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RSS FeedPosted by Michael Wonder on 24 Jun 2021
Lilly's donanemab receives U.S. FDA's breakthrough therapy designation for treatment of Alzheimer's disease
24 June 2021 - The U.S. FDA granted breakthrough therapy designation for donanemab, Eli Lilly's investigational antibody therapy for Alzheimer's ...
Posted by Michael Wonder on 24 Jun 2021
Eisai and Biogen announce U.S. FDA grants breakthrough therapy designation for lecanemab (BAN2401), an anti-amyloid beta antibody for the treatment of Alzheimer's disease
24 June 2021 - Eisai and Biogen today announced that the U.S. FDA has granted breakthrough therapy designation for lecanemab (BAN2401), ...
Posted by Michael Wonder on 24 Jun 2021
FDA accepts application for Genentech’s port delivery system with ranibizumab for treatment of wet age related macular degeneration
24 June 2021 - If approved, PDS would be the first and only eye implant with continuous drug delivery that offers ...
Posted by Michael Wonder on 24 Jun 2021
TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran
24 June 2021 - Today, the Therapeutic Goods Administration granted provisional determination to Moderna Australia in relation to the COVID-19 ...
Posted by Michael Wonder on 23 Jun 2021
FDA chief under fire over Alzheimer’s drug decision
22 June 2021 - US regulator’s approval of controversial treatment shows it is too close to Big Pharma, say critics. ...
Posted by Michael Wonder on 23 Jun 2021
FDA should lead the way on new ALS treatments, not Canada and Europe
22 June 2021 - Following the FDA’s recent decision to give the green light to aducanumab, the first treatment approved ...
Posted by Michael Wonder on 23 Jun 2021
Fees and charges: summary from 1 July 2021
23 June 2021 - The TGA is required to recover its costs for all activities that fall within the scope of ...
Posted by Michael Wonder on 23 Jun 2021
TGA approves first generic pomalidomide
23 June 2021 - The TGA has approved first generic version of Celgene's Pomalyst. ...
Posted by Michael Wonder on 23 Jun 2021
Aducanumab (Aduhelm) information
22 June 2021 - The FDA has posted the CDER’s Office of Neurology’s Summary Review Memorandum describing the agency’s extensive ...
Posted by Michael Wonder on 23 Jun 2021
Genmab announces that Janssen has received European marketing authorisations for Darzalex (daratumumab) subcutaneous formulation, including for the treatment of patients with newly diagnosed light-chain amyloidosis
22 June 2021 - Janssen received European approval for Darzalex SC (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone ...
Posted by Michael Wonder on 23 Jun 2021
LEO Pharma announces European Commission approval of Adtralza (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis
22 June 2021 - The European Commission regulatory approval is primarily supported by data from the ECZTRA 1, 2 and ECZTRA ...
Posted 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 ...