Blog
RSS FeedPosted by Michael Wonder on 19 Apr 2021
Agenus submits balstilimab biologics license application to the U.S. FDA for patients with recurrent or metastatic cervical cancer
19 April 2021 - Submission has been made for review under the accelerated approval pathway ...
Posted by Michael Wonder on 08 Apr 2021
Dying patients wait in vain after Trump-era easing of drug law
6 April 2021 - Companies hold back experimental medications from those who want them most. They say they have good reasons, ...
Posted by Michael Wonder on 11 Feb 2021
FDA’s generic drug program in 2020 helped ensure availability of high quality, affordable drugs amid COVID-19
11 February 2021 - Generic drugs play a vital role in facilitating access to lifesaving medicines for Americans and remain a ...
Posted by Michael Wonder on 28 Nov 2020
Alnylam announces innovative value-based agreement framework for Oxlumo (lumasiran) to accelerate access for patients with primary hyperoxaluria type 1 and deliver ultra-rare orphan disease pricing solutions to U.S. payers
24 November 2020 - Expedited access to Oxlumo aims to support children and adults living with PH1 who face inevitable disease ...
Posted by Michael Wonder on 12 Nov 2020
The challenges ahead with monoclonal antibodies: from authorisation to access
11 November 2020 - When President Trump received an infusion of a monoclonal antibody cocktail (REGN-COV2, Regeneron) on October 2, ...
Posted by Michael Wonder on 20 Oct 2020
COVID-19 vaccines: time to talk about the uncertainties
20 October 2020 - Plan now for decisions on which vaccines should go to whom, when and how often. ...
Posted by Michael Wonder on 20 Oct 2020
Roche CEO warns against high hopes for speedy Covid vaccines
20 October 2020 - Many people’s hopes for a speedy coronavirus vaccine are still too high, Roche Holding AG Chief ...
Posted by Michael Wonder on 15 Oct 2020
Testing requirements are likely slowing biosimilar entries in the US
14 October 2020 - Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation ...
Posted by Michael Wonder on 03 Sep 2020
California may be the first state to develop its own generic drugs
1 September 2020 - California is poised to become the first state to develop its own line of generic drugs, ...
Posted by Michael Wonder on 02 Sep 2020
23 attorneys general urge FDA to ensure affordable access to insulin
3 September 2020 - Michigan Attorney General Dana Nessel has joined a bipartisan coalition of 23 attorneys general in signing ...
Posted by Michael Wonder on 12 Aug 2020
US hoses down Russian vaccine, says it will have millions of doses ready year's end
12 August 2020 - US Health Secretary Alex Azar has criticised a COVID-19 vaccine being promoted by Russian President Vladimir ...
Posted by Michael Wonder on 08 Aug 2020
Hard questions as scientists and governments seek COVID-19 vaccines
8 August 2020 - They must work out how much to invest, and how best to distribute the goods. ...
Posted by Michael Wonder on 20 Jul 2020
Gene therapy shows promise for haemophilia, but could be most expensive U.S. drug ever
20 June 2020 - Jack Grehan, who was born with hemophilia, used to inject himself every couple of days with ...
Posted by Michael Wonder on 05 Jul 2020
FDA Commissioner says he can't predict when vaccine will be ready after Trump's timeline claims
5 July 2020 - Food and Drug Administration Commissioner Stephen Hahn said Sunday that he would not make a prediction ...
Posted by Michael Wonder on 09 Jun 2020
BioCryst announces berotralstat expanded access program for patients with hereditary angioedema in United States
9 June 2020 - BioCryst Pharmaceuticals today announced that the company has established an expanded access program with oral, once-daily ...