Blog
RSS FeedPosted by Michael Wonder on 22 Nov 2019
FDA grants breakthrough therapy designation to Usona Institute's psilocybin program for major depressive disorder
22 November 2019 - Usona Institute has received breakthrough therapy designation from the US FDA for psilocybin in the treatment ...
Posted by Michael Wonder on 22 Nov 2019
Biogen’s top scientist nearly dares FDA not to approve Alzheimer’s drug
22 November 2019 - Biogen’s top scientist offered unflinching support Thursday for the efficacy of the company’s controversial Alzheimer’s drug ...
Posted by Michael Wonder on 22 Nov 2019
Speaker Pelosi’s drug pricing plan could result in 56 fewer new medicines over 10 years
21 November 2019 - International reference pricing provisions in plan would decimate development of innovative medicines by nearly 90%. ...
Posted by Michael Wonder on 22 Nov 2019
Aerie Pharmaceuticals receives European Commission approval for Rhokiinsa (netarsudil 0.02% ophthalmic solution)
21 November 2019 - Aerie Pharmaceuticals today announced the European Commission has granted a marketing authorisation for Rhokiinsa (netarsudil 0.02% ophthalmic ...
Posted by Michael Wonder on 22 Nov 2019
BioMarin submits marketing authorisation application to EMA for valoctocogene roxaparvovec to treat severe haemophilia A
21 November 2019 - First marketing application submission for gene therapy directed at any type of haemophilia. ...
Posted by Michael Wonder on 22 Nov 2019
Health Canada approves Lonsurf (trifluridine/tipiracil) for adults with metastatic gastric cancer during stomach cancer awareness month
21 November 2019 - New indication improves overall survival for end stage metastatic disease ...
Posted by Michael Wonder on 21 Nov 2019
The challenges of sharing data in an era of politicised science
21 November 2019 - The goal of making science more transparent—sharing data, posting results on trial registries, use of preprint servers, ...
Posted by Michael Wonder on 21 Nov 2019
Kiniksa announces breakthrough therapy designation for rilonacept for the treatment of recurrent pericarditis
20 November 2019 - Kiniksa Pharmaceuticals today announced that the U.S. FDA granted breakthrough therapy designation for rilonacept for the ...
Posted by Michael Wonder on 21 Nov 2019
FDA approves new treatment for adults with partial-onset seizures
21 November 2019 - The U.S. Food and Drug Administration today approved Xcopri (cenobamate tablets) to treat partial-onset seizures in adults. ...
Posted by Michael Wonder on 21 Nov 2019
MC2 Therapeutics announces FDA acceptance of its new drug application for Wynzora cream for treatment of plaque psoriasis
20 November 2019 - MC2 Therapeutics today announced that the U.S. FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 21 Nov 2019
Drug for ultra rare disease comes with ultra high price tag
21 November 2019 - Givlaari’s net price will be $442,000 after discounts included. ...
Posted by Michael Wonder on 21 Nov 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia
21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...
Posted by Michael Wonder on 21 Nov 2019
Paion announces submission of the marketing authorisation application for remimazolam in procedural sedation to the European Medicines Agency
20 November 2019 - The Specialty Pharma Company Paoin today announces that a marketing authorisation application for remimazolam, Paion’s ultra-short-acting ...
Posted by Michael Wonder on 21 Nov 2019
Doctors who helped develop heart drug now balk at $225,000/year price
19 November 2019 - Wearing a revolutionary-era tricorn hat, doctor Mathew Maurer stood at a lectern in front of an ...
Posted by Michael Wonder on 20 Nov 2019
FDA approves first treatment for inherited rare disease
20 November 2019 - Today, the U.S. FDA granted approval to Givlaari (givosiran) for the treatment of adult patients with acute ...