Blog
RSS FeedPosted 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 11 Feb 2020
Fennec Pharmaceuticals completes rolling submission of new drug application to U.S. FDA for Pedmark and also submits marketing authorisation application to EMA
11 February 2020 - Pedmark is being developed for prevention of cisplatin-induced hearing loss in children. ...
Posted by Michael Wonder on 24 Dec 2019
U.S. FDA approves Eisai's Dayvigo (lemborexant) for treatment of insomnia in adult patients
23 December 2019 - Orexin receptor antagonist proven effective for both sleep onset and sleep maintenance in clinical development program of ...
Posted by Michael Wonder on 24 Dec 2019
European Medicines Agency validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
23 December 2019 - Potential first gene therapy in Europe directed at any type of haemophilia. ...
Posted by Michael Wonder on 18 Dec 2019
U.S. FDA accepts and grants priority review to sNDA for Braftovi (encorafenib) in combination with Erbitux (cetuximab) (Braftovi doublet) for the treatment of BRAF V600E-mutant metastatic colorectal cancer after prior therapy
18 December 2019 - Pfizer today announced that the U.S. FDA has accepted and granted priority review to the Company’s supplemental ...
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 06 Nov 2019
One shot drug to end Sicilian curse comes at $1.8 million cost
5 November 2019 - A new targeted gene therapy shows the promise and pitfalls of medical advances. ...
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 21 Oct 2019
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis
21 October 2019 - Stelara is the first and only approved treatment for ulcerative colitis to demonstrate improvement of the colon ...
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 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, ...
Posted by Michael Wonder on 10 Jul 2019
FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...
Posted by Michael Wonder on 06 Jun 2019
US FDA and EMA accept applications for ozanimod for the treatment of relapsing forms of multiple sclerosis
6 June 2019 - Celgene Corporation today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 19 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...