Blog
RSS FeedPosted by Michael Wonder on 18 Jun 2025
Cancer inhibitors scrapped from basic insurance for some users
18 June 2025 - National health care institute Zorginstituut Nederland has scrapped several cancer inhibiting drugs from the basic health ...
Posted by Michael Wonder on 31 Jan 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based regimen for the treatment of patients with transplant eligible, newly diagnosed multiple myeloma
30 January 2024 - Data supporting the application showed the addition of Darzalex Faspro to lenalidomide, bortezomib and dexamethasone induction and ...
Posted by Michael Wonder on 31 Jan 2024
Defender Pharmaceuticals receives complete response letter from the US FDA for its intranasal scopolamine new drug application for the prevention of nausea and vomiting induced by motion in adults
30 January 2024 - Defender Pharmaceuticals today announced that the US FDA has issued a complete response letter in response ...
Posted by Michael Wonder on 31 Jan 2024
Biden-Harris Administration announces action to increase access to sickle cell disease treatments
30 January 2024 - The Biden-Harris Administration announced today that sickle cell disease will be the first focus of the Cell ...
Posted by Michael Wonder on 31 Jan 2024
New Zealand Pharmaceutical Schedule - 1 February 2024
1 February 2024 - The February 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 Jan 2024
Schedule of Pharmaceutical Benefits - 1 February 2024
1 February 2024 - The February 2024 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Jan 2024
Ezharmia supplemental new drug application submitted in Japan for patients with peripheral T-cell lymphoma
31 January 2024 - Submission for second indication of Sakigake designated Ezharmia based on VALENTINE-PTCL01 results in patients with relapsed ...
Posted by Michael Wonder on 31 Jan 2024
Loncastuximab tesirine for treating relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma after 2 or more systemic treatments
31 January 2024 - NICE has published evidence-based recommendations on the use of loncastuximab tesirine (Zynlonta) for the treatment of ...
Posted by Michael Wonder on 31 Jan 2024
Lilly's Olumiant (baricitinib) now authorised in Canada for adults with severe alopecia areata
30 January 2024 - 17-22% of patients taking Olumiant 2 mg/day and 32-35% of patients taking Olumiant 4 mg/day achieved 80% ...
Posted by Michael Wonder on 31 Jan 2024
Astellas submits supplemental new drug application in Japan for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
31 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival versus platinum-containing ...
Posted by Michael Wonder on 31 Jan 2024
Xtandi (enzalutamide) receives Health Canada approval as the first and only treatment for high risk patients with non-metastatic castration sensitive prostate cancer
30 January 2024 - Today, Astellas Pharma Canada announced that Health Canada has approved a supplemental new drug application for ...
Posted by Michael Wonder on 31 Jan 2024
GSK Canada's submission for momelotinib for the treatment of myelofibrosis accepted for review by Health Canada
30 January 2024 - GSK announces that Heath Canada has accepted into review the new drug submission for momelotinib, a potential ...
Posted by Michael Wonder on 30 Jan 2024
2024 PBS post-market review framework
31 January 2024 - The 2024 post-market review framework is now available. ...
Posted by Michael Wonder on 30 Jan 2024
Regulatory applications accepted in the US and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma
30 January 2024 - US FDA grants both follicular lymphoma and mantle cell lymphoma applications priority review. ...
Posted by Michael Wonder on 30 Jan 2024
Pharma price cut proposals from US Government could be steep, analysts say
29 January 2024 - Pharmaceutical companies are due to receive by Thursday the US Government's opening proposal for what are ...
Posted by Michael Wonder on 30 Jan 2024
Ascidian Therapeutics announces fast tracks ACDN-01 in Stargardt disease and other ABCA4 retinopathies
29 January 2024 - Ascidian Therapeutics today announced that the US FDA has granted fast track ...