Blog
RSS FeedPosted by Michael Wonder on 22 Jun 2021
FDA approved Biogen Alzheimer’s drug despite some staff concerns
22 June 2021 - The agency has faced criticism for approving the drug, Aduhelm, without clear proof it works. ...
Posted by Michael Wonder on 22 Jun 2021
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...
Posted by Michael Wonder on 22 Jun 2021
New drug could cost the Government as much as it spends on NASA
22 June 2021 - The Alzheimer’s treatment will cost $56,000 per patient, and millions may use it. The result: “crazy numbers” ...
Posted by Michael Wonder on 22 Jun 2021
COVID-19 delta strain requires two vaccine doses for protection, Therapeutic Goods Administration boss says
22 June 2021 - Australians will need two doses of a COVID-19 vaccine to adequately protect themselves against the highly ...
Posted by Michael Wonder on 22 Jun 2021
Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine
22 June 2021 - EMA’s CHMP has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed ...
Posted by Michael Wonder on 22 Jun 2021
Targovax receives fast track designation for ONCOS-102 in melanoma
22 June 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in PD-1-refractory ...
Posted by Michael Wonder on 22 Jun 2021
Acrux receives approval from the FDA for its generic version of Jublia
22 June 2021 - Acrux is pleased to announce that the US FDA has granted approval of the Company’s generic version ...
Posted by Michael Wonder on 22 Jun 2021
Medtronic receives FDA expanded approval for Arctic Front family of cardiac cryoablation catheters for initial use for recurrent symptomatic paroxysmal atrial fibrillation
21 June 2021 - First and only approval to indicate cryoablation as an initial rhythm control strategy. ...
Posted by Michael Wonder on 22 Jun 2021
Fennec Pharmaceuticals announces FDA acceptance of new drug application resubmission for Pedmark
22 June 2021 - Prescription Drug User Fee Act target action date set for 27 November 2021. ...
Posted by Michael Wonder on 22 Jun 2021
Koselugo approved in the EU for children with neurofibromatosis type 1 and plexiform neurofibromas
22 June 2021 - First medicine approved in the EU to treat this rare and debilitating genetic condition. ...
Posted by Michael Wonder on 22 Jun 2021
Jardiance (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction
21 June 2021 - This new indication is based on the EMPEROR Reduced trial, which showed a significant 25% reduction in ...
Posted by Michael Wonder on 22 Jun 2021
FDA 'may require' post-marketing studies to analyse long-term effects of breast cancer drugs
21 June 2021 - The US FDA "may require” or seek agreement from sponsors to conduct post-marketing studies to analyse ...
Posted by Michael Wonder on 22 Jun 2021
Bristol Myers Squibb receives European Commission approval for Onureg (azacitidine tablets) as frontline oral maintenance therapy for adults with acute myeloid leukaemia
18 June 2021 - Onureg is the first and only once daily, frontline oral maintenance therapy in the European Union for ...
Posted by Michael Wonder on 21 Jun 2021
Notice of Compliance with Conditions granted for Retevmo (selpercatinib), the first therapy in Canada specifically for patients with advanced RET driven lung and thyroid cancers
21 June 2021 - Conditional marketing authorisation based on data from LIBRETTO-001 Phase 1/2, the largest trial ever reported in patients ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...