Blog
RSS FeedPosted 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 31 Mar 2020
Expanded access as a source of real‐world data: an overview of FDA and EMA approvals
22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...
Posted by Michael Wonder on 23 Mar 2020
Eiger BioPharmaceuticals completes submission of new drug application to FDA for lonafarnib for treatment of progeria and progeroid laminopathies
23 March 2020 - Progeria MAA submitted to EMA and granted accelerated assessment. ...
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 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. ...