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Alcan, China Biopharma, US FDA, MedImmune, more
Montreal, QC, Canada (Nov. 9)-Alcan (www.alcan.com) agreed to sell its Wheaton Science Products business to River Associates Investments, LLC (Chattanooga, TN, www.riverassociatesllc.com). The transaction is expected to be completed in November, following regulatory approval.
Princeton, NJ (Nov. 13)-China Biopharma Ltd. (www.chinabiopharma.net) completed the delivery of 1.5 million doses of flu vaccine in China. The vaccine is among the first to be made available to the public in China for the upcoming flu season. Company Chairman and CEO Peter Wang says that the company is on track to deliver a total of three million doses of vaccine by the end of 2006.
Rockville, MD (Nov. 15)-The US Food and Drug Administration (FDA, www.fda.gov) announced the availability of a final compliance policy guide (CPG) 160.900 entitledPrescription Drug Marketing Act-Pedigree Requirements under 21 CFR Part 203. The CPG describes how FDA plans to prioritize its enforcement efforts in the first year after the Dec. 1, 2006 effective date of 21 CFR. FDA also released Guidance for Industry: Prescription Drug Marketing Act (PDMA) Pedigree Requirements Questions and Answers. The guidance was issued in response to the questions received regarding the Prescription Drug Marketing Act pedigree requirements.
Hayward, CA (Nov. 13)-Illumina, Inc. (www.illumina.com) entered into a definitive merger agreement to acquire Solexa (San Diego, CA, www.solexa.com) for approximately $600 million. Together, Illumina and Solexa will be the only company with genome-scale technology for genotyping, gene expression, and sequencing. The merger will enable Illumina to expand its genetic analysis product offering to include Solexa’s next-generation sequencing platform, the “1G Genome Analyzer.” In addition, the merger is expected to increase Illumina’s addressable markets and drive Solexa’s manufacturing and commercialization. Subject to the approval of Illumina and Solexa stockholders and customary closing conditions, the merger is expected to close by the end of the first quarter of 2007.
Gaithersburg, MD (Nov. 9)-MedImmune (www.medimmune.com) filed an investigational new drug application with the US Food and Drug Administration to begin human clinical testing of a cell culture-based seasonal influenza vaccine using its live, attenuated, needle-free influenza vaccine technology. MedImmune will be using cell culture-based manufacturing methods to produce the vaccines, instead of the more traditional method of using chicken eggs. Once the cell culture-based production capability for its influenza vaccine has been added, MedImmune expects to be able to produce 300 million monovalent bulk doses of a pandemic vaccine annually by 2012.
Goettingen, Germany (Nov. 15)-Sartorius AG (www.sartorius.com) has created the Sartiorius International Biosciences Scholarship. The scholarship is geared toward upperclassmen or those who have already earned a degree in the natural sciences or technology who would like to gain real-world experience by working at a German technology company. Participants will work on selected research and development projects and assist with product marketing in the biotechnology division. Sartorius will pay scholarship funds as well as travel and accommodation expenses for the participants.
Boston, MA (Nov. 9)-The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) gave a comprehensive estimate of the average cost of developing a new biotechnology product: $1.2 billion. This includes the costs of drugs that fail, testing, and the time costs associated with bringing a new biopharmaceutical to the market. Capitalized out-of-pocket expenses are estimated to be approximately $615 million, and the clinical-period cost is approximately $626 million. In addition, Tufts discovered that it takes an average of 97.7 months for a new biotechology product to go through clinical development and regulatory review. Tufts reached its conclusions by using compound-specific costs for a sample of 17 investigational biopharmaceuticals from four firms that first entered clinical testing between 1990 and 2003. The full research and development cost estimate is based on the 30.2% clinical-approval success rate for biopharmaceuticals.
Swedesboro, NJ (Nov. 6)-The Wedgewood Village Pharmacy (www.wedgewoodpharmacy.com) declared its intention to “vigorously defend” itself following an Oct. 21 Warning Letter from the Food and Drug Adminstration. The Warning Letter claims that the compounds the pharmacy prepares are new drugs and, therefore, under FDA authority and subject to premarket clinical trials. The letter came only weeks after a Federal District Court in Midland, Texas ruled that FDA’s Compliance Policy Guidelines, on which the charges against Wedgwood are based, are not enforceable. George Malmberg, Wedgewood’s pharmacist-president and CEO has sworn to defend the pharmacy and its practices. In a letter sent to FDA on Nov. 3, Wedgewood requested a 30-day extension beyond the set 15-day deadline to respond to the Warning Letter.
Odense, Denmark (Nov. 13)-ACE BioSciences A/S (www.acebiosciences.com) appointed Roberto Machuca operations manager. In this capacity, he will be responsible for the commercial process and manufacture of ACE BioSciences’s portfolio of vaccines and antibodies. He will focus on the company’s lead product "ACE393," a commercial vaccine for travellers’ diarrhea. Machuca joins the company from Bavarian Nordic A/S, where he was director of technical assessments.
Dublin, OH (Nov. 10)-Cardinal Health (www.cardinal.com) named Mark Parrish chief executive officer of the company’s healthcare supply chain services sector. Parrish previously served as the group president of healthcare supply chain services’ pharmaceutical segment. He joined Cardinal in 1993.
Gaithersburg, MD (Nov. 9)-MedImmune, Inc. (www.medimmune.com) announced several management changes. Bernardus N.M. Machielse, who joined the company as the vice-president of quality in 1993, was promoted to executive vice-president of operations. In this role, he will be responsible for the company’s engineering and facilities activities and will also oversee manufacturing, supply chain, and quality. Frank Malinoski, MD, who joined the company as vice-president of infectious disease and medical affairs in 2005, takes on a new role as senior vice-president of medical and scientific affairs. John Lewis, the new vice-president of global engineering capital projects, will be responsible for all large-scale capital engineering projects, including the company’s expansion of its Frederick Manufacturing Center in Frederick, Maryland. Alan Taggart joined the company as vice-president of government-project management. He will be responsible for coordinating and managing MedImmune’s government projects, including a recent $170-million cell-culture contract awarded by the US Department of Health and Human Services.
Kansas City, MO (Nov. 6)-Jan Erik Kuhlmann was appointed president and CEO of Multivac, Inc. (www.multivac.com) Kuhlmann previously served as president of Wolf-Tec, Inc.
Baltimore, MD (Nov. 13)–David A Knapp, PhD, announced that he will step down as dean of the University of Maryland School of Pharmacy (www.pharmacy.umaryland.edu) on June 30, 2007. Knapp has served as dean for 18 years, during which he founded the university’s Center on Drugs and Public Policy and established the four-year professional Doctor of Pharmacy program. Knapp began his academic career in 1964 at Ohio State University’s College of Pharmacy. He joined the University of Maryland School of Pharmacy in 1971.