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 08 Nov 2022
Libtayo (cemiplimab-rwlc) in combination with chemotherapy approved by the FDA as first-line treatment for advanced non-small-cell lung cancer
8 November 2022 - Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient ...
Posted by Michael Wonder on 08 Nov 2022
Guard Therapeutics granted FDA fast track designation for RMC-035
8 November 2022 - Guard Therapeutics today announces that the US FDA has granted RMC-035 (ROSgard) fast track designation for reducing ...
Posted by Michael Wonder on 08 Nov 2022
Blue Earth Therapeutics awarded UK MHRA innovation passport for investigational 177Lu-rhPSMA-10.1 for treatment of metastatic castrate-resistant prostate cancer
8 November 2022 - Lutetium LU 177 labeled radiohybrid prostate specific membrane antigen (Lu 177-rhPSMA-10.1) is an optimised therapeutic radiopharmaceutical. ...
Posted by Michael Wonder on 08 Nov 2022
New COVID-19 variant leads to increase in cases
8 November 2022 - A statement from Professor Paul Kelly, Australian Government Chief Medical Officer, on the increase in COVID-19 cases ...
Posted by Michael Wonder on 08 Nov 2022
Immunomic Therapeutics receives FDA fast track designation for ITI-3000, a pDNA vaccine, in development for the treatment of Merkel cell carcinoma
8 November 2022 - Immunomic Therapeutics today announced that the US FDA has granted fast track designation to the ITI-3000 program ...
Posted by Michael Wonder on 08 Nov 2022
Omeros Corporation receives decision from FDA on formal dispute resolution request for narsoplimab
8 November 2022 - Decision denies Omeros’ appeal requesting immediate labeling discussions. ...
Posted by Michael Wonder on 08 Nov 2022
NICE final draft guidance adds further treatment option for triple negative breast cancer
8 November 2022 - NICE has today published final draft guidance which recommends pembrolizumab as an option for people with ...
Posted by Michael Wonder on 08 Nov 2022
BioMarin announces incremental progress on biologics license application review for valoctocogene roxaparvovec AAV gene therapy for adults with severe haemophilia A program
7 November 2022 - FDA requests submission of upcoming 3 year data analysis from Phase 3 GENEr8-1 trial. ...
Posted by Michael Wonder on 07 Nov 2022
Vabysmo (faricimab) receives positive CADTH recommendation for the treatment of diabetic macular oedema in adults
3 November 2022 - This CADTH recommendation is the latest step towards public access to Vabysmo (faricimab) for the estimated 60,000 ...
Posted by Michael Wonder on 07 Nov 2022
Can we use existing guidance to support the development of robust real world evidence for health technology assessment/payer decision-making?
2 November 2022 - Advances in the digitisation of health systems and expedited regulatory approvals of innovative treatments have led to ...
Posted by Michael Wonder on 07 Nov 2022
US Supreme Court to hear Amgen bid to revive cholesterol drug patents
4 November 2022 - The US Supreme Court on Friday agreed to hear Amgen's bid to revive patents on its ...
Posted by Michael Wonder on 07 Nov 2022
New PMPRB guidelines proposed for assessing prices of patented medicines sold in Canada
4 November 2022 - Controversial amendments to the Patented Medicines Regulations changing the basket of comparator countries considered by the ...
Posted by Michael Wonder on 07 Nov 2022
Non-opioid treatment alternatives for pain face clinical development and reimbursement challenges
4 November 2022 - Pain impacts tens of millions of Americans on a daily basis. ...
Posted by Michael Wonder on 07 Nov 2022
MHRA updates biosimilar guidance to allow interchangeability between products
7 November 2022 - The UK’s MHRA has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if ...
Posted by Michael Wonder on 07 Nov 2022
Sensorion announces US FDA grants rare paediatric disease designation to OTOF-GT for the treatment of otoferlin gene-mediated hearing loss
7 November 2022 - OTOF-GT targets the restoration of hearing in people living with otoferlin deficiency. ...