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 28 Aug 2021
No fault COVID-19 indemnity scheme
28 August 2021 - The Morrison Government has finalised the details of the no fault COVID-19 Vaccine Claim Scheme following extensive ...
Posted by Michael Wonder on 28 Aug 2021
ATAGI recommendations on the use of COVID-19 vaccines in all young adolescents in Australia
27 August 2021 - Vaccination against COVID-19 is recommended for all individuals from 12 years of age, extending the current ...
Posted by Michael Wonder on 28 Aug 2021
PhRMA's Steve Ubl: CBO report makes clear "patients face future with less hope under Congress' drug pricing plan"
27 August 2021 - Pharmaceutical Research and Manufacturers of America president and CEO Stephen J. Ubl made the following statement after ...
Posted by Michael Wonder on 28 Aug 2021
European Commission approves BioMarin's Voxzogo (vosoritide) for the treatment of children with achondroplasia from age 2 until growth plates close
27 August 2021 - First medicine approved to treat children with achondroplasia in Europe ...
Posted by Michael Wonder on 28 Aug 2021
Genentech provides update on Tecentriq U.S. indication for PD-L1 positive, metastatic triple negative breast cancer
27 August 2021 - Genentech today announced that the company has made the decision to voluntarily withdraw the U.S. accelerated approval ...
Posted by Michael Wonder on 28 Aug 2021
MHRA authorises UCB’s Bimzelx via post-Brexit licensing pathway
27 August 2021 - The UK’s MHRA has approved UCB’s Bimzelx (bimekizumab) for the treatment of adults with moderate to ...
Posted by Michael Wonder on 27 Aug 2021
FDA approves first of its kind stroke rehabilitation system
27 August 2021 - The U.S. FDA today approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation ...
Posted by Michael Wonder on 27 Aug 2021
NICE ‘no’ for Janssen’s Darzalex combo
27 August 2021 - NICE has published draft guidance stating that it does not recommend Janssen’s Darzalex (daratumumab) plus bortezomib, ...
Posted by Michael Wonder on 27 Aug 2021
Argenx announces validation of European marketing authorisation application for efgartigimod in generalised myasthenia gravis
25 August 2021 - Validation initiates formal evaluation of application which started on 19 August 2021; decision expected mid-2022. ...
Posted by Michael Wonder on 27 Aug 2021
BioCryst announces acceptance of regulatory applications for Orladeyo (berotralstat) by Health Canada and Swissmedic
25 August 2021 - BioCryst Pharmaceuticals today announced that the new drug submission for Orladeyo (berotralstat) has been accepted for ...
Posted by Michael Wonder on 26 Aug 2021
CVS juggles biosimilar options on its formulary
27 August 2021 - Whether payers put biosimilars on formulary, versus originator products, depends in large part on the respective ...
Posted by Michael Wonder on 26 Aug 2021
Biden Administration likely to approve COVID-19 boosters at six months
26 August 2021 - Pfizer, BioNTech have requested clearance for COVID-19 vaccine boosters that an official said could be administered six ...
Posted by Michael Wonder on 26 Aug 2021
Innovative Health Sciences receives FDA clearance for Insignis subcutaneous needle sets
26 August 2021 - Innovative Health Sciences announced today that it has received FDA clearance for its Insignis subcutaneous needle sets. ...
Posted by Michael Wonder on 26 Aug 2021
AbbVie receives a positive reimbursement recommendation from the Canadian Agencies for Drugs and Technology in Health (CADTH) pan-Canadian Oncology Drug Review Expert Review Committee (pERC) for Venclexta (venetoclax) in combination with azacitidine for acute myeloid leukaemia patients
26 August 2021 - pERC recommends reimbursement of Venclexta (venetoclax) in combination with azacitidine for the treatment of newly diagnosed acute ...
Posted by Michael Wonder on 26 Aug 2021
Government eases criteria for haemophilia A drug reimbursement
26 August 2021 - The Government said it would ease the immune tolerance induction treatment criteria for haemophilia A drug ...