Blog
RSS FeedPosted by Michael Wonder on 15 Sep 2020
Gilead’s magrolimab, an investigational anti-CD47 monoclonal antibody, receives FDA breakthrough therapy designation for treatment of myelodysplastic syndrome
15 September 2020 - On-going clinical program includes the Phase 3 ENHANCE trial in myelodysplastic syndrome. ...
Posted by Michael Wonder on 15 Sep 2020
FDA publishes comparative performance data for COVID-19 molecular diagnostic tests
15 September 2020 - Today, the U.S. FDA published comparative performance data for some authorised COVID-19 molecular diagnostic tests. ...
Posted by Michael Wonder on 15 Sep 2020
Estimating risk ratios and risk differences: alternatives to odds ratios
15 September 2020 - The goal of many medical research studies is to estimate the direction and magnitude of the effect ...
Posted by Michael Wonder on 15 Sep 2020
Rep Grothman introduces bill for automatic insulin biosimilar interchangeablity
15 September 2020 - Representative Glenn Grothman, (R-Wisconsin), says interchangeability for insulins makes sense based on the savings potential and safety ...
Posted by Michael Wonder on 15 Sep 2020
NIH 'very concerned' about serious side effect in AstraZeneca coronavirus vaccine trial
15 September 2020 - The FDA is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that ...
Posted by Michael Wonder on 15 Sep 2020
Apellis announces submission of pegcetacoplan marketing applications to FDA and EMA for patients with PNH
15 September 2020 - -- Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the ...
Posted by Michael Wonder on 15 Sep 2020
Plus Therapeutics receives fast track designation from FDA for its novel glioblastoma treatment
15 September 2020 - Plus Therapeutics today announced that the U.S. FDA has granted the Company fast track designation for its ...
Posted by Michael Wonder on 15 Sep 2020
US FDA grants fast track designation to Jardiance (empagliflozin) to improve outcomes following a heart attack
15 September 2020 - This fast track designation for empagliflozin emphasises the urgent need for potential treatments that may improve outcomes ...
Posted by Michael Wonder on 15 Sep 2020
Ziopharm Oncology granted rare paediatric disease designation for controlled IL-12 for the treatment of DIPG
14 September 2020 - -- Ziopharm Oncology today announced that the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 15 Sep 2020
European Medicines Agency approves safety label update for Novartis Beovu
14 September 2020 - Novartis worked with the EMA to update the Beovu (brolucizumab) label to guide physicians in their treatment ...
Posted by Michael Wonder on 15 Sep 2020
Vertex announces European Medicines Agency type II variation marketing authorisation application validation for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in people with one copy of the F508del mutation
14 September 2020 - Vertex Pharmaceuticals today announced the EMA has validated a type II variation marketing authorisation application for ...
Posted by Michael Wonder on 14 Sep 2020
EMA publishes agenda for 14-17 September CHMP meeting
14 September 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 14 Sep 2020
Vaccine makers keep safety details quiet, alarming scientists
13 September 2020 - Researchers say drug companies need to be more open about how vaccine trials are run to reassure ...
Posted by Michael Wonder on 14 Sep 2020
ESSA Pharma announces fast track designation granted by the FDA to EPI-7386 for the treatment of metastatic castration-resistant prostate cancer
14 September 2020 - ESSA Pharma today announced that the US FDA granted fast track designation to EPI-7386, its oral ...
Posted by Michael Wonder on 14 Sep 2020
Sol-Gel Technologies announces FDA acceptance for filing of new drug application for Epsolay for the treatment of inflammatory lesions of rosacea
10 September 2020 - Potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product. ...