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RSS FeedPosted by Michael Wonder on 06 Jun 2019
Strengthening engagement between EMA and general practitioners
6 June 2019 - EMA and the two major organisations representing general practitioners (GPs) and family physicians in Europe – ...
Posted by Michael Wonder on 06 Jun 2019
Enzyvant announces FDA acceptance of biologics license application and priority review status for RVT-802, a novel investigational tissue-based regenerative therapy for paediatric congenital athymia
5 June 2019 - RVT-802, a one-time therapy, leverages Enzyvant’s T cell generation platform designed to treat profound immunodeficiencies. ...
Posted by Michael Wonder on 06 Jun 2019
Alnylam completes rolling submission of new drug application to U.S. FDA for givosiran for the treatment of acute hepatic porphyria
5 June 2019 - First potential treatment demonstrating substantial reduction in the frequency of porphyria attacks. ...
Posted by Michael Wonder on 05 Jun 2019
Pharma groups combine to promote drug discovery with AI
5 June 2019 - Blockchain system allows companies to share data without revealing commercial secrets. ...
Posted by Michael Wonder on 05 Jun 2019
Sierra announces momelotinib granted FDA fast track designation
5 June 2019 - Fast Track designation highlights the potential for momelotinib to address the significant unmet needs of patients with ...
Posted by Michael Wonder on 05 Jun 2019
GSK's Nucala wins European panel thumbs-up for self-administration
4 June 2019 - GlaxoSmithKline said on Tuesday it had won marketing approval from a EM) panel for its Nucala ...
Posted by Michael Wonder on 05 Jun 2019
Janssen seeks to expand use of Erleada (apalutamide) in the treatment of patients with metastatic hormone-sensitive prostate cancer
4 June 2019 - Application supported by data from the Phase 3 TITAN study which were recently presented at the ...
Posted by Michael Wonder on 05 Jun 2019
Pfizer knew drug may prevent Alzheimer's. Why didn't it tell us?
5 June 2019 - A team of researchers inside Pfizer made a startling find in 2015: the company's blockbuster rheumatoid ...
Posted by Michael Wonder on 04 Jun 2019
FDA approves Lilly’s migraine drug as first ever cluster headache treatment
4 June 2019 - The drug will be priced the same as for migraine on a per milligram basis, but the ...
Posted by Michael Wonder on 04 Jun 2019
Hiding in plain sight: the FDA’s approach to disclosing new drug applications is a disservice to public health
4 June 2019 - Remember in high school when a friend told you a secret and you guarded it assiduously, ...
Posted by Michael Wonder on 04 Jun 2019
The European Medicines Agency’s goals for regulatory science to 2025
4 June 2019 - It is increasingly important that regulatory agencies catalyse the translation of scientific and technological innovation into improved ...
Posted by Michael Wonder on 04 Jun 2019
FDA to make it easier for doctors to get unapproved cancer drugs for patients
3 June 2019 - Agency will work closely with physicians seeking treatments through its “expanded access” program. ...
Posted by Michael Wonder on 04 Jun 2019
Celgene Corporation and Acceleron Pharma announce U.S. FDA accepts luspatercept biologics license application in myelodysplastic syndromes and beta-thalassemia
4 June 2019 - U.S. FDA grants priority review for beta-thalassemia indication and sets target action date of 4 December ...
Posted by Michael Wonder on 04 Jun 2019
U.S. FDA accepts new drug application for triple combination tablet for adults with type 2 diabetes
4 June 2019 - The U.S. FDA has accepted the new drug application for the investigational fixed-dose combination tablet of empagliflozin, ...
Posted by Michael Wonder on 04 Jun 2019
Consultation on draft guideline on quality requirements for medical devices in combination products
3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...