Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 28 Jul 2025
MAIA Biotechnology receives FDA’s fast track designation for ateganosine as a treatment for non-small cell lung cancer
28 July 2025 - Potential first to market small molecule telomere targeting agent targets a $34 billion non-small cell lung cancer ...
Posted by Michael Wonder on 28 Jul 2025
Imfinzi granted priority review and breakthrough therapy designation in the US for patients with resectable early-stage gastric and gastro-oesophageal junction cancers
28 July 2025 - Based on MATTERHORN Phase 3 trial results which demonstrated a statistically significant and clinically meaningful event-free survival ...
Posted by Michael Wonder on 28 Jul 2025
Highlights from the 21-24 July 2025 CHMP meeting
25 July 2025 - The EMA’s CHMP recommended 13 medicines for approval at its July 2025 meeting. ...
Posted by Michael Wonder on 28 Jul 2025
Drug giants targeting Australia’s PBS are paying tiny amounts of tax
28 July 2025 - Global pharmaceutical giants, including Pfizer and Johnson & Johnson, are paying a tiny fraction of the ...
Posted by Michael Wonder on 28 Jul 2025
Government continues to make medicines cheaper
28 July 2025 - The Albanese Government is making cheaper medicines even cheaper – with legislation being introduced to Parliament ...
Posted by Michael Wonder on 28 Jul 2025
Dupilumab for the treatment of adults with severe chronic rhinosinusitis with nasal polyps (review of TA648)
23 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 27 Jul 2025
Vertex announces marketing authorisation in Canada for Alyftrek, a once daily next generation CFTR modulator for the treatment of cystic fibrosis
22 July 2025 - Approximately 3,800 people in Canada are now eligible for Alyftrek, with up to 60 people potentially ...
Posted by Michael Wonder on 26 Jul 2025
Sobi announces US FDA approves Doptelet (avatrombopag) for the treatment of thrombocytopenia in paediatric patients one year and older with persistent or chronic immune thrombocytopenia
25 July 2025 - The primary outcome was met in 27.8% of patients, confirming the efficacy in children and adolescents ...
Posted by Michael Wonder on 26 Jul 2025
Pfizer and BioNTech receive positive CHMP opinion for LP.8.1 adapted COVID-19 vaccine in the European Union
25 July 2025 - Data indicate that the LP.8.1-adapted COVID-19 vaccine confers improved immune response against currently dominant and emerging sub-lineages ...
Posted by Michael Wonder on 26 Jul 2025
Gilead receives positive CHMP opinions under accelerated review from EMA for twice yearly lenacapavir for HIV prevention
25 July 2025 - Positive opinion also received for EMA’s EU-M4all Procedure, designed to facilitate availability in low- and lower-middle-income countries. ...
Posted by Michael Wonder on 26 Jul 2025
Roche provides regulatory update on Elevidys gene therapy for Duchenne muscular dystrophy in the EU
25 July 2025 - Roche will continue its dialogue with the EMA to explore a potential path forward to make Elevidys ...
Posted by Michael Wonder on 26 Jul 2025
Australia’s PBS must ‘absolutely’ be protected in trade talks, says Make America Healthy Again medical adviser Aseem Malhotra
26 July 2025 - The chief medical adviser to Make America Healthy Again campaign has defended Australia’s PBS, as the Trump ...
Posted by Michael Wonder on 26 Jul 2025
Shanton receives fast track designation from US FDA for refractory gout program
25 July 2025 - Shanton Pharma today announced that FDA has designated its Investigational new drug SAP-001 as a fast track ...
Posted by Michael Wonder on 26 Jul 2025
Health Canada grants marketing authorisation for Bayer’s Lynkuet (elinzanetant)
25 July 2025 - Authorisation is supported by data from the Phase 3 OASIS clinical trial program evaluating Lynkuet for the ...
Posted by Michael Wonder on 26 Jul 2025
Bayer provides regulatory update on elinzanetant in the US
25 July 2025 - Bayer today announced that the US FDA has notified the company that it has extended the ...