Washington, DC (Mar. 26)-The congressional Committee on Oversight and Government Reform held a hearing to evaluate the cost of biotech drugs as well as strategies for establishing an approval process for the US Food and Drug Administration approval of generic versions of these drugs.
Midland, MI (Mar. 21)-The Dow Chemical Company formed an alliance with Colorcon, Inc. for the global marketing, sales, technical service and development, and distribution of Dow pharmaceutical excipient products for use in controlled-release applications.
Improving performance at an active pharmaceutical ingredient manufacturing plant involves an integrated approach that incorporates methods for optimizing total production management, quality control and assurance, and inventory management. The authors analyze results from a recent benchmarking study to evaluate the critical success factors in high-performing API manufacturing plants.
Rockville, MD (Mar. 23)-The US Food and Drug Administration has submitted to Congress its final proposals for reauthorizing the fourth Prescription Drug User Fee Act (PDUFA IV), which will follow the expiration of the current user-fee on September 30, 2007.
Berlin and Basel, Switzerland (Mar. 26)-Bayer Schering Pharma AG and Novartis reached an agreement over multiple sclerosis therapy ?Betaseron.?
Paris (Mar. 15)-Sanofi-Aventis plans to close its manufacturing site in Waterford, Ireland.
Buffalo, NY (Mar. 7)-Scientists at the University at Buffalo?s Institute for Lasers, Phtonics, and Biophotonics and Roswell Park Cancer Institute have developed a drug delivery system comprising 100-nm nanocrystals of pure HPPH, (2-devinyl-2-1'-hexyloxyethyl pyropheophorbide).
Bangalore, India, (March 14)-Bristol-Myers Squibb Company is expanding its research and development (R&D) capabilities in India.
Kenilworth, NJ (Mar. 12)-Schering-Plough Corporation agreed to acquire Organon BioSciences N.V., the human and animal health businesses of Akzo Nobel N.V., for EUR 11 billion ($14.4 billion) in cash.
Gurgaon, Haryana, India (Mar. 13)-Ranbaxy Laboratories Limited confirmed that it has made a nonbinding bid for the generic drug business of Merck KGaA.
Vancouver, BC, Canada-Researchers from the University of British Columbia are developing a new method for delivering Amphotericin B, a potent antifungal agent for fatal blood-borne fungal infections that currently must be administered intravenously.
Berlin, Germany (Mar. 2)-Estimating it would save approximately EUR 700 million ($917.7 million), Bayer HealthCare will integrate the activities of its Pharma division with those of the former Schering AG, Germany.
Affectis, Dalton, Celgene, Novartis, GSK, More
Rockville, MD (Mar. 1)-Sending Warning Letters to 8 manufacturers and 12 distributors, The US Food and Drug Administration ordered a stop to the manufacture and distribution of unapproved drug products containing ergotamine tartrate.
Just because the wheels are turning doesn't mean they're going forward.
The low-volume pharmaceutical industry must adapt Lean Manufacturing tools invented for high-volume, single product industries.
The proposed rule would impose new record-keeping requirements on some 1200 manufacturing establishments.
Before we can intelligently set the limits of process variation, we need to know what the clinical impact of that variation will be.
Washington, DC (Feb. 22)-The Biotechnology Industry Organization criticized two separate studies respectively released by the Pharmaceutical Care Management Association and Express Scripts, Inc. regarding the cost-savings, interchangeability, and market penetration of follow-on biologics.
Brussels (Feb. 13)-The European Generic Medicines Association raised concerns over what it terms ?the serious lack? of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.
Enschede, Netherlands (Feb. 26)-Scientists from the University of Twente?s MESA+ Institute for Nanotechnology have designed a novel delivery system by combining synthetic iron-containing polymers with DNA macromolecules.
London (Feb. 22)-AstraZeneca unveiled further details of its plan to reduce staff at certain production facilities and announced a $120-million investment in a new process research and development (PR&D) facility in the United Kingdom.
Rockville, MD (Jan. 5)-The US Food and Drug Administration issued a Warning Letter to Bell-More Laboratories following the agency?s August 2006 inspection of the company?s Hampstead pharmaceutical facility.
Rockville, MD (Feb. 1)-The US Food and Drug Administration issued a revised warning letter to Actavis Totowa, LLC, citing ?significant deviations from the current Good Manufacturing Practice regulations.?
Continuing an ambitious growth strategy, SAFC eyes CGMP manufacturing capacity in India for its custom-synthesis business and seeks to gain large-scale organics manufacturing capacity in China for raw-materials supply. And, its biosciences segment seeks opportunity in single-use disposable manufacturing.
As the supply-chain strategies of the pharmaceutical industry evolve, managing risks in outsourcing takes on greater importance. A recent program by the Drug, Chemical, and Associated Technologies Association examined approaches to mitigating risk and improving the pricing-and-cost model in the outsourced relationship.