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 14 Oct 2021
Rhythm Pharmaceuticals completes submission of type II variation application to the European Medicines Agency for Imcivree (setmelanotide) for Bardet-Biedl and Alström syndromes
14 October 2021 - Rhythm Pharmaceuticals today announced that it has submitted its type II variation application to the EMA for ...
Posted by Michael Wonder on 14 Oct 2021
Celltrion applies for product approval for Avastin biosimilar in EU
12 October 2021 - Celltrion said that it has completed the approval application procedure for CT-P16, a biosimilar of Avastin ...
Posted by Michael Wonder on 14 Oct 2021
Drug pricing tug of war expected over CAR-T therapy Kymriah
14 October 2021 - The world’s first CAR-T therapy, Kymriah (tisagenlecleucel), passed the review of a panel at the Health ...
Posted by Michael Wonder on 14 Oct 2021
Biden eyeing FDA veteran Robert Califf to lead the agency
14 October 2021 - If nominated and confirmed, Califf would take over an agency poised to make key decisions on coronavirus ...
Posted by Michael Wonder on 14 Oct 2021
FDA accepts Regen-Cov (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
14 October 2021 - European Medicines Agency also announced earlier this week it would review marketing authorisation application for the antibody ...
Posted by Michael Wonder on 14 Oct 2021
EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
14 October 2021 - EMA’s CHMP has started a rolling review of Evusheld (also known as AZD7442), a combination of ...
Posted by Michael Wonder on 14 Oct 2021
Novartis and the pan-Canadian Pharmaceutical Alliance complete negotiations for Zolgensma for the treatment of paediatric patients with spinal muscular atrophy
13 October 2021 - Novartis Pharmaceuticals Canada today announced that it has completed negotiations with the pan-Canadian Pharmaceutical Alliance for a ...
Posted by Michael Wonder on 14 Oct 2021
New Sarclisa (isatuximab) combination now approved by Health Canada for adults with relapsed and/or refractory multiple myeloma
13 October 2021 - The approval is based on data from the Phase 3 IKEMA trial. ...
Posted by Michael Wonder on 14 Oct 2021
Agilent receives FDA companion diagnostic approval for Ki-67 IHC MIB-1 pharmDx in high risk early breast cancer
13 October 2021 - Agilent Technologies today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as ...
Posted by Michael Wonder on 14 Oct 2021
Pharmacists opt out of third shot as doses of vaccine set to expire
14 October 2021 - The rollout of third doses of the COVID-19 vaccine to thousands of immunocompromised people has been ...
Posted by Michael Wonder on 14 Oct 2021
COVID-19 vaccine weekly safety report (14 October 2021)
14 October 2021 - To 10 October 2021, approximately 31 million vaccine doses have been given in Australia – 18 million ...
Posted by Michael Wonder on 13 Oct 2021
Why we can have both innovative drugs and lower drug prices
13 October 2021 - The debate in Congress over negotiating drug prices is based on a phony premise that higher prices ...
Posted by Michael Wonder on 13 Oct 2021
AstraZeneca COVID-19 vaccine will no longer be made in Australia
13 October 2021 - The AstraZeneca COVID-19 vaccine will no longer be manufactured in Australia due to the demand for ...
Posted by Michael Wonder on 13 Oct 2021
FDA approves pembrolizumab combination for the first-line treatment of cervical cancer
13 October 2021 - Today, the FDA approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for ...
Posted by Michael Wonder on 13 Oct 2021
SMC accepts Cabometyx/Opdivo combo for advanced kidney cancer patients
13 October 2021 - The SMC has recommended Cabometyx (cabozantinib) plus Opdivo (nivolumab) for use by via NHS Scotland for ...