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RSS FeedPosted by Michael Wonder on 16 Sep 2019
Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer
16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020. ...
Posted by Michael Wonder on 16 Sep 2019
FDA grants fast track designation for Farxiga in heart failure
16 September 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 16 Sep 2019
Janssen submits application to U.S. FDA seeking first-in-class approval of Tremfya (guselkumab) for treatment of adults with active psoriatic arthritis
16 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license ...
Posted by Michael Wonder on 15 Sep 2019
The startup that manipulated data to get a miracle drug to market
14 September 2019 - AveXis had a revolutionary gene therapy for babies with a deadly disease, and sold to Novartis for ...
Posted by Michael Wonder on 14 Sep 2019
U.S. officials worried about Chinese control of American drug supply
13 September 2019 - "Basically we've outsourced our entire industry to China," retired Brig. Gen. John Adams told NBC News. "That ...
Posted by Michael Wonder on 14 Sep 2019
Right to try ‘remains a bust,’ as many drug makers prefer FDA reviews
12 September 2019 - Despite the hubbub over the “right-to-try” law, a recent survey found that nearly half of drug ...
Posted by Michael Wonder on 14 Sep 2019
The U.S. health care system found a way to make peanuts cost $4,200
13 September 2019 - A new, billion-dollar pharmaceutical to treat peanut allergies is up for approval. It’s simply peanut flour. ...
Posted 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 ...