Blog
RSS FeedPosted by Michael Wonder on 12 Sep 2019
China’s grip on pharmaceutical drugs is a national security issue
10 September 2019 - If you take a pill every day to treat high blood pressure or high cholesterol, you ...
Posted by Michael Wonder on 12 Sep 2019
Draft Pelosi plan targets drugs lacking biosimilar or generic option
12 September 2019 - While chances of her leaked plan to force lower drug prices in the United States getting through ...
Posted by Michael Wonder on 12 Sep 2019
In U.S. biosimilars run into more roadblocks
12 September 2019 - In a recent op-ed in the Wall Street Journal Peter Bach asks whether it's time to ...
Posted by Michael Wonder on 12 Sep 2019
Why Canada can't be America's pharmacy
11 September 2019 - Canada doesn't have enough drugs to share, and it doesn't want that role. ...
Posted by Michael Wonder on 12 Sep 2019
Big Pharma is abusing patents, and it's hurting Americans
12 September 2019 - The American patent system has, since our nation's founding, served as a cornerstone of innovation. But ...
Posted by Michael Wonder on 12 Sep 2019
Ardelyx receives FDA approval for Ibsrela (tenapanor), an NHE3 sodium transport inhibitor, for the treatment of irritable bowel syndrome with constipation
12 September 2019 - Approval supported by two Phase 3 trials demonstrating a statistically significant reduction in constipation and abdominal pain ...
Posted by Michael Wonder on 12 Sep 2019
Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma
12 September 2019 - GlaxoSmithKline today announced that the US FDA has approved Nucala (mepolizumab) for use in children as young ...
Posted by Michael Wonder on 12 Sep 2019
Aspen's drug to prevent preterm birth approved by FDA
13 September 2019 - The U.S. Food and Drug Administration (FDA) has approved Aspen Pharmacare’s hydroxyprogesterone caproate, which is used to ...
Posted by Michael Wonder on 12 Sep 2019
When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates
11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...
Posted by Michael Wonder on 11 Sep 2019
We need to make biosimilars easier to get
11 September 2019 - If potential biosimilar manufacturers can’t get their product to market, they won’t proceed with development. ...
Posted by Michael Wonder on 11 Sep 2019
Puma Biotechnology announces U.S. FDA acceptance of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer
11 September 2019 - Puma Biotechnology announced that the U.S. FDA has accepted for review its supplemental new drug application for ...
Posted by Michael Wonder on 11 Sep 2019
United Therapeutics announces FDA acceptance of Trevyent new drug application for review
11 September 2019 - United Therapeutics today announced that the U.S. FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 11 Sep 2019
Merck announces FDA breakthrough therapy designation for investigational therapy tepotinib in patients with metastatic NSCLC with METex14 skipping alterations
11 September 2019 - Investigational oral MET inhibitor has previously received SAKIGAKE ’fast-track’ regulatory designation in Japan. ...
Posted by Michael Wonder on 10 Sep 2019
Xeris Pharmaceuticals receives U.S. FDA approval for Gvoke (glucagon), the first ready-to-use stable liquid glucagon for severe hypoglycaemia
10 September 2019 - First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies. ...
Posted by Michael Wonder on 10 Sep 2019
Why do post-marketing drug studies required by the FDA take so long?
10 September 2019 - Often times when a new drug is approved by the FDA, the agency requires more studies be ...