Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2018
EMA to review cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma
3 April 2018 - The EMA has accepted for review the marketing authorisation application for cemiplimab for the treatment of ...
Posted by Michael Wonder on 28 Mar 2018
Ipsen announces EMA validation of filing of a new application for additional indication for Cabometyx
28 March 2018 - Ipsen today announced that the EMA has validated the filing of a new application for an ...
Posted by Michael Wonder on 26 Mar 2018
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo four-week dosing schedule for advanced melanoma and previously treated renal cell carcinoma
26 March 2018 - Bristol-Myers Squibb Company today announced that the CHMP of the EMA has recommended approval of an ...
Posted by Michael Wonder on 25 Mar 2018
Ipsen receives positive CHMP opinion for Cabometyx (cabozantinib) for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma
23 March 2018 - Cabozantinib is the first and only monotherapy to demonstrate superior clinical efficacy over sunitinib in treatment-naïve patients ...
Posted by Michael Wonder on 23 Mar 2018
CHMP grants positive opinion for Clovis Oncology's Rubraca (rucaparib) tablets
23 March 2018 - First PARP inhibitor recommended for treatment indication in the EU. ...
Posted by Michael Wonder on 20 Mar 2018
U.S. FDA grants priority review for a supplemental new drug application for Xtandi (enzalutamide) in non-metastatic castration-resistant prostate cancer
19 March 2018 - Application seeks to expand the indication of Xtandi to include men with non-metastatic castration-resistant prostate cancer. ...
Posted by Michael Wonder on 27 Feb 2018
EU cancer drugs rejection shows contrasts with FDA
26 February 2018 - Europe’s expert medicines panel has rejected Puma Biotechnology’s breast cancer drug neratinib, citing limitations in its ...
Posted by Michael Wonder on 26 Feb 2018
Lynparza receives positive EU CHMP opinion in platinum-sensitive relapsed ovarian cancer
23 February 2018 - AstraZeneca and MSD’s new Lynparza tablet formulation recommended for maintenance therapy regardless of BRCA status. ...
Posted by Michael Wonder on 24 Feb 2018
Puma Biotechnology receives results of CHMP formal decision for neratinib for extended adjuvant treatment of HER2-positive early stage breast cancer
23 February 2018 - Puma Biotechnology announced that the CHMP of the EMA has adopted a negative opinion, recommending the ...
Posted by Michael Wonder on 24 Feb 2018
Pfizer announces update on European marketing authorisation application for Sutent (sunitinib) in adult patients at high risk of recurrent renal cell carcinoma
23 February 2018 - Pfizer today announced that the CHMP of the EMA has recommended against expanding use of Sutent ...
Posted by Michael Wonder on 24 Feb 2018
Pfizer receives positive CHMP opinion for two haematology medicines, Mylotarg and Bosulif
23 February 2018 - Pfizer today announced that the CHMP of the EMA has adopted positive opinions recommending that two Pfizer ...
Posted by Michael Wonder on 13 Feb 2018
U.S., EU and Japan health authorities accept regulatory submissions for review of Pfizer's third-generation ALK inhibitor lorlatinib
12 February 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 23 Jan 2018
Jeremy Hunt admits supply of EU cancer drugs to Britain could be disrupted if Brexit talks break down
23 January 2018 - Health Secretary also throws doubt on Theresa May’s hopes of a transitional agreement before April – warning ...
Posted by Michael Wonder on 23 Jan 2018
Seattle Genetics announces Adcetris (brentuximab vedotin) receives European Commission approval for CD30-positive cutaneous T-cell lymphoma after at least one prior systemic therapy
22 January 2018 - Approval based on positive Phase 3 ALCANZA trial results, which demonstrated a highly statistically significant improvement in ...
Posted by Michael Wonder on 22 Jan 2018
European Commission approves Bristol-Myers Squibb’s Yervoy (ipilimumab) for treatment of paediatric patients 12 years and older with unresectable or metastatic melanoma
22 January 2018 - Yervoy is the first and only immuno-oncology agent to receive approval in the European Union in this ...