Blog
RSS FeedPosted by Michael Wonder on 08 Jun 2022
BioCryst announces approval of Orladeyo (berotralstat) by Swissmedic
7 June 2022 - -- BioCryst Pharmaceuticals today announced that Swissmedic has granted marketing authorisation for oral, once-daily Orladeyo (berotralstat) ...
Posted by Michael Wonder on 07 Jun 2022
U.S. probes how pharmacies set drug prices as costs rise
7 June 2022 - The U.S. Federal Trade Commission has opened a probe into how big pharmacy benefit managers like ...
Posted by Michael Wonder on 07 Jun 2022
AARP continues fight for lower prescription drug prices
7 June 2022 - Older Americans shouldn’t have to choose between their medication and rent or groceries. ...
Posted by Michael Wonder on 05 Jun 2022
The FDA’s Pazdur on accelerated approval, single-arm studies and his own future
4 June 2022 - When cancer drugs granted accelerated approval in the U.S. later turn out not to benefit patients, the ...
Posted by Michael Wonder on 02 Jun 2022
Possible resurrection of build back better from the dead: drug price measures could be key component
2 June 2022 - While a large Build Back Better bill was scuttled last winter, a substantially slimmed down version may ...
Posted by Michael Wonder on 01 Jun 2022
Health Canada authorises Vabysmo (faricimab injection) for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular oedema
1 June 2022 - Vabysmo (faricimab injection) is the first bispecific antibody that acts by neutralising both VEGF-A and Ang-2 ...
Posted by Michael Wonder on 01 Jun 2022
VBI Vaccines announces UK MHRA marketing authorisation for PreHevbri, a 3 antigen adult hepatitis B vaccine
1 June 2022 - Approval follows the European Commission’s marketing authorisation, granted in April 2022. ...
Posted by Michael Wonder on 01 Jun 2022
Summary of US FDA chimeric antigen receptor T-cell biologics license application approvals from a statistical perspective
25 May 2022 - The approval of tisagenlecleucel and axicabtagene ciloleucel in 2017 marked a milestone in the development of oncology ...
Posted by Michael Wonder on 01 Jun 2022
FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns
1 June 2022 - Possible increased risk of death outweighs the benefits. ...
Posted by Michael Wonder on 30 May 2022
Why won’t the FDA let doctors prescribe fluvoxamine for COVID?
30 May 2022 - Trials show it keeps patients from getting sicker, but the agency won’t approve its emergency use. ...
Posted by Michael Wonder on 29 May 2022
Perverse incentives - HIV prevention and the 340B drug pricing program
28 May 2022 - A decade after preexposure prophylaxis against HIV became available, less than a quarter of people in the ...
Posted by Michael Wonder on 29 May 2022
Accelerated approval: unfulfilled promises for FDA’s expedited review program
27 May 2022 - As practicing physicians, approval by the U.S. FDA reassures us that the treatments we prescribe our patients ...
Posted by Michael Wonder on 27 May 2022
Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals
27 May 2022 - The Senate is taking pains to avoid another Aduhelm controversy. ...
Posted by Michael Wonder on 27 May 2022
Biden has confidence in the FDA and its commissioner, White House says
27 May 2022 - U.S. President Joe Biden has confidence in the U.S. FDA and its commissioner Robert Califf, White House ...
Posted by Michael Wonder on 26 May 2022
Prescription medicines: applications under evaluation (May 2022)
26 May 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...