Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 05 Oct 2021
Nivolumab and ipilimumab: added benefit in pleural mesothelioma with non-epithelioid tumour histology
1 October 2021 - For the first time, a pure antibody combination has been approved as a first-line therapy for ...
Posted by Michael Wonder on 05 Oct 2021
TGA grants provisional determination to Pfizer's COVID-19 treatment PF-07321332 and ritonavir
5 October 2021 - On 1 October 2021, the TGA granted provisional determination to Pfizer in relation to a new ...
Posted by Michael Wonder on 05 Oct 2021
Venetoclax comes close to gaining support from NICE
4 October 2021 - A proposal from AbbVie for a Cancer Drugs Fund listing may get it over the line. ...
Posted by Michael Wonder on 05 Oct 2021
Adjuvant treatment for NSCLC: osimertinib mesylate may benefit certain people
1 October 2021 - Hint of considerable additional benefit if, after complete tumour resection, adjuvant platinum-based chemotherapy has already been ...
Posted by Michael Wonder on 05 Oct 2021
NICE recommends first treatment in two decades for sickle cell disease
5 October 2021 - Hundreds of people will be eligible for a new treatment for sickle cell disease following draft guidance ...
Posted by Michael Wonder on 05 Oct 2021
Medicare reverses course on decision to universally cover breakthrough medical devices for 4 years
4 October 2021 - In January 2021, in the waning days of the Trump Administration, the CMS finalised a rule ...
Posted by Michael Wonder on 05 Oct 2021
WHO prioritises access to diabetes and cancer treatments in new Essential Medicines Lists
1 October 2021 - High prices and low availability still a major barrier for patients’ access to new and old medicines. ...
Posted by Michael Wonder on 05 Oct 2021
Heron Therapeutics announces filing of a supplemental new drug application for significant expansion of Zynrelef indication statement based on successful outcome of FDA type C meeting
4 October 2021 - FDA agreed to the immediate filing of supplemental new drug application to significantly expand the Zynrelef indication ...
Posted by Michael Wonder on 05 Oct 2021
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
4 October 2021 - EMA’s CHMP has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax ...
Posted by Michael Wonder on 05 Oct 2021
FDA’s naming rule for biosimilars has undermined Congress and health care
4 October 2021 - I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my ...
Posted by Michael Wonder on 05 Oct 2021
Turning Point Therapeutics granted breakthrough therapy designation for repotrectinib treatment in patients with NTRK positive, TKI pretreated advanced solid tumours
4 October 2021 - Turning Point Therapeutics today announced the U.S. FDA granted a seventh regulatory designation to lead drug ...
Posted by Michael Wonder on 05 Oct 2021
EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
4 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known ...
Posted by Michael Wonder on 05 Oct 2021
Pharmaceutical industry backs workplace vaccinations
5 October 2021 - Medicines Australia strongly recommends full COVID-19 vaccinations for the health and safety and protection of all ...
Posted by Michael Wonder on 04 Oct 2021
ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir for children living with HIV
4 October 2021 - ViiV Healthcare has announced it has made a regulatory submission to the U.S. FDA for approval of ...
Posted by Michael Wonder on 04 Oct 2021
Enhertu granted breakthrough therapy designation in U.S.for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2 based regimens
4 October 2021 - Based on groundbreaking DESTINY-Breast03 results where Enhertu reduced the risk of disease progression or death by 72% ...