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Pfizer Initiates Voluntary Recall of Three I.V. Drugs
Pfizer is voluntarily recalling metronidazole, ciprofloxacin, and ondansetron intravenous products because of the presence of floating matter and non-sterility discovered by the manufacturer Claris Lifesciences. 
USP and Russia Make Headway on Improving Drug Quality
The US Pharmacopeial Convention and the Russian Federation’s regulatory agency, Roszdravnadzor, is moving forward on its memorandum of understanding to work toward protecting and improving the quality of medicines worldwide.
Group Challenges Proposed Limits on Vial Labeling
The Consortium for the Advancement of Patient Safety told a meeting of the US Pharmacopeia’s Nomenclature Expert Committee that the latter’s proposal to restrict printing on ferrules and cap overseals was ambiguous and could unintentionally reduce patient safety.
WHO May Have Overrated H1N1 Pandemic
The handling of the H1N1 pandemic by the World Health Organization, EU agencies, and national governments led to a “waste of large sums of public money, and unjustified scares and fears about the health risks faced by the European public,” according to a recent report. |
 Film coater enables continuous operation
The DRIACONTI-T pharma film coater from Driam (Eriskirch am Bodensee, Germany) is designed to enable continuous operation. The unit’s cylindrical drum is divided into sections, each of which is dedicated to a particular process step. When a process step is complete, flaps in the drum move simultaneously to transfer the groups of tablets to the next drum section for further processing. Unlike traditional film coaters, the DRIACONTI-T pharma device can handle batches of all sizes.
Operators can set up the machine so that tablets enter its loading hopper directly from a tablet press. This configuration eliminates the need for loading, unloading, and intermediate storage. The film coater’s segmented drum ensures consistent consumption of energy and coating media. The relatively small size of the drum sections enables gentle product handling. Operators can control the machine through a touch screen monitor. The unit’s spraying system can be removed easily.
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| Albemarle (Baton Rouge, LA), a supplier of fine-chemistry services, is building a kilo laboratory in Louvain la Neuve, Belgium. The facility is expected to be operational by the third quarter of 2010.
Ascenta Therapeutics (Malvern, PA), a biopharmaceutical company, signed an agreement with sanofi-aventis (Paris) focused on several early-stage agents being investigated for their potential to restore tumor cell apoptosis (programmed cell death). Ascenta will receive an upfront payment, and milestone payments that could reach a total of $398 million, plus royalties on product sales.
Grifols (Barcelona) a producer of plasma protein therapies, agreed to acquire Talecris (Research Triangle Park, NC), a biotherapeutics products company, for $3.4 billion. The transaction will be a combination of cash and newly issued Grifols non-voting shares.
Hospira (Lake Forest, IL), a specialty pharmaceutical and medication delivery company, signed a pact with specialty pharmaceutical company Durect (Cupertino, CA) to develop and market Durect's Posidur (SABER-bupivacaine) a long-acting version of the anesthetic bupivacaine currently in Phase III clinical trials. Hospira will make an upfront payment of $27.5 million, potentially $185 million in milestone payments, plus royalties on product sales. Phase III trials are expected to be completed in 2011.
Immunovaccine (Halifax, Canada), a developer of vaccine-delivery technology, signed a collaborative research agreement with Vaxil BioTherapeutics (Nes-Ziona, Israel), a developer of vaccines, focused on Vaxil’s cancer antigens in Immunovaccine’s DepoVax vaccine enhancement platform.
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Pharmalucence (Bedford, MA), a producer of radiopharmaceuticals, will construct a 70,000-ft2 contract manufacturing facility and new corporate headquarters in Billerica, Massachusetts. The company expects to create 25 to 30 new jobs as a result of this expansion and that the facility will be operational in 2012.
QPharma (Morristown, NJ), a provider of regulatory and compliance solutions, launched its Engineering Services group. The group will provide services designed to aid in implementing and maintaining systems, processes, and facilities.
Royal Philips Electronics (Eindhoven, The Netherlands) signed a pact with RXi Pharmaceuticals (Worcester, MA), a biopharmaceutical company, to research combining proprietary technologies from both companies for the targeted delivery of experimental therapeutics based on RNA interference (RNAi). The joint research program between Philips and RXi will focus on RNAi drug delivery by exploring, in preclinical studies, using RXi's sd-rxRNA (self-delivering rxRNA) in conjunction with Philips's ultrasound technology to achieve the targeted delivery and monitoring of RNAi-based compounds in cells.
sanofi-aventis (Paris) signed a research agreement with the Charité University of Berlin. The public-private partnership is the first of this kind in Germany, according to a company press release. In a separate announcement, sanofi said it formed an alliance with the Massachusetts Institute of Technology Center for Biomedical Innovation (Cambridge, MA), which will be known as the sanofi-aventis Biomedical Innovation Program (SABIP).
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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.
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TransTech Pharma (High Point, NC), a pharmaceutical company, and Forest Laboratories (New York) entered into a drug-development deal for small-molecule compounds discovered and developed by TransTech for up to $1.105 billion. These compounds are functionally liver-selective glucokinase activators (GKAs), designed for the treatment of diabetes. Under the agreement, Forest will pay an upfront license fee of $50 million. TransTech could receive up to $1.105 billion in upfront and milestone payments for the development and commercialization of the GKA compounds, plus royalty payments.
VaxGen (South San Francisco, CA), a biopharmaceutical company, agreed to acquire diaDexus (South San Francisco, CA), a privately held diagnostics company, in a stock-for-stock merger. Upon the closing of the transaction, diaDexus will become a wholly owned subsidiary of VaxGen. The officers of the combined company will be the current officers of diaDexus, and the combined company will be renamed diaDexus. The companies anticipate that the merger will close in the third quarter of 2010.
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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Biotechnology company Biogen Idec (Cambridge, MA) is in the final stages of selecting a new CEO and expects to announce the selection soon. James C. Mullen, president, CEO, and director, retired June 8, 2010. The company also announced that Chief Operating Officer Robert A. Hamm will retire on Dec. 31, 2010. In addition, John G. Cox was promoted to the new position of executive vice-president of pharmaceutical operations and technology.
Kelly Martin will remain CEO and director of Elan (Dublin) through May 1, 2012. It is expected that Martin will then serve as executive advisor to the board of directors through Jan. 31, 2013.
Par Pharmaceutical (Woodcliff Lake, NJ) announced the resignation of Lawrence A. Kenyon, executive vice-president and chief financial officer, effective June 30, 2010. Michael A. Tropiano, Par's treasurer, will replace Kenyon.
ProChon Biotech (Woburn, MA), a biotechnology company focused on tissue regeneration, appointed Brian Callahan executive vice-president of regulatory and quality affairs. Callahan will coordinate with regulatory authorities on the company’s clinical trial programs and will be responsible for ensuring quality compliance for its internal and outsourced operations.
Talecris Biotherapeutics (Research Triangle Park, NC) promoted John R. Perkins to the position of executive vice-president of global commercial operations. Perkins will be responsible for the global commercial business, including portfolio management, sales, and marketing.
Specialty pharmaceutical company ULURU’s (Addison, TX) President and CEO Renaat Van den Hooff resigned. Kerry P. Gray, chairman of the company's board of directors, has been appointed by the board to serve as the company's president and CEO.
YM BioSciences (Mississauga, Canada), a life sciences product development company, appointed Nick Glover to the newly created position of president and CEO. Glover was previously the president and CEO of Viventia Biotech (Mississauga, Canada), a biopharmaceutical company.
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Expanding FDA’s Power
Question: US House Oversight and Government Reform Committee Chairman Edolphus Towns intends to introduce legislation that would give FDA mandatory recall authority and the power to halt drug production. Should FDA have this authority?
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View the poll archive. |
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