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Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease


Hilleman Laboratories invests US $ 58 mn to establish vaccine hub in Singapore
Biotech | December 07, 2021

Hilleman Laboratories invests US $ 58 mn to establish vaccine hub in Singapore

The facility will supply clinical trial materials for the development of vaccines and biologics up to Phase II stage and is expected to be fully operational by early 2023.


Premas Biotech and Oravax to test their vaccine candidate against Omicron
News | December 02, 2021

Premas Biotech and Oravax to test their vaccine candidate against Omicron

Oravax's vaccine technology is highly scalable for manufacturing and is easily transferable for wide scale logistical distribution, as there is no need for freezer storage


Moderna seeks approval from EMA for its Covid-19 vaccine for children between 6-11 years
News | November 10, 2021

Moderna seeks approval from EMA for its Covid-19 vaccine for children between 6-11 years

The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11


EMA encourages companies to submit type I variations by end- November
Policy | November 01, 2021

EMA encourages companies to submit type I variations by end- November

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021


Boehringer Ingelheim announces EMA marketing authorisation for spesolimab
Drug Approval | October 29, 2021

Boehringer Ingelheim announces EMA marketing authorisation for spesolimab

Generalized pustular psoriasis is characterized by episodes of widespread eruptions of painful, sterile pustules


Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


EMA authorises booster dose of Moderna’s Spikevax
Drug Approval | October 06, 2021

EMA authorises booster dose of Moderna’s Spikevax

A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects


Temasek to buy a stake in Integrace
Startup | October 05, 2021

Temasek to buy a stake in Integrace

The company claims to be a market leader in core orthopaedic and gynaecology segments like bone and joint disorders, pain management and, pregnancy and women’s nutrition