Blog
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
Canada again delays overhaul to patented medicine pricing system
29 June 2021 - Health Minister Patty Hajdu is delaying the first big overhaul of Canada’s patented medicines pricing system ...
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
Costly new Alzheimer’s drug could force Medicare to restrict access
28 June 2021 - The federal health insurance program may limit who can get the drug, which Biogen priced at $56,000 ...
Posted by Michael Wonder on 29 Jun 2021
Biden won’t end cancer — or any other disease — by importing drug price controls from Europe
28 June 2021 - In his first budget, President Biden set aggressive health goals. “Let’s end cancer as we know ...
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
Walmart unveils low-price insulin as more patients with diabetes struggle to pay for drug
29 June 2021 - The company has made a bigger push into health care as it tries to leverage its massive ...
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
Innovent announces the China NMPA approval of Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab biosimilar injection) as first-line therapy for people with hepatocellular carcinoma
28 June 2021 - Innovent Biologics today announced that the National Medical Products Administration of China has approved the supplemental ...
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
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. ...