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 10 Aug 2021
Moderna COVID-19 vaccine gets Swiss approval for 12 to 17 year-olds
9 August 2021 - Swissmedic has approved the Moderna COVID-19 vaccine for 12- to 17-year-olds, the Swiss agency said on ...
Posted by Michael Wonder on 10 Aug 2021
Jason Falinski slams TGA’s slow Moderna Covid vaccine approval
10 August 2021 - The TGA took eight months to approve the Moderna Covid-19 vaccine in Australia despite its use in ...
Posted by Michael Wonder on 09 Aug 2021
Scotland backs Bavencio for bladder cancer after NICE says no
9 August 2021 - Patients with bladder cancer in Scotland will be the first in the UK to claim access ...
Posted by Michael Wonder on 09 Aug 2021
Ophthalmologist group wants U.S. Government to push back against Avastin biosimilars
10 August 2021 - The American Academy of Ophthalmology says biosimilar alternatives to Avastin have never been tested in the ...
Posted by Michael Wonder on 09 Aug 2021
HHS proposes nixing Trump rule tying drug costs to foreign rates
7 August 2021 - Issue previously raised in Trump administration. ...
Posted by Michael Wonder on 09 Aug 2021
SMC - August 2021 decisions
9 August 2021 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 09 Aug 2021
Daré Bioscience announces FDA acceptance and priority review of new drug application for DARE-BV1 for the treatment of bacterial vaginosis
9 August 2021 - New drug application supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure ...
Posted by Michael Wonder on 09 Aug 2021
Skyrizi (risankizumab-rzaa) now available in the U.S. as a single 150 mg injection for adults with moderate to severe plaque psoriasis
9 August 2021 - Skyrizi is now the only four-dose-a-year biologic for psoriasis with options to administer via a single-dose pen ...
Posted by Michael Wonder on 09 Aug 2021
Calliditas receives FDA fast track designation for setanaxib in PBC
9 August 2021 - Calliditas Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead NOX ...
Posted by Michael Wonder on 09 Aug 2021
TGA provisionally approves Moderna’s COVID-19 vaccine
9 August 2021 - Today, the Therapeutic Goods Administration, granted provisional approval to Moderna Australia for its COVID-19 vaccine—Spikevax (elasomeran)—making ...
Posted by Michael Wonder on 09 Aug 2021
Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type 2 diabetes mellitus
9 August 2021 - Approval based on unprecedented DAPA-CKD Phase 3 data is the most significant advancement in chronic kidney ...
Posted by Michael Wonder on 09 Aug 2021
Barriers to US biosimilar market growth: lessons from biosimilar patent litigation
6 August 2021 - High biologic drug prices have placed substantial strain on the US health care system. ...
Posted by Michael Wonder on 09 Aug 2021
Japan drug maker Shionogi to seek approval for oral COVID-19 drug
6 August 2021 - Pharmaceutical firm Shionogi plans to seek state approval for its oral coronavirus drug by the end ...
Posted by Michael Wonder on 09 Aug 2021
Competition from biosimilars drives price reductions for biologics in the French single payer health system
6 August 2021 - France has a single payer health insurance system that has the authority to impose pharmaceutical price reductions ...
Posted by Michael Wonder on 09 Aug 2021
Version 4 and counting
9 August 2021 - The Department of Health has published yet another revised agenda for the November 2021 PBAC meeting. ...