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RSS FeedPosted by Michael Wonder on 10 Jul 2018
President Trump attacks symptom, not disease, in prescription drug price attack
10 July 2018 - President Trump launched a new broadside against prescription drug manufacturers yesterday, tweeting, "Pfizer & others should ...
Posted by Michael Wonder on 10 Jul 2018
Medicines Australia welcomes priority review pathway programme milestone
10 July 2018 - Last week saw the listing of Eryland (apalutamide) for the treatment men with non-metastatic (castration-resistant) prostate ...
Posted by Michael Wonder on 07 Jul 2018
Drug makers try evasion, tougher negotiations to fight new U.S. insurer tactic
5 July 2018 - In the escalating battle over U.S. prescription drug prices, major pharmaceutical companies are scrambling to limit the ...
Posted by Michael Wonder on 05 Jul 2018
Drug makers defy Trump's call to drop prices
3 July 2018 - President Donald Trump in May said that drug makers would soon announce “massive” price cuts, and ...
Posted by Michael Wonder on 03 Jul 2018
Why July is a risky month for drug price backlash
3 July 2018 - Less than two months after its unveiling, President Donald Trump’s plan to lower prescription drug prices ...
Posted by Michael Wonder on 03 Jul 2018
Deloitte survey finds biopharma companies are accelerating adoption of real-world evidence
28 June 2018 - A recent survey shows that 90% of biopharma companies are making significant investments in real-world evidence ...
Posted by Michael Wonder on 02 Jul 2018
Valeant is back to its old drug pricing ways
1 July 2018 - Prices for diarrhoea drug are up as smaller pill package is dropped, milligram price is raised. ...
Posted by Michael Wonder on 28 Jun 2018
The biopharmaceutical industry provides 75% of the FDA's drug review budget. Is this a problem?
28 June 2018 - Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its ...
Posted by Michael Wonder on 28 Jun 2018
Bias, operational bias, and generalisability in Phase II/III trials
27 June 2018 - Adaptive clinical trial designs improve the efficiency of the drug development process by allowing treatment decisions to ...
Posted by Michael Wonder on 25 Jun 2018
As the drug industry eyes the burgeoning biosimilar market, its united front is starting to crack
25 June 2018 - The pharmaceutical industry’s massive lobbying operation has a well-earned reputation for maintaining a united front on ...
Posted by Michael Wonder on 22 Jun 2018
FDA announces program to enhance early communications with biological product developers
22 June 2018 - The FDA’s new INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program was created ...
Posted by Michael Wonder on 21 Jun 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...
Posted by Michael Wonder on 17 Jun 2018
Personalised medicine and pay for performance: should pharmaceutical firms be fully penalised when treatment fails?
17 June 2018 - In this article, we model the behaviour of a pharmaceutical firm that has marketing authorisation for a ...
Posted by Michael Wonder on 14 Jun 2018
Building synergy between regulatory and HTA agencies beyond processes and procedures—can we effectively align the evidentiary requirements? A survey of stakeholder perceptions
13 June 2018 - The pathway for bringing a new medicine to the market is dependent on two sequential processes: achieving ...
Posted by Michael Wonder on 12 Jun 2018
Trump health chief renews call to end key drug pricing tactic
12 June 2018 - HHS Secretary Azar testifies before Senate on drug pricing. ...