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Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more...
Accumed (Lawrenceville, NJ) received a warning letter, recently posted on FDA’s website, citing the company for “significant” CGMP deviations at its Lawrenceville, New Jersey, facility. Some deviations include the failure of the quality control unit to follow the written responsibilities and procedures and the failure to prepare batch-production and control records for each batch of drug product produced.
The US Food and Drug Administration approved Bristol-Myers Squibb’s (Princeton, NJ) and AstraZeneca’s (London) Onglyza (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor. Onglyza is indicated to treat Type 2 diabetes mellitus in addition to diet and exercise to improve blood sugar (glycemic) control in adults. The once-daily drug can be used in combination with commonly prescribed oral antidiabetic medications such as metformin, sulfonylureas or thiazolidinediones, or as a monotherapy to significantly reduce glycosylated hemoglobin levels.
The contract manufacturing organization Cherokee Pharmaceuticals (Riverside, PA) signed a five-and-a-half-year commercial supply agreement with DuPont Applied BioSciences, a division of DuPont (Wilmington, DE). Cherokee will manufacture a new product for DuPont using a DuPont proprietary fermentation process at its Riverside, Pennsylvania, facility.
Eli Lilly (Indianapolis, IN) launched an online registry detailing recent payments it has made to physicians and other healthcare professionals. The report is known as the company’s faculty registry. Lilly faculty are physicians and other health care professionals contracted to provide specific services on behalf of Lilly and the Lilly alliance partnerships, according to a company press release. The data are for the first quarter of 2009; going forward, Lilly will update the registry quarterly.
The biopharmaceutical company GenVec (Gaithersburg, MD) received a $600,000 grant over two years from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health to support the company’s malaria vaccine program. Using the funding from this grant, GenVec will collaborate with the US Naval Medical Research Center to apply its adenovector technology to the development of malaria vaccine candidates.
Genzyme (Cambridge, MA) announced that FDA will re-inspect the company’s Allston Landing, Massachusetts, manufacturing facility. The re-inspection is a follow-up to FDA’s May 2009 inspection and is intended to verify that corrective and preventative actions identified in a February warning letter have been implemented. During the re-inspection, the FDA will also review Genzyme’s remediation efforts related to the recent identification of a virus at the Allston plant that required the company to temporarily halt production. The sanitization of the facility is complete and production of Fabrazyme (agalsidase beta) and Cerezyme (imiglucerase for injection) has resumed.
ImClone (Branchburg, NJ), a biopharmaceutical subsidiary of Eli Lilly (Indianapolis, IN), will locate its research headquarters at New York City’s new Alexandria Center for Science and Technology at the East River Science Park. ImClone will be the anchor tenant for the new commercial bioscience complex on Manhattan’s East Side, initially bringing 125 scientists with plans to expand. The company signed a long-term lease to occupy more than 90,000 ft2 at East River Science Park’s first tower, expected to be complete in Summer 2010.
Mylan (Pittsburg, PA) responded to a news report on manufacturing-facility violations by issuing a press release calling the report “uninformed.” A second statement issued by the company said it was visited by FDA, and the agency “has determined that the baseless accusations in the article were unfounded.” FDA found no evidence of data deletion and confirmed that corrective actions to a standard operating procedure deviation were handled properly, according to the Mylan press release.
The US-based PATH Malaria Vaccine Initiative (MVI), the United States Agency for International Development (USAID) Malaria Vaccine Development Program (MVDP), and the biopharmaceutical company Crucell (Leiden, The Netherlands) announced a development pact for a promising type of malaria vaccine. Through funding from the USAID MVDP, the partners will conduct studies to determine the effectiveness of Crucell’s prime-boost vaccine approach, which uses the company’s proprietary recombinant adenoviruses to deliver a malaria antigen to the immune system.
Pfizer (New York) recently announced research agreements with two Chinese institutions. The company will establish a graduate program in clinical data management and statistical programming at Fudan University (Shanghai). The three-year masters degree program is designed to develop qualified professionals to support clinical research, which is rapidly increasing in China. Additionally, Pfizer formed a joint initiative with the Shanghai Institutes for Biological Sciences (SIBS) to support fundamental research in China, under which Pfizer China will provide $500,000 each year over three years to fund health-related fundamental research projects at SIBS and its application to drug discovery and development programs in the country.
SAFC Biosciences, a business segment within SAFC, a member of the Sigma-Aldrich Group (St. Louis, MO), developed a new, chemically defined cell-culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials. The company’s Ex-cell CD hydrolysate fusion, a synthetically produced animal-component free, chemically defined alternative to undefined hydrolysates, was created for use in Chinese hamster ovary, NS0, and Sp2/0 biopharmaceutical production processes.
Sanofi aventis (Paris) and Merck & Co. (Whitehouse Station, NJ) announced that Merck will sell its 50% interest in the companies' current animal-health joint venture, Merial, to sanofi for $4 billion in cash. Merial is an animal-health company that is a 50/50 joint venture between Merck and sanofi, and following the transaction sanofi will own 100% of Merial. In addition, Merck, sanofi, and Schering-Plough (Kenilworth, NJ) signed a call option agreement allowing sanofi, following the closing of the Merck/Schering-Plough merger, the option to combine the Intervet/Schering-Plough animal-health business with Merial to form an animal health joint venture that would be owned equally by the new Merck and sanofi aventis.
Savient Pharmaceuticals (East Brunswick, NJ) received a complete response letter from the US Food and Drug Administration stating that the agency cannot approve the company's biologics license application (BLA) for Krystexxa (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy. According to a Savient press release, the letter cites deficiencies with the chemistry, manufacturing and controls section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a risk evaluation and mitigation strategy (REMS). Savient said it will request a meeting with FDA to discuss and clarify the issues raised in the complete response letter.
FDA filed a consent decree of permanent injunction that prohibits Teva Animal Health from manufacturing and distributing adulterated veterinary drugs. The injunction, once entered by the court, will prevent the company from manufacturing and distributing veterinary drugs until they achieve compliance with current good manufacturing practices (CGMP) and obtain FDA approval. During inspections between 2007 and 2009, FDA found significant CGMP violations at Teva Animal Health's facilities, located in St. Joseph, Missouri, according to an FDA press release.
The specialty pharmaceutical company URL Pharma (Philadelphia, PA) acquired the assets of PharmPro, a division of Fluid Air (Aurora, IL). The facility, located in Aurora, Illinois, is FDA-inspected and licensed by the Drug Enforcement Administration. The 19,000-ft2 facility includes fluid-bed technology, enabling water and solvent coating processes critical to the development and manufacture of a various modified-release products. The acquisition also includes DuraGran, a proprietary platform technology that enables the production of uniform, small granules in the development and manufacture of modified-release dosage forms.
The specialty pharmaceutical company Valeant Pharmaceuticals International (Aliso Viejo, CA) will acquire Tecnofarma (Mexico City), a privately held generic pharmaceuticals company with approximately $33 million in annual sales. Tecnofarma has a number of manufacturing sites, including a new 160,000 ft2 manufacturing plant that will allow Valeant Latin America to reduce its dependence upon third-party manufacturers, according to a Valeant press release. Tecnofarma has 80 registered products that can be introduced into the branded generics market in Mexico.
Ambrilia Biopharma (Montreal, Canada) laid off Philippe Calais, its president and CEO, and Monique Letourneau, its executive vice-president of finance and chief financial officer. The layoffs were designed to reduce costs, according to a company press release. Richard La Rue was appointed interim president and CEO, and Brian Davies was appointed chief financial officer.
Cardiome Pharma (Vancouver, Canada), a drug-development company, appointed Doug Janzen president and CEO. Janzen previously served as president and chief business officer. Bob Rieder, formerly chairman and CEO, was appointed executive chairman of the board.
Cold Chain Technologies (Holliston, MA), a provider of temperature-sensitive shipping solutions, appointed Raffaele Potami senior mechanical engineer. Potami will be responsible for special research and development projects and thermal-design optimization.
Inspire Pharmaceuticals (Durham, NC), a biopharmaceutical company, announced that Christy L. Shaffer, president and CEO, will step down once a successor is in place. The company has initiated an external CEO search process.
Mylan (Pittsburgh, PA) made several changes to its management team. Heather Bresch was promoted from chief operating officer to president, Rajiv Malik was promoted from head of the company’s global technical operations to chief operating officer, and Timothy B. Sawyer joined Mylan as senior vice-president of strategic corporate development. Malik and Sawyer will report to Bresch.
The nanotechnology provider NanoInk (Skokie, IL) appointed John Kubricky to its scientific advisory board. Kubricky previously served as US Deputy Under Secretary of Defense (Advanced Systems and Concepts) from 2006 to earlier this year.