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Shire said Thursday it will abandon the development of its blockbuster hyperactivity drug Vyvanse as a treatment for major depressive disorder after two failed Phase III trials. Read More
To help the European Medicines Agency (EMA) meet 90-day deadlines for orphan drug designation reviews, the agency is asking sponsors to give two months’ advance notice of their intent to file. Read More
Merck & Amgen will collaborate on a Phase Ib/II trial evaluating Merck’s MK-3475 in combination with Amgen’s talimogene laherparepvec anti-cancer immunotherapies. Read More
Merck and Ablynx have signed an agreement that will further their collaboration in the area of nanobodies, this time to target tumors’ immune-coopting mechanisms. Read More
The FDA wants IND sponsors to stop the practice of routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More
European regulators want drugmakers to develop pharmacovigilance plans that include tracking pharmacogenomic data to assess drug safety risks that may apply only to small patient populations. Read More
Sponsors of vaccine trials intended to support a marketing submission in China have seven days to report study-related fatalities and another eight days to file follow up reports, according to a new China Food and Drug Administration guideline. Read More