Pharmaceutical Technology Editors

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.

Aventrx, ImmBio, Eli Lilly, more

Berlin and Basel, Switzerland (Mar. 26)-Bayer Schering Pharma AG and Novartis reached an agreement over multiple sclerosis therapy ?Betaseron.?

Cobra, InterMune, Pall, More

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).

Avantium, Eisai, Generex, Lonza, more

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.

The proposed rule would impose new record-keeping requirements on some 1200 manufacturing establishments.

DSM, Crucell, Genentech, More

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.

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.?

Aptuit, AstraZeneca, Corautus, FDA, more

Geneva, Switzerland (Feb. 16)-During a two-day meeting, the World Health Organzation announced ?encouraging progress? in the development of a pandemic influenza vaccine but admitted that the industry still ?lacks the manufacturing capacity to meet potential pandemic influenza vaccine demand.?

Actavis, Cardinal, FDA, more

Washington, DC (Feb. 14)?A congressional team has reintroduced the ?Access to Life-Saving Medicine Act,? which establishes a process through which the US Food and Drug Administration can approve generic copies of biologic drugs.

London, UK (Feb. 1)?Researchers at the University of London?s School of Pharmacy have chemically modified carbon nanotubes to enable them to enter human cancer cells.

Cambrex, Lonza, EaglePicher, more

Washington, DC (Jan. 26)-The US Department of Health and Human Services has granted targeted liability protections for manufacturers of a vaccine to prevent a pandemic of influenza A (H5N1).

The injunction blocks rules that required secondary wholesalers to supply pedigrees tracing the chain of custody to the maker.

Akorn, PrimaPharm, ARTEL, FMC, more

Rockville, MD (Jan. 30)?-In response to a set of recommendations made by the Institute of Medicine, the US Food and Drug Administration issued a report detailing a series of initial steps to improve its safety programs.

The US Department of Health and Human Services (HHS, Washington, DC) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million does of the vaccine or enough adjuvant for 150 million doses within six months after the onset of an influenza pandemic.

The US Food and Drug Administration announced the creation of the Office of the Chief Medical Officer as well as two important staff changes at the agency.

Abbott, SAFC Pharma, More

Acambis, Baxter, NovoNordisk, more