The PSC argued that adverse event reports, internal company documents that discussed possible associations, the biological plausibility opinions of Levin and Sadler, the putative mechanism opinions of Cabrera, differential diagnoses offered to support specific causation, and the hip-shot opinions of a former-FDA-commissioner-for-hire, David Kessler could come together magically to supply sufficient evidence to have their cases submitted to juries. [read post]

FDA and FTC Approaches to Help Ensure Truthful and Non‐misleading Advertising and Promotional Communications Lowell Schiller, Principal Associate Commissioner for Policy, FDA: have seen troubling communications suggesting biosimilars are less safe/less effective than reference products or that there may be clinically meaningful differences b/t them when biosimilars can’t be approved unless there are no clinically meaningful differences. [read post]

’s Office of the High Commissioner for Human Rights reported the killings of almost 2,000 civilians in the conflict as of mid-April. [read post]

  E.U. energy commissioner Kadri Simson has announced that a sixth package of E.U. sanctions against Russia in response to its invasion of Ukraine is expected “very soon”. [read post]