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 24 May 2021
Libtayo (cemiplimab) receives positive CHMP opinion for the treatment in Europe of two advanced cancers
24 May 2021 - CHMP has now issued three positive opinions for Libtayo in advanced cancers. ...
Posted by Michael Wonder on 24 May 2021
Gilead withdraws submission for Jyseleca
24 May 2021 - Decision should not come as a major surprise given FDA rejection last year. ...
Posted by Michael Wonder on 24 May 2021
Positive CHMP opinion for Ryeqo (relugolix combination tablet)
21 May 2021 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 24 May 2021
Bristol Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for treatment of mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer after prior chemotherapy
21 May 2021 - Application based on positive results from the Phase 2 CheckMate-142 trial demonstrating a durable clinical benefit in ...
Posted by Michael Wonder on 24 May 2021
ATAGI/THANZ statement provides further guidance for the AstraZeneca vaccine and narrows contra-indication
23 May 2021 - The Australian Technical Advisory Group on Immunisation and the Thrombosis and Haemostasis Society of Australia and New ...
Posted by Michael Wonder on 23 May 2021
EU regulator backs extending approval for remdesivir for another year
21 May 2021 - The EMA on Friday recommended extending conditional marketing approval by a year for Gilead Sciences’ COVID-19 ...
Posted by Michael Wonder on 23 May 2021
Prescription medicines: applications under evaluation (May 2021 update)
21 May 2021 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 23 May 2021
'I would be able to live into my thirties:' Nova Scotia woman has high hopes for new cancer treatment
21 May 2021 - Maria Stevens was diagnosed with cervical cancer two years ago. Now, with a new treatment on ...
Posted by Michael Wonder on 23 May 2021
Positive CHMP opinion for Bayer’s new symptomatic chronic heart failure treatment vericiguat
21 May 2021 - Vericiguat is being considered for adult patients with reduced ejection fraction who are stabilised after a recent ...
Posted by Michael Wonder on 23 May 2021
First gene therapy to treat children with rare inherited neurological disease
21 May 2021 - The EMA has recommended granting a marketing authorisation in the European Union for the gene therapy ...
Posted by Michael Wonder on 23 May 2021
New treatment for obesity caused by rare genetic disorders
21 May 2021 - EMA has recommended granting a marketing authorisation in the European Union for Imcivree (setmelanotide) to support weight ...
Posted by Michael Wonder on 23 May 2021
Pfizer and BioNTech to supply the European Union with up to 1.8 billion additional doses of Comirnaty
20 May 2021 - New agreement to supply 900 million doses to the European Commission, with option to request up to ...
Posted by Michael Wonder on 23 May 2021
Congress loves a big pharma villain. But will that lead to any real policy changes on drug prices?
21 May 2021 - There's a funny cycle that resurfaces every now and then within the life sciences industry. ...
Posted by Michael Wonder on 23 May 2021
COVID-19 vaccine rollout: Aussies could get COVID-19 jabs by Christmas
23 May 2021 - The federal government has made a major change to the Pfizer rollout, and it could see Australians ...
Posted by Michael Wonder on 22 May 2021
US biotech Novavax could make COVID vaccine onshore in Australia
20 May 2021 - American biotechnology company Novavax has outlined plans to make doses of its coronavirus vaccine in Australia ...