Blog
RSS FeedPosted by Michael Wonder on 09 May 2021
‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients
6 May 2021 - A new medication for children with a rare and life-threatening cancer called neuroblastoma had a curious ...
Posted by Michael Wonder on 09 May 2021
US wary of boosting China biotech with COVID vaccine patent waiver
9 May 2021 - The Biden administration is examining ways to ensure that a waiver of COVID-19 vaccine patents to ...
Posted by Michael Wonder on 08 May 2021
AstraZeneca weighs seeking full U.S. approval for COVID-19 shot, skipping emergency use application
7 May 2021 - British drugmaker faces challenges gathering data; may wait to apply for full approval by the FDA, which ...
Posted by Michael Wonder on 07 May 2021
Pfizer and BioNTech initiate rolling submission of biologics license application for U.S. FDA approval of their COVID-19 vaccine
7 May 2021 - - Pfizer and BioNTech today announced the initiation of a biologics license application with the U.S. FDA ...
Posted by Michael Wonder on 07 May 2021
International regulators and WHO call for wider public access to clinical data
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
Posted by Michael Wonder on 07 May 2021
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
7 May 2021 - EMA’s CHMP has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and ...
Posted by Michael Wonder on 06 May 2021
The difference between an interchangeable biosimilar and one that isn't
5 May 2021 - Permitting automatic substitution of biosimilars for originator brand biologics at the pharmacy counter is often talked about ...
Posted by Michael Wonder on 06 May 2021
Viome receives FDA approval for its unique mRNA technology and AI platform to detect cancers
6 May 2021 - FDA breakthrough designation validates Viome's proprietary mRNA analysing technology and state of the art AI platform to ...
Posted by Michael Wonder on 06 May 2021
Injectafer (ferric carboxymaltose injection) receives FDA approval for single dose option for the treatment of adult patients with iron deficiency anaemia
6 May 2021 - For patients weighing 50 kg (110 lb) or more, Injectafer may now be administered as a 1000 ...
Posted by Michael Wonder on 06 May 2021
Merck and Eisai receive priority review from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) applications for advanced renal cell carcinoma and for advanced endometrial carcinoma
6 May 2021 - Applications based on progression-free survival, overall survival, and objective response rate data from respective pivotal Phase 3 ...
Posted by Michael Wonder on 06 May 2021
Medicines Australia updated position on intellectual property (in light of TRIPS waiver)
6 May 2021 - Medicines Australia continues to express our sympathies to all those affected by the pandemic. The importance ...
Posted by Michael Wonder on 06 May 2021
Designing an independent public health agency
6 May 2021 - The COVID-19 pandemic has revealed the importance of having trustworthy and competent institutions to protect public ...
Posted by Michael Wonder on 06 May 2021
Australia has backed a global push to fast-track generic COVID-19 jabs
6 May 2021 - The Morrison government has joined an international push to fast-track the production of generic COVID-19 jabs, ...
Posted by Michael Wonder on 06 May 2021
European Commission approves Benlysta for adult patients with active lupus nephritis
5 May 2021 - First and only biologic approved for both systemic lupus erythematosus and lupus nephritis ...
Posted by Michael Wonder on 06 May 2021
Health Canada issues Notice of Compliance for Bausch Health's Bryhali
5 May 2021 - Bausch Health Canada today announced that Health Canada has approved the use of Bryhali (halobetasol propionate 0.01% ...