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 Sep 2021
Alnylam submits marketing authorisation application to the European Medicines Agency for investigational vutrisiran for the treatment of hereditary ATTR amyloidosis with polyneuropathy
13 September 2021 - If approved, vutrisiran will provide a new, subcutaneously administered, once quarterly treatment option for patients with hATTR ...
Posted by Michael Wonder on 14 Sep 2021
Mirum Pharmaceuticals submits European marketing authorisation application for maralixibat in Alagille syndrome supported by new positive results from natural history study comparison
13 September 2021 - Natural history analysis shows significant improvement in event-free survival and transplant-free survival. ...
Posted by Michael Wonder on 14 Sep 2021
A court decision on “skinny labeling” another challenge for less expensive drugs
13 September 2021 - Brand name drugs, such as apixaban (Eliquis) and lenalidomide (Revlimid), account for approximately 80% of US drug ...
Posted by Michael Wonder on 13 Sep 2021
Reimagining pharmaceutical market exclusivities: should the duration of guaranteed monopoly periods be value based?
13 September 2021 - The amount of time in which brand pharmaceutical markets are protected does not correspond with the products’ ...
Posted by Michael Wonder on 13 Sep 2021
TLV is commissioned to secure access to antibiotics
13 September 2021 - TLV, the Swedish Public Health Agency and the Medical Products Agency have been commissioned by the Government ...
Posted by Michael Wonder on 13 Sep 2021
SMC - September 2021 decisions
13 September 2021 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...
Posted by Michael Wonder on 13 Sep 2021
UK terminates Valneva COVID-19 vaccine supply agreement
13 September 2021 - The UK government has terminated its supply agreement with French firm Valneva for its COVID-19 vaccine ...
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 ...