Blog
RSS FeedPosted by Michael Wonder on 20 Mar 2019
Biosimilar approval and adoption in the U.S. needs to be expedited
20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...
Posted by Michael Wonder on 20 Mar 2019
The shadow of Brexit on speed of access
20 March 2019 - No-one can miss the ongoing saga that is the UK’s exit from the European Union. ...
Posted by Michael Wonder on 15 Mar 2019
Karyopharm announces FDA extension of review period for selinexor new drug application
14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...
Posted by Michael Wonder on 14 Mar 2019
One in four cancer patients wait two months for treatment, as NHS performance hits record low
14 March 2019 - The number of cancer sufferers waiting at least two months for treatment after an urgent referral ...
Posted by Michael Wonder on 13 Mar 2019
Bavarian Nordic announces FDA delay in the review of the biologics license application for MVA-BN smallpox vaccine
11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review ...
Posted by Michael Wonder on 04 Mar 2019
Senators tell FDA to speed up approvals of generic insulin
1 March 2019 - A bipartisan group of senators want the Food and Drug Administration (FDA) to change its policy ...
Posted by Michael Wonder on 22 Feb 2019
Choosing a time horizon in cost and cost-effectiveness analyses
21 February 2019 - When designing a comparative outcomes or a cost-effectiveness analysis, the time horizon defining the duration of time ...
Posted by Michael Wonder on 07 Feb 2019
Incyte announces U.S. FDA has extended the review period for ruxolitinib (Jakafi) in acute graft-versus-host disease
7 February 2019 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines
30 January 2019 - As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many ...
Posted by Michael Wonder on 22 Jan 2019
Shutdown risks delaying FDA approval of potentially life-saving drugs and therapies
22 January 2019 - It's not accepting new applications or fees during the shutdown. ...
Posted by Michael Wonder on 22 Jan 2019
FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists
18 January 2019 - "We are in uncharted territory. This is a watershed moment in the life of this agency," he ...
Posted by Michael Wonder on 17 Jan 2019
FDA review of Aimmune drug put on hold due to government shutdown
14 January 2019 - The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win ...
Posted by Michael Wonder on 16 Jan 2019
The FDA has five weeks till money runs out for approving new drugs
16 January 2019 - The US FDA has roughly five weeks of funding left to review new drug applications during ...
Posted by Michael Wonder on 15 Jan 2019
If the shutdown drags on at FDA, it will put anticipated new treatments in jeopardy
14 January 2019 - The government shutdown could soon jeopardise highly anticipated new drugs from Janssen, Sanofi, and Novartis for ...
Posted by Michael Wonder on 15 Jan 2019
How a 'regulatory dead zone' may be holding up copycat insulin
14 January 2019 - The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp ...