Blog
RSS FeedPosted by Michael Wonder on 22 Aug 2021
Accelerated approval - an unexpected pathway to value-based pricing?
18 August 2021 - Accelerated approval is an important regulatory pathway that provides early access to treatments for patients with serious ...
Posted by Michael Wonder on 22 Aug 2021
TGA approves new COVID-19 treatment for use in Australia
20 August 2021 - Australians with COVID-19 who are at risk of hospitalisation will now have access to an additional antibody ...
Posted by Michael Wonder on 21 Aug 2021
Competition, consolidation and evolution in the pharmacy market
12 August 2021 - Implications for efforts to contain drug prices and spending. ...
Posted by Michael Wonder on 20 Aug 2021
FDA approves nivolumab for adjuvant treatment of urothelial carcinoma
20 August 2021 - On 19 August 2021, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the adjuvant treatment of ...
Posted by Michael Wonder on 20 Aug 2021
Bristol Myers Squibb receives European Commission approval for Abecma (idecabtagene vicleucel), the first anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma
19 August 2021 - Abecma represents the only cell therapy approved for multiple myeloma. ...
Posted by Michael Wonder on 20 Aug 2021
Acting FDA Chief Janet Woodcock ruled out as Biden nominee
19 August 2021 - Woodcock faced backlash over controversial Alzheimer’s drug. ...
Posted by Michael Wonder on 20 Aug 2021
TGA provisionally approves GlaxoSmithKline's COVID-19 treatment sotrovimab (Xevudy)
20 August 2021 - Today, the Therapeutic Goods Administration granted provisional approval to GSK for its COVID-19 treatment - sotrovimab ...
Posted by Michael Wonder on 20 Aug 2021
Astellas receives European Commission approval for first in class Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
20 August 2021 - Roxadustat is the first orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor available for adult patients with anaemia ...
Posted by Michael Wonder on 19 Aug 2021
Booster shots ‘make a mockery of vaccine equity,’ the WHO’s Africa director says
19 August 2021 - The Africa director at the World Health Organization, Dr. Matshidiso Moeti, criticized the decisions by some ...
Posted by Michael Wonder on 19 Aug 2021
Contradicting WHO, US advises adults to receive COVID-19 boosters
19 August 2021 - The Biden administration is advising all American adults to receive a COVID-19 booster shot after accumulating ...
Posted by Michael Wonder on 19 Aug 2021
EMA validates Gilead’s marketing authorisation application for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
19 August 2021 - EMA MAA validation follows submission of NDA for Lenacapavir to the U.S. FDA. ...
Posted by Michael Wonder on 19 Aug 2021
Senhwa's silmitasertib receives US FDA fast track designation for the treatment of recurrent sonic hedgehog driven medulloblastoma
19 August 2021 - Senhwa Biosciences today announced that the US FDA has granted fast track designation for silmitasertib, a highly ...
Posted by Michael Wonder on 19 Aug 2021
Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy
19 August 2021 - Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps determine which solid tumour patients may ...
Posted by Michael Wonder on 19 Aug 2021
TGA approves name change of COVID-19 Vaccine AstraZeneca to Vaxzevria
19 August 2021 - The Therapeutic Goods Administration has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine ...
Posted by Michael Wonder on 19 Aug 2021
BeiGene announces acceptance by Swissmedic of marketing authorisation application for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
18 August 2021 - BeiGene announced that Swissmedic has accepted the marketing authorisation application for Brukinsa, a treatment option for adult ...