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Cambrex (East Rutherford, NJ) acquired IEP GmbH (Wiesbaden, Germany), a privately held company that offers customized biocatalytic-process development and sales of enzymes to the pharmaceutical industry. The business will be renamed Cambrex IEP and will remain in Germany. Financial terms were not disclosed.
Biopharmaceutical company Dynavax Technologies (Berkeley, CA) and Merck & Co. (Whitehouse Station, NJ) ended its partnership regarding the clinical development and marketing of Heplisav, Dynavax's hepatitis B vaccine. Merck agreed to pay Dynavax $4 million to cover final expenses. In a separate release, Dynavax says it plans to file a biologics application for Heplisav in the third quarter of 2011.
Contract manufacturer DPT Laboratories (San Antonio, TX) restructured its facilities to create three new centers of excellence to support clients’ pharmaceutical development and manufacturing needs. DPT Laboratories in Lakewood, New Jersey, will house The Center for Sterile & Specialty Products; The Center for Semisolids & Liquids will be in San Antonio; and Center for Research & Development will also be in San Antonio.
Eli Lilly (Indianapolis, IN) is working with the US Food and Drug Administration and other law enforcement officials to recover cases of pharmaceutical products stolen from a distribution center in Connecticut on March 14, 2010. Lilly stopped distributing product with the affected lot numbers on March 15, 2010.
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Formatech (Andover, MA), a contract development and manufacturing organization, as part of its Fillanthropy program, agreed to donate the services required to aseptically fill and finish one lot of biopharmaceutical company Tracon Pharmaceuticals’ (San Diego, CA) anticancer drug.
GlaxoSmithKline (London) notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine Rotarix. PCV-1 does not multiply in humans and is not known to cause illness in humans. The material was first detected following work done by a research team in the US and then confirmed by additional tests conducted by GlaxoSmithKline. FDA issued a statement that said there is no evidence that this finding poses a safety risk. FDA, however, is recommending that US clinicians and public health professionals temporarily suspend the use of Rotarix as a precautionary measure. FDA intends to convene an advisory committee within approximately four to six weeks to review the available data and make recommendations on rotavirus vaccines licensed in the US. FDA will also seek input on the use of new techniques for identifying viruses in vaccines.
FDA issued a Complete Response Letter to the pharmaceutical company MannKind (Valencia, CA) regarding its new drug application for Afrezza (insulin human [rDNA origin) inhalation powder for the treatment of adults with Type 1 and Type II diabetes. The letter requested information and currently available clinical data that support the clinical utility of Afrezza and information about the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in clinical trials. The letter cited no safety concerns, but requested updated safety data related to Afrezza. The letter also requested changes to the proposed labeling of the cartridges, foil pouches, and cartons.
Merck & Co. (Whitehouse Station, NJ), in response to FDA’s ongoing safety review of the risk of skeletal muscle effects from high-dose simvastatin, said in a release that it would continue to share data with the FDA and other regulatory agencies from completed and ongoing clinical studies of simvastatin. Merck said it supported FDA's recommendation that patients continue taking their medication as prescribed, and that patients speak to their physician if they have symptoms or questions.
The European Commission granted Novartis (Basel) marketing authorization for Menveo, a conjugate vaccine available in Europe that helps protect against four major groups of meningococcal disease. Menveo is indicated for the active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135, and Y, to prevent invasive disease.
Contract-research organization PPD (Wilmington, NC) and collaborative-research organization Southern Research Institute (Birmingham, AL) signed an agreement to provide pandemic and seasonal influenza vaccine research. Southern Research will transfer its seasonal assays and reagents to PPD, which will help build Southern Research's preclinical influenza and clinical pandemic/highly pathogenic avian influenza (HPAI) testing business through client referrals.
Sigma-Aldrich (St. Louis) agreed to sell approximately 100 of Pfizer’s (New York) small-molecule compounds to life-science researchers for target characterization, assay development, screening, and in vivo animal-model applications. Financial terms of the agreement were not disclosed.
Biopharmaceutical company Tekmira Pharmaceuticals (Vancouver, Canada) and Pfizer (New York) agreed to collaborate on evaluating Tekmira’s stable nucleic acid-lipid particle technology to deliver small interfering RNA (SNALP) molecules provided by Pfizer. Tekmira will be responsible for preparing the SNALP formulations, and Pfizer will evaluate the formulations in preclinical models. Financial terms of the collaboration were not disclosed.
The generic-drug company Teva Pharmaceutical (Jerusalem) agreed to acquire the German generic-drug maker Ratiopharm for EUR 3.6 billion ($4.8 billion). The pro forma sales of the combined company would be $16.2 billion, and the move would increase Teva’s European sales from $3.3 billion in 2009 to joint pro forma sales of $5.2 billion. Teva expects to complete the transaction by the end of 2010.
Specialty pharmaceutical company Valeant Pharmaceuticals International (Aliso Viejo, CA) agreed to acquire a private-branded generics and over-the-counter company in Brazil for $28 million. The Brazilian company had annual sales of approximately $19 million in 2009, and a large portion of its product portfolio is in dermatology. Valeant said it also plans to buy a new manufacturing plant to produce solids, semisolids, and liquids for approximately $28 million. Both transactions are expected to close in the second 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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| Jose Castillo of Ft. Lauderdale, Florida, Federico M. Fermin of Miami Beach, and Terri L. DeCubas of Pembroke Pines, Florida, were indicted on Mar. 18, 2010 on charges of mail fraud, distribution of prescription drugs without a license, money laundering, and conspiracy to commit those offenses. In addition, DeCubas was charged with making a false statement to a US Food and Drug Administration agent, according to a press release from the US Attorney’s office in the Southern District of Florida. The FDA Office of Criminal Investigations’s Miami Field Office also was involved in the investigation. The fraud encompassed the diversion of prescription drugs through street purchases. In related news, the US Attorney for the Western District of Missouri, Beth Phillips, announced that a business owner pleaded guilty to conspiring to fraudulently market dietary supplements over the Internet, making claims that the products could prevent, treat, or cure several diseases. FDA’s Office of Criminal Investigations also participated in this investigation.
FDA released a safety announcement on Mar. 19, 2010 regarding the potentially increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication Zocor (simvastatin) 80 mg, compared with the risk to patients taking lower doses of simvastatin and possibly other drugs in the statin class. The agency is reviewing related clinical-trial data and adverse-event reports. Patients and healthcare professionals can obtain more information on the agency’s website.
Every year, FDA’s Center for Drug Evaluation and Research releases an ombudsman report. The document focuses on the role of the ombudsman and the interactions he or she has with constituents during the year. For example, the report notes that in 2009, the ombudsman’s office received 764 communications. The most common topics of communications from industry were the requirement for electronic drug establishment registration, the lengthy response times to citizen and suitability petitions, and import-export issues such as drug-product seizers at the border. The full report is available here.
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GlaxoSmithKline (London) named Emma Walmsley president of its Consumer Healthcare Europe and president designate of its Worldwide Consumer Healthcare division.
Biopharmaceutical company Insmed (Richmond, VA) appointed Nicholas A. LaBella Jr. as its chief scientific officer. LaBella will oversee scientific and regulatory analysis related to the company's strategic review.
The Pharmaceutical Research and Manufacturers of America (PhRMA) elected Pfizer’s (New York) chairman and CEO, Jeffrey B. Kindler, as its board chairman. PhRMA also elected Christopher Viehbacher, sanofi-aventis’ (Paris) CEO, as its chairman-elect of the PhRMA board of directors; and John C. Lechleiter, chairman, president, and CEO of Eli Lilly (Indianapolis, IN), as board treasurer. |
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