More than a year after a federal appeals court ruled that prosecuting a former pharma sales rep for off-label marketing violated his freedom of speech, the FDA continues on a collision course with the First Amendment.
To say 2013 was not a banner year for novel biologic approvals would be an understatement. The FDA approved 27 new molecular entities (NMEs) last year, but only two were biologics – Gazyva (obinutuzumab) and Kadcyla (ado-trastuzumab emtansine). Both were developed by the same company, Roche AG subsidiary Genentech Inc.
Once again, the Cardiovascular and Renal Drug Advisory Committee (CRDAC) shot down many of the red flags the FDA raised about Chelsea Therapeutics International Ltd.’s droxidopa (Northera).
While the Asia-Oceania region, as a whole, continues to increase its investment in biomedical R&D, Japan remains the powerhouse when it comes to innovation, accounting for 60 percent of the region’s R&D spending.
The FDA unveiled long-awaited draft guidance Monday on the use of social media to promote prescription drugs, but it’s not the final word on the subject.
Transgene SA was riding high Thursday after releasing top-line preliminary data from a Phase IIb/III study of TG4010, an immunotherapy being developed for non-small-cell lung cancer (NSCLC).
With an eye on the bottom line, the Centers for Medicare & Medicaid Services (CMS) is proposing a Part D rule change that would tip the formulary scale in favor of generics and, in time, biosimilars.
The FTC is set to butt into the biosimilar debate next month with a workshop on the potential competitive impacts of proposed naming schemes and state regulations.
Congress’ top priority when it heads back to Washington next week is to churn out an omnibus spending bill to keep the government running after Jan. 15, when the current continuing resolution expires.
