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RSS FeedPosted by Michael Wonder on 15 Apr 2021
EU drug regulator to issue view on J&J vaccine next week
15 April 2021 - Europe's drug regulator said on Wednesday it planned to issue a recommendation on Johnson & Johnson's ...
Posted by Michael Wonder on 15 Apr 2021
EMA starts review of VIR-7831 for treating patients with COVID-19
15 April 2021 - EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as ...
Posted by Michael Wonder on 15 Apr 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) as first-line treatment for patients with advanced renal cell carcinoma
14 April 2021 - Approval based on Phase 3 CheckMate-9ER trial results showing Opdivo in combination with Cabometyx significantly improved overall ...
Posted by Michael Wonder on 14 Apr 2021
Europe bets heavily on Pfizer in vaccine strategy overhaul
15 April 2021 - Europe has hinted it will not renew contracts for coronavirus vaccines produced by pharmaceutical giants AstraZeneca ...
Posted by Michael Wonder on 14 Apr 2021
AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
14 April 2021 - EMA continues to monitor very rare blood clots with low blood platelets that occurred after vaccination ...
Posted by Michael Wonder on 14 Apr 2021
COVID-19 vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
14 April 2021 - As announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots ...
Posted by Michael Wonder on 10 Apr 2021
Johnson & Johnson COVID-19 vaccine under review by EMA over blood clots
10 April 2021 - Europe’s drug regulator says it is reviewing rare blood clots in four people in the United States ...
Posted by Michael Wonder on 08 Apr 2021
AstraZeneca worldwide: who’s using the jab, and who’s not
9 April 2021 - A growing list of countries are either restricting or suspending the use of AstraZeneca vaccine amid it’s ...
Posted by Michael Wonder on 08 Apr 2021
The European Commission grants marketing authorisation for the new subcutaneous administration of Tysabri (natalizumab) to treat relapsing-remitting multiple sclerosis
7 April 2021 - The subcutaneous option provides a shorter administration time and expands access to treatment for patients and physicians ...
Posted by Michael Wonder on 08 Apr 2021
With millions vaccinated, rare side-effects of jabs are emerging
7 April 2021 - Sorting signal from noise. ...
Posted by Michael Wonder on 07 Apr 2021
AbbVie submits regulatory applications for Skyrizi (risankizumab) in psoriatic arthritis to FDA and EMA
7 April 2021 - Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which Skyrizi demonstrated ...
Posted by Michael Wonder on 07 Apr 2021
AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
7 April 2021 - EMA confirms overall benefit-risk remains positive. ...
Posted by Michael Wonder on 05 Apr 2021
Copikta (duvelisib) receives positive CHMP opinion for the treatment of relapsed and refractory CLL and refractory FL
1 April 2021 - Secura Bio announced that the CHMP of the EMA adopted a positive opinion recommending the approval of ...
Posted by Michael Wonder on 03 Apr 2021
Autolus Therapeutics receives PRIME designation for AUTO1 for the treatment of adult ALL
1 April 2021 - Autolus Therapeutics today announced that it has received PRIority MEdicines (PRIME) designation from the EMA for AUTO1, ...
Posted by Michael Wonder on 01 Apr 2021
European Commission approves Cabometyx in combination with Opdivo as a first-line treatment for patients living with advanced renal cell carcinoma
31 March 2021 - Approval based on pivotal Phase 3 CheckMate-9ER trial data, also recently published in the New England Journal ...