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 30 Jun 2022
Update to continued dispensing arrangements
30 June 2022 - From 1 July 2022, on-going continued dispensing arrangements have been expanded to include additional medicines groups to ...
Posted by Michael Wonder on 30 Jun 2022
Review into COVID-19 vaccine and treatment purchases
30 June 2022 - The Australian Government is undertaking an independent review of Australia’s vaccine and treatment procurements, led by former ...
Posted by Michael Wonder on 30 Jun 2022
From FDA to MHRA: are drug regulators for hire?
29.June 2022 - Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit ...
Posted by Michael Wonder on 30 Jun 2022
Zanubrutinib for the treatment of adults with Waldenström’s macroglobulinaemia
29 June 2022 - NICE has published a second appraisal consultation document on the use of zanubrutinib for the treatment ...
Posted by Michael Wonder on 30 Jun 2022
Akeso's cadonilimab (PD-1/CTLA-4), the first dual immune checkpoint inhibitor to treat cancer, approved for marketing in China
29 June 2022 - Globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing. ...
Posted by Michael Wonder on 30 Jun 2022
Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 6 months up to 5 years
30 June 2022 - On 28 June 2022, the TGA granted a provisional determination to Pfizer Australia in relation to ...
Posted by Michael Wonder on 29 Jun 2022
Patient focused drug development: selecting, developing, or modifying fit for purpose clinical outcome assessments
29 June 2022 - This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) ...
Posted by Michael Wonder on 29 Jun 2022
Clinical benefit and expedited approval of cancer drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
22 June 2022 - Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in ...
Posted by Michael Wonder on 29 Jun 2022
Sanofi caps out of pocket insulin cost at $35 for uninsured U.S. patients
29 June 2022 - French drug maker Sanofi said on Wednesday uninsured diabetes patients in the United States will pay ...
Posted by Michael Wonder on 29 Jun 2022
Breaking the rule of drug pricing In America
29 June 2022 - Having worked in healthcare most of my life, very little surprises me. But four years ago, ...
Posted by Michael Wonder on 29 Jun 2022
Reimbursement price of GERD drug Fexclu finalised at $0.73
29 June 2022 - The Ministry of Health and Welfare’s health insurance policy committee set the reimbursement price of Fexclu ...
Posted by Michael Wonder on 29 Jun 2022
Accuretic supply issue, almost 36,000 New Zealanders taking the blood pressure medicine will need to change treatments
30 June 2022 - PHARMAC has updated health care professionals that supply of quinapril with hydrochlorothiazide (branded as Accuretic), from supplier ...
Posted by Michael Wonder on 29 Jun 2022
Janssen announces U.S. FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma
29 June 2022 - Novel GPRC5DxCD3 bispecific antibody receives breakthrough therapy designation based upon results from the Phase 1/2 MonumenTAL-1 study. ...
Posted by Michael Wonder on 29 Jun 2022
Bavarian Nordic announces grant of PRIME eligibility from the EMA for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults
28 June 2022 - Bavarian Nordic announced today that the EMA has granted access to its priority medicines (PRIME) scheme for ...
Posted by Michael Wonder on 29 Jun 2022
ObsEva announces UK MHRA marketing authorisation for Yselty (linzagolix), an oral GnRH antagonist, for the treatment of uterine fibroids
28 June 2022 - Theramex to commercialise Yselty; ObsEva to receive royalties on commercial sales, as well as development, commercial, and ...