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RSS FeedPosted by Michael Wonder on 19 Jan 2018
European Commission approves Amgen and Allergan's Mvasi (biosimilar bevacizumab) for the treatment of certain types of cancer
18 January 2018 - First biosimilar bevacizumab approved in the European Union. ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 08 Jan 2018
Brexit fears are diverting millions of pounds from vital cancer battle, say drug firms
7 January 2018 - Brexit could see pharmaceutical firms having to contend with more regulations. ...
Posted by Michael Wonder on 21 Dec 2017
European Commission approves Roche’s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer
21 December 2017 - Approval based on phase III ALEX data showing Alecensa reduced the risk of disease progression or death ...
Posted by Michael Wonder on 18 Dec 2017
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Yervoy (ipilimumab) for the treatment of paediatric patients 12 years and older with unresectable or metastatic melanoma
18 December 2017 - First positive CHMP opinion for an immuno-oncology agent for paediatric patients. ...
Posted by Michael Wonder on 02 Dec 2017
European Medicines Agency accepts marketing authorisation applications for Mylan and Biocon's proposed biosimilars trastuzumab and pegfilgrastim
30 November 2017 - Mylan and Biocon today announced that the EMA has accepted for review Mylan's marketing authorisation applications ...
Posted by Michael Wonder on 28 Nov 2017
The European Medicines Agency accepts regulatory submission for Tagrisso in first-line EGFR-mutated non-small cell lung cancer
28 November 2017 - Acceptance is based on positive Phase III FLAURA trial results. ...
Posted by Michael Wonder on 28 Nov 2017
European Medicines Agency validates Bristol-Myers Squibb’s Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in intermediate and poor-risk patients with advanced renal cell carcinoma
28 November 2017 - Application is based on results from the Phase 3 CheckMate-214 study. ...
Posted by Michael Wonder on 27 Nov 2017
Merck invited to submit a CDF proposal for Merkel cell cancer drug
27 November 2017 - NICE has asked Merck to submit a Cancer Drugs Fund proposal for an immunotherapy called avelumab. ...
Posted by Michael Wonder on 21 Nov 2017
Janssen seeks expanded use of Darzalex (daratumumab) from EMA in newly diagnosed multiple myeloma
21 November 2017 - Janssen-Cilag International today announced the submission of a Type II variation application to the EMA, for the ...
Posted by Michael Wonder on 21 Nov 2017
European Commission extends license for Janssen’s Zytiga plus prednisone/prednisolone to include earlier stage prostate cancer patients
20 November 2017 - Oral, once-daily medication Zytiga (abiraterone acetate) plus prednisone/prednisolone now approved in newly diagnosed high-risk metastatic hormone-sensitive ...
Posted by Michael Wonder on 21 Nov 2017
Tesaro announces European Commission approval of Zejula for women with recurrent ovarian cancer
20 November 2017 - Approval supported by robust data from a randomised, well-controlled Phase 3 trial.
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Posted by Michael Wonder on 20 Nov 2017
Samsung Bioepis receives regulatory approval for Europe's first trastuzumab biosimilar, Ontruzant
20 November 2017 - Samsung Bioepis sets an industry record by obtaining European regulatory approval for four biosimilars in just two ...
Posted by Michael Wonder on 20 Nov 2017
Novartis drug Tasigna (nilotinib) secures EU approval for first and second-line treatment of Ph+ CML-CP in children
20 November 2017 - Tasigna is the first and only second-generation tyrosine kinase inhibitor approved in the EU for the treatment ...
Posted by Michael Wonder on 17 Nov 2017
Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma
16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...