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RSS FeedPosted by Michael Wonder on 04 May 2022
Novartis Kymriah receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma
4 May 2022 - Approval for relapsed or refractory follicular lymphoma is the third indication for Kymriah in the EU ...
Posted by Michael Wonder on 04 May 2022
European Commission approves Cabometyx as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer
3 May 2022 - Approval based on data from the COSMIC-311 Phase 3 trial, in which Cabometyx (cabozantinib) demonstrated a 78% ...
Posted by Michael Wonder on 03 May 2022
VBI Vaccines announces European Commission marketing authorisation for PreHevbri, a 3 antigen adult hepatitis B vaccine
2 May 2022 - Regulatory review in the United Kingdom is on-going as part of the European Commission Decision Reliance ...
Posted by Michael Wonder on 02 May 2022
Myovant Sciences announces European Commission approval for Orgovyx (relugolix) for the treatment of advanced hormone sensitive prostate cancer
29 April 2022 - Myovant expects to secure European commercialisation partner ahead of anticipated launches. ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and Biohaven's Vydura (rimegapant) granted first ever marketing authorisation by European Commission for both acute treatment of migraine and prophylaxis of episodic migraine
27 April 2022 - Pfizer and Biohaven Pharmaceutical today announced that the European Commission has granted marketing authorisation for Vydura (rimegepant), ...
Posted by Michael Wonder on 26 Apr 2022
ObsEva announces confirmation of positive CHMP opinion for linzagolix, an oral GnRH antagonist, for the treatment of uterine fibroids
25 April 2022 - ObsEva today announced that the CHMP of the EMA has confirmed its previously adopted positive opinion, ...
Posted by Michael Wonder on 24 Apr 2022
CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment for a subset of people with early-stage non-small-cell lung cancer
22 April 2022 - In the Phase III IMpower010 trial, adjuvant Tecentriq reduced the risk of disease recurrence or death by ...
Posted by Michael Wonder on 24 Apr 2022
CHMP adopts positive opinion for Filsuvez for the treatment of dystrophic and junctional EB
22 April 2022 - Positive opinion based on largest ever pivotal global Phase 3 EASE trial undertaken in epidermolysis bullosa. ...
Posted 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 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 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 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 ...