Reversal Of Fortune? A J&J Pill And Provenge
After years of controversy, the Provenge prostate cancer vaccine that was hailed as a breakthrough medication was finally approved last year. Many patients and investors cheered. The saga – which was replete with contoversy engulfing the FDA and its approval process – appeared set for a happy ending in which prostate cancer treatment would enter […]
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Warning Letter For Herbal Nitro Inc. 9/22/11
Mr. Dante Spano, President Herbal Nitro Inc. Yucaipa, CA 92399 Dear Mr. Spano: On May 3 through May 10, 2011, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement firm located at 35133 Ravencrest Ct., Yucaipa, CA. During the inspection, you informed our investigators that your firm is an own-label dietary supplement distributor […]
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Company Warned for Arbitrarily Assigning Pill Expiration Dates
File this under Inventory Management 101. Want to know a novel way to determine an expiration date for your pills? Align it with sales performance. No, a drugmaker did not engage in such unusual thinking, but a dietary supplement maker has done so. And while this site generally does not venture often into the supplement […]
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India Will Not Cap Foreign Investment In Pharma
After more than a year of intense debate, the Indian government has decided not to proceed with a proposal to place a 49 percent cap on foreign investment in its domestic pharmaceutical industry, The Economic Times reports. The decision comes amid concerns that unhampered foreign investment would render India unable to pursue its policy of […]
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Glaxo R&D Chief Offers A Progress Report
Every so often, an update appears on how GlaxoSmithKline is faring with its so-called DPUs. These are known inside the drugmaker as drug performance units and were formed in 2008 to prompt the R&D folks to think differently about their budgets, goals and performance (back story). The upshot: every three years, they make a pitch […]
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FDA Publishes Final Guidance For Industry On Applications For Nonprescription Drug Products
The U.S. Food and Drug Administration (FDA) recently released a guidance on “Time and Extent Applications for Nonprescription Drug Products” (the “Guidance”). The Guidance describes the FDA’s latest thinking on the information applicants should provide when requesting that conditions be added to the FDA’s over-the-counter (OTC) drug monograph system. Specifically, the Guidance focuses on the […]
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FDA Wants to Ease Way for Innovation
The FDA has announced a new “blueprint” to spur biomedical innovation, which contains a plan to make it easier for drugs and devices that are considered “personalized medicine” to come to market. FDA Commissioner Margaret Hamburg told reporters on Wednesday that the overall plan — released as part of a sweeping report on improving innovation […]
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AstraZeneca to build $200 million plant in China
AstraZeneca has unveiled plans for a $200 million investment in a new manufacturing facility in China. The plant, in China Medical City (CMC), Taizhou, Jiangsu province, represents the company’s “largest-ever investment in a single manufacturing facility globally”. It will produce both intravenous and oral solid medicines and construction of the site is scheduled to be […]
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California Gov Signs Controversial Vaccine Law
Following months of controversy, California Governor Jerry Brown late last week signed into law a bill that removes parental consent for vaccinating children 12 and older against sexually transmitted diseases. Although state law already allows children 12 and older to consent to treatment for sexually transmitted diseases without parental involvement, the new law expands that […]
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A Melnyk Comeback? A Little Shpritz, A Lot Of Sex
Who’s a hockey puck? Eugene Melnyk, whose tenure as chairman of Biovail was marked by turmoil and controversy, seems determined to make a comeback. And as the largest shareholder in Trimel Pharmaceuticals, he may yet find a way. The nascent drugmaker says its successfully completed a test for an experimental sexual dysfunction medicine delivered in […]
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