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Join FDAnews Tuesday, Jan. 23, for "Pharma Marketing Laws: State by State: Strategies for Compliance with Patchwork Regulations." In this 90-minute interactive audioconference, Keith Korenchuk, attorney with Covington & Burling, will deliver clear guidance on the regulations in the three states (California, Florida and New Hampshire) that enacted new drug marketing laws in 2006, along with the states that already have drug marketing laws in place. On Feb. 1, join FDAnews for "Clinical Trial Billing Under Medicare: How the New National Coverage Decision Will Impact You." In this special 105-minute audioconference with Q&A session, noted attorney Mark Barnes will provide the information you need to receive reimbursement from the Centers for Medicare & Medicaid Services for clinical trial expenses without running afoul of the Office of Inspector General.
Biovail announced that its marketing partner GlaxoSmithKline (GSK) has been granted approval to market Wellbutrin XR (bupropion hydrochloride modified-release tablets) for treating adult patients with major depressive episodes in the Netherlands.
Shire announced that the FDA has approved Lialda (mesalamine) with MMX technology for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Aradigm has received orphan drug designation from the FDA for an inhaled liposomal formulation of ciprofloxacin for the management of bronchiectasis (BE).
Genaera has presented preclinical data supporting the mechanism of action of trodusquemine, the company's centrally acting small-molecule appetite suppressant, at the Keystone Symposia Obesity Meeting.
Trubion Pharmaceuticals announced it has completed enrollment and dosing of patients in its Phase IIb clinical trial of TRU-015, the company's lead Small Modular ImmunoPharmaceutical (SMIP) drug candidate for the treatment of rheumatoid arthritis (RA).
Daiichi Sankyo and Eli Lilly have announced the completion of patient enrollment in their pivotal Phase III head-to-head clinical study, TRITON TIMI-38, to evaluate the safety and efficacy of prasugrel compared with Plavix (clopidogrel) in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI).