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 09 Sep 2021
Controversy over using quality adjusted life years in cost effectiveness analyses: a systematic literature review
8 September 2021 - Researchers and policy makers in the US are exploring the implementation of health technology assessment and value ...
Posted by Michael Wonder on 09 Sep 2021
Albireo receives UK MHRA approval of Bylvay (odevixibat)
8 September 2021 - Bylvay now approved in U.S., EU and UK as first drug treatment for patients with progressive familial intrahepatic ...
Posted by Michael Wonder on 09 Sep 2021
COVID-19 vaccine weekly safety report (9 September 2021)
9 September 2021 - To 5 September 2021, approximately 21 million vaccine doses have been given in Australia – 13.1 million ...
Posted by Michael Wonder on 09 Sep 2021
Albireo sells priority review voucher for $105 million
7 September 2021 - PRV was granted to Albireo with the FDA approval of Bylvay (odevixibat) in July. ...
Posted by Michael Wonder on 09 Sep 2021
Consumers to have more say on medicine access issues
7 September 2021 - Consumer involvement in Australia’s medicines choices has been further strengthened under a new strategic agreement Medicines ...
Posted by Michael Wonder on 09 Sep 2021
MSD Australia endorses new medicines strategic agreement
8 September 2021 - MSD Australia has today welcomed the signing of a new Medicines Strategic Agreement between Medicines Australia ...
Posted by Michael Wonder on 08 Sep 2021
Withdrawals from pharmaceutical benefits on 1 October 2021
8 September 2021 - Suboxone is among the medicines that will be withdrawn from the drug benefits at the companies' ...
Posted by Michael Wonder on 08 Sep 2021
Nivolumab scores a rare 'no' from NICE
8 September 2021 - Nivolumab scores only its second final rejection to date from NICE. ...
Posted by Michael Wonder on 08 Sep 2021
Ultragenyx Canada announces Health Canada approval of a second indication for Crysvita (burosumab injection) for the treatment of tumour induced osteomalacia in adults
7 September 2021 - Ultragenyx Pharmaceutical today announced that Crysvita (burosumab Injection) has been approved by Health Canada for the treatment ...
Posted by Michael Wonder on 08 Sep 2021
Intelivation Technologies received FDA approval for the Advantage-C PEEK cervical interbody fusion device
8 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Advantage-C PEEK cervical ...
Posted by Michael Wonder on 08 Sep 2021
Phathom Pharmaceuticals submits two NDAs to U.S. FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection
8 September 2021 - Phathom Pharmaceuticals announced today that it has submitted two new drug applications to the U.S. FDA for ...
Posted by Michael Wonder on 08 Sep 2021
FDA grants Madorra breakthrough device designation status for treatment of moderate to severe vulvovaginal atrophy
8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...
Posted by Michael Wonder on 08 Sep 2021
HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU
8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...
Posted by Michael Wonder on 08 Sep 2021
Congress is ready to dig into drug prices
7 September 2021 - After months of drama and procedural votes, Congress is about to dive into the legislative process on ...
Posted by Michael Wonder on 08 Sep 2021
NICE draft guidance recommends apalutamide for treating prostate cancer
8 September 2021 - NICE has today published final draft guidance which now recommends apalutamide (Erleada; Janssen) plus androgen deprivation therapy ...