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RSS FeedPosted 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
Anticancer agent Tazverik 200 mg tablets (tazemetostat hydrobromide) approved in Japan for EZH2 gene mutation positive follicular lymphoma
23 June 2021 - Eisai announced today that it has obtained manufacturing and marketing approval for the EZH2 inhibitor Tazverik ...
Posted by Michael Wonder on 24 Jun 2021
Lynparza approved in China for the treatment of BRCA mutated metastatic castration resistant prostate cancer
24 June 2021 - First PARP inhibitor approved in China in advanced prostate cancer. ...
Posted by Michael Wonder on 24 Jun 2021
Moving patient stories highlight opportunities to strengthen our health care systems for all Australians
24 June 2021 - It was an emotional evening among the nearly 200 in-person and online attendees at Parliament House last ...
Posted by Michael Wonder on 23 Jun 2021
Access to medicine: the states with the most and least pharmacies per capita
21 June 2021 - Many people live in pharmacy deserts. ...
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
Evio Pharmacy Solutions established to tackle affordability, outcomes, and experience with medications
22 June 2021 - Privately funded venture will offer innovative medication solutions to patients, providers and customers. ...
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
Rare disease patient advocates continue battle for affordable drugs
23 June 2021 - Beth Vanstone, mother of local Cystic Fibrosis Warrior Madi Vanstone and director of the CF Get ...
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
Price disclosure 2021 October cycle outcomes summary
23 June 2021 - The summary of price disclosure price reductions for the 2021 October cycle has now been published. ...
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 ...