Abstract:
Highlights of our annual review of new approvals and launches on global drug markets include the approval and launch of Trikafta, the most widely applicable treatment to date for cystic fbrosis; approval of the frst Ebola vaccine for general (rather than emergency) use; the pilot rollout in three African countries of the world's frst malaria vaccine; approval of a new treatment option for multidrug-resistant bacterial infections; and the approval and launch in China of the frst new drug to treat Alzheimer's disease in more than a decade. Several new immune checkpoint inhibitors and antibody-drug conjugates were approved for cancer indications, confrming continued industry enthusiasm for cancer immunotherapy. The most notable trend of 2019 was the granting by the Food and Drug Administration (FDA) of a record number of accelerated approvals, many of which were issued several months ahead of the expected action date.