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 12 Apr 2023
Kala Pharmaceuticals receives FDA fast track designation for KPI-012, a human MSC-S therapy for persistent corneal epithelial defect
12 April 2023 - Kala Pharmaceuticals today announced that the US FDA has granted fast track designation for Kala’s human mesenchymal ...
Posted by Michael Wonder on 12 Apr 2023
ICER releases draft evidence report on gene therapies for sickle cell disease
12 April 2023 - Public comment period now open until 9 May 2023; Requests to make oral comment during public ...
Posted by Michael Wonder on 12 Apr 2023
Takeda receives FDA approval to expand the use of Hyqvia to treat primary immunodeficiency in children
11 April 2023 - Approval supported by pivotal Phase 3 study that demonstrated reliable infection protection in children 2-16 years pld. ...
Posted by Michael Wonder on 12 Apr 2023
TLV has decided on an increase in ceiling prices
12 April 2023 - TLV has decided to increase ceiling prices in certain package size groups. The decision to raise ceiling ...
Posted by Michael Wonder on 12 Apr 2023
HTA reform starts today – consultations open
11 April 2023 - Medicines Australia welcomes the official start of the Health Technology Assessment (HTA) Review consultation that should ...
Posted by Michael Wonder on 12 Apr 2023
Reach Neuro receives FDA breakthrough device designation for device to restore arm and hand movement to chronic stroke patients
10 April 2023 - Reach Neuro's Avantis device delivers small electrical impulses to the spinal cord to help stroke survivors ...
Posted by Michael Wonder on 11 Apr 2023
ICER publishes 2023 research protocol for assessing unsupported price increases on prescription drugs
11 April 2023 - Annual unsupported price increase report to be published on December 12. ...
Posted by Michael Wonder on 11 Apr 2023
Cancer drug shortages are creating dire circumstances for some patients
11 April 2023 - Robert Landfair, 76, was diagnosed with Stage 4 prostate cancer in 2018. ...
Posted by Michael Wonder on 11 Apr 2023
Abortion ruling could undermine the FDA’s drug approval authority
10 April 2023 - Legal scholars say the ruling by a Texas judge, if upheld, could spur disputes over many medications ...
Posted by Michael Wonder on 11 Apr 2023
How big pharma games the system — and keeps drugs prices high
11 April 2023 - Layers of market protections and courtroom tricks keep competitors off the market far longer than rules intended, ...
Posted by Michael Wonder on 11 Apr 2023
PHARMAC funds second treatment for spinal muscular atrophy
11 April 2023 - PHARMAC has announced the funding of risdiplam (Evrysdi) for people with the rare genetic disorder spinal muscular ...
Posted by Michael Wonder on 11 Apr 2023
RegenxBio receives FDA fast track designation for RGX-202, a novel gene therapy candidate for the treatment of Duchenne muscular dystrophy
11 April 2023 - RGX-202 is a potential one-time AAV therapeutic for the treatment of Duchenne and includes an optimised transgene ...
Posted by Michael Wonder on 11 Apr 2023
Health technology assessment policy and methods review consultation
11 April 2023 - The first round of public consultation for the HTA Review is open. Submissions will be accepted ...
Posted by Michael Wonder on 11 Apr 2023
New life saving medicines
11 April 2023 - The Australian Government has added the two medicines, Kanuma (sebelipase alfa) and Cerdelga (eliglustat) to the Life ...
Posted by Michael Wonder on 10 Apr 2023
Health care regulators’ outdated thinking will cost American ives
10 April 2023 - In a matter of months, ChatGPT has radically altered our nation’s views on artificial intelligence—uprooting old ...