Drug Discovery World
MARCH 29, 2023
International competitiveness The EFPIA’s reaction to the leak legislation includes concern about how Europe’s leading companies are reporting difficulties in researching and developing medicines and vaccines in Europe and their intent to take that research to the US and Asia 4. You can compare timelines.
Agency IQ
OCTOBER 20, 2023
BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.
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The Pharma Data
DECEMBER 13, 2020
Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Although much of the U.S. Read on for this week’s.
Drug Discovery World
OCTOBER 20, 2022
Similarly, biosimilars are expected to grow. This is unsurprising – our drug discovery industry does, after all, centre itself around creating initiatives that leave no one behind, from cancer therapies to malaria vaccines. . Investment and collaboration .
Agency IQ
JANUARY 19, 2024
Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022.
The Pharma Data
MAY 15, 2023
Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011.
Agency IQ
OCTOBER 6, 2023
As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range.
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