FDA's Dr. Srinivasan Discusses Question-based Reviews for Generic Drugs
The US Food and Drug Administration’s Office of Generic Drugs is reviewing the benefits and challenges faced by pharmaceutical firms involved in its question-based review initiative.

Final Guidance on Listing Drug-Substance Impurities in ANDAs
The US Food and Drug Administration last week posted the final version of its guidance for industry, ANDAs: Impurities in Drug Substances.

House Bill Would Require Manufacturer Rebates
Last week, US Reps. George Miller (D-CA), Charles Rangel (D-NY), and Henry Waxman (D-CA), introduced the America’s Affordable Health Choices Act (H.R. 3200) to reform the nation’s healthcare system.

Extreme Rise in Drugs Detained by EU Authorities
A new report from the European Commission show a significant increase in the amount of intellectual property rights (IPR) infringements between 2007 and 2008, including a 57% increase in the number of counterfeit medicine cases between the two years.

Alnylam Pharmaceuticals (Cambridge, MA), an RNAi therapeutics company, and Novartis (Basel, Switzerland) extended their existing RNAi therapeutics collaboration for a fifth and final planned year, through October 2010. The alliance is focused on the discovery, development, and commercialization of RNAi therapeutics toward a defined number of Novartis-selected disease gene targets. Under the agreement, both companies are jointly responsible for RNAi discovery activities, and Novartis is generally responsible for development and commercialization of RNAi therapeutic products.

AlphaRx (Markham, Canada), a specialty pharmaceutical company, will open a research and development (R&D) and pilot plant facility in China with local partners. The R&D facility will focus on the development of innovative drug products targeting infectious disease and various forms of cancer, according to a company press release. Additionally, the company plans to develop adjuvant vaccines to treat influenza, such as H5N1 and H1N1 strains.

AstraZeneca (London) and The Mental Health Research Institute in Melbourne, Australia, entered into a research collaboration agreement to develop new ways of identifying Alzheimer's disease patients at early stages of the disease. Researchers will test cognition at short intervals (every one to three months) over an 18-month period to assess the possibility of identifying the point at which individuals begin to suffer cognitive decline as a result of Alzheimer's disease. The study will be conducted in conjunction with The Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing.

Bruker Daltonics (Billerica, MA), an operating company of Bruker Corporation and developer and provider of tools based on mass spectrometry, formed a long-term collaboration with the University of Warwick (Coventry, UK) to develop applications and instrument technology in the area of extreme resolution mass spectrometry. The Department of Chemistry at Warwick recently obtained a Bruker solariX 12 Tesla FTMS system and a maXis UHR-TOF system to enable research.

Cambridge Major Laboratories (Germantown, WI) plans to dedicate a new, large-scale manufacturing facility offering active pharmaceutical ingredient supply on July 30, 2009. The facility will feature six good-manufacturing-practice manufacturing suites and will have a capacity of 18,000 gallons. If necessary, the facility can be expanded to provide an additional 30,000 gallons. Products from the company's three development centers will be transferred to the new facility for scale-up in August 2009.

Gilead Sciences (Foster City, CA) formed a license and collaboration agreement with Tibotec Pharmaceuticals (Mechelen, Belgium) to develop and commercialize a once-daily fixed-dose antiretroviral regimen containing Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg) for treatment-naïve HIV-infected individuals. Subject to regulatory approval, Gilead will assume the lead role in the manufacturing, registration, distribution, and commercialization of the fixed-dose combination of Truvada and rilpivirine worldwide, excluding the developing world and Japan. Tibotec will commercialize rilpivirine as a stand-alone product and will hold rights to copromote the fixed-dose combination in these territories. The companies will also work toward an agreement to make the fixed-dose combination available in the developing world.

Teva Pharmaceutical (Jerusalem, Israel) and Ortho McNeil Janssen (Raritan, NJ), a unit of Johnson & Johnson, have extended their agreement to cease shipments of generic versions of Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol ) until July 29, 2009, or until a court's ruling on the motion for preliminary injunction, filed by Johnson & Johnson, regarding a patent infringement case.

FDA has approved a vaccine for 2009-2010 seasonal influenza in the United States, according to an FDA release. The vaccine will not protect against the 2009 H1N1 influenza. The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur; and FluMist, MedImmune Vaccines.

The US Food and Drug Administration issued on July 15 a draft guidance for industry, Postmarketing Studies and Clinical Trials—Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act. According to the Federal Register issuance, the Food and Drug Administration Amendments Act of 2007 (FDAAA) added provisions to the Federal Food, Drug, and Cosmetic Act authorizing the agency to require certain postmarketing studies and clinical trials for prescription drugs and biological products approved under the act or under the Public Health Service Act. The draft guidance provides implementation information for the new provisions and describes the types of postmarketing studies and clinical trials that will generally be required under the new legislation as well as the types that will generally be agreed-upon commitments. Comments on the draft guidance are due Oct. 13, 2009, at www.regulations.gov.

The Government Accountability Office (GAO) has issued a new report, “FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs” recommending that the FDA Commissioner “take steps to establish a comprehensive and reliable basis for substantiating the agency’s resource needs.” The report was commissioned to review the resources supporting FDA’s medical product oversight responsibilities, specifically looking at the agency’s funding and staffing resources as well as its oversight responsibilities in this area from fiscal years 1999 through 2008. In a written response to GAO, which is included in the report, FDA agrees with the recommendations made and plans to: conduct an expanded assessment of its staffing resources, take inventory of all regulatory work products, identify and implement measures to ensure the agency is effectively meeting its responsibilities, and link these responsibility metrics to the FDA budget and funding allocation.

Biogen Idec (Cambridge, MA) announced that Phillip A. Sharp is retiring from the company’s board of directors. Sharp, a Nobel Laureate, cofounded the company in 1978 and has served as a director since 1982.

Catalent Pharma Solutions (Somerset, NJ), a provider of development, manufacturing, and packaging services and technologies, appointed John LaHaye vice-president of business development for the commercial packaging business of its Packaging Services segment. LaHaye is responsible for the US commercial packaging sales force and is based at Catalent’s Philadelphia, Pennsylvania, facility.

Immucor (Norcross, GA) appointed Geoffrey S. Crouse chief operating officer. Crouse previously was vice president of the life sciences business at Millipore (Billerica, MA), and he also worked at Roche (Basel, Switzerland).

NeoStem (New York), a company focused on the collection, processing, and long-term storage of adult stem cells, entered into an advisory consulting agreement with Cai Jianqian of the Shandong Provincial Association of Chinese Medicine. Cai will assist the company with its expansion into China and facilitate collaborations with hospitals in the country.

Ore Pharmaceuticals (Gaithersburg, MD) appointed Benjamin L. Palleiko senior vice-president and chief financial officer. Palleiko will report to Mark J. Gabrielson, the company’s president and CEO, and will work with Ore’s management team to drive strategy and growth.

SynCo Bio Partners (Amsterdam), a contract manufacturer of biological-based vaccines and therapeutics, added Raoul Fisser as a second Qualified Person to its quality affairs team. Fisser joined SynCo from Astellas Pharma (Tokyo, Japan) where he worked in pharmaceutical development.