FDAnews Drug Daily Bulletin
Feb. 28, 2005 | Vol. 2 No. 41
Any pharmaceutical importation plan that fixes the terms of trade is equivalent to importing price controls, which could endanger the future of drug innovation and limit access to new drugs, according to the head of the Senate health panel.
On the heels of a recent workshop on follow-on biologics, the Generic Pharmaceutical Association (GPhA) is again encouraging the FDA to create an abbreviated approval pathway for generic biologics
The FDA has launched a web-based User Fee System that is integrated with the agency's accounting system, through which customers can create and submit Form FDA 3397, agency officials announced at the Drug Information Association's Electronic Document Management Conference in Philadelphia.
Two House Democrats have introduced legislation that would hold pharmaceutical executives criminally liable when they fail to disclose evidence of serious adverse events related to their products.
Japanese drugmaker Sankyo Co. unveiled plans on Friday to buy Daiichi Pharmaceutical in October in a deal worth $7.7 billion, accelerating a shakeup in the world's second-largest pharmaceuticals market.
Eisai Co. Ltd. has announced that it has established a pharmaceuticals marketing subsidiary, Eisai S.r.l. (Eisai Societa a responsabilita limitata) in Italy on Feb. 21.
Kyowa Hakko Kogyo has announced that it will dissolve a distribution partnership with Janssen Pharmaceutical for Itrizole Capsule, an oral antimycological agent, as of the end of March.
UK biotech firm Vernalis said it was raising a net 27.6 million pounds ($52.7 million) in a share sale to start a business in North America, buy new products and develop its experimental medicines.
A federal judge has thrown out a class-action lawsuit against Vertex Pharmaceuticals.
Leading brokers slashed sales forecasts for AstraZeneca cholesterol drug Crestor on Friday, lopping more than 1.5 percent off shares in Europe's third largest drugmaker.
FedEx Corp. has stopped delivering packages from online pharmacies to portions of eastern Kentucky where prescription drug abuse has become widespread.
The law firm of Milberg Weiss Bershad & Schulman LLP announces that a class action lawsuit was filed today on behalf of all persons who purchased or otherwise acquired the securities of Axonyx between June 26, 2003 and Feb. 4, 2005, inclusive, seeking to pursue remedies under the Securities Exchange Act of 1934.
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