Blog
RSS FeedPosted by Michael Wonder on 30 Oct 2017
A new team aims to slash drug development time — with help from the feds
27 October 2017 - A global pharma company is teaming up with federal research labs and academics in an ambitious ...
Posted by Michael Wonder on 16 Oct 2017
The cost of developing drugs is insane. That paper that says otherwise is insanely bad.
16 October 2017 - You probably know this poem, or at least the story it tells. One man likens the ...
Posted by Michael Wonder on 10 Oct 2017
A flawed study depicts drug companies as profiteers
9 October 2017 - Even the authors admit their selection criteria are a ‘critical limitation.’ That’s an understatement. ...
Posted by Michael Wonder on 02 Oct 2017
Reducing the hurdles for complex generic drug development
2 October 2017 - Earlier this year, I announced our Drug Competition Action Plan to advance new policies aimed at bringing ...
Posted by Michael Wonder on 27 Sep 2017
Making advances against Sickle cell disease
26 September 2017 - The medical definition of sickle cell disease – a group of inherited red blood cell disorders caused ...
Posted by Michael Wonder on 19 Sep 2017
Drug development at the portfolio level is important for policy, care decisions and human protections
19 September 2017 - The development of a new drug is often portrayed as a series of increasingly demanding clinical trials, ...
Posted by Michael Wonder on 14 Sep 2017
Tragedy, perseverance, and chance — the story of CAR-T therapy
13 September 2017 - In 2010, 5-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukaemia. Though her parents were told that ...
Posted by Michael Wonder on 12 Sep 2017
FDA is advancing the goals of the Orphan Drug Act
12 September 2017 - Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests ...
Posted by Michael Wonder on 13 Aug 2017
A cancer conundrum: too many drug trials, too few patients
12 August 2017 - With the arrival of two revolutionary treatment strategies, immunotherapy and personalised medicine, cancer researchers have found ...
Posted by Michael Wonder on 03 Aug 2017
A rush for immunotherapy cancer drugs means new bedfellows
3 August 2017 - Fierce rivals in pharma are co-operating. ...
Posted by Michael Wonder on 03 Aug 2017
Addressing antimicrobial resistance and stewardship: the Priority Antimicrobial Value and Entry (PAVE) award
3 August 2017 - Antimicrobial-resistant infections affect more than 2 million people annually in the United States alone, accounting for an ...
Posted by Michael Wonder on 29 Jul 2017
Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
26 July 2017 - Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to ...
Posted by Michael Wonder on 27 Jul 2017
Priority review vouchers for tropical disease drugs simply aren’t working
25 July 2017 - A controversial program created by Congress to spur development of new drugs for neglected tropical diseases ...
Posted by Michael Wonder on 24 Jul 2017
Companies rush to develop ‘utterly transformative’ gene therapies
23 July 2017 - The approval of gene therapy for leukaemia, expected in the next few months, will open the ...
Posted by Michael Wonder on 13 Jul 2017
CAR-Ts clear one roadblock but face many more
14 July 2017 - Novartis wins over an FDA panel but the road to commercial viability is long. ...