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The authors of the legislation that paved the way for improved market access for generic drug firms are confident that legislation to facilitate biogeneric entry is likely to move forward before the end of 2007.
The U.S. Patent and Trademark Office rejected claims in a key patent covering Genentech's respiratory treatment drug, Synagis, the company said, noting that it is contemplating challenging the decision.
Women who take estrogen as hormone replacement therapy to counter the effects of menopause may be better off using a transdermal patch than swallowing a pill, according to a recent study.
The FDA ordered 20 companies to stop manufacturing unapproved drug products containing ergotamine tartrate as part of the agency's safety efforts to keep unapproved drugs off the market.
GlaxoSmithKline (GSK) has alerted healthcare providers about the increased risk of fractures related to Avandia, Avandamet and Avandaryl tablets, which are used to treat Type 2 diabetes mellitus.
A new Medicaid rule being proposed by the Centers for Medicare & Medicaid Services (CMS) could discourage generic drug use and should be amended to reflect actual acquisition costs for retailers that fill prescriptions with generic drugs, a pharmacist group said.
FDA Commissioner Andrew von Eschenbach made his second appearance in two days before Congress to support the agency's proposed 2008 budget, but he also had to defend the agency's handling of Ketek and other controversial topics.
GlaxoSmithKline (GSK) has acquired exclusive rights to weight-loss drug orlistat for OTC use in markets outside the U.S., excluding Japan, and said it plans to file for approval in Europe by the end of the year.
The UK's National Health Service's (NHS) drug price regulation scheme should be changed to a value-based system that focuses more on patients and providing better benefits, an Office of Fair Trading (OFT) report recommended.
FDA Commissioner Andrew von Eschenbach defended the agency's budget proposal for 2008 in front of a Senate subcommittee, saying funding increases and new user fees would help accelerate drug approvals and improve product safety reviews.