab studies in patients with osteoarthritis on June 23. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain, according to a company release.
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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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Samsung Medical Center (Seoul, Korea) and Pfizer (New York) formed a research partnership to analyze tumors from Korean patients to generate gene-expression profiles. The companies said the research may lead to therapies for liver cancer.
Tekmira Pharmaceuticals (Vancouver, Canada), a company focused on RNA interference (RNAi) therapeutics, was awarded a new contract with the United States Department of Defense to advance an RNAi therapeutic using Tekmira's lipid nanoparticle technology, SNALP (stable nucleic acid-lipid particle) to treat Ebola virus infection. Tekmira is eligible to receive up to $34.7 million over the next three years for development through the completion of a Phase I clinical trial. Tekmira could receive up to $140 million if an Ebola therapeutic is approved by FDA.
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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AcuTemp Thermal Systems (Dayton, OH), a manufacturer of temperature-controlled packaging, appointed Rick Lenhard lead engineer of passive systems. Lenhard will be responsible for expanding the company’s line of AcuTemp Qualified Shippers and for developing custom passive shippers.
Amgen (Thousand Oaks, CA) appointed Jonathan M. Peacock chief financial officer, effective Sept. 1, 2010. Peacock will report to Kevin W. Sharer, Amgen's chairman and chief executive officer, and will succeed Michael A. Kelly, who served as acting CFO since May 2010.
Mary Foster, vice-president of quality for Catalent (Somerset, NJ), was elected chair of the United States Pharmacopeia (USP) Packaging, Storage, and Distribution Expert Committee for the 2010–2015 USP cycle. The Committee will focus on the following areas: supply chain, including drug pedigrees and anticounterfeiting; testing for extractables and leachables; and testing of glass, plastic, and metal container-closure systems. The Committee will continue the work on current chapters under revision such as General Chapter <1079> Good Storage and Transportation Practices. Foster also serves on the USP Advisory Panel for bulk pharmaceutical excipients.
Phage Pharmaceuticals (San Diego) appointed David Jackson vice-president of operations planning. Jackson is responsible for overseeing the company’s therapeutic-protein manufacturing facility in San Diego. He will report to Robert J. Beckman, the company’s CEO.
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Contract research organization PPD (Wilmington, NC) appointed Henrietta Ukwu senior vice-president of global regulatory affairs. Ukwu previously served as vice-president of global regulatory affairs at Wyeth Pharmaceuticals, now Pfizer (New York).
Spectrum Pharmaceuticals (Irvine, CA), a biotechnology company, appointed George Tidmarsh senior vice-president, chief scientific officer, and head of research and development operations. Tidmarsh will report directly to Rajesh C. Shrotriya, CEO, president, and chairman of the board of directors of Spectrum Pharmaceuticals.
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FDA published this week as a draft recommendation the Step-2 version of the International Conference on Harmonization’s Q3C(R5) Guideline on Residual Solvents to account for new toxicity data related to cumene (Cumol; isopropylbenzene; isopropylbenzol; (1-methyl/ethyl)benzene; 2Phenylpropane). ICH finalized and approved Q3C(R4), the fourth revision to this guideline, in July 2007. This Step-2 guideline represents a fifth revision, which ICH issued in the form of a final concept paper in June 2009 and approved in March 2010. In Q3C(R4), cumene is listed as a Class-3 solvent in ICH's table of residual solvents. The fifth revision aims to place cumene into Class 2 based on new toxicity data.
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), has released a Quality Agreement template designed for the custom manufacture and release of active pharmaceutical ingredients (APIs). The organization released a general API Quality Agreement Template in May 2010. The templates are meant to help manufacturers, suppliers, and distributors comply with current regulations, including the International Conference on Harmonization Q7 guideline, by putting into place standardized quality agreements.
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| Comparison of Superdisintegrants in Orally Disintegrating Tablets |
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By Yeli Zhang, Amy Wrzesinski, Marley Moses, Holly Bertrand
The functionality and performance of three types of commercial superdisintegrants were evaluated in the application of orally disintegrating tablets.
Coming Soon: A peer-reviewed article discusses design space development in Pharmaceutical Technology's August issue. |
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Outsourcing
What is your opinion of the rising trend in the pharma industry to outsource functions to emerging countries?
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View the poll archive. |
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