Topic: adverse event reporting
Turning Point’s update on repotrectinib in NSCLC showed more than four-fifths of patients responded to the drug, but its stock fell 10%.
The FDA is shutting down its alternative summary reporting program, ending its practice of allowing devicemakers to conceal reports from the public.
The FDA has seen a jump in reported cases of lymphoma linked to breast implants, which it says results from its education of stakeholders and patients.
Bayer dismissed poor safety reports related to its Essure contraceptive, a week after it said it would pull the device from the market in December.
David Herron will succeed John Hubbard as Bioclinica's CEO, as the CRO launched a new cloud-based clinical adjudication service.