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 24 Aug 2021
Humanetics Corporation’s BIO 300 receives fast track designation from FDA
24 August 2021 - Humanetics announced today that BIO 300, a drug under development to increase survival in persons exposed to ...
Posted by Michael Wonder on 24 Aug 2021
ICER uses observational real world evidence to update 2018 assessment on therapies for hereditary angioedema, finds therapies far less cost effective than earlier estimates
24 August 2021 - Patients initiating therapy in real world dataset had less frequent baseline attack rates than rates from clinical ...
Posted by Michael Wonder on 24 Aug 2021
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech/Pfizer and Moderna
24 August 2021 - EMA’s CHMP has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the ...
Posted by Michael Wonder on 24 Aug 2021
FDA approves expanded peripheral artery disease indication for Xarelto (rivaroxaban) plus aspirin to include patients after lower extremity revascularisation due to symptomatic peripheral artery disease
24 August 2021 - Xarelto is the first and only therapy indicated for both coronary artery disease and peripheral artery disease, ...
Posted by Michael Wonder on 24 Aug 2021
European Commission approves Rinvoq (upadacitinib) as first JAK inhibitor in the European Union for the treatment of both adults and adolescents with moderate to severe atopic dermatitis
24 August 2021 - Approval supported by data from one of the largest registrational Phase 3 programs in atopic dermatitis evaluating ...
Posted by Michael Wonder on 24 Aug 2021
UCB announces European Commission approval of Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis
24 August 2021 - The approval in the European Union represents the first marketing authorisation for UCB’s new psoriasis treatment worldwide. ...
Posted by Michael Wonder on 24 Aug 2021
FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update
23 August 2021 - The FDA and the drug industry have jointly agreed to create several new pilot programs aimed ...
Posted by Michael Wonder on 24 Aug 2021
Clovis Oncology announces availability of and reimbursement for Rubraca (rucaparib) tablets for women with relapsed ovarian cancer in Switzerland
24 August 2021 - Rubraca is commercially available in Germany, United Kingdom, Italy, Spain, France, Netherlands, United States of America and ...
Posted by Michael Wonder on 24 Aug 2021
Method paper: IQWiG puts draft version 6.1 up for discussion
23 August 2021 - The IQWiG has presented the draft for the next version of its General Methods. ...
Posted by Michael Wonder on 24 Aug 2021
Optimising the data available via Health Canada’s clinical information portal
23 August 2021 - Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast ...
Posted by Michael Wonder on 24 Aug 2021
FDA grants breakthrough device designation for renal failure
23 August 2021 - ImpediMed is pleased to announce SOZO has received FDA breakthrough device designation for a proposed indication ...
Posted by Michael Wonder on 24 Aug 2021
Limited access to 'lifesaving' cystic fibrosis drug Trikafta under Pharmaceutical Benefits Scheme
24 August 2021 - A mother whose son lives with cystic fibrosis says young people are dying as they wait for ...
Posted by Michael Wonder on 23 Aug 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full U.S. FDA approval for individuals 16 years and older
23 August 2021 - Comirnaty is the first COVID-19 vaccine to be granted FDA approval. ...
Posted by Michael Wonder on 23 Aug 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA approval of Korsuva (difelikefalin) injection for the treatment of moderate to severe pruritus in hemodialysis patients
23 August 2021 - Promotional launch of Korsuva injection in the U.S. is expected in Q1 2022, with reimbursement in H1 ...
Posted by Michael Wonder on 23 Aug 2021
Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz
23 August 2021 - Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the ...