Blog
RSS FeedPosted by Michael Wonder on 24 Apr 2022
Novartis receives positive CHMP opinion for Tabrecta for patients with METex14 advanced non-small-cell lung cancer
22 April 2022 - Opinion based on Phase 2 GEOMETRY mono-1 study showing an overall response rate (ORR) of 51.6% ...
Posted by Michael Wonder on 23 Apr 2022
CHMP recommends EU conditional approval of Roche’s potential first in class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma
22 April 2022 - The recommendation is based on the GO29781 study where mosunetuzumab induced high complete response rates, with ...
Posted by Michael Wonder on 23 Apr 2022
Highlights from the 19-22 April 2022 CHMP meeting
22 April 2022 - The EMA’s CHMP recommended four medicines for approval in the European Union at its April 2022 ...
Posted by Michael Wonder on 19 Apr 2022
EMA publishes agenda for 19-22 April 2022 CHMP meeting
19 April 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Apr 2022
European Commission approves Padcev (enfortumab vedotin) for locally advanced or metastatic urothelial cancer
13 April 2022 - Enfortumab vedotin is the first medicine approved in the EU for patients who received a prior ...
Posted by Michael Wonder on 12 Apr 2022
EMA and the EUnetHTA 21 consortium set priorities for their collaboration
12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...
Posted by Michael Wonder on 11 Apr 2022
Drug makers pledge speedier European market launches to avert stricter regulation
11 April 2022 - Drug makers on Monday pledged to speed up the market launch of new drugs in underserved ...
Posted by Michael Wonder on 07 Apr 2022
Dupixent (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation
7 April 2022 - Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung ...
Posted by Michael Wonder on 07 Apr 2022
BeiGene announces European Medicines Agency acceptance of marketing authorisation applications for tislelizumab for the treatment of patients with ESCC and NSCLC
6 April 2022 - First European submissions for BeiGene’s anti PD-1 antibody licensed to Novartis for North America, Europe and ...
Posted by Michael Wonder on 06 Apr 2022
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) with chemotherapy as first-line treatment for patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
5 April 2022 - Opdivo with chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy alone ...
Posted by Michael Wonder on 05 Apr 2022
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
5 April 2022 - Opdivo plus Yervoy is one of two newly approved Opdivo based treatment regimens to demonstrate superior overall ...
Posted by Michael Wonder on 05 Apr 2022
European Commission approves Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
4 April 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall ...
Posted by Michael Wonder on 04 Apr 2022
Novartis announces European Commission approval of Beovu for people living with diabetic macular oedema
31 March 2022 - Approval is based on year one data from the Phase 3 KESTREL and KITE trials investigating Beovu ...
Posted by Michael Wonder on 31 Mar 2022
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
31 March 2022 - EMA, in collaboration with the European Organisation for Research and Treatment of Cancer, has launched the Cancer ...
Posted by Michael Wonder on 29 Mar 2022
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for resectable non-small-cell lung cancer
29 March 2022 - Application based on CheckMate-816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete ...