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 13 Sep 2021
EMA publishes agenda for 13-16 September CHMP meeting
13 September 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Sep 2021
Joint statement of support for an Australian Patent Box
13 September 2021 - Australia’s health innovators support the introduction of a Patent Box, and we welcome this initiative by the ...
Posted by Michael Wonder on 13 Sep 2021
Medicare Benefits Schedule continuous review to improve patient care
13 September 2021 - Medicare items and services will be reviewed by experts on an on-going basis to ensure the Medicare ...
Posted by Michael Wonder on 13 Sep 2021
BeiGene announces U.S. FDA acceptance of biologics license application for tislelizumab in oesophageal squamous cell carcinoma
13 September 2021 - This marks the first ex-China regulatory filing for tislelizumab, following approval in five indications in China. ...
Posted by Michael Wonder on 13 Sep 2021
Trodelvy approved following heroic efforts of breast cancer sufferer Alison Day
12 September 2021 - A dying woman’s selfless campaign will give Australian women battling a rare aggressive form of breast cancer ...
Posted by Michael Wonder on 13 Sep 2021
1 October 2021 price disclosure confirmed prices
13 September 2021 - Confirmed 1 October 2021 prices resulting from the 2021 October cycle of price disclosure have now been ...
Posted by Michael Wonder on 12 Sep 2021
Biden Administration’s prescription drug pricing plan promotes incremental change, not overhaul of system
12 September 2021 - On Thursday, September 9th, the White House released a long awaited plan to reduce prescription drug ...
Posted by Michael Wonder on 12 Sep 2021
NHS lung cancer patients in England get early access to ‘breakthrough’ cancer drug
10 September 2021 - The MHRA has approved a first-of-its-kind cancer drug – capable of targeting a gene mutation that ...
Posted by Michael Wonder on 11 Sep 2021
MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines
9 September 2021 - The regulatory changes made by the MHRA today give further options for the deployment programme. ...
Posted by Michael Wonder on 11 Sep 2021
Representativeness of participants eligible to be enrolled in clinical trials of aducanumab for Alzheimer disease compared with Medicare beneficiaries with Alzheimer disease and mild cognitive impairment
9 September 2021 - In June 2021, the US FDA granted accelerated approval for aducanumab to treat patients with mild cognitive ...
Posted by Michael Wonder on 11 Sep 2021
Estimated savings from international reference pricing for prescription drugs
10 September 2021 - High prescription drug prices have important implications for health care spending, patient financial burden, and adherence. ...
Posted by Michael Wonder on 10 Sep 2021
MHRA approves Amgen’s Lumykras under Project Orbis
10 September 2021 - Amgen has announced that is first-in-class KRAS G12C inhibitor Lumykras (sotorasib) has been received a conditional ...
Posted by Michael Wonder on 10 Sep 2021
ICER publishes evidence report on treatments for myasthenia gravis
10 September 2021 - While eculizumab and efgartigimod each provide important health benefits, both would need to be priced more than ...
Posted by Michael Wonder on 10 Sep 2021
UK approval for Pfizer’s JAK inhibitor Cibinqo
10 September 2021 - The UK MHRA has approved a marketing authorisation for Pfizer’s oral Janus kinase 1 inhibitor Cibinqo ...
Posted by Michael Wonder on 10 Sep 2021
PBAC Public Summary Documents (first time decisions not to recommend, deferrals and other matters) – May 2021 meeting
10 September 2021 - The Public Summary Documents (first time decisions not to recommend, deferrals and other matters) from the May ...