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RSS FeedPosted by Michael Wonder on 27 Apr 2021
EMA grants accelerated assessment procedure for Nefecon for the treatment of IgA nephropathy
23 April 2021 - Calliditas Therapeutics today announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation ...
Posted by Michael Wonder on 27 Apr 2021
FDA guidance says sponsors should provide 'convincing' proof of concept data to support INDs for individualised medicine
26 April 2021 - Recent draft guidance from the US FDA addresses the non-clinical safety data to support investigational new ...
Posted by Michael Wonder on 27 Apr 2021
Glenmark’s Ryaltris nasal spray now approved in Europe for the first-line treatment of allergic rhinitis in patients over 12 years of age
26 April 2021 - This marks Glenmark’s first innovative product approval in the European Union. ...
Posted by Michael Wonder on 27 Apr 2021
Health Canada initiates the review of the rolling submission for the first Canadian based COVID-19 vaccine candidate
23 April 2021 - Medicago is pleased to announce that Health Canada received for review the first portion of Medicago’s ...
Posted by Michael Wonder on 27 Apr 2021
Reata announces FDA accepted for filing the NDA for bardoxolone for the treatment of patients with chronic kidney disease caused by Alport syndrome
26 April 2021 - Application assigned a PDUFA date of 25 February 2022. ...
Posted by Michael Wonder on 27 Apr 2021
Karyopharm announces European Medicines Agency's validation of its type II variation marketing authorisation application for Nexpovio (selinexor) in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma
26 April 2021 - EMA regulatory decision expected in the fourth quarter of 2021. ...
Posted by Michael Wonder on 27 Apr 2021
The European Union sues AstraZeneca over missing vaccine doses
26 April 2021 - The European Union has sued AstraZeneca over what the bloc has described as delays in shipping ...
Posted by Michael Wonder on 26 Apr 2021
EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
26 April 2021 - The EMA and the European Centre for Disease Prevention and Control today kicked off a new ...
Posted by Michael Wonder on 26 Apr 2021
Vertex and CRISPR Therapeutics announce Priority Medicines (PRIME) designation granted by the European Medicines Agency to CTX001 for transfusion-dependent beta thalassaemia
26 April 2021 - Vertex Pharmaceuticals and CRISPR Therapeutics today announced the EMA has granted Priority Medicines (PRIME) designation to ...
Posted by Michael Wonder on 26 Apr 2021
Axsome Therapeutics announces FDA acceptance and priority review of new drug application for AXS-05 for treatment of major depressive disorder
26 April 2021 - FDA grants priority review and sets PDUFA action goal date of 22 August 2021. ...
Posted by Michael Wonder on 26 Apr 2021
Selumetinib recommended for approval in the EU by CHMP as the first medicine for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
26 April 2021 - Recommendation based on the SPRINT Phase 2 trial, which showed selumetinib reduced tumour volume in children. ...
Posted by Michael Wonder on 26 Apr 2021
Tagrisso recommended for approval in the EU by CHMP for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
26 April 2021 - Opinion based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk of ...
Posted by Michael Wonder on 26 Apr 2021
European Commission approves GSK’s Jemperli (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer
23 April 2021 - The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. ...
Posted by Michael Wonder on 26 Apr 2021
Global sarcoma therapy now approved for Australian patients
23 April 2021 - Globally regarded soft tissue sarcoma therapy has been approved by the Therapeutic Goods Administration for Australian patients. ...
Posted by Michael Wonder on 26 Apr 2021
LEO Pharma receives positive CHMP opinion of Adtralza (tralokinumab) for the treatment of adults with moderate-to-severe atopic dermatitis
23 April 2021 - The CHMP opinion is primarily supported by data from ECZTRA 1, 2, and 3 trials included in ...