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 21 Apr 2022
Hansa Biopharma granted added benefit ASMR 3 by French Transparency Commission for Idefirix (imlifidase) as desensitisation treatment for highly sensitised kidney transplant patients
20 April 2022 - The opinion by the Transparency Commission follows after Idefirix was granted a funded Early Access Program by ...
Posted by Michael Wonder on 20 Apr 2022
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 years with at least one F508del mutation
20 April 2022 - Vertex has submitted this indication to CADTH & INESSS for health technology assessments. ...
Posted by Michael Wonder on 20 Apr 2022
Otsuka announces Health Canada approval of Tavneos (avacopan) for ANCA associated vasculitis
20 April 2022 - Launch is expected in Canada in the fourth quarter of 2022. ...
Posted by Michael Wonder on 20 Apr 2022
Extrapolation of drug indications from study populations by FDA is ‘common’
19 April 2022 - Extrapolation of indications in new drug approvals by the U.S. FDA to populations not originally studied ...
Posted by Michael Wonder on 20 Apr 2022
Making #MedicinesMatter for all Australians
21 April 2022 - Medicines Australia has launched a social media campaign to highlight key policy issues for the election ...
Posted by Michael Wonder on 20 Apr 2022
New drug application resubmission update
20 April 2022 - Polarean Imaging announces that further to the RNS issued on 31 March 2022, the Company can confirm ...
Posted by Michael Wonder on 20 Apr 2022
FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel for prevention of multiple life-threatening infections from six viruses in allogeneic haematopoietic cell transplant patients
20 April 2022 - Posoleucel’s third regenerative medicine advanced therapy designation marks an unprecedented regulatory distinction among cell and gene therapies. ...
Posted by Michael Wonder on 20 Apr 2022
Teva and MedinCell receive complete response letter for TV-46000/mdc-IRM
19 April 2022 - Teva Pharmaceuticals and MedinCell announced that the U.S. FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 20 Apr 2022
FDA granted CMG901 fast track designation for unresectable or metastatic gastric and gastro-oesophageal junction cancer which have relapsed and/or are refractory to approved therapies
19 April 2022 - Keymed Biosciences announced that the U.S. FDA granted CMG901 fast track designation as monotherapy for the ...
Posted by Michael Wonder on 20 Apr 2022
NICE terminates appraisal of nivolumab
20 April 2022 - This is the first appraisal of nivolumab to be terminated by NICE. ...
Posted by Michael Wonder on 19 Apr 2022
Medicare’s decision not to fund Aduhelm changes landscape for US pharma industry
19 April 2022 - The decision by the agency responsible for Medicare to restrict coverage of Biogen’s Alzheimer’s drug aducanumab ...
Posted by Michael Wonder on 19 Apr 2022
Prioritising reference products over biosimilars led to millions of missed savings for Part D
20 April 2022 - Medicare Part D plans missed out on between $84 million and $143 million in savings by ...
Posted by Michael Wonder on 19 Apr 2022
Innovative Cellular Therapeutics receives FDA fast track designation for GCC19CART, its lead solid tumour candidate, in the treatment of patients with relapsed or refractory metastatic colorectal cancer
19 April 2022 - GCC19CART is an autologous CAR T therapy candidate that has shown promising results in over 30 relapsed ...
Posted by Michael Wonder on 19 Apr 2022
iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect
19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...
Posted by Michael Wonder on 19 Apr 2022
Supply related data in manufacturer dossiers: things are not going smoothly yet
19 April 2022 - The criteria for supply related data established by IQWiG in 2020 were positively received in science. ...