Blog
RSS FeedPosted by Michael Wonder on 08 Jun 2020
U.K. lab to sidestep pharma industry to sell potential virus vaccine
7 June 2020 - Imperial College aims to develop a vaccine that is cheaper and easier to manufacture and is forming ...
Posted by Michael Wonder on 23 May 2020
Intercept provides regulatory update
22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept ...
Posted by Michael Wonder on 20 Apr 2020
FDA and EMA accept applications for Genentech’s Ocrevus (ocrelizumab) shorter two hour infusion time
19 April 2020 - Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary ...
Posted by Michael Wonder on 14 Apr 2020
Regulators split on anti-malarials for COVID-19
11 April 2020 - US and French authorities have authorised the use of chloroquine and hydroxychloroquine, but the EU regulator and ...
Posted by Michael Wonder on 08 Apr 2020
Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer
8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial. ...
Posted by Michael Wonder on 08 Apr 2020
Alnylam completes rolling submission of new drug application to the U.S. FDA and submits marketing authorisation application to the EMA for lumasiran for the treatment of primary hyperoxaluria type 1
7 April 2020 - Lumasiran is the first potential therapeutic to demonstrate substantial reduction in urinary oxalate excretion. ...
Posted by Michael Wonder on 23 Mar 2020
FDA and EMA collaborate to facilitate SARS-CoV-2 vaccine development
23 March 2020 - Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed ...
Posted by Michael Wonder on 24 Feb 2020
Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis
24 February 2020 - Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and ...
Posted by Michael Wonder on 14 Jan 2020
PTC Therapeutics provides corporate update
13 January 2020 - PTC-AADC MAA submitted; BLA now expected to be submitted in 2Q 2020. ...
Posted by Michael Wonder on 14 Dec 2019
ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir for children living with HIV
13 December 2019 - If approved, this new formulation of DTG will be the first integrase inhibitor available as a dispersible ...
Posted by Michael Wonder on 30 Oct 2019
EMA and FDA accept marketing applications for Chugai's satralizumab in neuromyelitis optica spectrum disorder
30 October 2019 - The applications will be reviewed under accelerated assessment by EMA. ...
Posted by Michael Wonder on 09 Sep 2019
Allergan and Molecular Partners announce acceptance of U.S. FDA biologics license application and validation of EMA marketing authorisation for abicipar pegol in patients with neovascular (wet) age-related macular degeneration
9 September 2019 - Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of abicipar quarterly ...
Posted by Michael Wonder on 02 Aug 2019
FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications
31 July 2019 - The FDA and the EMA are publishing the discussion and main conclusions from a workshop held ...
Posted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...
Posted by Michael Wonder on 15 Jul 2019
Report on the current status of the use of real‐world data and real‐world evidence in drug development and regulation
10 July 2019 - Radically expanding use of real‐world data and real‐world evidence holds the potential to substantially impact drug development, ...