Blog
RSS FeedPosted by Michael Wonder on 30 Aug 2021
Health Canada approves Myinfla (colchicine 0.5 mg extended release tablets), a new repurposed treatment for cardiovascular disease
27 August 2021 - A unique partnership between Pharmascience and the Montreal Heart Institute leads to the approval of Myinfla (colchicine ...
Posted by Michael Wonder on 30 Aug 2021
FDA orphan drug approval: Octapharma’s Octagam 10% receives 7 years of market exclusivity for adult dermatomyositis
30 August 2021 - Octagam 10% expected to become the first treatment option for adults with rare immune-mediated inflammatory disease. ...
Posted by Michael Wonder on 29 Aug 2021
Moderna COVID-19 vaccine gets Health Canada approval for kids 12+
27 August 2021 - As the Delta variant rages through unvaccinated populations in Canada ahead of the back-to-school season, children ...
Posted by Michael Wonder on 29 Aug 2021
COVID-19 vaccine claims scheme
29 August 2021 - Medicines Australia commends the Australian Government on the COVID-19 Vaccine Claim Scheme for anyone who experiences ...
Posted by Michael Wonder on 28 Aug 2021
European Medicines Agency grants Marinus Pharmaceuticals accelerated assessment of ganaxolone for treatment of CDKL5 deficiency disorder
26 August 2021 - Marinus Pharmaceuticals today announced that the CHMP of the EMA has granted its request for accelerated ...
Posted by Michael Wonder on 28 Aug 2021
Incyte and MorphoSys announce the European Commission approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
26 August 2021 - In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL. ...
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
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 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
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
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. ...