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RSS FeedPosted by Michael Wonder on 03 Nov 2020
The FDA's cutoff for COVID-19 vaccine effectiveness is 50 percent. What does that mean?
3 November 2020 - Over the summer, the FDA announced that in order for an experimental COVID-19 vaccine to get ...
Posted by Michael Wonder on 03 Nov 2020
Food and Drug Administration accepts BioMarin's new drug application for vosoritide to treat children with achondroplasia
2 November 2020 - If approved, first therapy in U.S. for the treatment of achondroplasia. ...
Posted by Michael Wonder on 03 Nov 2020
Gilead faces pressure to relinquish valuable FDA voucher awarded with remdesivir approval
2 November 2020 - A prominent advocacy group is asking Gilead Sciences to relinquish a valuable voucher that came with ...
Posted by Michael Wonder on 03 Nov 2020
Provention Bio completes rolling submission of the biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
2 November 2020 - Submission of chemistry, manufacturing and controls and administrative information modules represent completion of the Company's submission for ...
Posted by Michael Wonder on 02 Nov 2020
Janssen submits paliperidone palmitate 6 month supplemental new drug application to U.S. FDA for treatment of schizophrenia in adults
2 November 2020 - If approved, paliperidone palmitate 6 month will be the first and only long-acting injectable schizophrenia treatment with a ...
Posted by Michael Wonder on 02 Nov 2020
Takeda price hikes for a GI drug may give some patients another kind of stomachache
2 November 2020 - Two weeks ago, Takeda Pharmaceuticals raised the list price of its Entyvio treatment for ulcerative colitis ...
Posted by Michael Wonder on 01 Nov 2020
FDA approves Bronchitol for US market
2 November 2020 - Pharmaxis to manufacture product and export to USA. ...
Posted by Michael Wonder on 01 Nov 2020
The FDA’s Digital Health Center Of Excellence: why it matters and what it means to you
29 October 2020 - Last month, the US FDA launched the Digital Health Center of Excellence, bolstering the shift toward digital ...
Posted by Michael Wonder on 01 Nov 2020
A CDER study of factors that may predict the likelihood of generic drug marketing applications
28 October 2020 - The investigators compiled proprietary data related to abbreviated new drug applications and other internal or public ...
Posted by Michael Wonder on 31 Oct 2020
Gilead’s COVID-19 drug is mediocre. It will be a blockbuster anyway.
29 October 2020 - Gilead Sciences said Wednesday that remdesivir, which has been authorised for emergency use since the spring, brought ...
Posted by Michael Wonder on 31 Oct 2020
Social media disinformation campaigns tied to vaccine hesitancy
29 October 2020 - Social media disinformation campaigns designed to cast doubt on the safety and effectiveness of vaccines are contributing ...
Posted by Michael Wonder on 30 Oct 2020
How will a COVID vaccine be distributed once it's approved by FDA?
29 October 2020 - Distributing the first wave of doses will be a massive undertaking. ...
Posted by Michael Wonder on 29 Oct 2020
The FDA will not inspect vaccine production plants
29 October 2020 - Approval of a vaccine by the FDA typically requires inspection of the vaccine’s manufacturing plants. ...
Posted by Michael Wonder on 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
29 October 2020 - The new FDA approval allows the test to be used as a companion diagnostic for a broad ...
Posted by Michael Wonder on 29 Oct 2020
FDA accepts for priority review Libtayo (cemiplimab-rwlc) for advanced non-small cell lung cancer with PD-L1 expression of ≥50%
29 October 2020 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the supplemental biologics license ...