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Sterile Pharmaceutical Dosage Forms: Basic Principles
June 1–June 2, 2011
Bethesda, MD
Lyophilization Technology - Practical Application of the Scientific Principles
June 13–June 15, 2011
Los Angeles, CA
Chemspec Europe 2011
June 15–June 16, 2011
Geneva, Switzerland
10th Annual Biological Production Forum 2011
June 20–June 22, 2011
Frankfurt, Germany
IVT’s 2nd Annual ACE
June 21–June 23, 2011
Philadelphia, PA
NC3Rs/Society of Biology Symposium
June 22, 2011
London, United Kingdom 
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Takeda to Acquire Nycomed
Takeda Pharmaceutical has agreed to acquire Nycomed, a Swiss pharmaceutical company for $13.5 billion, excluding Nycomed's US dermatology business. The deal is intended to increase Takeda's presence in European and emerging markets. 
IMS Predicts Slowed Growth in Drug Spending
Global spending on medicines will total almost $1.1 trillion by 2015, according to an IMS Institute for Healthcare Informatics study.
More Than 800 Medicines in Development for Diseases Affecting Women
America's pharmaceutical research and biotechnology companies are developing 851 medicines for diseases that disproportionately affect American women, says a PhRMA report.
EMA Responds to Transparency Criticism
Following recent accusations that the EMA puts companies' commercial interests ahead of public safety, the EMA has responded by emphasizing recent initiatives at the agency to improve data access.
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 Chromatography station increases efficiency
Bio-Rad’s Chromatography Station includes preprogrammed methods intended to reduce the time required for preparation, processing, and postprocessing for small-scale GMP biopharmaceutical manufacturing. Users can program methods for each chromatography media type to transfer slurry into and out of the column, perform bed-consolidation and unpacking procedures, and clean the machinery in place. The automation helps reduce operator variability, and clients can validate the automated methods to ensure reproducibility.
Unlike other chromatography equipment, the Chromatography Station incorporates a column, process skid, and media-transfer accessories in a single unit. The unit’s compact design gives it a small footprint that helps to optimize cleanroom space.
In addition, clients can scale up the Chromatography Station from small-scale (i.e., size 00, with column diameters ranging from 100 to 300 mm) to large-scale manufacturing (i.e., size 02, with column diameters ranging from 200 to 600 mm). The station’s wireless tablet computer offers flexible control to the operators.
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Almac, a contract development and manufacturing organization, officially opened its new $120-million, 240,000-ft2 North American headquarters in Souderton, Pennsylvania. The company’s global headquarters is located in Craigavon, United Kingdom.
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Eli Lilly has formed BioCritica, a new biotechnology company, with private-equity investors Care Capital and NovaQuest Capital, which will focus on hospital-based critical-care drugs. The initial focus of the company will be on the US development and commercialization of Xigris (drotrecogin alfa [activated]), a drug to treat sepsis.
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Johnson & Johnson (J&J) subsidiary Cilag GmbH International agreed to acquire the over-the-counter brands of JB Chemicals and Pharmaceuticals for approximately $260 million in cash. The brands included in the acquisition are Rinza, a Russian multisymptom cough-and-cold brand, and Doktor Mom, Russia’s number-two selling cough medicine brand, in addition to several other brands. J&J subsidiary Johnson & Johnson LLC and its affiliates will market these products in Russia, the Commonwealth of Independent States, and other countries.
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Optimum FTIR Performance, Sensitivity, and Reliability
Shimadzu’s IRAffinity-1 FTIR is ideal for high-precision infrared analysis in a multitude of pharmaceutical applications, from identification of foreign matter to analysis of contaminants. It features best-in-class sensitivity, long-term stability, increased reliability with self-diagnosis and continuous monitoring during operation, protection from humidity with a triple protection interferometer, and analysis support programs.  Learn more |
In other news, FDA approved Tibotec Therapeutics’ Edurant (rilpivirine) tablets for use in combination with other antiretroviral agents in the treatment of HIV Type I in treatment-naïve adults.
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Reports from the Waters Bioanalysis World Tour:
Our recent special event series has been creating a lot of buzz among bioanalysts, with engaging discussions on topics from microsampling to peptide bioanalysis. Read reports written by the Bioanalysis Journal, watch our on-demand webinars, and look for future symposia dates at  www.waters.com/biotour |
Merck & Co. and Roche have agreed to explore new combinations of investigational and marketed medicines used to treat chronic hepatitis C. Under the terms of the nonexclusive agreements in the United States, Genentech, a part of Roche, will include Victrelis (boceprevir) as part of its promotion to healthcare professionals on the use of Pegasys (peginterferon alfa-2a) in a triple-combination therapy regimen.
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Walker Barrier Systems custom designs & manufacturers Isolators, Restricted Access Barrier (RAB’s), and Downflow Booths to provide both product & personnel protection for containment, aseptic, and sterility test applications. Walker Barrier Systems also provides aftermarket support for all isolator and downflow booth needs. See us at ISPE Washington June 6-8 or visit our website at  www.walkerbarrier.com for information. |
Par Pharmaceutical, a specialty pharmaceutical company, has agreed to acquire Edict Pharmaceuticals, a generic-drug company based in Chennai, India, for $37.5 million. The acquisition, which is subject to customary closing conditions and approvals, is expected to close by the end of 2011.
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Rafagen, a biotechnology company, has partnered with the contract manufacturing organization Goodwin Biotechnology, for cell-line development and biological contract manufacturing.
The private-equity firm Ridgemont Equity Partners has acquired a majority stake in Gallus Biopharmaceuticals, a contract biologics manufacturer based in St. Louis, Missouri. The investment by Ridgemont allows Gallus to acquire a 200,000-ft2 biologics manufacturing facility in Berkeley, Missouri, from Centocor Biologics, part of J&J. The plant currently manufactures two Centocor Biologics’ products, Remicade (infliximab) and Stelara (ustekinumab). Ridgemont’s investment also will be used to expand the facility’s manufacturing capabilities, including building a clinical-services suite and expanding the existing development laboratory. Gallus plans to make an initial capital investment of $20 million to expand the facility, according to a release by the governor’s office in Missouri.
In other news, Gallus and the biomanufacutring company Xcellerex have entered into a biomanufacturing collaboration. Under the terms of the agreement, Gallus will acquire several Xcellerex bioproduction systems for new suites and laboratories at its existing manufacturing facility. Along with single-use XDR bioreactors to quickly expand capabilities in an existing commercial manufacturing suite, Gallus is acquiring small-scale 10-L bioreactors for its expanded development laboratory and a turnkey FlexFactory cGMP manufacturing line with XDR single-use bioreactors up to 2000-L scale for clinical supply.
Ropak, a provider of contract manufacturing and packaging services, has begun stickpack production in its new 15,000-ft2 manufacturing suite. The nearly $9-million facility provides unidose packaging of solid oral dosage in four Class 100000 cleanrooms at low relative humidity (20%), controlled temperature, and controlled residual oxygen to 4%. The new production suite is part of Ropack’s 210,000-ft2 manufacturing, packaging, warehouse, and distribution space. In addition to stickpacks, Ropack is equipped to perform standard and cold-form blistering, encapsulation, bottling, sachet filling, syringe assembly, clinical trials, and blending.
SAFC, the custom manufacturing and business services arm of Sigma-Aldrich, has formed a licensing agreement with Agilent Technologies, which makes SAFC a preferred partner in the sale of Agilent’s nucleic acids synthesis products and technologies. The product–line addition builds on a previous licensing agreement and covers Agilent’s proprietary TC-RNA phosphoramidites, which are chemistries that can enable the production of RNA-based oligos.
Shire, a specialty biopharmaceutical company, has agreed to acquire the regenerative medicine company Advanced BioHealing, for $750 million. The deal provides Shire a strategic platform for tissue regeneration using cell-based therapies and adds Dermagraft, a medication to treat diabetic foot ulcers, to its portfolio. The deal is subject to customary closing conditions and regulatory approval.
Thermo Fisher Scientific, a life-sciences services and product firm, has acquired Sterilin, a provider of single-use plastic products serving the microbiology, life-sciences, and clinical markets. Sterlin recorded 2010 sales of $35 million. Thermo Fisher also has agreed to acquire Phadia, a provider of allergy and autoimmunity diagnostics, from the European private-equity firm Cinven, for €2.47 billion ($3.5 billion) to build its specialty diagnostics business. The deal is expected to close in the fourth quarter of 2011, subject to customary closing conditions and regulatory approval.
Vetter Pharma, a contract development and manufacturing organization, has completed the structural work on its new center for visual inspection and logistics in Ravensburg, Germany. This high-bay warehouse will be used to house cold-storage and room-temperature products and will be powered by photovoltaics, biogas, and geothermal sources of energy. The €31 million ($44 million) project is scheduled to be completed in late 2011.
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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Fereydoun Firouz has resigned from his position as president and CEO of EMD Serono, an affiliate of Merck KGaA, following two decades of service. James Hoyes, who is currently chief commercial officer, will serve as acting head of the organization on an interim basis.
Sanofi Pasteur, the vaccines division of Sanofi, has appointed Damian Braga as senior vice-president of global commercial operations. Previously, Braga was president of Sanofi Pasteur US and vice-president of Sanofi Pasteur Americas.
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Last week, FDA held a joint meeting of its Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee to discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children under age 2. The full meeting agenda is here. Johnson & Johnson’s McNeil Consumer Healthcare, which recalled several children’s OTC products during the past year, provided briefing materials for the meeting, which can be accessed online. At press time, minutes of the meeting had not been posted. Reportedly, the committee recommended adding dosing guidelines to products containing acetaminophen for children under age 2, including Children’s Tylenol. The panel also recommended that dosage labels be revised according to weight, not age, for these products. FDA does not have to accept the panel’s recommendations, but typically does.
Excipact, Rx-360, and IPEA are collaborating on the use of a self-regulated and voluntary audit scheme based on the widely accepted IPEC-PQG GMP and GDP Guides according to a May 24 press release. The goal is to help improve patient safety and global supply chain security. IPEA is the arm of the International Pharmaceutical Excipients Council (IPEC) that focuses on auditing. Excipact is an international group of excipients manufactures, suppliers, and distributors, including the IPEC regional organizations. The audit scheme is based upon the new Excipact standard, launching this year, and the pending equivalent ANSI NSF363 standard, says the release. The Excipact standard includes additional requirements for GMP and GDP certification and is based on the ISO 9001 Quality Management System Standard.
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Shared Audits
Do you think shared audits can be a tool to help manage the pharmaceutical supply chain?
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View the poll archive. |
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