Vivus proposes a Risk Evaluation and Mitigation Strategy for its obesity drug Qnexa, including a voluntary pregnancy registry, to address potential safety issues that will be discussed at a July 15 advisory committee meeting.
Controversy over the quality of GlaxoSmithKline's clinical trial data heats up at first day of Avandia advisory committee meeting.
PhRMA recruits new CEO John Castellani from the Business Roundtable, which played an important role with the pharmaceutical group and other stakeholders in supporting health care reform legislation.
Auxilium’s Xiaflex, approved by FDA for DuPuytren’s contracture in February, has launched slowly but use indicators, such as the number of sites ordering the drug, are increasing. While awaiting a Medicare code that should quicken the pace of reimbursement, Auxilium hopes to build Xiaflex gradually by altering the treatment paradigm from surgery.
A final rule on the Medicare and Medicaid electronic health record incentive program addresses concerns that the proposed rule took a one-size-fits-all approach.
Trevena Inc., a startup developing medicines around biased ligands that activate G-protein coupled receptor pathways, has completed a $35 million Series B round from NEA and Polaris Venture Partners, with prior investors Alta Partners and Healthcare Ventures participating. Formed to commercialize research conducted at Duke University, Trevena previously raised $25 million in Series A funding from the same four firms in early 2008, and will use the funds to support continued Phase I and II trials on a heart failure drug.
