Blog
RSS FeedPosted by Michael Wonder on 15 Feb 2017
Amgen submits supplemental biologics license application for Blincyto (blinatumomab) in relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
14 February 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to ...
Posted by Michael Wonder on 15 Feb 2017
Quality of life, overall survival and costs of cancer drugs approved based on surrogate outcomes
14 February 2017 - The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US ...
Posted by Michael Wonder on 14 Feb 2017
American patients can access far more new cancer drugs than others can
13 February 2017 - New research by scholars at the University of Pittsburgh shows that American patients have significantly better access ...
Posted by Michael Wonder on 14 Feb 2017
New “21st Century Cures” legislation: speed and ease vs science
14 February 2017 - The 21st Century Cures Act was signed into law in December 2016. Praised by its advocates as ...
Posted by Michael Wonder on 14 Feb 2017
Lawmakers slam new $89,000 price tag on rare disease treatment: ‘unconscionable’
13 February 2017 - Politicians are, once again, concerned that a drug company that plans to sell an old medicine ...
Posted by Michael Wonder on 14 Feb 2017
An open letter to the Duchenne community
13 February 2017 - We are pausing our commercialisation efforts in order to meet with Duchenne community leaders and explain our ...
Posted by Michael Wonder on 14 Feb 2017
FDA drug trials snapshots and diversity when testing new drugs
13 February 2017 - Did you know that some drugs affect men and women differently? ...
Posted by Michael Wonder on 13 Feb 2017
Grassley launches inquiry into orphan drugs after KHN investigation
10 February 2017 - Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential ...
Posted by Michael Wonder on 13 Feb 2017
The challenges of generating evidence to support precision medicine
13 February 2017 - Major recent advances in science and technology now enable new kinds of measurements that can characterise an ...
Posted by Michael Wonder on 12 Feb 2017
Marathon dystrophy drug’s approval sends cost sky high
13 February 2017 - A drug to treat muscular dystrophy will hit the US market with a price tag of ...
Posted by Michael Wonder on 11 Feb 2017
A Ted Cruz proposal to speed FDA approvals may have limited impact
9 February 2017 - In late 2015, Senator Ted Cruz introduced a bill to make more drugs available to Americans ...
Posted by Michael Wonder on 10 Feb 2017
An old drug gets a new price to fight a rare disease: $89,000 a year
10 February 2017 - An old steroid treatment, long available outside the United States, received approval this week for a ...
Posted by Michael Wonder on 09 Feb 2017
Amid flurry of new cancer drugs, how many offer real benefits?
9 February 2017 - Marlene McCarthy's breast cancer has grown relentlessly over the past seven years, spreading painfully through her ...
Posted by Michael Wonder on 09 Feb 2017
FDA approves drug to treat Duchenne muscular dystrophy
9 February 2017 - The U.S. FDA today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 ...
Posted by Michael Wonder on 09 Feb 2017
FDA approves Bio Products Laboratory's Gammaplex 10% for treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura
8 February 2017 - Bio Products Laboratory today announced that the U.S. FDA has approved Gammaplex 10% (immune globulin intravenous ...