Blog
RSS FeedPosted by Michael Wonder on 25 Mar 2022
New gene therapy to treat adult patients with multiple myeloma
25 March 2022 - EMA has recommended a conditional marketing authorisation in the European Union for Carvykti (ciltacabtagene autoleucel) for the ...
Posted by Michael Wonder on 11 Mar 2022
Janssen seeks approval of a new indication for Imbruvica (ibrutinib) for use in patients with untreated mantle cell lymphoma
8 March 2022 - Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ...
Posted by Michael Wonder on 10 Mar 2022
Servier submits a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for patients with IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma
10 March 2022 - The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway. ...
Posted by Michael Wonder on 09 Mar 2022
Bayer submits applications in the U.S. and EU for additional indication of Nubeqa (darolutamide)
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New ...
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 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 22 Feb 2022
BeiGene announces European Medicines Agency acceptance of applications for Brukinsa (zanubrutinib) in chronic lymphocytic leukaemia and marginal zone lymphoma
22 February 2022 - The CLL filing is supported by two global Phase 3 trials of Brukinsa in chronic lymphocytic leukaemia ...
Posted by Michael Wonder on 18 Feb 2022
Sandoz launches generic lenalidomide in 19 countries across Europe, expanding access to essential oncology medicine
18 February 2022 - Cost savings from Lenalidomide Sandoz can expand treatment options for patients with haemato-oncology conditions. ...
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 02 Feb 2022
New order: European cancer coalition calls for cancer treatment overhaul
2 February 2022 - Coalition urges reformation of EU wide drug research and development to drive treatment optimisation ...
Posted by Michael Wonder on 01 Feb 2022
Janssen submits marketing authorisation application to the EMA seeking approval of bispecific antibody teclistamab for the treatment of patients with relapsed or refractory multiple myeloma
31 January 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application ...
Posted by Michael Wonder on 30 Jan 2022
European Commission approves Lorviqua (lorlatinib) as a first-line treatment for ALK positive advanced lung cancer
28 January 2022 - Approval based on results from Phase 3 CROWN trial, showing Lorviqua reduced risk of disease progression ...