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 13 Apr 2023
‘A global outlier’: how drug firms are fighting back against UK tax increases
13 April 2023 - With the UK tax on net sales of branded medicines quadrupling over the past three years, medicine ...
Posted by Michael Wonder on 13 Apr 2023
How ‘surrogate outcomes’ influence long-term health outcomes
13 April 2023 - NICE working with international organisations to develop guidance. ...
Posted by Michael Wonder on 13 Apr 2023
Regulatory, health technology assessment and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement
11 April 2023 - The aims of this study were to review the current interactions within and across regulatory and HTA ...
Posted by Michael Wonder on 13 Apr 2023
U.S. FDA issues complete response letter for mirikizumab
13 April 2023 - Eli Lilly announced the US FDA has issued a complete response letter for the mirikizumab biologic license ...
Posted by Michael Wonder on 13 Apr 2023
ICER publishes evidence report on treatments for non-alcoholic steatohepatitis
13 April 2023 - Current evidence suggests that resmetirom would achieve common thresholds for cost effectiveness if priced between $39,600–$50,100 per ...
Posted by Michael Wonder on 13 Apr 2023
FDA accepts application for Merck’s Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
13 April 2023 - Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit ...
Posted by Michael Wonder on 13 Apr 2023
Blocking FDA approval of abortion pill could stifle innovation in the biopharma industry, experts say
13 April 2023 - If courts affirm US District Judge Matthew Kacsmaryk’s decision to suspend the FDA’s approval, it could make ...
Posted by Michael Wonder on 13 Apr 2023
Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years
10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...
Posted by Michael Wonder on 12 Apr 2023
ASCO policy statement on biosimilar and interchangeable products in oncology
12 April 2023 - Given the current market dynamics and the regulatory landscape, this ASCO manuscript now seeks to propose several ...
Posted by Michael Wonder on 12 Apr 2023
HTA barriers for conditional approval drugs
12 April 2023 - The objective of this study is to assess whether conditionally approved drugs face higher probabilities of HTA ...
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 ...