Remove 2018 Remove Biosimilars Remove Pharmaceuticals Remove Vaccine
article thumbnail

A review of Japan’s drug discovery and development landscape  

Drug Discovery World

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. Similarly, biosimilars are expected to grow. Investment and collaboration .

Drugs 130
article thumbnail

European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

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. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”.

FDA 52
article thumbnail

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

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.

article thumbnail

New Sandoz Board of Directors appointed

The Pharma Data

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. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

Science 40
article thumbnail

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA 52
article thumbnail

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Vaccine 52