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Amylin Pharmaceuticals (San Diego, CA) and Takeda Pharmaceutical (Osaka, Japan) entered into a drug-development pact for the treatment of obesity and related indications. The agreement includes products to be developed from Amylin's pipeline, including pramlintide/metreleptin and davalintide, which are compounds currently in Phase II development for treatment of obesity. The agreement also includes additional compounds from both companies' obesity-research programs. Amylin will receive an up-front payment of $75 million from Takeda and is eligible to receive more than $1 billion in milestone payments, as well as tiered, double-digit royalty payments based on global product sales.
BioMarin Pharmaceutical (Novato, CA) acquired Huxley Pharmaceuticals, which has rights to a proprietary form of 3,4-diaminopyridine (3,4-DAP), amifampridine phosphate, for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS). Last week, the Committee for Medicinal Products for Human Use of the European Medicines Evaluations Agency adopted a positive opinion recommending approval of amifampridine phosphate for LEMS. If approved by the European Commission, amifampridine phosphate will be the first approved treatment for LEMS, thereby conferring orphan drug protection and providing 10 years of market exclusivity in Europe, according to a BioMarin press release.
CNS Protein Therapeutics (Sunnyvale, CA), a biotechnology company, completed its corporate name change to Amarantus Therapeutics. The company appointed Martin D. Cleary chief executive officer. Cleary succeeds co-founder Gerald E. Commissiong, who has served as CEO since 2008. Commissiong will remain with Amarantus as chief business officer.
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Eli Lilly (Indianapolis, IN) opened a new biotechnology center on the West Coast known as the Lilly Biotechnology Center—San Diego. The facility opened three months after Lilly announced it would move its ImClone (New York) research headquarters, which specializes in developing cancer biologics, into a new biopharmaceutical research cluster in New York. One year ago, Lilly completed construction of its biotechnology research and development complex at the company headquarters in Indianapolis, Indiana.
Evonik Industries (Essen, Germany) finalized the sale of the AlzChem Group to the Luxembourg-based private equity fund bluO for EUR 78.5 million ($116 million) in cash. The deal closed on Oct. 27, 2009, after it was approved by the boards and the relevant antitrust authorities. AlzChem produces calcium cyanamide-based ingredients for the plastics, agriculture, and pharmaceutical industries.
GlaxoSmithKline (GSK, London) and Genmab (Copenhagen, Denmark) announced the accelerated approval of Arzerra (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab. GSK also recently saw its kidney cancer drug Votrient (pazopanib) approved by FDA. Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney.
Johnson & Johnson (New Brunswick, NJ) announced global restructuring initiatives that include the elimination of approximately 6–7% of its global workforce, or roughly 7,000 to 8,000 positions. The company expects pre-tax cost savings of $1.4–$1.7 billion when the restructuring plans are fully implemented in 2011, with $800–$900 million expected to be achieved in 2010. “Cost savings will be achieved primarily by reducing layers of management, increasing individual spans of control, and simplifying business structures and processes across the company’s global operations,” the company said in a press release.
Ligand Pharmaceuticals (San Diego, CA) will acquire the biopharmaceutical company Metabasis Therapeutics (La Jolla, CA). The Ligand and Metabasis boards of directors unanimously voted in favor of the transaction.
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Merrion Pharmaceuticals (Dublin, Ireland) opened a new facility in Dublin, Ireland. The 29,500-ft2 pharmaceutical facility includes 6000 ft2 of offices, a 6500-ft2 formulation process development area, a Class D cleanroom, 21 processing rooms, 4000 ft2 of analytical laboratories, a development laboratory, a feasibility laboratory, and 2100 ft2 of warehouse space.
Morphotek (Exton, PA), a subsidiary of Eisai (Woodcliff Lake, NJ), entered into a license agreement with Johnson & Johnson’s Centocor Ortho Biotech (Horsham, PA) for development and commercialization of an antibody that targets a tumor-associated antigen over-expressed in many solid tumors. Financial terms were not disclosed.
Penn Pharma (Tredegar, UK) completed the first phase of its £12-million ($19.7 million) expansion program by investing £315,000 ($517,000) in upgrading its Tredegar, Wales, headquarters. The company expanded its facilities by 2400-m2 and overhauled the transport and delivery infrastructure at the facility. The £12-million expansion will continue throughout the next five years.
PPD (Wlimington, NC), a contract research organization, will acquire the Chinese contract research organization Excel PharmaStudies (Beijing). In a separate announcement, PPD said it will invest $100 million in Celtic Therapeutics Holdings, an investment partnership organized for the purpose of identifying, acquiring, and investing in a diversified portfolio of 10 to 15 novel therapeutic product candidates. Celtic Therapeutics will focus on mid-stage drug-development candidates that have progressed through human proof-of-concept studies and are targeted to address unmet medical needs.
PPD also announced last week that it will spin off its compound partnering business from its core contract research organization business. The CRO business will continue to operate under the PPD name and will be focused solely on its drug discovery and development service businesses. The compound partnering business will have the opportunity to focus on developing and commercializing its drug candidates and to access external capital, if needed, without any constraints associated with operating in combination with the CRO business, according to a company press release.
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sanofi aventis (Paris) formed a BiTE antibody pact with the biopharmaceutical company Micromet (Bethesda, MD). BiTE antibodies are novel therapeutic antibodies that activate patients’ T cells to seek out and destroy cancer cells. The collaboration will focus on the development of a BiTE antibody against an antigen present at the surface of carcinoma cells. Micromet will be responsible for the discovery, development, and completion of Phase I clinical trials under the supervision of a Joint Steering Committee, and sanofi aventis will then have the full responsibility for the further development and worldwide commercialization of the BiTE antibody.
Symyx Technologies (Sunnyvale, CA) and Thermo Fisher Scientific (Waltham, MA) announced an out-of-the-box integration of Symyx Notebook and Thermo Scientific Watson LIMS. The integration enables scientists engaged in bioanalytical workflows to electronically pass information, sample lists, experimental results, and reports between the electronic laboratory notebook (ELN) and the laboratory information management system (LIMS).
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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The US Food and Drug Administration published on Nov. 2, 2009, a guidance for industry and staff on In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA), according to an agency release about the guidance. This guidance outlines what information manufacturers need to include in EUA requests. The EUA authority allows FDA to authorize use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a declaration of emergency, when certain criteria are met. Department of Health and Human Services Secretary Kathleen Sebelius declared such an emergency period for H1N1 in April 2009.
In related news, Novartis (Basel, Switzerland) confirmed last week that it has shipped more than 7.5 million doses of Influenza A (H1N1) vaccine and expects 25 to 30 million doses of unadjuvanted vaccine to become available in prefilled syringes and multidose vials by the end of November. “Production of the H1N1 vaccine is progressing, despite the unexpected very low yields observed with the initial seed virus at 23% as compared to average yield seen with seasonal vaccines,” said the company in a release.
FDA and WebMD Health Corporation have expanded their partnership, according to late October news releases. The partnership, started in December 2008, aims to provide viewers with access to the agency’s consumer health information. WebMD will now include additional content and multimedia tools based on FDA information.
FDA awarded contract research organization PPD a $2.7-million contract to evaluate the agency's Center for Drug Evaluation and Research (CDER) postmarket spontaneous-adverse-event surveillance system. PPD will conduct a thorough evaluation of the value of the system and report its findings, according to a PPD release. The two-year project falls under FDA's Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product's Life Cycle (IMPACT), which is aimed at fulfilling a Prescription Drug User Fee Act (PDUFA) IV commitment. FDA will use PPD’s findings to develop an implementation strategy for ensuring optimal use of the system, according to the release. |
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Aceto (Lake Success, NY), a fine-chemicals distributor, announced that Chairman and CEO Leonard S. Schwartz will leave the company on Nov. 20, 2009, after 40 years of service. The company has separated the office of chairman of the board from that of CEO. Effective immediately, President Vincent Miata will assume the responsibilities of CEO, and Albert Eilender, currently a board member and the lead independent director, will be the non-executive chairman of the Aceto board.
Intrexon (San Francisco, CA), a life-sciences company focused on modular DNA control systems for biotherapeutics, appointed Gerardo A. Zapata president of its Protein Production Division and a senior vice-president of the company. Zapata will be based at Intrexon’s headquarters in San Francisco, California.
Laureate Pharma (Princeton, NJ), a biopharmaceutical development and protein production company, added new members to its business development team: Andrew Arrage joins the company as director of business development—East, and Bruce Frazier joins as manager of business development—West.
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NeoPharm (Lake Bluff, IL), a biopharmaceutical company, appointed Aquilur Rahman to the position of president and CEO. Rahman succeeds Laurence P. Birch, who will leave the company to pursue other opportunities. Rahman is a co-founder of NeoPharm and currently serves as the company's chief scientific advisor.
Quintiles Consulting (Research Triangle Park, NC) made the following appointments in its US Regulatory and Quality consulting practice: Bob Rhoades joins the company as head of the Quality Systems business units within the United States; Michael Swiatocha joins as head of the R&D Compliance business unit; and Barbara (Jan) Holladay Pierre joined the company as a principal consultant.
Rosetta Genomics (Rehovot, Israel), a developer of microRNA-based molecular diagnostics, appointed Kenneth A. Berlin president and CEO. The company’s board of directors recommended that Berlin be appointed to serve on the Rosetta Genomics’ board of directors, and will vote at the upcoming shareholders meeting.
Watson Pharmaceuticals (Morristown, NJ) appointed R. Todd Joyce senior vice-president and chief financial officer. Joyce succeeds Mark W. Durand, who has left as CFO for personal reasons. On July 27, 2009, Joyce took over as acting principal financial officer when Durand took a leave of absence for health reasons.
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