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FDA Removes from Market Unapproved Cough and Cold Prescription Products
FDA is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. 
FDA Sends sanofi aventis Two Warning Letters
FDA recently sent sanofi aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.
Merck Sells Contract Biopharmaceutical Business to Fujifilm
Fujifilm and Merck & Co. have formed a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a contract biopharmaceutical manufacturing and development business of Merck.
EU–India FTA Dispute Continues
European Union stakeholders urge the Indian government to fight against certain provisions in the free trade agreement amid fears that access to generic drugs may be affected.
EMA Challenged Over Conflict-of-Interest Case
Several European public health and transparency campaigners believe that the European Medicines Agency may have breached conflict-of-interest rules.
Rare Disease Day 2011–"Rare but Equal"
The European Organization for Rare Diseases, an alliance of patient organizations and individuals, celebrated its fourth Rare Disease Day on February 28.
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 Sanitary valve prevents cross-contamination
Spirax Sarco’s CVS10 sanitary check valve is designed to open when media exerts pressure on it. The valve has an internal spring-cracking pressure of 0.507 psi, and when media stops flowing, the spring force closes the valve before reverse flow and cross-contamination can occur. The valve helps protect equipment from pressure surges associated with hydraulic forces, such as waterhammer. In addition, the device has a high flow coefficient and causes minimal pressure loss.
The CVS10 valve is available with a metal seat for clean- and pure-steam or condensate applications. A soft-seat version also is available for high-purity water and liquid applications, such as water-for-injection systems. All wetted materials throughout the valve are fully traceable.
In addition, clients can choose from various surface finishes, including a finish as low as 15 microinch Ra electropolished. Low surface finishes help to maintain sterility in the system by reducing the risk of microbial growth in crevices on the valve’s surface.
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Almac added packaging, storage, and distribution capabilities for Schedule I–V controlled substances to its new North American headquarters facility in Souderton, Pennsylvania.
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It’s all about Aptuit service. Our customers say they respect our commitment to resolving challenging issues. They will work with us again because of our ability to accomplish goals in aggressive timelines while staying on budget. They are voicing their positive response to our recent breakthrough systems, and providing even greater global service efficiencies. Across the entire drug development continuum, it’s all about Aptuit service.
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Aphena Pharma Solutions was formed from the merger of four pharmaceutical contract packaging and repackaging companies: Celeste Contract Packaging, PrePak Systems, TestPak, and Integrated Pharmaceutical Packaging. Aphena Pharma Solutions is headquartered in Cookeville, Tennessee.
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IMPORTFAB is a well-established contract manufacturer, specializing in the manufacturing and packaging of semi-solid and
liquid products. Our objective is to maintain our position as a reliable reference point in the manufacturing of quality pharmaceutical products: essentially, a benchmark for modern, efficient production, assured through the use of highly performing equipment. IMPORTFAB is cGMP compliant by the FDA and Health Canada.
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BASF and Sigma-Aldrich signed a global distribution agreement for a number of BASF’s pharmaceutical excipients. Sigma-Aldrich will repackage the products into small pack sizes, making them available for academic-oriented research and development segments, such as universities and laboratories.
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CBI’s Forum on Packaging and Labeling for Pharmaceutical and Biotechs
Improve Patient Adherence – Enhance Anti-counterfeiting Techniques – Comply with Global Serialization standards Join industry thought leaders to discuss the current trends in new package designs being implemented, strategies for anti-counterfeiting and tactics to increase adherence. Trust the experts — Register today at www.cbinet.com/packaging and save $400 with promo code TGZ748!.
 www.cbinet.com/packaging
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Carbogen Amcis, a Switzerland-based contract manufacturing organization, will restructure its operations in Bubendorf, Aarau, and Hunzenschwil. Under the restructuring plan, the Aarau site will focus more strongly on development and the Hunzenschwil site on the pilot production of early-phase projects. Large-volume production and the manufacturing of highly active agents will continue at the Bubendorf site. The company will reduce headcount by 60 employees.
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World’s Only No Compromise UHPLC
At 19,000 psi, Shimadzu’s modular Nexera meets all analysis requirements: conventional, ultra-high speed, high resolution, high temperature, green, multidimensional, etc. with no compromise in data integrity. Features include the world’s fastest injection (10-second cycle time), near-zero carryover (0.0015% without rinsing), maximum resolution with the widest pressure/flow range (130MPa up to 3mL/min), and excellent injection reproducibility (0.25% area %RSD).
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Centocor Ortho Biotech, a subsidiary of Johnson & Johnson, received a decision from the Court of Appeals for the Federal Circuit that overturned a 2009 federal court jury verdict that awarded the company $1.8 billion after finding Abbott Laboratories liable for patent infringement. A panel of the court ruled that the patent relating to Centocor anti-tumor necrosis factor (TNF) -alpha rheumatoid arthritis treatments was invalid. The original verdict was returned in June 2009 by a US District Court jury in Marshall, Texas. The patent is co-owned by New York University and Centocor, the exclusive licensee.
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Feel the empowerment that comes from knowing that SAFC is ready to meet your contract manufacturing needs with quality products, innovative ideas and superior service. We stand ready to work with you every step of the way, anticipating your needs and offering keen insight. If you missed us at Informex, please visit our website and discover for yourself the SAFC difference.
 www.safcglobal.com
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Specialty chemical company Clariant has established a global medical and pharmaceutical segment within its Masterbatches Business Unit that will manage the development, production, marketing and technical support for Clariant’s MEVOPUR color masterbatches and custom performance compounds, which are manufactured exclusively for medical and pharmaceutical applications. The group will be led by Stephen Duckworth, head of the global market segment medical and pharmaceutical.
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C.W. Brabender® Instruments, Inc. introduces the Stainless Steel 12mm Clamshell Segmented Twin-Screw Compounder with application to the pharmaceutical industry for hot melt extrusion, new product development, compounding, pilot-scale & nanocomposites applications. The clamshell barrel allows visual assessment of processing steps, ease of screw mounting and quick cleaning. The modular segmented screws offer various individual processing possibilities. C.W. Brabender® Instruments, Inc. is… where quality is measure.
 12mm miniature co-rotating twin-screw extruder
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Daiichi Sankyo agreed to acquire Plexxikon, a pharmaceutical company with a late-stage oncology product, PLX4032, for $805 million. With the acquisition, Daiichi Sankyo obtains certain copromotion rights in the United States for PLX4032, which is being jointly developed by Plexxikon and Roche for the treatment of late-stage melanoma.
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At Solvay Chemicals, we manufacture BICAR® Sodium Bicarbonate and Soda Ash IPH to meet the exacting specifications of the US and EP Pharmacopeias and National Formulary. Produced according to cGMP, these are the products of choice for API or excipient applications requiring effervescent or desiccant properties. Solvay Chemicals, Inc. is part of the Solvay Group, the leading global producer of sodium bicarbonate and soda ash.
 http://www.solvaychemicals.us/marketsapplications/marketshidden/0,,40615-2-0,00.htm
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Biotechnology companies Elan and Celgene settled the patent dispute over the breast-cancer treatment Abraxane (paclitaxel injection). Elan initiated legal action in 2006 against Abraxis, and Abraxis was acquired by Celgene in October, 2010. Under the patent settlement and license agreement, Celgene will pay Elan a one-time fee of $78 million. Elan will not receive any additional payments for sales of Abraxane, or any other nab(R)-Paclitaxel product in the United States or globally. Celgene will acquire a fully paid up, exclusive, worldwide license to select Elan US and foreign patents for Abraxane.
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Thousands of pharmaceutical, biologic, generic, and contract services professionals gather annually at INTERPHEX (March 29-31, 2011, Javits Convention Center, New York City) to see new products, network, and learn about emerging trends surrounding drug manufacturing. At INTERPHEX 2011, you’ll find the solutions and education you need to ensure quality, improve efficiency, and solve your manufacturing and supply chain problems. Register for a free exhibit hall pass at
 www.INTERPHEX.com
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Novavax agreed to license its proprietary recombinant virus-like-particle (VLP) vaccine technology to LG Life Sciences (LGLS). Under the agreement, LGLS receives an exclusive license to manufacture, develop, and commercialize influenza vaccines using Novavax’s recombinant VLP technology in South Korea. LGLS also receives a nonexclusive license to manufacture, develop, and commercialize influenza VLP vaccines in certain other countries.
Novavax was awarded a contract valued at up to $179 million by the Office of Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services for the clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza. The contract includes $97 million in a three-year base period and $82 million in a two-year option period.
PDL BioPharma announced that the Technical Board of Appeal of the European Patent Office (EPO) has cancelled its hearing in which three appellants sought to have a 2007 decision upholding PDL's European Patent No. 0 451 216B overturned and the patent revoked. The effect of the termination of the opposition appeal proceeding is that the 2007 EPO decision upholding the claims of PDL's patent as valid will become the final decision of the EPO.
Pfizer completed its acquisition of King Phar
maceuticals, and King is now a wholly owned subsidiary of Pfizer. The companies began joint operations on Mar. 1, 2011.
Pilgrim Software, a provider of enterprise risk, compliance and quality management software solutions, formed an alliance with QPharma, a provider of regulatory and compliance services, to offer software for validation services. The collaboration makes QPharma’s validation, quality, and regulatory compliance consulting services available to Pilgrim’s customers in collaboration with Pilgrim’s SmartSolve suite of products.
Contract research organization Quintiles agreed to make a minority 10% investment of approximately $30 million to start a new joint venture company with the Samsung Group in the first half of 2011 to provide biopharmaceutical contract manufacturing services in South Korea. Samsung will own the remaining 90% of the joint venture company. The joint venture marks Samsung’s entry into the biopharmaceutical market.
sanofi aventis completed the acquisition of BMP Sunstone, a specialty pharmaceutical company with a portfolio of pharmaceutical and healthcare products in China. Stockholders approved the merger agreement that had been previously amended in November 2010.
Contract manufacturing organization SCM Pharma expanded its high-potency capabilities following a £500,000 ($812,000) investment at its UK-based facility. The expansion includes 500-ft2 cleanroom dedicated to making potent products, and a production technique designed to handle continuous throughput via isolators to boost its aseptic processing capacity.
Thermo Fisher Scientific is planning a new manufacturing facility in China within the Suzhou Science and Technology Town, part of the company's strategy to expand its presence in the Asia-Pacific region, according to a company press release. The new facility, scheduled for completion in early 2012, will develop and manufacture laboratory instruments, equipment, and consumables for China's life-sciences markets.
Thermo Fisher Scientific will sell its Athena Diagnostics and Lancaster Laboratories businesses for a total of $940 million in cash. Thermo agreed to sell Athena Diagnostics to Quest Diagnostics for $740 million. Thermo also agreed to sell its contract-testing laboratory Lancaster Laboratories to Eurofins Scientific for $200 million, subject to a post-closing adjustment.
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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Omni Bio Pharmaceutical named James Crapo as its CEO, and the company’s board of directors anticipates appointing him as a director in the near term. Charles Dinarello, who has served as Omni Bio's acting CEO since its inception in March 2009, will become the company’s chief scientific officer and chief medical director.
MorphoSys, a biotechnology company, appointed Jens Holstein CFO and a member of the executive management board, effective May 1, 2011. Holstein currently serves as regional CFO and director at Fresenius Kabi. Holstein will succeed Dave Lemus, who will leave his position of CFO in March 2011.
Pearl Therapeutics appointed Chuck Bramlage president, CEO, and a member of the board of directors. Bramlage previously held several executive positions at Covidien, most recently president of pharmaceutical products.
Rochem International, an ingredients supplier, appointed Matt Thiel as its COO. He previously served as the company's executive vice-president. Rochem promoted Charles Dods from vice-president of operations in Europe/Asia and global planning to the position of executive vice-president. During his six years with Rochem International, Dods has assumed greater responsibilities within the executive management team. He will to draw on his industry experience to oversee Rochem’s operations in China, the company's Pharmaceutical New Business Development group, and Rochem’s European sales team.
Biotechnology company Verenium will make the following changes to its management team, effective Mar. 31, 2011: Carlos Riva, currently director, president and CEO, will retire; James Levine, currently executive vice-president and CFO, will be promoted to president and CEO, and will be elected to the board of directors; Jeffrey Black, currently senior vice-president and chief accounting officer, will become CFO.
David Redfern was named the new chairman of the board for ViiV Healthcare, a specialist HIV company established by GlaxoSmithKline (GSK), and Pfizer. Redfern’s appointment is effective Apr. 1, 2011, following the retirement of Julian Heslop. Redfern will continue to serve as chief strategy officer at GSK.
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FDA and Georgetown University Medical Center have entered a partnership to stimulate innovation in regulatory science, ethics, education, and training, according to a Feb. 24, 2011, agency press announcement. Joint activities will include: research and public-health activities in areas such as novel technologies, public health preparedness, ethics, and bioinformatics; mentorship of doctoral and postdoctoral students in collaborative research relevant to FDA’s mission; scientific staff exchanges and professional-development opportunities, including selected FDA staff serving as adjunct
faculty in teaching and clinical activities at Georgetown and selected Georgetown staff participating in research and other activities with FDA; and shared access to and development of important training and continuing
education activities.
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FDA Transparency
Has FDA's transparency initiative helped your company?
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