Blog
RSS FeedPosted by Michael Wonder on 07 Mar 2022
Jardiance (empagliflozin) becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction
7 March 2022 - The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with ...
Posted by Michael Wonder on 01 Mar 2022
CHMP recommends Idorsia’s dual acting treatment Quviviq for insomnia patients
28 February 2022 - Quviviq can be used on a long-term basis, addressing a key limitation of existing therapies ...
Posted by Michael Wonder on 01 Mar 2022
Glucophage is the first oral diabetes treatment approved in Europe for use during pregnancy
28 February 2022 - The approval was granted on the basis of Merck’s own safety cohort study CLUE and a large ...
Posted by Michael Wonder on 28 Feb 2022
Astellas and Seagen announce CHMP confirms positive opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
28 February 2022 - Astellas Pharma and Seagen today announced that the CHMP of the EMA has confirmed its previously ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus chemotherapy for first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
25 February 2022 - Recommendation based on positive results from the Phase 3 CheckMate -648 trial, in which the combination demonstrated ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
25 February 2022 - Recommendation based on results from the Phase 3 CheckMate -648 trial, in which the immunotherapy combination demonstrated ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) as adjuvant treatment for patients with radically resected, high-risk muscle-invasive urothelial carcinoma with tumour cell PD-L1 expression ≥1%
25 February 2022 - Recommendation based on results from the Phase 3 CheckMate-274 trial, in which Opdivo significantly reduced patients’ risk ...
Posted by Michael Wonder on 28 Feb 2022
Biohaven and Pfizer receive positive CHMP opinion for migraine treatment
25 February 2022 - Biohaven Pharmaceutical and Pfizer today announced that the CHMP of the EMA adopted a positive opinion for ...
Posted by Michael Wonder on 26 Feb 2022
Highlights from CHMP 21-24 February 2022 meeting
25 February 2022 - EMA’s CHMP recommended thirteen medicines for approval at its February 2022 meeting. ...
Posted by Michael Wonder on 25 Feb 2022
New medicine for rare type of eye cancer
25 February 2022 - EMA has recommended granting a marketing authorisation in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy ...
Posted by Michael Wonder on 24 Feb 2022
EMA recommends approval of Spikevax for children aged 6 to 11
24 February 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use ...
Posted by Michael Wonder on 22 Feb 2022
Celltrion's auto-immune disease biosimilar wins further approval in Europe
22 February 2022 - South Korean pharmaceutical giant Celltrion said Tuesday that a high concentration version of its auto-immune disease ...
Posted by Michael Wonder on 21 Feb 2022
Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes
21 February 2022 - Kerendia is the first non-steroidal, selective mineralocorticoid receptor antagonist to demonstrate positive kidney and cardiovascular outcomes in ...
Posted by Michael Wonder on 18 Feb 2022
European Commission approves Tepmetko (tepotinib) for patients with advanced NSCLC with METex14 skipping alterations
18 February 2022 - Approval is based on Phase II results from VISION, the largest interventional study to date of patients ...
Posted by Michael Wonder on 16 Feb 2022
European Commission approves Oxbryta (voxelotor) for the treatment of haemolytic anaemia in patients with sickle cell disease age 12 years and older
16 February 2022 - The first sickle haemoglobin polymerisation inhibitor approved in Europe, Oxbryta increases haemoglobin levels and reduces sickling ...