Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 10 Mar 2022
Pegcetacoplan for treating paroxysmal nocturnal haemoglobinuria
9 March 2022 - NICE has published evidence based recommendations on the use of pegcetacoplan (Aspaveli) for the treatment of ...
Posted by Michael Wonder on 10 Mar 2022
Filing of humanised anti-CD20 monoclonal antibody Gazyva for additional indication of chronic lymphocytic leukaemia
7 March 2022 - Chugai files for regulatory approval following the results from the Phase 3 ELEVATE-TN trial evaluating Gazyva ...
Posted by Michael Wonder on 10 Mar 2022
When desperate patients go to court for unproven treatments - the battle for hospital independence
9 March 2022 - During the COVID-19 pandemic, patients have asked courts to compel hospitals to administer unproven therapies, including ivermectin. ...
Posted by Michael Wonder on 10 Mar 2022
COVID-19 vaccine weekly safety report (10 March 2022)
10 March 2022 - To 6 March 2022, the TGA has received 460 reports which have been assessed as likely ...
Posted by Michael Wonder on 09 Mar 2022
TGA approves provisional determination for Biocelect for COVID-19 vaccine Nuvaxovid
10 March 2022 - The TGA has granted a second provisional determination to Biocelect (on behalf of Novavax) in relation ...
Posted by Michael Wonder on 09 Mar 2022
Dapagliflozin for treating chronic kidney disease
9 March 2022 - NICE has published evidence based recommendations on dapagliflozin propanediol monohydrate (Forxiga) for adults with chronic kidney ...
Posted by Michael Wonder on 09 Mar 2022
Empagliflozin for treating chronic heart failure with reduced ejection fraction
9 March 2022 - NICE has published evidence based recommendations on the use of empagliflozin (Jardiance) for the treatment of ...
Posted by Michael Wonder on 09 Mar 2022
Time to ask companies why they don’t submit to NICE?
9 March 2022 - Companies can choose whether or not to submit to NICE to have their products appraised. ...
Posted by Michael Wonder on 09 Mar 2022
Insightec receives FDA IDE approval and breakthrough designation for NSCLC brain mets study
9 March 2022 - Designation and approvals mark key milestones in advancing Insightec blood brain barrier clinical roadmap using acoustic ...
Posted by Michael Wonder on 09 Mar 2022
Bayer submits applications in the U.S. and EU for additional indication of Nubeqa (darolutamide)
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New ...
Posted by Michael Wonder on 09 Mar 2022
SMC approval welcome news for breast cancer patients
9 March 2022 - Trodelvy is accepted for use in metastatic triple negative breast cancer. patients who have already received two ...
Posted by Michael Wonder on 09 Mar 2022
NICE unable to provide guidance on a new use of lenalidomide
9 March 2022 - NICE is unable to make a recommendation on the use of lenalidomide for the treatment of patients ...
Posted by Michael Wonder on 09 Mar 2022
More Government regulation of biopharma would harm patients and the economy
8 March 2022 - The United States leads the world in creating the new drugs and vaccines that cure or control ...
Posted by Michael Wonder on 09 Mar 2022
Pūahoaho: clarity around PHARMACs priority lists
9 March 2022 - PHARMAC has released up to date information about its priority lists, including a list of ...
Posted by Michael Wonder on 09 Mar 2022
7 Hills Pharma’s clinical stage novel immunostimulant 7HP349 granted FDA fast track designation for anti-PD-1 resistant metastatic melanoma
8 March 2022 - 7 Hills Pharma announced today that the U.S. FDA has granted fast track designation to 7HP349, 7HP’s ...