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 20 Jan 2021
Enhertu approved in the EU for the treatment of HER2 positive metastatic breast cancer
20 January 2021 - Approval based on the DESTINY-Breast01 Phase 2 trial which showed clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 20 Jan 2021
AstraZeneca COVID-19 vaccine claims ‘not evidence-based’
19 January 2021 - Claims that the AstraZeneca COVID-19 vaccine prevents death “100 per cent of the time” are not ...
Posted by Michael Wonder on 20 Jan 2021
2021 April price disclosure cycle – indicative prices
20 January 2021 - Indicative 1 April 2021 prices resulting from the 2021 April Cycle of Price Disclosure have now been ...
Posted by Michael Wonder on 20 Jan 2021
Amryt’s Myalepta scores NICE backing for rare lipid disorder
20 January 2021 - NICE has recommended Amryt Pharma’s Myalepta (metreleptin) for use within the NHS. ...
Posted by Michael Wonder on 19 Jan 2021
New labelling for antibiotics in Australia
19 January 2021 - The Pharmaceutical Society of Australia is to be applauded for changing the way pharmacists label the antibiotics ...
Posted by Michael Wonder on 19 Jan 2021
Health professionals warn Australia is struggling to deal with post-COVID-19 medication shortage
20 January 2021 - Australians with chronic health conditions are having to take drastic stop-gap measures because of a continuing ...
Posted by Michael Wonder on 19 Jan 2021
COVID-19 coronavirus: Ashley Bloomfield - vaccine approval just a couple of weeks away
20 January 2021 - The approval process for the Covid vaccine is on track to be granted in the coming ...
Posted by Michael Wonder on 19 Jan 2021
Medicines NZ hopes country can roll out COVID-19 vaccines early
19 January 2021 - Medical professionals are hopeful New Zealand is in a position to roll out COVID-19 vaccines early. ...
Posted by Michael Wonder on 19 Jan 2021
Taysha Gene Therapies receives rare paediatric disease and orphan drug designations for TSHA-105 for the treatment of epilepsy caused by SLC13A5 deficiency
19 January 2021 - Designations reinforce unmet need for treatment options for patients with rare form of genetic epilepsy. ...
Posted by Michael Wonder on 19 Jan 2021
Biologics license application for narsoplimab in HSCT-TMA accepted for priority review by U.S. FDA
19 January 2021 - FDA sets PDUFA date of 17 July 2021. ...
Posted by Michael Wonder on 19 Jan 2021
Mark Cuban is going to help big pharma’s image
19 January 2021 - In his terrific book, The Great American Drug Deal, Peter Kolchinsky talks about one of the most ...
Posted by Michael Wonder on 19 Jan 2021
Global regulators highlight key role of health care professionals in fostering confidence in COVID-19 vaccines
19 January 2021 - EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities ...
Posted by Michael Wonder on 19 Jan 2021
Occlutech's atrial flow regulator receives U.S. FDA breakthrough device designation for heart failure
19 January 2021 - Occlutech announced today that the U.S FDA has granted the Company a breakthrough revice designation for its ...
Posted by Michael Wonder on 19 Jan 2021
Metacrine announces FDA fast track designation for MET642 as a treatment of NASH
19 January 2021 - Metacrine today announced that the U.S. FDA has granted fast track designation to MET642, the company’s second ...
Posted by Michael Wonder on 19 Jan 2021
Regulators OK Yuhan's Leclaza as 31st novel drug
18 January 2020 - Yuhan said Monday that it has received sales approval for Leclaza (lazertinib), a drug targeting epidermal ...