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Castellani to Replace Tauzin as Head of PhRMA
The Pharmaceutical Research and Manufacturers of America announced earlier this week that John J. Castellani will replace Billy Tauzin as president and chief executive officer. 
Merck Announces Major Restructuring Plan
Merck & Co. released details of a restructuring plan last week, which calls for phasing out operations at eight research sites and eight manufacturing sites, resulting in a 15% reduction of its global workforce.
USP Works With Philippines to Strengthen Drug Quality
The Laboratory Services Division of the Philippine Food and Drug Administration has attained internationally recognized accreditation for its testing and calibration laboratories, according to a US Pharmacopeia announcement.
New Treaty to Curb Counterfeit Drugs
The Council of Europe (CoE) is hoping its Medicrime treaty can help curb the lucrative global trade in fake medicines.
J&J Expands Product Recall Again
McNeil Consumer Healthcare, a division of Johnson & Johnson, has once again expanded the recall of certain OTC products because of a musty or moldy odor, which has been linked to trace amounts of the chemical 2,4,6 triburomoanisole. State Laws Affect Generic-Substitution Rates and Medicaid Costs, Says Study
States can reduce their Medicaid programs’ healthcare expenditures by changing laws to enable generic drugs to be substituted for branded medications more easily and quickly, according to a new study. |
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 Screener increases efficiency
Rotex Global (Cincinnati) has introduced a smaller version of the MEGATEX XD screener that measures 9 x 9 x 12 feet. The unit uses a stacked, multiple-deck design to split and distribute the incoming flow of material evenly to all screen decks. The device’s screens are wide, rather than long, which increases its capacity.
The machine’s long-stroke, low-frequency, gyratory screening action maximizes efficiency by creating equal feed distribution to all screen decks and spreading material across the entire screen surface effectively. In addition, the device produces noise levels lower than those emitted by vibratory screeners. The machine incorporates an easily accessible external drive that allows for high product recoveries at material temperatures of 400 °F. The stacked, multideck configuration also allows operators to access individual trays without the need to remove all decks. A Lift-Rail system with nonbinding stainless-steel cam activation enables easy screen frame installation and removal.
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Advertisement:
Expansion of Vetter Development Service (VDS)
The North American market is critical to Vetter’s strategic global growth as nearly half of its client base is already located here. In order to maximize on this opportunity, Vetter has decided to create a facility, its first outside of Germany, at the Illinois Science + Technology Park in suburban Chicago. The facility, which focuses on preclinical to phase II clinical batch projects, is an expansion of Vetter Development Service. With significant progress already having been made, the facility is scheduled to be operational by beginning of the fourth quarter 2010.
Click here for more information.
 Click here for more information.
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Adimab (Lebanon, NH), a biotechnology company focused on the discovery of fully human antibodies, formed a research collaboration with Novartis (Basel). This agreement represents the fifth major partnership Adimab has announced since launching its discovery platform one year ago, according to a company press release. In addition, Adimab recieved a second milestone payment from its ongoing collaboration with Merck and Co. (Whitehouse Station, NJ).
The Indianapolis Business Journal (IBJ) reported that Eli Lilly (Indianapolis) will cut 170 jobs from its manufacturing and quality division by the end of the year. IBJ cited an email from company spokeswoman Janice Chavers in the report. According to Chavers, the job cuts will take place in Lilly’s Indianapolis and Clinton, Indiana, facilities.
Genzyme (Cambridge, MA) formed a supply agreement with Hospira (Lake Forest, IL), under which Hospira will fill and finish drugs for Genzyme, according to a recent filing by Genzyme with the US Securities and Exchange Commission. Hospira will provide the services for Cerezyme (imiglucerase for injection), Genzyme’s therapy for Gaucher disease; Fabrazyme (agalsidase beta), its treatment for Fabry disease; the thyroid drug Thyrogen (thyrotropin alfa for injection); Myozyme (alglucosidase alfa) and Lumizyme (alglucosidase alfa), for the muscle disorder Pompe disease; Thymoglobulin (Anti-thymocyte Globulin [Rabbit])to prevent rejection of transplanted kidneys; the cancer treatment Campath (alemtuzumab); and certain other products. Genzyme was required to move filling and finishing operations out of its Allston, Massachusetts, plant under the terms of a consent decree with FDA. The Allston plant was closed last year due to viral contamination. GlaxoSmithKline (GSK, London) confirmed that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) will review the safety profile of Avandia (rosiglitazone) at its meeting July 19–22. Earlier this week, an FDA advisory committee also reviewed the safety of the drug. On Tuesday, July 13, GSK responded to the Senate Finance Committee’s (SFC’s) release of a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the ongoing product-liability litigation for Avandia. GSK said in a press release that the released documents “include drafts and other documents taken out of context,” and that “Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading.” GSK said the documents also do not include information about GSK’s evaluation of Avandia. The company also said is has been diligent in providing safety data and requested documentation to FDA and SFC. Human Genome Sciences (HGS, Rockville, MD) formed a supply agreement with Lonza (Basel) for HGS’s drug candidate Benlysta (belimumab). Benlysta, which is currently under regulatory review in the United States and Europe for the treatment of systemic lupus erythematosus, is being codeveloped with GlaxoSmithKline (London).
The Institute for OneWorld Health (iOWH), a nonprofit organization focused on providing medication to developing countries, received a $10.7 million grant from the Bill & Melinda Gates Foundation to prepare for large-scale production and commercialization of semisynthetic artemisinin. iOWH recently completed development of semisynthetic artemisinin, which is a key ingredient in first-line malaria treatments.
Contract manufacturer OctoPlus (Leiden, the Netherlands) signed a development and manufacturing contract with The Medicines Company (Parsippany, NJ).
OctoPlus will perform process development and clinical manufacturing for The Medicines Company related to MDCO-216 (ApoA-I Milano/phospholipid complex). Financial terms were not disclosed. Scientists at the National Institutes of Health (NIH) discovered two human antibodies that can stop more than 90% of HIV strains from infecting human cells in the laboratory, and they have demonstrated how one of the antibodies does so. The scientific team was part of the Vaccine Research Center, a division of the National Institute of Allergy and Infectious Diseases at NIH. The scientists said the antibodies could be used to design improved HIV vaccines, or could be further developed to prevent or treat HIV infection, according to a press release. Additionally, the method used to find these antibodies could be applied to isolate therapeutic antibodies for other infectious diseases. Contract services providers Xcelience (Tampa, FL) and Penn Pharma (Tredegar, UK) formed a joint venture to provide Capsugel’s (Peapack, NJ) Xcelodose precision powder microdosing system technology in Europe and Asia-Pacific markets. Using Capsugel’s technology, Xcelience and Penn will provide services to place active pharmaceutical ingredients into capsules for clinical-trial materials.
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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Pharmaceutical manufacturer Aesica (Newcastle upon Tyne, UK) appointed Gerard Scarlato business development director for the West Coast. Scarlato will be responsible for activities at the company’s new site in San Diego. Almac’s (Craigavon, UK) Clinical Technologies division appointed Bill Kane director of quality assurance and regulatory compliance. He will support internal, client, and agency audits, as well as improve internal quality and compliance programs.
Generic-drug manufacturer Amneal Pharmaceuticals (Hauppauge, NY) appointed Shankar Hariharan chief scientific officer and executive vice-president of specialty pharmaceuticals. Hariharan was previously chief scientific officer and executive vice-president of Par Pharmaceutical (Woodcliff Lake, NJ).
The European Medicines Agency (EMA) said on its website that the vacancy notice for the executive director will soon be republished in the media as the conditions and requirements are being reviewed. The agency attempted to cancel the previous publication, and a number of advertisements have appeared in some national media in recent days. EMA said the European Commission will publish a new vacancy notice shortly in the Official Journal of the European Union, which will also be advertised in national media and selected journals. International Specialty Chemicals & Pharmaceuticals (Tarrytown, NY), a provider of fine and specialty chemicals, appointed John Cox executive vice-president of the company. Cox previously served as executive vice-president at Charkit Chemical (Norwalk, CT). Talecris Biotherapeutics (Research Triangle Park, NC) appointed Lafmin Morgan vice-president of US product management. Morgan joins the global commercial-operations team and will be responsible for product management and marketing of the company's product portfolio in the US. |
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The US Food and Drug Administration announced last week that it will be “conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of [21 CFR] Part 11.” The agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the 2003 Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application. (See related blog post.)
FDA also issued a new Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 13. This particular annex harmonizes the analytical procedures used for bulk density and tapped density of powders across the US, Europe, and Japan. ICH adopted Annex 13 in June 2010. FDA has published other harmonized Q4B annexes as guidance’s over the past year, including Annex 5 Disintegration Test, 7 Dissolution Test, 8 Sterility Test, 9 Tablet Friability, and 10 Polyacrylamide Gel Electrophoreses.
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Green Manufacturing Efforts
Has your company initiated a program to make its processes more green?
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