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| August 2, 2012 |
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 Second-Quarter 2012 Financial Reports Show Pfizer, Novartis Down; Merck Up Pharmaceutical industry leaders Pfizer, Novartis, Merck, and other companies released second-quarter 2012 results, emphasizing growth of new products and strength in emerging markets. ...Read More |
| Advertisement Brabender® Pharma USA, Inc. is an innovative company specializing in the manufacturing of twin-screw extruders for HME applications. The effort has been to concentrate on the finest quality equipment to produce small batch sizes up to production scale processes. The 12mm Mini-Compounder is ideally suited to this undertaking while other models offer options to achieve production capacity. For further details on the Mini-Compounder |
Merck Serono to Spin Off Parkinson's R&D Merck Serono will be closing down operations in Geneva as part of its restructuring activities, which includes a spin off of the its Parkinson’s disease R&D portfolio to a new company named Prexton Therapeutics. ...Read More |
| Advertisement Ropack provides solid dose packaging services to leading pharmaceutical and healthcare companies. Operating in 250,000 square feet, Ropack is equipped for humidity- and temperature-sensitive production and packaging of stick-packs. Other services include blister, bottle and pouch, powder blending and encapsulation and in-country clinical trial packaging and distribution management. Ropack has the capacity, technology and resources to grow your business. Contact: paul.dupont@ropack.com |
Medicines Top EU's Counterfeit List A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European Union customs in 2011. ...Read More |
 Cleveland BioLabs has signed a contract valued at 139 million Russian rubles ($4 million) with the Ministry of Industry and Trade of the Russian Federation for development of CBLB612, a drug in development for stimulation of hematopoietic stem-cell proliferation and mobilization. The contract provides funding over a period of approximately three years, which will be used to support completion of preclinical studies, filing of an investigational new drug application, and Phase I and II clinical studies. The contract was issued by Russia’s Pharma 2020 plan, a government initiative to stimulate pharmaceutical-based economic development. ...Read More |
| Advertisement Realize Effective Pharmaceuticals Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market. Learn more at www.agilent.com/lifesciences/realizepharma |
FDA has issued a Complete Response Letter to Luitpold Pharmaceuticals, part of Daiichi Sankyo, for the company’s Sept. 30, 2011, new drug application (NDA) for Injectafer (ferric carboxymaltose injection), for treating iron deficiency anemia. In the Complete Response Letter, FDA noted its decision to withhold approval at this time. The decision was not related to any issues with the Injectafer NDA filing, but with Luitpold’s manufacturing facility in Shirley, New York. During a recent inspection, FDA inspectors noted issues in the facility where Injectafer is manufactured for the US market. Luitpold Pharmaceuticals said it’s working with FDA to resolve the issues found in the recent inspection. ...Read More |
| Advertisement Maximize GC Headspace Productivity Develop reliable testing for residual solvents with the Agilent 7697A Headspace Sampler injection system and maximize your precision, accuracy and throughput. Agilent’s method translation tools allow for conversion from other headspace samplers to deliver unparalleled confidence in your analytical results. See the animated demo |
Novasep has announced a EUR 3-million ($3.69 million) investment to expand its highly potent API manufacturing capabilities at its Le Mans, France, facility. The expansion is expected to be fully operational by the beginning of 2013. ...Read More |
| Advertisement CMC Writing and Submission Strategies: A Global Regulatory Approach September 10-11 Burlingame, CA. Use Priority Code PT200 and Save $200 on tuition. This CfPA course will provide in-depth instruction on CMC requirements and review processes for clinical trial, registration and postapproval drug applications in the US, Europe and Japan. Integrative approaches for submissions in emerging markets and current national and ICH guidelines will be discussed. Read More |
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. ...Read More |
| Advertisement Be part of CPhI South America, the leading pharma ingredients event in Sao Paulo, Brazil 21-23 August. At CPhI South America you will join 3,500 pharma professionals from around the world looking for partners and business opportunities in the rapidly growing Latin American market. Senior pharma professionals attend to meet suppliers and new partners to drive business the rest of the year. Read More |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
 FDA has announced rates for prescription drug user fees for fiscal year (FY) 2013, as authorized by the Prescription Drug User Fee Amendments (PDUFA V) signed into law on July 9, 2012. FDA is required to set fee revenue amounts for applications, establishments, and products each year. The FY 2013 rates, effective Oct. 1, 2012 through Sept. 30, 2013 as listed in the Federal Register, are: application fees for an application requiring clinical data, $1,958,800; an application not requiring clinical data or a supplement requiring clinical data, $979,400; establishment fees, $526,500; and product fees, $98,380. The new fee schedule applies to applications and supplements submitted on or after Oct. 1, 2012. |
| Advertisement Path to Zero Landfill: Learn How One Company is Leading the Way Live Webcast: Tuesday, August 21, 2012, 11:00 am EDT Register Free at www.pharmtech.com/landfill |
Cooperation and interaction between Japanese and European pharmaceutical regulators has improved since 2009, according to a report released by the European Medicines Agency (EMA). EMA reports an increase in the exchange of information and interaction between the two regions, including a new Japanese liaison officer and increased conference attendance. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the new Japan and EMA cooperation. |
| Advertisement Omega-3 Innovations in Pharmaceutical and Diagnostic Markets Live Webcast: September 11, 2012 (10:00 – 11:15 am EDT) Register Free at www.pharmtech.com/omega3 |
Coming soon: Pharm Tech’s August issue will feature coverage in metals analysis and elemental impurities. Know Before You Go—2012 Conference Previews Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences. Find company backgrounds, new product releases, booth materials, and more. PharmTech's online Gateway is your guide to the season's leading shows. |
 Webcast: Atypical Visible Particles (Black Specks); Approaches for Manufacturers and Users Webcast: Unlocking the Power of New Softgel Technology for Multiple API Formulations Webcast: Bioavailability Enhancement Using Lipid-Based Drug Delivery Webcast: Screening Methods for Elemental Impurities: Proposed Compendial Requirements Podcast: The Awesome Power of Virtual "Quality" in a Regulated Environment |
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The Drug Development Process - From Discovery to Commercialization CPhI South America Pharmaceutical Regulatory Summit Pharma Extractables & Leachables |
