Blog
RSS FeedPosted by Michael Wonder on 10 Dec 2021
International regulators stress continued need for COVID-19 therapeutics
11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...
Posted by Michael Wonder on 10 Dec 2021
Intercept announces withdrawal of EMA marketing authorisation application for obeticholic acid for advanced liver fibrosis due to NASH
9 December 2021 - Intercept Pharmaceuticals today announced that it has formally notified the EMA of its decision to withdraw ...
Posted by Michael Wonder on 09 Dec 2021
Consensus lacking on ‘value’ for new anti-cancer drugs
8 December 2021 - The high price tag of new anticancer drugs has fuelled debate about the value of these treatments, ...
Posted by Michael Wonder on 07 Dec 2021
EMA accepts regulatory submission for olipudase alfa, the first potential therapy for ASMD
6 December 2021 - Olipudase alfa has been granted PRIority MEdicines (PRIME) designation in Europe, breakthrough therapy designation in the United ...
Posted by Michael Wonder on 07 Dec 2021
ICMRA high-level meeting on global health emergencies and regulatory approaches
6 December 2021 - On 1 - 2 December, International Coalition of Medicines Regulatory Authorities, a group of leading medicines regulatory ...
Posted by Michael Wonder on 06 Dec 2021
EMA recommends approval for use of RoActemra in adults with severe COVID-19
6 December 2021 - The EMA’s CHMP has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of ...
Posted by Michael Wonder on 04 Dec 2021
Janssen seeks approval of Imbruvica (ibrutinib) in a fixed duration regimen for patients with untreated chronic lymphocytic leukaemia
30 November 2021 - Application based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the safety ...
Posted by Michael Wonder on 04 Dec 2021
U.S. Food and Drug Administration accepts for priority review supplemental biologics license application for Reblozyl (luspatercept-aamt) in adults with non-transfusion dependent beta thalassaemia
3 December 2021 - Submission based on results from Phase 2 BEYOND study of Reblozyl plus best supportive care in ...
Posted by Michael Wonder on 04 Dec 2021
European Medicines Agency validates Amicus Therapeutics marketing authorisation applications for AT-GAA for the treatment of Pompe disease
3 December 2021 - Amicus Therapeutics today announced that the EMA validated the marketing authorisation applications for AT-GAA, the Company’s ...
Posted by Michael Wonder on 03 Dec 2021
ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
3 December 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation have reviewed some of ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for patients with certain types of endometrial carcinoma
29 November 2021 - Approval based on KEYNOTE-775/Study 309 results demonstrating statistically significant improvements in overall survival and progression-free survival ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) as first-line treatment for adult patients with advanced renal cell carcinoma
29 November 2021 - Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of ...
Posted by Michael Wonder on 30 Nov 2021
AbbVie submits application for risankizumab (Skyrizi) in moderate to severe Crohn's disease to European Medicines Agency
30 November 2021 - Submission supported by three pivotal Phase 3 trials in which risankizumab demonstrated significant improvements in clinical remission ...
Posted by Michael Wonder on 30 Nov 2021
The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain
30 November 2021 - Camurus today announces that the EMA has accepted the company’s submission of a Type II variation application ...
Posted by Michael Wonder on 29 Nov 2021
Bristol Myers Squibb’s applications for deucravacitinib for the treatment of moderate to severe plaque psoriasis accepted by U.S. Food and Drug Administration and validated by European Medicines Agency
29 November 2021 - Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy ...