TRAILBLAZER-ALZ 2 试验表明,Donanemab 能适度减缓早期有症状的阿尔茨海默病患者的认知和功能衰退。然而,美国食品药品监督管理局(Food and Drug Administration,FDA)和欧洲药品管理局(European Medicines Agency,EMA)对 Donanemab 的审批决定截然不同,这凸显了监管理念和重点的关键差异,也引发了关于如何在创新与患者安全之...
EMA Recommends Two Biosimilars, One Orphan Drug, for Approval
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, ...
In 2019, the US Food & Drug Administration (FDA) approved 48 new molecular entities (NMEs), lower than the 59 NMEs approved in 2018. Related Reading: A Review of U.S. ANDA Approvals Received by Chinese Pharmaceutical Enterprises in the First Half of 2019 ...
EMA recommends revoking authorization of Novartis' sickle cell drug Zachary Brennan Senior Editor The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday ...
HCT/Ps that do not meet all of the criteria listed in 1271.10(a) are also regulated under Section 351 of the PHS Act and/or the Federal Food, Drug and Cosmetic Act as drugs, devices and/or biological products requiring premarket approval for demonstration of safety and effectiveness. An ...
The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Multiple myeloma is an ...
National processes allow the medicine to be approved by one of the EU states using its own drug approval processes. Drugs not mandated to go through the centralized process may be supported through national processes. Once a drug has been approved through a national process in ...
is a fully human monoclonal antibody that targets interferon gamma. Emapalumab development was sponsored by NovImmune SA, further developed by Sobi and FDA approved on November 20, 2018.1,5 The approval of emapalumab was followed by the designation of orphan drug, priority review and breakthrough...
(PFS) compared with sunitinib in patients with previously untreated advanced RCC determined to be intermediate- or poor-risk by the International Metastatic RCC Database Consortium (IMDC) criteria. In December 2017, the US Food and Drug Administration (FDA) approved Cabometyx for the expanded ...