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 30 Jan 2023
Nanoscope Therapeutics receives fast track designation by the FDA for MCO-010 for the treatment of Stargardt disease
30 January 2023 - Nanoscope Therapeutics today announced that the US FDA has granted fast track designation to MCO-010, an ...
Posted by Michael Wonder on 30 Jan 2023
Moderna granted FDA breakthrough therapy designation for mRNA-1345, an investigational respiratory syncytial virus vaccine candidate
30 January 2023 - Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated ...
Posted by Michael Wonder on 30 Jan 2023
Life sciences industry calls for better funding for medicine and technology regulator
31 January 2023 - The life sciences, health and medicine sectors have come together to call for improved funding of ...
Posted by Michael Wonder on 30 Jan 2023
Achieving patient centeredness in Medicare’s new drug price negotiation program
27 January 2023 - The Inflation Reduction Act mandated the creation of a Drug Price Negotiation Program focused on developing a ...
Posted by Michael Wonder on 30 Jan 2023
argenx receives notification of PDUFA date extension for SC efgartigimod
27 January 2023 - argenx today announced that the US FDA has extended the review of the biologics license application ...
Posted by Michael Wonder on 30 Jan 2023
Sandoz receives positive CHMP opinion for citrate free high concentration formulation of adalimumab biosimilar
30 January 2023 - Sandoz is seeking approval of high concentration formulation adalimumab for use in all indications of reference medicine. ...
Posted by Michael Wonder on 30 Jan 2023
Lecanemab receives priority review status in Japan
29 January 2023 - Eisai and Biogen announced today that an application for manufacturing and marketing approval for lecanemab, an anti-amyloid-β ...
Posted by Michael Wonder on 30 Jan 2023
Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic oesophagitis
30 January 2023 - Approximately 60% of patients aged 12 years and older treated with Dupixent 300 mg weekly in the ...
Posted by Michael Wonder on 29 Jan 2023
Government must place a higher value on vaccines and medicines that deliver long term benefits
30 January 2023 - Medicines Australia has used its budget submission to remind Government of its commitment to lower Australia’s ...
Posted by Michael Wonder on 29 Jan 2023
Pfizer receives positive CHMP opinion for conversion of Paxlovid conditional marketing authorisation to full marketing authorisation in the European Union
27 January 2023 - Pfizer today announced that the CHMP of the EMA has recommended converting the conditional marketing authorisation ...
Posted by Michael Wonder on 29 Jan 2023
COVID-19 vaccine safety report (27 January 2023)
27 January 2023 - Since the beginning of the vaccine rollout to 22 January 2023, almost 65 million doses of COVID-19 ...
Posted by Michael Wonder on 29 Jan 2023
How a drug company made $114 billion by gaming the US patent system
28 January 2023 - AbbVie for years delayed competition for its blockbuster drug Humira, at the expense of patients and taxpayers. ...
Posted by Michael Wonder on 28 Jan 2023
Ipsen receives CHMP negative opinion for palovarotene as a treatment for fibrodysplasia ossificans progressiva in EU
27 January 2023 - Ipsen to request re-examination of CHMP opinion on palovarotene as a potential treatment for fibrodysplasia ossificans progressiva ...
Posted by Michael Wonder on 28 Jan 2023
Bristol Myers Squibb receives positive CHMP opinion for Reblozyl (luspatercept) for adult patients with anaemia-associated, non-transfusion-dependent beta thalassaemia
27 January 2023 - In the pivotal BEYOND study, Reblozyl significantly increased haemoglobin levels, which were sustained over longer time ...
Posted by Michael Wonder on 27 Jan 2023
CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone sensitive prostate cancer
27 January 2023 - CHMP recommendation is based on Phase 3 data, which demonstrated that darolutamide plus androgen deprivation therapy in ...