Blog
RSS FeedPosted by Michael Wonder on 12 Apr 2018
ICER posts draft scoping document on therapies for prevention of hereditary angioedema attacks
12 April 2018 - Document open to public comment until 2 May 2018; report expected to review lanadelumab (Shire), and C1 ...
Posted by Michael Wonder on 12 Apr 2018
FDA finalises guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
12 April 2018 - The agency is leveraging new tools and policies to advance the creation of innovative genetic and genomic-based ...
Posted by Michael Wonder on 12 Apr 2018
Demand cancer drugs that truly help patients
10 April 2018 - Already this year, the US FDA has approved or extended the use of several cancer drugs ...
Posted by Michael Wonder on 12 Apr 2018
As cancer drug prices climb, value not keeping pace
13 April 2018 - The cost of new anti-cancer drugs increased more than five-fold from 2006 to 2015, but a ...
Posted by Michael Wonder on 12 Apr 2018
Mallinckrodt shares slide on whistleblower lawsuit involving its best-selling drug
12 April 2018 - The lawsuit filed by Rasvinder Dhaliwal, former associate director at Mallinckrodt, claims the company didn't know what ...
Posted by Michael Wonder on 12 Apr 2018
Why we may lose generic drugs
11 April 2018 - Manufacturers say they may stop making medicines that don’t turn a profit. ...
Posted by Michael Wonder on 12 Apr 2018
ICER releases draft evidence report on CGRP inhibitors for migraine prevention
11 April 2018 - Public comment period now open until 8 May; requests to make oral comment during public meeting also ...
Posted by Michael Wonder on 11 Apr 2018
Breakthrough-therapy designation — an FDA perspective
12 April 2018 - Recent medical advances, such as targeted therapies for specific tumour genomic defects, checkpoint inhibitors for cancers, and ...
Posted by Michael Wonder on 11 Apr 2018
The FDA breakthrough-drug designation — four years of experience
12 April 2018 - In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA of ...
Posted by Michael Wonder on 11 Apr 2018
CVS pharmacists will have new tools to help patients save money on drugs
11 April 2018 - CVS Health is rolling out a new tool to alert its 30,000 pharmacists to cheaper drug ...
Posted by Michael Wonder on 11 Apr 2018
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
11 April 2018 - The U.S. FDA today permitted marketing of the first medical device to use artificial intelligence to detect ...
Posted by Michael Wonder on 11 Apr 2018
Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with penta-refractory multiple myeloma
10 April 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to the company’s lead, ...
Posted by Michael Wonder on 11 Apr 2018
Novartis’ Afinitor Disperz wins new TSC-related approval
11 April 2018 - Novartis’ Afinitor Disperz has become the first medicine to be specifically approved by US regulators to ...
Posted by Michael Wonder on 10 Apr 2018
Feds broaden the definition of ‘pharmacy’ in a bid to level playing field for startup
6 April 2018 - Across the US, upstart pharmacies are turning the prescription drug business on its head, offering digitally ...
Posted by Michael Wonder on 10 Apr 2018
ICER publishes guidance on improving the development and use of real world evidence for drug coverage and formulary decisions
10 April 2018 - The ICER, in collaboration with the Office of Health Economics, has released two new white papers to ...