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 29 Jan 2021
Novartis receives positive CHMP opinion for Kesimpta (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis
29 January 2021 - CHMP opinion is based on two Phase 3 ASCLEPIOS trials that met the primary outcomes where Kesimpta ...
Posted by Michael Wonder on 29 Jan 2021
Highlights from 25-29 January 2021 CHMP meeting
29 January 2021 - EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its January 2021 meeting. ...
Posted by Michael Wonder on 29 Jan 2021
EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
29 January 2021 - COVID-19 Vaccine AstraZeneca is now authorised across the EU. This follows the granting of a conditional marketing ...
Posted by Michael Wonder on 29 Jan 2021
Biogen and Eisai announce FDA's 3 month extension of review period for the biologics license application for aducanumab
29 January 2021 - The new Prescription Drug User Fee Act action date set by the FDA is 7 June ...
Posted by Michael Wonder on 29 Jan 2021
First COVID-19 vaccine safety update published
29 January 2021 - Today EMA has released its first safety update on a COVID-19 vaccine — Comirnaty. ...
Posted by Michael Wonder on 29 Jan 2021
Recommendations made by the PBAC - December 2020 Intracycle meeting
29 January 2021 - The recommendations from the December 2020 PBAC meeting are now available. ...
Posted by Michael Wonder on 29 Jan 2021
AstraZeneca vaccine warnings based on maths, not safety
29 January 2021 - The warning from the German health ministry’s vaccine committee that the AstraZeneca jab should not be ...
Posted by Michael Wonder on 28 Jan 2021
ICER publishes evidence report on roxadustat for treating anaemia in chronic kidney disease
28 January 2021 - Other than a proven ability to reduce the need for intravenous iron supplements, the evidence is insufficient ...
Posted by Michael Wonder on 28 Jan 2021
Germany moves to exclude seniors from AstraZeneca’s COVID-19 vaccine
28 January 2021 - Ahead of its expected approval for use by Europe’s medicines regulator Friday, Germany’s vaccine committee has recommended ...
Posted by Michael Wonder on 28 Jan 2021
AstraZeneca, Pfizer hope to meet vaccine supply dates despite ‘fluid’ Europe situation
28 January 2021 - Pfizer and AstraZeneca warn global supply chain issues and the European Union’s plan to add control ...
Posted by Michael Wonder on 28 Jan 2021
Prescription drug rices in the U.S. are 2.56 times higher than other nations – brand-named drugs 3.44 times higher
27 January 2021 - Prescription drug prices in the United States are significantly higher than in other nations, with prices ...
Posted by Michael Wonder on 28 Jan 2021
M6P Therapeutics receives six rare paediatric disease designations from the U.S. FDA for company’s deep pipeline of programs for lysosomal storage disorders
28 January 2021 - U.S. FDA also grants two orphan drug designations for the company’s gene therapy programs for Gaucher disease ...
Posted by Michael Wonder on 28 Jan 2021
Bio-Thera Solutions announces FDA accepts biologics license application for BAT1706, a proposed biosimilar to Avastin
28 January 2021 - Bio-Thera Solutions today announced that the U.S. FDA has accepted its biologics license application for BAT1706, a ...
Posted by Michael Wonder on 28 Jan 2021
Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner
27 January 2021 - As the Biden White House attempts to fashion its health policies, a coalition of consumer and ...
Posted by Michael Wonder on 28 Jan 2021
Clarification of Comirnaty dosage interval
28 January 2021 - EMA’s human medicines committee (CHMP) has updated the product information for the COVID-19 vaccine Comirnaty to ...