Blog
RSS FeedPosted by Michael Wonder on 21 Apr 2020
Imbruvica (ibrutinib) receives 11th FDA approval
21 April 2020 - Granted under FDA's real-time oncology review pilot program, Project Orbis and priority review. ...
Posted by Michael Wonder on 21 Apr 2020
Coronavirus puts big pharma’s IP regime to the test
21 April 2020 - “Chaotic” is how Jorge Contreras, a law professor at the University of Utah, describes a struggle ...
Posted by Michael Wonder on 21 Apr 2020
If pharma helps quench the COVID-19 pandemic, what will it want in return?
21 April 2020 - Make no mistake: the only long-term solution to the COVID-19 pandemic is a safe and effective ...
Posted by Michael Wonder on 21 Apr 2020
Alk announces Health Canada approval of Itulatek SLIT tablets for the treatment of tree pollen allergy
20 April 2020 - Over 20% of Canadians with allergies are impacted by tree pollen. ...
Posted by Michael Wonder on 21 Apr 2020
The controversial malaria drug has been approved for an official trial
21 April 2020 - A massive new clinical trial has begun in Australia to test if an HIV or a ...
Posted by Michael Wonder on 21 Apr 2020
Why countries can’t meet the demand for gear against COVID-19
19 April 2020 - A host of efforts are under way to unblock bottlenecks. ...
Posted by Michael Wonder on 20 Apr 2020
Crisis or not, Alberta must not do an end-run around Health Canada
20 April 2020 - On April 12, in response to a perceived delay in Health Canada’s approval of a Canadian-made ...
Posted by Michael Wonder on 20 Apr 2020
Hydroxychloroquine and other auto-immune drugs don’t fully protect against coronavirus, early data suggest
18 April 2020 - Data compiled by rheumatology researchers show dozens of patients who were taking Plaquenil and other drugs became ...
Posted by Michael Wonder on 20 Apr 2020
Update to guidance on regulatory expectations in the context of COVID-19 pandemic
20 April 2020 - The European Commission, EMA and the national competent authorities have agreed a series of measures to ...
Posted by Michael Wonder on 20 Apr 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #2
20 April 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 20 Apr 2020
COVID-19 treatment remedsivir is not available for Australian trial
20 April 2020 - A landmark Australian COVID-19 trial will not get to test the most promising therapy, as it can ...
Posted by Michael Wonder on 20 Apr 2020
Big pharma has the chance to come to the world’s rescue
20 April 2020 - The pandemic may finally do for the pharmaceutical industry what relentless TV advertising cannot: show off its ...
Posted by Michael Wonder on 20 Apr 2020
FDA and EMA accept applications for Genentech’s Ocrevus (ocrelizumab) shorter two hour infusion time
19 April 2020 - Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary ...
Posted by Michael Wonder on 20 Apr 2020
Improved Consumer Medicine Information template
20 April 2020 - The Therapeutic Goods Regulations 1990 have been amended to support improved Consumer Medicine Information. ...
Posted by Michael Wonder on 20 Apr 2020
Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalised COVID-19 patients
20 April 2020 - Novartis has reached an agreement with the US FDA to proceed with a Phase III clinical trial ...