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RSS FeedPosted by Michael Wonder on 30 Jun 2021
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy for certain patients with oesophageal cancer or HER2 negative gastro-oesophageal junction adenocarcinoma
29 June 2021 - Keytruda is first anti-PD-1 therapy approved in Europe in combination with chemotherapy for first-line treatment of ...
Posted by Michael Wonder on 30 Jun 2021
Médunik Canada once again receives Notice of Compliance from Health Canada for Ruzurgi (amifampridine) following review ordered by court ruling
29 June 2021 - Médunik Canada is pleased to announce that Health Canada has reissued the approval (Notice of Compliance) ...
Posted by Michael Wonder on 30 Jun 2021
Cend Therapeutics’ CEND-1 granted fast track designation for pancreatic cancer
29 June 2021 - The US FDA has granted fast track development status for Cend’s investigational drug, CEND-1, for the ...
Posted by Michael Wonder on 30 Jun 2021
FDA grants fast track designation to CNS Pharmaceuticals for berubicin for the treatment of recurrent glioblastoma multiforme
29 June 2021 - FDA fast track designation for berubicin highlights the serious unmet medical need for new treatments for glioblastoma ...
Posted by Michael Wonder on 29 Jun 2021
MediWound receives complete response letter from US FDA for NexoBrid biologics license application
29 June 2021 - Company remains committed to working with FDA toward a potential approval for this important therapy. ...
Posted by Michael Wonder on 29 Jun 2021
Neuros Medical receives FDA breakthrough device designation for its novel Altius high frequency nerve block system
29 June 2021 - Neuros Medical announced today that it has received Breakthrough Device Designation from the U.S. FDA for the ...
Posted by Michael Wonder on 29 Jun 2021
Inside ‘Project Onyx’: how Biogen used an FDA back channel to win approval of its polarising Alzheimer’s drug
29 June 2021 - It was perhaps the most contentious drug approval in decades, shocking drug company executives, insurance companies, ...
Posted by Michael Wonder on 29 Jun 2021
Roche’s Enspryng approved by European Commission as first and only at home subcutaneous treatment for neuromyelitis optica spectrum disorder
28 June 2021 - In Phase 3 trials, ENSPRYNG significantly reduced the number and severity of relapses in people with AQP4-IgG ...
Posted by Michael Wonder on 29 Jun 2021
Medexus receives Notice of Compliance to commercialise Treosulfan in Canada
28 June 2021 - Medexus Pharmaceuticals today announced that it has received a Notice of Compliance from Health Canada to ...
Posted by Michael Wonder on 29 Jun 2021
Update of EU recommendations for 2021–2022 seasonal flu vaccine composition
28 June 2021 - EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine ...
Posted by Michael Wonder on 29 Jun 2021
Agios submits marketing authorisation application to European Medicines Agency for mitapivat for treatment of adults with pyruvate kinase deficiency
28 June 2021 - Agios Pharmaceuticals today announced that it has submitted a marketing authorisation application for mitapivat to the EMA ...
Posted by Michael Wonder on 29 Jun 2021
BioMarin resubmits marketing authorisation application to European Medicines Agency for valoctocogene roxaparvovec to treat severe haemophilia A
28 June 2021 - Valoctocogene roxaparvovec MAA granted request for accelerated assessment. ...
Posted by Michael Wonder on 29 Jun 2021
Chiasma announces submission of marketing authorisation application for Mycapssa to the European Medicines Agency
28 June 2021 - Submission supported by previously announced data from Phase 3 MPOWERED trial. ...
Posted by Michael Wonder on 29 Jun 2021
Gilead submits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
28 June 2021 - If approved, lenacapavir would be the first capsid inhibitor and the only HIV-1 treatment option administered ...
Posted by Michael Wonder on 28 Jun 2021
Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in factor VII deficiency
28 June 2021 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for Marzeptacog alfa (activated), MarzAA, ...