Tablets & Capsules

TC0714

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markets OSDF excipients market to grow 7.4 percent annually, report says PARSIPPANY, NJ—The market for excipients used in oral solid dosage forms (OSDF) in the USA, Europe, India, and China is currently valued at nearly $2.3 billion and it will grow 7.4 percent yearly until 2018, according to a report from Kline and Company, a consulting and research firm. The report, "Specialty Excipients for Oral Solid Dosage Form Pharmaceuticals Global Series: Business Analysis and Opportunities," examines the factors that underlie geographical differences in excipient usage. It predicts that sales growth in emerging markets such as India and China—which often favor less expen- sive ingredients such as native starches—will outpace growth in the USA and Europe. More information is available at www.klinegroup.com, as is information about another report: "Polymers for Solubility Enhancement in Pharmaceutical Oral Solid Dosage Forms: Global Market Analysis and Opportunities." industry news Merck to acquire Idenix in quest for hep C treatment WHITEHOUSE STATION, NJ— Merck agreed to acquire Idenix Phar - ma ceuticals, Cambridge, MA, for $3.85 billion, almost three times its market value. The acquisition would give Merck access to Idenix's investi- gational hepatitis C candidates, which complement the therapies Merck is developing. The goal is to 6 July 2014 Tablets & Capsules formulate a once-daily oral drug product. Today, the only FDA- approved oral-dosage hepatitis C treatment is Sovaldi (sofosbuvir) from Gilead Sciences, Foster City, CA. Iroko's phase 3 demonstrates pain reliever efficacy at lower doses PHILADELPHIA, PA—A clinical study by Iroko Pharmaceuticals showed that its investigational form of meloxicam relieved pain in osteoarthritis patients at doses 30 percent lower than those of conven- tional meloxicam products. The meloxicam in the study was formu- lated using Iroko's proprietary SoluMatrix fine-particle technology, which accelerates API dissolution by transforming the API into 200- to 800-nanometer particles. Universities join FDA regulatory science program SILVER SPRING, MD—The FDA named Johns Hopkins University, Baltimore, MD and the University of California at San Francisco/Stanford University as sites for its Centers of Excellence in Regulatory Science and Innovation program. The program seeks to improve preclinical testing, optimize clinical trials, harness scien- tific expertise to streamline drug devel- opment, and apply quantitative phar- macology to help the Agency evaluate and approve new medications. Abbott to buy CFR Pharma ABBOTT PARK, IL—Abbott Lab - or atories plans to buy CFR Pharma - ceuticals, Santiago, Chile, for approxi- mately $2.9 billion. The acquisition will more than double Abbott's pharma sales in Latin America, putting it among the top 10 firms in that mar- ket, which is expected to reach $73 billion by end of 2014. www. tabletscapsules .com FDA approves first-in-class anti- clotting drug SILVER SPRING, MD—The FDA approved Merck's Zontivity (vora- paxar) to reduce risk of heart attack, stroke, and other cardiovascular events in high-risk patients. The 2.5 milligram tablet, a protease-activated receptor-1 antagonist that inhibits blood-clot formation, is the first of its type to gain approval. Actavis to expand in Puerto Rico DUBLIN, Ireland—Actavis plans to increase its production in Puerto Rico by adding a solid dosage manu- facturing and packaging facility to its Manatí site. It will also expand hor- mone production at its Fajardo site. The projects are expected to create up to 300 jobs over 3 years. Draft Guidance addresses supply- chain security SILVER SPRING, MD—The FDA issued "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification," the first draft Guidance aimed at implementing the Drug Supply Chain Security Act (DSCSA). The Guid - ance addresses three key issues: iden- tifying scenarios in which counterfeit and suspect products might likely enter the supply chain; recommend- ing ways trading partners can iden- tify suspect products; and, creating a process for terminating illegitimate product notifications. Briefly noted… P e r n i x T h e r a p e u t i c s , Morris - town, NJ, acquired US rights to GlaxoSmithKline's Treximet, a com- bination tablet of sumatriptan and naproxen sodium for treatment of acute migraine symptoms in adults. b-TOCFN_1-7_Masters 7/2/14 11:03 AM Page 6

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