EU regulator advises caution on EUA for Sputnik COVID-19 vaccine
Sputnik V has already been approved or is being assessed for approval in three EU member states - Hungary, Slovakia and the Czech…
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European Commission
EC buys additional 150 mn doses of Moderna’s COVID-19 vaccine
150 million doses scheduled to be delivered in Q3 and Q4, 2021
Biocon Biologics and Viatris get EC Approval for Kixelle, biosimilar insulin Aspart
Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1…
European Commission to purchase additional 80 mn doses of Moderna’s COVID-19 vaccine
Total of 160 million doses ordered by the European Commission to date
Biocon Biologics, Mylan get CHMP recommendation for approval of biosimilar insulin Aspart
The European Commission decision on the approval is expected early next year
EU reaches supply deal with Moderna for 160 mn doses of COVID-19 vaccine
The deal will be formally approved by the EU executive tomorrow
Bristol Myers Squibb get EC approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with…
Opdivo plus Yervoy-based combinations now indicated in the EU for three different advanced cancer types: non-small cell lung…
Pfizer and BioNTech to potentially supply EU with 200 mn doses of COVID-19 vaccine candidate
The proposed agreement also has an option to purchase additional 100 million doses, with deliveries starting by the end of 2020,…
Janssen gets EC approval for expanded use of IMBRUVICA (ibrutinib) plus rituximab to treat CLL
Data from Phase 3 E1912 study showed previously untreated patients aged 70 years or younger treated with ibrutinib plus rituximab…
Rozlytrek from Roche gets EC approval to treat solid tumours and NSCLC
The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I…