Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 28 Apr 2025
Jazz Pharmaceuticals receives CHMP positive opinion for zanidatamab for the treatment of advanced HER2 positive biliary tract cancer
25 April 2025 - Jazz Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 28 Apr 2025
Come to grips’: fighting lymphoma from home
28 April 2025 - Australian patients with the most common form of lymphoma will for the first time have access ...
Posted by Michael Wonder on 28 Apr 2025
New treatment against Duchenne muscular dystrophy
25 April 2025 - Duvyzat can be used in a wide patient population from the age of six. ...
Posted by Michael Wonder on 28 Apr 2025
First treatment against severe thyroid eye disease
25 April 2025 - Tepezza significantly improves symptoms for patients with moderate to severe thyroid eye disease ...
Posted by Michael Wonder on 28 Apr 2025
New position statement aims to guide the use of AI methods in health technology assessment
25 April 2025 - Canada’s Drug Agency has published a new position statement on the use of artificial intelligence methods ...
Posted by Michael Wonder on 27 Apr 2025
Ketamine nasal spray to become cheaper for Australians with treatment-resistant depression
28 April 2025 - A nasal spray that uses a form of ketamine to treat stubborn depression will be added ...
Posted by Michael Wonder on 27 Apr 2025
Dupilumab for the treatment of patients with moderate to severe chronic obstructive pulmonary disease
24 April 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 27 Apr 2025
Public Summary Documents (first time decisions not to recommend and deferrals) – December 2024 PBAC meeting
24 April 2025 - The Public Summary Documents (first-time decisions not to recommend and deferrals) from the December 2024 PBAC meeting ...
Posted by Michael Wonder on 27 Apr 2025
Recommendations made by the PBAC – March 2025
24 April 2025 - Recommendations made by the PBAC in March 2025 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 27 Apr 2025
MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone
23 April 2025 - The MHRA) has today approved omaveloxolone (Skyclarys), the first treatment for patients aged 16 and over, in ...
Posted by Michael Wonder on 27 Apr 2025
The role and value of real-world evidence in health technology decision-making in France, Germany, Italy, Spain, and the UK: insights on external control arms
22 April 2025 - Real-world evidence is increasingly used and accepted by health technology assessment (HTA) bodies as supportive evidence ...
Posted by Michael Wonder on 27 Apr 2025
AbbVie submits biologics license application to US FDA for trenibotulinumtoxinE (TrenibotE) for the treatment of glabellar lines
24 April 2025 - Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program. ...
Posted by Michael Wonder on 27 Apr 2025
Acoramidis approved to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy
25 April 2025 - The MHRA has approved the medicine acoramidis (Beyonttra) to treat adult patients with cardiomyopathy caused by ...
Posted by Michael Wonder on 27 Apr 2025
Tremfya (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
25 April 2025 - Johnson & Johnson today announced that the European Commission has approved a Marketing Authorisation for Tremfya (guselkumab) ...
Posted by Michael Wonder on 26 Apr 2025
CHMP recommends approval of Oczyesa for treatment of acromegaly in the EU
25 April 2025 - Camurus today announced that the EMA's CHMP has adopted a positive opinion for market authorisation of Oczyesa, ...