FDAnews Drug Daily Bulletin
Feb. 25, 2005 | Vol. 2 No. 40
A pair of prominent House Democrats has introduced legislation that would prevent government officials from tampering with federal research and scientific policymaking.
Teva Pharmaceutical's U.S. generic pipeline currently consists of 140 product applications, 26 of which it hopes to gain marketing exclusivity for, the company said in its fourth-quarter earnings report.
Despite assurances that all medically necessary drugs must be made available under the Medicare prescription drug benefit, the final guidelines for designing the Rx formularies could still leave numerous drugs off the list, says a pharmaceutical industry expert.
The FDA is holding a two-day workshop in April to discuss statutory and regulatory requirements for clinical trials.
Conceding to the industry's demand, the government hiked the abatement limit of excise duty on the retail price of drugs to 40 percent from 35 percent at present.
Pfizer has acquired San Diego-based Idun Pharmaceuticals, a company focused on discovery and development of therapeutics in the area of liver disease, inflammation and cancer.
A factory in Gabon will produce six types of generic antiretroviral drugs for people living with AIDS.
Shire Pharmaceuticals is facing a new generic challenge to its key Adderall XR drug from Israel-based drug concern Teva Pharmaceutical.
Torrent Pharmaceuticals has signed a research collaboration agreement with the U.S.-based AstraZeneca.
Curacyte AG, a late stage drug discovery and development company has announced its merger with IBFB PHARMA GmbH. IBFB PHARMA is a biopharmaceutical company engaged in discovery and development of therapeutics to treat a variety of inflammatory diseases.
Alpharma has entered into an agreement with Orchid Chemicals & Pharmaceuticals, a Chennai-based global pharmaceutical company, whereby Orchid will develop, manufacture and supply generic prescription products for exclusive sale by Alpharma.
Shire Pharmaceuticals Group Plc is confident Canadian regulators will reverse a decision to suspend its top-selling hyperactivity drug, since the ban is not justified, the company's chief executive has said.
Prolexys Pharmaceuticals, a biopharmaceutical company dedicated to the development of novel cancer therapies, has signed an exclusive licensing agreement with the Massachusetts Institute of Technology, acting as licensing agent for the Whitehead Institute for Biomedical Research of Cambridge, Mass., and Columbia University of New York City.
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