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RSS FeedPosted 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 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
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 ...
Posted by Michael Wonder on 20 Nov 2019
Alkermes submits new drug application to U.S. FDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder
19 November 2019 - Alkermes today announced that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 20 Nov 2019
Newron receives FDA rare paediatric disease designation for sarizotan for the treatment of Rett syndrome
19 November 2019 - Newron announced today that the U.S. FDA has granted the rare paediatric disease designation for sarizotan, ...
Posted by Michael Wonder on 20 Nov 2019
Generic drug approvals soar, but patients still go without
19 November 2019 - Brand name makers’ patent action limits release of the lower-price medicines, hindering cost-control efforts. ...
Posted by Michael Wonder on 19 Nov 2019
Orphazyme receives breakthrough therapy designation for arimoclomol in Niemann-Pick disease Type C
19 November 2019 - Orphazyme today announces that the US FDA has granted breakthrough therapy designation for arimoclomol, an investigational drug ...
Posted by Michael Wonder on 19 Nov 2019
FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate
19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...