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 Jan 2021
Cognito Therapeutics receives FDA breakthrough device designation for next-generation digital therapeutic in Alzheimer’s disease
12 January 2021 - Breakthrough designation is based on positive outcomes from clinical studies, and will advance the industry’s first next-generation ...
Posted by Michael Wonder on 13 Jan 2021
Leading BioSciences announces FDA fast track designation granted to LB1148 for the treatment of post-operative gastro-intestinal dysfunction associated with paediatric cardiovascular surgery
13 January 2021 - LBS expects to initiate a pivotal trial in 2021. ...
Posted by Michael Wonder on 13 Jan 2021
Innovent announces NMPA acceptance of a supplemental new drug application for Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab injection) as first-line therapy in hepatocellular carcinoma
12 January 2021 - Innovent Biologics today announced that the National Medical Products Administration of China has accepted the supplemental ...
Posted by Michael Wonder on 13 Jan 2021
Government races to secure more vaccines but stares down AstraZeneca critics
13 January 2021 - The Morrison government is seeking new deals to vaccinate millions of Australians by the middle of ...
Posted by Michael Wonder on 13 Jan 2021
Swissmedic authorises COVID-19 Vaccine Moderna for use in Switzerland
12 January 2021 - Swiss Federal Government has secured 7.5 million doses and first deliveries expected to begin in January. ...
Posted by Michael Wonder on 13 Jan 2021
Regeneron announces U.S. Government agreement to purchase additional COVID-19 antibody cocktail doses
12 January 2021 - New agreement covers 1.25 million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential ...
Posted by Michael Wonder on 13 Jan 2021
Chronocort marketing authorisation application submitted to the UK MHRA
12 January 2021 - Independent UK (MHRA) application to run in parallel with ongoing European (EMA) application, following end of Brexit ...
Posted by Michael Wonder on 13 Jan 2021
Health Canada approves Onureg (azacitidine tablets), first maintenance therapy for patients in remission from acute myeloid leukaemia
12 January 2021 - Onureg has shown clinically meaningful increase in overall survival for patients. ...
Posted by Michael Wonder on 13 Jan 2021
MorphoSys and Incyte announce acceptance by Health Canada of the new drug submission for tafasitamab
12 January 2021 - MorphoSys and Incyte today announced that Health Canada has accepted the new drug submission for tafasitamab, an ...
Posted by Michael Wonder on 13 Jan 2021
Health Canada approves Lundbeck's Vyepti (eptinezumab)--the first and only intravenous preventive treatment for migraine
12 January 2021 - Lundbeck is pleased to announce that Vyepti (eptinezumab) has been approved by Health Canada for the preventive ...
Posted by Michael Wonder on 12 Jan 2021
Further insights from the agenda for the 2021/1 PBAC meeting
13 January 2021 - The case for improved clarity and transparency gets stronger. ...
Posted by Michael Wonder on 12 Jan 2021
STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies
12 January 2021 - In alignment with the International Council of Harmonization’s strategic goals, a public private consortium has developed a ...
Posted by Michael Wonder on 12 Jan 2021
Middlemen sue to block a signature Trump drug pricing proposal
12 January 2021 - The Pharmaceutical Care Management Association, which represents drug middlemen in Washington, filed a lawsuit Tuesday to ...
Posted by Michael Wonder on 12 Jan 2021
U.S. FDA accepts for priority review the biologics license application for V114, Merck’s investigational 15 valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older
12 January 2021 - Merck today announced the U.S. FDA accepted for priority review a biologics license application for V114, Merck’s ...
Posted by Michael Wonder on 12 Jan 2021
U.S. FDA grants priority review to new drug application for finerenone to treat patients with chronic kidney disease and type 2 diabetes mellitus
12 January 2021 - Bayer announced today that the U.S. FDA has accepted its new drug application and granted priority review ...