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 15 Dec 2020
FDA approves Genentech’s Ocrevus (ocrelizumab) shorter 2 hour infusion for relapsing and primary progressive multiple sclerosis
14 December 2020 - Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional ...
Posted by Michael Wonder on 15 Dec 2020
COVID-19 vaccine codes: updated effective date for Pfizer-BioNTech
14 December 2020 - During the COVID-19 public health emergency, Medicare will cover and pay for the administration of the vaccine ...
Posted by Michael Wonder on 15 Dec 2020
AMAG Pharmaceuticals files submission in response to the FDA’s notice of opportunity for a hearing and proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection)
14 December 2020 - AMAG Pharmaceuticals has submitted its response to the FDA’s Notice of Opportunity for a Hearing regarding the ...
Posted by Michael Wonder on 15 Dec 2020
Over-the-counter access to low dose cannabidiol
15 December 2020 - Today the Therapeutic Goods Administration announced a final decision to down-schedule certain low dose cannabidiol preparations ...
Posted by Michael Wonder on 14 Dec 2020
Australia secures 20 million extra Astra Zeneca vaccines
11 December 2020 - Australia secures 20 million extra Astra Zeneca vaccines for onshore manufacturing to cover entire population and a ...
Posted by Michael Wonder on 14 Dec 2020
Avelas receives FDA breakthrough therapy designation for pegloprastide (AVB-620) for use during breast cancer surgery
14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 14 Dec 2020
U.S. Government exercises first option for additional 100 million doses of Moderna’s COVID-19 vaccine candidate
11 December 2020 - Additional doses ordered today will be delivered in Q2 2021. ...
Posted by Michael Wonder on 14 Dec 2020
Public posting of a comprehensive surrogate endpoint table for CDER and CBER regulated products
11 December 2020 - The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate outcomes was ...
Posted by Michael Wonder on 14 Dec 2020
Gannex received U.S. FDA fast track designation for its NASH drug candidate ASC42, an FXR agonist
13 December 2020 - Gannex announced today that it received fast track designation from the U.S. FDA for its non-alcoholic steatohepatitis ...
Posted by Michael Wonder on 14 Dec 2020
Novartis receives EU approval for Leqvio (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year
11 December 2020 - Leqvio (inclisiran) is the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol lowering treatment in ...
Posted by Michael Wonder on 14 Dec 2020
ExCellThera receives Priority Medicines (PRIME) designation from European Medicines Agency for ECT-001 cell therapy
11 December 2020 - ExCellThera announced today that ECT-001 cell therapy has been granted PRIority MEdicines (PRIME) designation by the EMA ...
Posted by Michael Wonder on 14 Dec 2020
Trixeo Aerosphere approved in the EU for maintenance treatment of COPD
14 December 2020 - Fourth major approval for AstraZeneca’s triple-combination therapy which is marketed as Breztri Aerosphere in the US, ...
Posted by Michael Wonder on 14 Dec 2020
NICE u-turn on Novartis' migraine drug Aimovig
14 December 2020 - In a rare move, NICE has reconsidered its position on Novartis migraine prevention treatment Aimovig (erenumab), ...
Posted by Michael Wonder on 14 Dec 2020
Diabetes drugs delay shows problem with PHARMAC’s funding model, doctor claims
14 December 2020 - Pharmac’s decision to delay funding approval for two new diabetes drugs has highlighted the shortcomings of ...
Posted by Michael Wonder on 14 Dec 2020
From publication bias to lost in information
11 December 2020 - In BMJ Evidence-Based Medicine, IQWiG researchers call for a central, public and worldwide portal for clinical ...