Blog
RSS FeedPosted by Michael Wonder on 29 Dec 2017
ICER’s guideline on the acceptance and use of “in-confidence” data from manufacturers of pharmaceuticals, devices, and other health care interventions
22 December 2017 - ICER takes its obligations to transparency and fairness seriously. ...
Posted by Michael Wonder on 21 Dec 2017
Drug makers dodged 1.3 billion dollars in payments to Medicaid, report finds
20 December 2017 - Drug makers dodged more than $1.3 billion in Medicaid drug rebates between 2012 and 2016 because ...
Posted by Michael Wonder on 18 Dec 2017
Time for big pharma to step up before the drug price debate rises again
18 December 2017 - In today’s social and political climate, public opinion and public action can galvanise and turn on an ...
Posted by Michael Wonder on 15 Dec 2017
Statement from FDA Commissioner on new FDA efforts to support more efficient development of targeted therapies
15 December 2017 - In recent years, the medical community has experienced a shift in the way health care is ...
Posted by Michael Wonder on 14 Dec 2017
Bumper crop of new drugs fails to lift big pharma R&D returns
14 December 2017 - It is shaping up to be a bumper year for drug approvals, with U.S. officials clearing twice ...
Posted by Michael Wonder on 07 Dec 2017
FDA required studies of approved drugs make a big difference for public health
7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be ...
Posted by Michael Wonder on 07 Dec 2017
Speed, safety, and industry funding - from PDUFA I to PDUFA VI
7 December 2017 - The FDA Reauthorization Act of 2017 includes the sixth version of the Prescription Drug User Fee Act. ...
Posted by Michael Wonder on 30 Nov 2017
Advancing medicinal nicotine replacement therapies as new drugs – a new step in FDA’s comprehensive approach to tobacco and nicotine
29 November 2017 - As the leading cause of preventable disease and death in the United States, tobacco causes more than ...
Posted by Michael Wonder on 28 Nov 2017
Pharma's paradox: cure a deadly childhood disease and then get attacked on price
28 November 2017 - It’s a diagnosis that no parents want to hear - their child has acute lymphoblastic leukaemia. ...
Posted by Michael Wonder on 28 Nov 2017
FDA issues guidance that could make it easier for EpiPen rivals to come to market
28 November 2017 - FDA issued guidance that says generic copies with some design differences may be approved as substitutable products. ...
Posted by Michael Wonder on 19 Nov 2017
More than $150,0000 spent on mysterious 'Election 2017 project' by drug lobby group
19 November 2017 - A 'big pharma' lobby group has sunk more than $150,000 into a mysterious scheme called "Election ...
Posted by Michael Wonder on 18 Nov 2017
Drug companies are warming up to the idea of an Amazon pharmacy
17 November 2017 - Takeda CEO ‘in favour of a more effective distribution system’. ...
Posted by Michael Wonder on 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...
Posted by Michael Wonder on 16 Nov 2017
FDA announces comprehensive regenerative medicine policy framework
16 November 2017 - Framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy. ...
Posted by Michael Wonder on 05 Nov 2017
NHS patients should have a choice of drug for wet age-related macular degeneration, despite pressure from pharma
1 November 2017 - Commissioners have to pay more than lip service to the obligation on us to find cost ...