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Alexion Pharmaceuticals (Cheshire, CT) received approval from the US Food and Drug Administration for the company’s Rhode Island manufacturing facility in Smithfield, Rhode Island, as a second source of commercial supply for Soliris (eculizumab). Earlier this year, Alexion reported that the European Medicines Agency had approved the facility as a second source of supply for Soliris in the European Union.
Aspen Pharmacare Holdings (Durban, South Africa) agreed to acquire the pharmaceutical business unit of Sigma Pharmaceuticals (Melbourne, Australia) for A$900 million ($796 million) in cash. The Sigma pharmaceutical unit includes the manufacture and sale of presripction, generic, and over-the-counter products.
Biogen Idec (Weston, MA) and Knopp Neurosciences (Pittsburgh, PA) formed a drug-development deal under which Biogen Idec will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, and potentially other indications. Biogen Idec will purchase $60 million of Knopp stock, provide an up-front payment of $20 million and up to $265 million in milestone payments. Biogen Idec will also pay royalties to Knopp on worldwide sales.
The governing board of California Institute for Regenerative Medicine (Palo Alto, CA), the state stem-cell agency, approved the concept for up to $243 million round of funding to move stem cell-based therapies to clinical trial. The funding will support multidisciplinary teams of researchers working toward filing a request with the US Food and Drug Administration to begin clinical trials, or completing an early stage trial, within four years.
CSL Behring (King of Prussia, PA) received approval from the US Food and Drug Administration of a supplemental biologics license application (sBLA) to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% liquid, from 18 months to 24 months. Hizentra is the only 20% subcutaneous immunoglobulin (SCIg) approved by FDA, and the only SCIg in the US that may be stored at room temperature.
DePuy Orthopaedics, a Johnson & Johnson (New Brunswick, NJ) business unit that makes joint replacements, received a Warning Letter from the US Food and Drug Administration for the marketing of two of its products. FDA says it never approved DePuy's TruMatch Personalized Solution System and that the company is marketing its Corail Hip System for two uses that FDA did not approve. The agency asked DePuy to stop selling the products and correct the violations detailed in the letter.
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The Institute for Systems Biology (ISB, Seattle) will move its global headquarters to Seattle's South Lake Union neighborhood. ISB has signed a lease for approximately 140,000 ft2 of office and laboratory space at 401 Terry Avenue N., which will be home to more than 330 ISB employees starting in spring 2011, according to a company press release.
Oxford BioMedica (Oxford, UK), a gene-therapy company, signed a licensing agreement with Emergent Product Development Germany GmbH, a subsidiary of the biopharmaceutical company Emergent BioSolutions Inc (Rockville, MD). Emergent gains rights to Oxford BioMedica’s Hi-8 PrimeBoost technology patents and a sub-license under poxvirus patents licensed to Oxford for the development and commercialization of vaccines and therapeutics targeting eight infectious diseases, including tuberculosis. Emergent will pay an upfront licensing fee of $1 million, potential milestone payments of up to $20.4 million, and undisclosed royalties on sales.
Parexel International (Boston, MA), a global biopharmaceutical services organization, introduced an integrated temperature-recording solution for study drug transportation as part of its expanded Clinical Logistics Services. Parexel’s temperature-control process is designed to save 24 to 48 hours of time compared with traditional cold-chain methods, according to a company press release.
Quark Pharmaceuticals (Fremont, CA), a developer of RNAi-based therapeutics, formed an agreement with Novartis (Basel). Novartis obtained an exclusive worldwide license to develop and commercialize Quark’s p53 temporary inhibitor siRNA drug QPI-1002, currently the subject of a Phase II clinical trial. Quark will receive an upfront fee of $10 million, up to $670 million in milestone and other payments, and royalties on potential product sales.
Roche (Basel) formed a collaboration with Aileron Therapeutics (Cambridge, MA) to develop a new class of drugs called stapled peptide therapeutics, which are based on Aileron’s peptide stabilization technology. Roche will work with Aileron to develop drug candidates against up to five undisclosed targets. Roche will pay Aileron $25 million upfront and up to $1.1 billion in milestone payments. In addition, Aileron will receive royalties on sales of potential products.
SAFC, a member of the Sigma-Aldrich Group (St. Louis, MO), and Novozymes Biopharma (Copenhagen) agreed to a 10-year extension of their joint agreement under which SAFC retains exclusive marketing and distribution rights for Novozymes Biopharma's LONG R³IGF-I (LONG R³) growth factor used for industrial cell-culture applications. The highly potent growth factor is manufactured specifically for customers in the cell-culture market.
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Shire (Philadelphia, PA) plans to withdraw its hypotension drug ProAmatine (midodrine hydrochloride) effective September 30, 2010. The company notified the FDA in November 2009 and healthcare professionals earlier this year of this decision. Shire's withdrawal was not related to any concerns regarding the safety of ProAmatine, the company said in a press release, but because FDA requested additional post marketing trials to be conducted for the drug.
Thermo Fisher Scientific (Waltham, MA) opened a technology center in Shanghai. The center houses engineers and support staff focused on developing a product pipeline to serve China-based customers across a range of industries.
TraceLink (Woburn, MA), a provider of supply-chain management software, and Patheon (Research Triangle Park, NC), a provider of contract development and manufacturing services, announced a partnership to provide a suite of visibility and collaboration software solutions, advanced integration capabilities, and customized professional services.
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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Larry Kranking was named the new president and CEO of Coldstream Laboratories (Lexington, KY), a provider of sterile pharmaceutical manufacturing services. Kranking previously served at Aveta Lifesciences (Valparaiso, IN).
Discovery Laboratories (Warrington, PA), a biotechnology company, realigned its executive management by appointing Thomas F. Miller as COO, Charles F. Katzer as chief technical officer, and John G. Cooper as president and chief financial officer. These officers will report directly to W. Thomas Amick, chairman of the board and interim CEO. The company hopes to fill the CEO position in 2011, according to a press release.
Christopher B. Begley, chairman and CEO of Hospira (Lake Forest, IL), announced his intent to retire from the CEO position. He will remain executive chairman of the Hospira board, and will serve as CEO until his successor is named.
Icon (Dublin), a global provider of outsourced development services, appointed Alan Morgan group president of clinical-research services. Morgan is currently group president of Icon’s early-phase and laboratory services, and previously was COO of Icon's clinical research division. He joined the company in 2006.
Torbjorn Bjerke was appointed CEO of Karolinska Development (Stockholm), a life-sciences company. Bjerke succeeds Conny Bogentoft, who will assume the position of chief scientific officer for Karolinska Development.
MPI Research (Mattawan, MI), a contract research organization, named Alan P. Breau vice-president of its bioanalytical and analytical services (B/AS) division. B/AS is one of the company's three core research divisions, along with drug-safety evaluation and discovery services.
Sigma-Aldrich (St. Louis) appointed Magnus Borg vice-president and chief information officer. Borg will report to Rakesh Sachdev, senior vice-president, chief financial officer, and chief administrative officer.
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The US Food and Drug Administration announced last week that it mailed invoices for product and establishment fees as part of the Prescription Drug User Fee Act (PDUFA). Payments are due Oct. 1, 2010. PDUFA, originally enacted in 1992, authorizes FDA to collect fees from companies that produce certain human drug and biological products. User fees help to expedite the drug approval process. The rates for fiscal year 2011 are posted here.
According to new data released by the US Centers for Disease Control and Prevention (CDC), vaccinations among teenagers (ages 13 to 17) are on the rise. Coverage for this age group increased 15% according to the 2009 National Immunization Survey-Teen (NIS-Teen) results, which included more than 20,000 teens and was conducted by CDC. Among vaccines on the rise are: tetanus-diphtheria-acellular pertussis, meningococcal conjugate, and human papillomavirus (one dose as compared to three doses). "This year's data are mixed," said Anne Schuchat, MD, director of CDC's National Center for Immunization and Respiratory Diseases in the press release about the study. "We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system's ability to reach this age group."
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Single-Use Technologies
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Automated system aseptically fills and seals bags
