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Pfizer Names New Head; PhRMA Appoints New Chairman
Pfizer appointed Ian C. Read, currently head of the company’s global biopharmaceutical operations, as president, chief executive officer, and director. He succeeds Jeffrey B. Kindler, who retired from the company. 
PDUFA Discussions Continue, New Review Models Proposed
The US Food and Drug Administration posted on its website the minutes of the latest meetings between the agency and industry, and among stakeholders, regarding the reauthorization of the Prescription Drug User Fee Act V.
China and India to Be World Leaders of Innovation
China and India will become the world leaders in innovation during the next decade, according to an international survey released by AstraZeneca.
Sanofi Withdraws Emerflu Application
Sanofi Pasteur has formally withdrawn its application to the European Medicines Agency (EMA) for a centralized marketing authorization for its pandemic influenza vaccine Emerflu.
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 Technology allows real-time monitoring of cell cultures
Stratophase’s (Romsey, UK) SpectroSens optical microchips allow real-time, in-line monitoring of cell-culturing processes. Because the technology can monitor several parallel processes from a single control unit, it is appropriate for environments that use multiple bioreactors for development, pilot, or commercial-scale production. The technology’s optical microchip sensors can be incorporated easily into multiple-use insertion probes or disposable probe formats.
The output signal from SpectroSens optical microchips depends on the chemical composition of the media and can reflect the uptake of metabolites and the generation of waste. Personnel can use these key indicators to identify and maintain optimal growth conditions.
The SpectroSens technology monitors the growth media in situ, thus providing a direct measure of relative composition and allowing a process to be profiled. The microchips also could enable the timely deployment of fully quantitative analytical techniques, thus reducing the amount of analysis required.
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Interphex
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
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The drug-delivery companies APR Applied Pharma Research (Balerna, Switzerland) and Labtec (Langenfeld, Germany) submitted an oral dispersible film formulation of zolmitriptan for approval in Europe. The drug was developed in collaboration with Monsol Rx (Warren, NJ). If approved, the drug would be manufactured at Labtec’s facility in Hamburg, Germany. The companies also plan to submit an investigational new drug application in the US in the first quarter of 2011. Zolmitriptan is the active ingredient in AstraZeneca’s (London) Zoming, an antimigraine drug.
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Contract Manufacturing and Packaging for Solid Oral Dosage
Ropack, a leader in packaging solutions for the pharmaceutical, biopharmaceutical and nutraceutical industries, now provides the technology and expertise for stickpack packaging of solid oral dosage in a low relative humidity and temperature-controlled environment. Stickpacks – slim, tube-shaped packets the size of a stick of gum – offer impressive benefits: fill accuracy, portability, product differentiation, reduction in paper and foil usage, product differentiation and ideal sample option.
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The Netherlands Arbitration Institute found Johnson & Johnson (New Brunswick, NJ) in breach of its license agreement with Basilea Pharmaceutica (Basel), which caused US and European regulatory authorities to reject ceftobiprole, a broad-spectrum antibiotic. The tribunal awarded Basilea $130 million, including lost milestones, other damages, and interest.
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Automated Contracts & ChargeBacks help you grow from clinical trials into full scale production.
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The European Commission approved BASF’s (Ludwigshafen, Germany) acquisition of Cognis, a specialty-chemical company, subject to Cognis divesting certain businesses totaling less than EUR 100 million ($113 million). Cognis makes chemicals for industrial and consumer markets, including pharmaceutical excipients. The divestiture includes the company’s businesses in hydroxy methyacrylates, multifunctional methyacrylates and adducts, and polyalkyene glycols (PAG) and PAG-based lubricants. BASF agreed to acquire Cognis in June 2010 for EUR 3.1 billion ($4.1 billion). The transaction is expected to close in December 2010.
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Advanced Cleanroom Microclean
Fogging is no substitute for cleaning. A thorough cleaning and a Spring clean must be performed prior to any fogging actions. If there is gross contamination – e.g. dust or covered surfaces – then the efficacy of the fogging will be severely reduced. It should also be noted that certain bacteria can remain viable in dust for long periods. Hence, for fogging decontamination to work well, the rooms should be subject to a Super and Spring clean. It is not possible to over-emphasize the importance of thorough cleaning of the room prior to the fogging process.
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Bayer HealthCare Singapore, a subsidiary of Bayer AG (Leverkusen, Germany), is investing S$14.5 million ($11.1 million) in its research and development (R&D) activities in Singapore. The company will work in partnership with the National University of Singapore, National University Health System, SingHeath, and A*STAR’s Singapore Bioimaging Consortium for cancer R&D. The collaboration is part of Bayer HealthCare’s investment in joint research projects with Singapore-based universities, hospitals, research institutes, and companies.
Baxter International (Deerfield, IL) and Takeda Pharmaceutical (Osaka, Japan) will expand their previously announced collaboration for Vero cell-culture-based influenza vaccines for the Japanese market. Under the agreement, Baxter will license its Vero cell-culture-based vaccine technology for the Japanese market, and the companies will jointly pursue development and licensure of an H5N1 influenza vaccine in Japan. The companies will undergo a technology transfer to enable Takeda to manufacture the vaccine at full scale by the end of Takeda’s 2013 fiscal year, Mar. 31, 2014.
GlaxoSmithKline (GSK, London) has agreed to acquire the Chinese pharmaceutical company Nanjing MeiRui Pharma for $70 million in cash. MeiRui has a portfolio of urology and allergy products. GSK will gain a manufacturing facility in Nanjing City, Jiangsu Province, China. The deal is expected to close by the end of 2010, subject to regulatory approval.
Advertisement:
Interphex
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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In other news, GSK and Valeant Pharmaceuticals (Montreal) received a Complete Response letter from the US Food and Drug Administration for the companies’ new drug application (NDA) for ezogabine, an investigational antiepileptic drug. The companies are evaluating the letter, in which the FDA cited nonclinical reasons for the action. The companies are working on a response to FDA for submission as soon as possible in 2011, according to a GSK press release. The companies filed an NDA in October 2009.
Johnson & Johnson (J&J, New Brunswick, NJ) expects to commence a public offer for the biologics manufacturer Crucell (Leiden, The Netherlands) by Dec. 10, 2010. J&J announced its intention to make a bid for Crucell earlier this year, but withheld making an offer pending a review of the company’s manufacturing issues at Crucell’s facility in Shingal, Korea. On Oct. 28, 2010 and Nov. 9, 2010, Crucell put on temporary hold shipments of its liquid pentavalent childhood-disease vaccine Quinvaxem, and recombinant hepatitis B vaccine Hepavax-Gen. Crucell also suspended production at the Shinghal facility because of microbiological contamination in its sterile-manufacturing operations. Crucell expects to resume manufacturing at the facility by February 2011.
Merrion Pharmaceuticals (Dublin) has exercised an oral drug-delivery feasibility and option agreement with an undisclosed major pharmaceutical company. The agreement will evaluate the ability of Merrion’s proprietary GIPET technology to increase the bioavailablity of three compounds. Following the feasibility studies, the company will have the option to enter into a licensing agreement for Merrion’s GIPET technology.
Novartis Pharmaceuticals (East Hanover, NJ), the US arm of Novartis (Basel), is restructuring its general-medicines field force in the US and will eliminate approximately 1400 positions, effective Jan. 1, 2011. The restructuring is expected to result in a one-time cost of approximately $85 million.
The contract research organization Parexel (Boston) has opened two new clinical logistics-services facilities, a depot in Singapore, and a warehouse in Russia. The facilities will support the clinical-trial material supply in those countries.
West Pharmaceutical Services (Lionville, PA), a manufacturer of components and systems for injectable drug delivery, will close its manufacturing facility in Montgomery, Pennsylvania, and downsize operations at its facility in St. Austell, Cornwall, United Kingdom. The Pennsylvania facility performs contract manufacturing of molded plastic components and assemblies for consumer-product applications. The Cornwall facility produces molded elastomeric components for disposable medical devices and elastomeric and plastic components for pharmaceutical packaging. The closure of the Pennsylvania facility will result in 170 job losses, beginning in January 2011 through the third quarter of 2011. The company plans to transfer production to other facilities in the US. Production at its Cornwall facility will be reduced through late 2012 due to the expiration of a customer contract. The company will transfer production in Cornwall to other sites in Europe and eliminate 150 positions during the next two years. West will retain production of a select pharmaceutical packaging line in Cornwall. The company is in negotiation with a third party to acquire a portion of the Cornwall facility and to continue production for certain plastic packaging componets. Upon completion of the transaction, 46 West employees will be retained. The ancillary restructuring of administrative, engineering, and other operating positions will result in the net reduction of approximately 50 positions at other locations.
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The market for parenteral drugs has been growing for years, and competition in the sector is fierce. The focus on patient- and user-friendliness is intensifying. In response, Germany-based contract manufacturer Vetter built its state-of-the-art Vetter Secondary Packaging facility.
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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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Frank Baldino, Jr., Cephalon’s (Frazer, PA) chairman and chief executive officer, will not resume his duties at the company in 2010. He will remain on a medical leave of absence indefinitely. J. Kevin Buchi, the company’s chief operating officer, will continue to perform Baldino’s day-to-day responsibilities pending his return.
China Biologic Products (Tai’an City, China), one of the leading plasma-based biopharmaceutical companies in China, appointed Stanley Lau as its new president. As president, Lau will oversee strategic planning and business development, partnership management, and organization development. Lau has more than 30 years of experience in the pharmaceutical arena, in both international and Chinese markets.
Coldstream Laboratories (Lexington, KY), a provider of drug-product research and manufacturing services, named David A. Gelber vice-president of operations. In this newly created position, Gelber will assume responsibility of the company’s manufacturing operations. Gelber also will serve as a key advisor to Coldstream’s CEO Larry Kranking.
Halozyme Therapeutics (San Diego), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, appointed Gregory I. Frost to serve as president and CEO. Jonathan E. Lim resigned as president, CEO, and member of the board of directors to pursue other opportunities. The company also promoted H. Michael Shepard to chief scientific officer and accepted the resignation of Robert J. Little, vice-president and chief commercial officer.
HemaQuest Pharmaceuticals (San Diego), a biotechnology company focused on developing small-molecule therapeutics to treat hemoglobin-associated diseases, appointed John P. Longenecker to serve as president, CEO, and director. The company also named Richard Ghalie chief medical officer. Longenecker most recently served as president, CEO, and director of Favrille (San Diego) and has more than 25 years of executive management experience in the biotechnology industry.
Wesley P. Wheeler, CEO and president of Patheon (Research Triangle Park, NC), has left the company. Patheon appointed Peter Bigelow, president of Patheon’s North American operations, as interim CEO.
PPD (Wilmington, NC) appointed Elena Logan as senior vice-president of global central laboratories. In this role, Logan will provide strategic direction for the company’s global central laboratory operations.
Receptos (San Diego), a drug-discovery and -development company, appointed Faheem Hasnain as president, CEO, and a member of the board of directors. Hasnain was most recently president and CEO of Facet Biotech, and joins Receptos after more than 15 years in executive leadership positions. William H. Rastetter will step down as interim CEO of Receptos and will continue to serve as chairman of the board of directors.
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Needleless devices
Do you believe that needleless devices will ever fully replace traditional syringes for patient self medication?
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