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 Powder rheometer performs uniaxial testing
Freeman Technology (Welland, UK) now provides a uniaxial accessory that fits onto its FT4 powder rheometer. The accessory includes a split mold that allows a 25-mm-wide column of powder to be prepared through conditioning and compaction. The FT4 unit’s custom-made conditioning process helps generate a uniform, homogeneous test sample, thus improving repeatability and reducing the influence of the operator. After the mold is removed, the compacted column of powder is axially loaded in a controlled way until failure is induced. Unlike other instruments, the FT4 device measures dynamic flow, bulk, and shear properties of conditioned, consolidated, aerated, and fluidized powders under various levels of packing and stress. Users thus can simulate the conditions that a powder will endure in various processes and measure the powder’s behavior under those conditions. The FT4 also allows operators to establish a reliable database of flow properties that can be correlated with performance in given processes.
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Akorn (Lake Forest, IL), a niche generic pharmaceutical company, reported that its Akorn-Strides LLC joint venture agreed to sell 16 abbreviated new drug approvals (ANDAs) and six filed ANDAs to Pfizer (New York) for $35 million in cash. Akorn-Strides LLC will continue to manufacture and distribute the approved products until April 30, 2011.
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AMRI (Albany, NY) formed a research and licensing agreement with Genentech (South San Francisco, CA), part of the Roche Group (Basel), for a family of antibacterial compounds discovered from AMRI's research of its natural products sample collection. Genentech will receive an exclusive license to develop and commercialize multiple potential products from AMRI's proprietary antibacterial program, and the companies will conduct research to identify antibacterial agents. AMRI will receive an upfront license fee and research funding, milestone payments, and royalties on product sales.
BASi (Bioanalytical Systems Inc., West Lafayette, IN) a contract research organization, entered into a preferred provider agreement with Pharmasset (Princeton, NJ), a clinical-stage pharmaceutical company, to provide preclinical services. The agreement includes provisions to provide exclusive toxicology services as well as pharmaceutical analysis and bioanalytical services as needed.
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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
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Gilead Sciences (Foster City, CA) agreed to acquire Arresto Biosciences (Palo Alto, CA), a biotechnology company that develops medicines to treat fibrotic diseases and cancer, for $225 million and potential future payments based on achievement of certain sales levels. Gilead anticipates that the deal would close in the first quarter of 2011.
Lpath (San Diego), a therapeutic antibody company, formed an agreement with Pfizer (New York) for an exclusive option for a worldwide license to develop and commercialize iSONEP, Lpath's lead monoclonal antibody product candidate, which is being evaluated for the treatment of wet age-related macular degeneration (wet AMD) and other ophthalmology disorders. Pfizer will pay $14 million upfront and share the cost of the planned Phase Ib and Phase IIa trials. Following completion of the two studies, Pfizer can exercise its option for worldwide rights to iSONEP for an undisclosed option fee, which will make Lpath eligible to receive up to $497.5 million in milestone payments. Lpath will also be entitled to receive royalties based on product sales. The agreement also grants Pfizer a time-limited right of first refusal for asonep, Lpath's anticancer product candidate.
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FDA informed the biopharmaceutical company MannKind (Valencia, CA) on Dec. 27, 2010, that it would not be able to complete the review of the new drug application (NDA) for Afrezza (insulin human [rDNA origin]) Inhalation Powder by the action date of Dec. 29, 2010. The agency said it will require approximately four additional weeks to complete its review of the NDA.
Santaris Pharma (Hoersholm, Denmark), a biopharmaceutical company focused microRNA-targeted therapies, and Pfizer (New York) expanded their collaboration to develop and commercialize RNA-targeted medicines using Santaris’s Locked Nucleic Acid (LNA) drug platform. Santaris will receive $14 million up front from Pfizer, up to $600 million in milestone payments, plus royalties on product sales. The newly expanded alliance builds on the original collaboration formed in January 2009 between Santaris and Wyeth, which was acquired by Pfizer.
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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Novo Nordisk (Bagsværd,
Denmark), a global healthcare company focusing on diabetes care, appointed Anne Phillips vice-president of clinical development for medical and regulatory affairs for North America. Phillips reports directly to Jerzy Gruhn, president of Novo Nordisk Inc., the company's US affiliate, and senior vice-president for Novo Nordisk A/S North America. Phillips will serve as a member of the US executive team.
Dominique Baly is responsible for the cross-divisional management of marketing, sales, and service for the Sartorius (Goettingen, Germany) laboratory business as president of Sartorius Group Laboratory Business. Baly reports to CEO Joachim Kreuzburg and is a member of the group executive committee.
Savient Pharmaceuticals (East Brunswick, NJ), a specialty biopharmaceutical company, initiated a search for a CEO. Paul Hamelin, Savient's president since November 2008 and its most senior executive officer, will continue to lead the day-to-day operations of the company until Savient hires a CEO.
Ziopharm Oncology (New York), a biopharmaceutical company, appointed Mark O. Thornton executive vice-president and chief development officer. He will report to Jonathan Lewis, the company’s CEO and chief medical officer.
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According to the FDA Press Office on Jan. 5, 2010, John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy
commissioner for the next 60 days. It was reported earlier this week that Joshua Sharfstein, principal deputy commissioner under Margaret Hamburg, was
leaving the agency to work for the state of Maryland as secretary of health. Dr. Hamburg issued a memo on the subject today.
The US Pharmapcopeia (USP) released proposals for universal standards to guide the content, language, format, and appearance of prescription drug labels. USP is seeking comments from pharmacists and other healthcare professionals for the newly proposed General Chapter <17> Prescription Container Labeling. Comments are due Mar. 31, 2011. The development of the proposed standards was led by the Institute of Medicine (IOM) and aim to “improve health literacy in the United States by bringing together government, industry, associations, and other groups to advance practical strategies that can be implemented to maximize patient comprehension of health information,” according to the USP notice. The core components of the standard proposals include labeling prescriptions in a
patient-centered manner; emphasizing instructions and other important information; giving explicit instructions, including the purpose for use;
improving readability; and limiting auxiliary information.
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Take the 8th Annual Global BioManufacturing Survey |
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Budget trends, new technologies, capacity, outsourcing and hiring issues, downstream processing, disposables, cost cutting, and quality initiatives, are just a few of the important topics covered in this year's 8th Annual Biopharmaceutical Manufacturing Report and Survey held by BioPlan Associates, Inc. Last year, more than 400 biomanufacturers and suppliers participated globally, and this year we're expecting even more. You will receive a free summary of the results from the study. In addition, for each completed survey, BioPlan Associates will donate $10 (up to $10,000) to the Global Alliance for Vaccine Initiative, or American Cancer Society.
Coming Soon: A special report discusses process analytical technology in the February issue of Pharmaceutical Technology. |
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| DCAT President Discusses the Pharmaceutical Supply Chain |
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By Patricia Van Arnum
Pharmaceutical Technology discusses the key issues and trends facing the pharmaceutical supply chain with Bob Kanuga, executive director of the external manufacturing organization with Merck & Co. Inc. and president of the Drug, Chemical and Associated Technologies Association (DCAT).
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Granulation Techniques
Which granulation technique is most commonly used in your company?
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View the poll archive. |
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