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 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
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
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 ...
Posted by Michael Wonder on 18 Apr 2020
NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options
17 April 2020 - The National Institutes of Health (NIH) and the Foundation for the NIH are bringing together more than ...
Posted by Michael Wonder on 18 Apr 2020
Finding effective treatments for COVID-19: scientific integrity and public confidence in a time of crisis
16 April 2020 - Everyone wants new treatments and vaccines to address the devastation of coronavirus disease 2019 (COVID-19). ...
Posted by Michael Wonder on 17 Apr 2020
FDA approves first targeted treatment for patients with cholangiocarcinoma, a cancer of bile ducts
17 April 2020 - Today, the U.S. FDA granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with ...
Posted by Michael Wonder on 17 Apr 2020
FDA approves first new drug under international collaboration, a treatment option for patients with HER2-positive metastatic breast cancer
17 April 2020 - Today, as part of Project Orbis, the U.S. FDA approved Tukysa (tucatinib) in combination with chemotherapy ...
Posted by Michael Wonder on 17 Apr 2020
Chi-Med announces surufatinib granted U.S. FDA fast track designations for the treatment of both pancreatic and non-pancreatic neuroendocrine tumours
17 April 2020 - Hutchison China MediTech today announces that the U.S. FDA has granted two fast track designations for the ...
Posted by Michael Wonder on 17 Apr 2020
The coronavirus is mutating. What does that mean for a vaccine?
16 April 2020 - Around the world, hope for a return to normalcy is pinned on a vaccine, the “ultimate ...
Posted by Michael Wonder on 17 Apr 2020
FDA accepts for priority review biologics license application for REGN-EB3 to treat Ebola
16 April 2020 - REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy. ...
Posted by Michael Wonder on 16 Apr 2020
Provention Bio initiates rolling submission of biologic license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals
16 April 2020 - Rolling submission initiated under breakthrough therapy designation. ...