Blog
RSS FeedPosted by Michael Wonder on 21 Jan 2020
The biosimilar solution to expensive cancer care
20 January 2020 - In a recent column in Evidence-Based Oncology, Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer ...
Posted by Michael Wonder on 21 Jan 2020
Will the FDA give the go-ahead to a prescription video game? The wait goes on, as new data come in.
21 January 2020 - In mid 2018, the startup Akili Interactive Labs asked the Food and Drug Administration to let ...
Posted by Michael Wonder on 20 Jan 2020
FDA delays decision on Intercept's NASH drug by three months
20 January 2020 - Action date pushed back to 26 June. ...
Posted by Michael Wonder on 20 Jan 2020
Lynparza regulatory submission granted priority review in the US for HRR-mutated metastatic castration-resistant prostate cancer
20 January 2020 - Submission based on PROfound, the first positive Phase III trial testing a targeted treatment in biomarker-selected ...
Posted by Michael Wonder on 20 Jan 2020
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study
17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...
Posted by Michael Wonder on 19 Jan 2020
FDA harnesses technology and collaboration to support rare disease product development
17 January 2020 - Announcing an orphan drug technology modernisation effort and the 2020 FDA Rare Disease Day meeting. ...
Posted by Michael Wonder on 17 Jan 2020
BioMarin explores pricing experimental gene therapy at $2 million to $3 million
16 January 2020 - Valrox would be first gene therapy approved in U.S. for inherited type of haemophilia. ...
Posted by Michael Wonder on 17 Jan 2020
Fortress Biotech announces rare paediatric disease designation for CUTX-101 for the treatment of Menkes disease
16 January 2020 - Cyprium Therapeutics, a Fortress partner company, on track to begin submitting rolling new drug application for CUTX-101 ...
Posted by Michael Wonder on 17 Jan 2020
Ozempic approved in the US for CV risk reduction in people with type 2 diabetes and established CVD
16 January 2020 - Rybelsus label updated with additional information from the PIONEER 6 CV outcomes trial. ...
Posted by Michael Wonder on 16 Jan 2020
FDA grants fast track designation to Arena Pharmaceuticals' APD418 for development in decompensated heart failure patients
16 January 2020 - Arena Pharmaceuticals today announced that the U.S. FDA granted fast track designation for APD418, a β3-adrenergic ...
Posted by Michael Wonder on 16 Jan 2020
TG Therapeutics initiates rolling submission of new drug application to U.S. FDA for umbralisib as a treatment for patients with previously treated marginal zone lymphoma or follicular lymphoma
16 January 2020 - Completion of rolling submission for the MZL/FL NDA expected in 1H20. ...
Posted by Michael Wonder on 16 Jan 2020
Nektar issues statement regarding FDA Advisory Committee vote for oxycodegol
15 January 2020 - Nektar Therapeutics issued a statement today following a meeting of the FDA's Anesthetic and Analgesic Drug ...
Posted by Michael Wonder on 16 Jan 2020
U.S. targets drug pricing, no-poach deals for anti-trust action in 2020
15 January 2020 - Justice Department antitrust chief also promises decision on music licensing, criticizes states’ lawsuit against T-Mobile and Sprint. ...
Posted by Michael Wonder on 16 Jan 2020
Novavax granted fast track designation for NanoFlu in older adults
15 January 2020 - Novavax today announced that the U.S. FDA has granted fast track designation for NanoFlu, its recombinant quadrivalent ...
Posted by Michael Wonder on 15 Jan 2020
Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer
15 January 2020 - FDA has assigned PDUFA date of 15 May 2020. ...