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 16 Jan 2021
NICE’s approach to measuring value
5 January 2021 - Appleby asks whether COVID-19 vaccines would be considered cost effective using the NICE approach to measuring ...
Posted by Michael Wonder on 16 Jan 2021
FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis
15 January 2021 - Today, the FDA granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination ...
Posted by Michael Wonder on 16 Jan 2021
FDA approves fam-trastuzumab deruxtecan-nxki for HER2 positive gastric adenocarcinomas
15 January 2021 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or ...
Posted by Michael Wonder on 15 Jan 2021
FDA grants fast track designation to padeliporfin ImPACT for Steba biotech
15 January 2021 - Ambitious development program for multiple solid tumours with high unmet need, starting with low grade upper tract ...
Posted by Michael Wonder on 15 Jan 2021
Regulation of software based medical devices
15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device. ...
Posted by Michael Wonder on 15 Jan 2021
NICE backs GSK’s Zejula in advanced ovarian cancer
15 January 2021 - The UK’s NICE has recommended the use of GlaxoSmithKline’s Zejula (niraparib) on the NHS for women ...
Posted by Michael Wonder on 15 Jan 2021
China National Medical Products Administration approves tislelizumab in combination with chemotherapy in first-line advanced squamous non-small cell lung cancer
13 January 2021 - BeiGene today announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products ...
Posted by Michael Wonder on 15 Jan 2021
Pfizer's Xalkori (crizotinib) approved by FDA for ALK positive anaplastic large cell lymphoma in children and young adults
14 January 2021 - Xalkori is the first biomarker driven therapy for relapsed or refractory ALCL in young people. ...
Posted by Michael Wonder on 15 Jan 2021
Imfinzi approved in the EU for less frequent, fixed dose use in unresectable non-small cell lung cancer
15 January 2021 - New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 15 Jan 2021
Funding of pharmaceutical innovation during and after the COVID-19 pandemic
14 January 2021 - The COVID-19 pandemic has highlighted the available mechanisms for funding research, development, manufacturing, and distribution in the ...
Posted by Michael Wonder on 14 Jan 2021
Inhibrx granted fast track designation for INBRX-109 for the treatment of unresectable or metastatic conventional chondrosarcoma patients
13 January 2020 - Registration enabling study expected to begin dosing in the second or third quarter of this year. ...
Posted by Michael Wonder on 14 Jan 2021
The era of bipartisan work on lowering drug prices might be over
14 January 2021 - Dare we say it: The window for bipartisan work on drug pricing reform may be closed. ...
Posted by Michael Wonder on 14 Jan 2021
COVID-19: NZ vaccine timeline remains the same in light of new variant strains
13 January 2021 - New Zealand does not have any plans to fast-track its Covid-19 vaccine roll-out in light of ...
Posted by Michael Wonder on 14 Jan 2021
Johnson & Johnson could apply for EMA approval in February
14 January 2021 - US pharmaceutical company Johnson & Johnson may submit an official application for approval of its COVID-19 ...
Posted by Michael Wonder on 14 Jan 2021
Oxford vaccine chief says Australia can't afford to delay the jab's rollout
14 January 2021 - A key scientist behind the Oxford coronavirus vaccine has warned against pausing the planned rollout in ...