News in brief
04-Mar-2015 - The SEC’s enforcement director is calling out pharma companies for failing to disclose and misinforming investors about correspondence with the US FDA.
04-Mar-2015 - The US Food and Drug Administration (FDA) has ordered makers of testosterone therapies to change their labelling and conduct clinical trials to investigate heart attack and stroke risk.
03-Mar-2015 - A robust US biosimilars market is still some way off according to analysts who say interchangability, doctors’ safety concerns and patient demands should be considered alongside the regulatory environment by firms mulling entry.
03-Mar-2015 - The US FDA is requiring manufacturers to place label warnings on all multi-dose diabetes pens as patients continue to share the devices.
02-Mar-2015 - Med Prep Consulting execs committed fraud and violated the Federal Food, Drug and Cosmetic Act (FDCA) according to the US DoJ, which has accused the New Jersey compounder of knowingly selling drugs produced in unsanitary conditions.
People on the Move
02-Mar-2015 - Big management changes at US FDA, GSK, and Association of the British Pharmaceutical Industry.
27-Feb-2015 - The German Institute for Quality and Efficiency in Health Care (IQWiG) says the EMA’s proposal to establish a publicly accessible database of clinical trial data does not do enough to make the data transparent.