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RSS FeedPosted by Michael Wonder on 23 Apr 2024
Medicure receives US FDA fast track designation for MC-1 for PNPO deficiency
23 April 2024 - Medicure announced today that through its subsidiary, Medicure International, the US FDA has granted fast track designation ...
Posted by Michael Wonder on 23 Apr 2024
FDA approves lutetium Lu 177 dotatate for paediatric patients 12 years and older with GEP-NETs
23 April 2024 - Today, the FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) for paediatric patients 12 ...
Posted by Michael Wonder on 23 Apr 2024
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...
Posted by Michael Wonder on 23 Apr 2024
Voydeya approved in the EU as add-on treatment to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia
23 April 2024 - ALPHA Phase 3 trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris ...
Posted by Michael Wonder on 23 Apr 2024
New recommendations to strengthen supply chains of critical medicines
23 April 2024 - EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines ...
Posted by Michael Wonder on 23 Apr 2024
More treatment options proposed for people with multiple myeloma and myelodysplastic syndrome
23 April 2024 - PHARMAC is proposing to fund more treatments for people with a type of blood cancer, multiple ...
Posted by Michael Wonder on 23 Apr 2024
Acadia Pharmaceuticals announces trofinetide new drug submission for treatment of Rett syndrome has been accepted for filing and priority review by Health Canada
22 April 2024 - Acadia Pharmaceuticals today announced that Health Canada has accepted its new drug submission for trofinetide for the ...
Posted by Michael Wonder on 23 Apr 2024
Health Canada approves new indication for Merck’s Prevymis (letermovir) for prevention of cytomegalovirus disease in high risk adult kidney transplant recipients
19 April 2024 - Merck announced that Health Canada has approved a new indication for Prevymis (letermovir) for the prophylaxis ...
Posted by Michael Wonder on 23 Apr 2024
Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments
22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...
Posted by Michael Wonder on 23 Apr 2024
European Commission approves Pfizer’s Emblaveo for patients with multidrug-resistant infections and limited treatment options
22 April 2024 - Emblaveo was reviewed under EMA accelerated assessment procedure, used when a pharmaceutical product is of major ...
Posted by Michael Wonder on 22 Apr 2024
Kura Oncology receives breakthrough therapy designation for ziftomenib in NPM1 mutant AML
22 April 2024 - Ziftomenib is the first investigational treatment to be granted breakthrough therapy designation for NPM1 mutant AML. ...
Posted by Michael Wonder on 22 Apr 2024
FDA approves nogapendekin alfa inbakicept-pmln for BCG unresponsive non-muscle invasive bladder cancer
22 April 2024 - Today, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience) with Bacillus Calmette-Guérin (BCG) for adult ...
Posted by Michael Wonder on 22 Apr 2024
EMA publishes agenda for 22-25 April 2024 CHMP meeting
22 April 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Apr 2024
Alvotech signs US agreement to expand access for newly approved high concentration interchangeable biosimilar to Humira (adalimumab)
19 April 2024 - Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to ...
Posted by Michael Wonder on 22 Apr 2024
Sandoz confirms European Commission approval of Pyzchiva (ustekinumab), further strengthening immunology offering
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...