Blog
RSS FeedPosted by Michael Wonder on 24 Apr 2021
CHMP recommends EU approval of Roche’s Enspryng (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder
23 April 2021 - Recommendation is based on results from the two pivotal Phase 3 SAkuraStar and SAkuraSky trials, in which ...
Posted by Michael Wonder on 21 Apr 2021
GW Pharmaceuticals receives European Commission approval for Epidyolex (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex
20 April 2021 - Tuberous sclerosis complex represents a third indication for GW’s cannabidiol in Europe. ...
Posted by Michael Wonder on 19 Apr 2021
European Commission approves second indication of Sarclisa (isatuximab) for relapsed multiple myeloma
19 April 2021 - Approval based on Phase 3 IKEMA study demonstrating Sarclisa added to standard of care carfilzomib and dexamethasone ...
Posted by Michael Wonder on 17 Apr 2021
Oncopeptides submits application for conditional marketing authorisation of melflufen in the EU
16 April 2021 - Oncopeptides today announces that the Company has submitted an application to the EMA for conditional marketing authorisation ...
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 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 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 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 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 ...
Posted by Michael Wonder on 31 Mar 2021
Merck receives positive EU CHMP opinion for updated label of Keytruda (pembrolizumab) to include results of Phase 3 KEYNOTE-361 trial in certain adult patients with locally advanced or metastatic urothelial cancer
30 March 2021 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending that the ...
Posted by Michael Wonder on 31 Mar 2021
Ontozry (cenobamate) receives European Commission approval for the treatment of drug resistant focal onset seizures in adults
30 March 2021 - SK Biopharmaceuticals and Angelini Pharma will collaborate to launch the treatment in countries in the European Economic ...
Posted by Michael Wonder on 31 Mar 2021
Novartis receives EU approval for Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis
30 March 2021 - Approval based on two Phase 3 ASCLEPIOS studies that met primary endpoints where Kesimpta showed a reduction ...
Posted by Michael Wonder on 31 Mar 2021
Roche’s Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy
30 March 2021 - Roche is actively engaging with health authorities in the European Union to achieve broad and rapid access ...
Posted by Michael Wonder on 31 Mar 2021
Amarin receives European Commission approval for Vazkepa to reduce cardiovascular risk
30 March 2021 - Marks first and only European Commission approved treatment to reduce cardiovascular risk in high risk, statin treated ...