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RSS FeedPosted by Michael Wonder on 17 Aug 2020
Acute myeloid leukaemia: developing drugs and biological products for treatment
17 August 2020 - The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological ...
Posted by Michael Wonder on 17 Aug 2020
Myovant Sciences announces FDA acceptance of new drug application for once daily relugolix combination tablet for uterine fibroids
17 August 2020 - FDA sets target action date of 1 June 2021. ...
Posted by Michael Wonder on 17 Aug 2020
G1 Therapeutics announces acceptance and priority review of NDA for trilaciclib for patients with small cell lung cancer
17 August 2020 - G1 launching expanded access program for patients with small cell lung cancer in the U.S.. ...
Posted by Michael Wonder on 17 Aug 2020
AstraZeneca seals deal with EC for coronavirus vaccine supply
17 August 2020 - AstraZeneca has finalised an agreement with the European Commission to supply up to 400 million doses ...
Posted by Michael Wonder on 17 Aug 2020
United Therapeutics announces U.S. FDA filing acceptance of supplemental new drug application for Tyvaso for pulmonary hypertension associated with interstitial lung disease
17 August 2020 - United Therapeutics today announced that the U.S. FDA accepted for review the supplemental new drug application ...
Posted by Michael Wonder on 17 Aug 2020
CSL in talks with AstraZeneca to produce COVID-19 vaccine in Melbourne
17 August 2020 - Australia’s biggest health company, CSL, has confirmed it is in talks with British pharmaceutical giant AstraZeneca ...
Posted by Michael Wonder on 16 Aug 2020
Piqray is approved and now available in Canada as the first and only treatment specifically for patients with a PIK3CA mutation in HR positive, HER2 negative advanced breast cancer
13 August 2020 - Approval is based on results from SOLAR-1, where Piqray in combination with fulvestrant nearly doubled median progression-free ...
Posted by Michael Wonder on 16 Aug 2020
Submissions received: scope of regulated software based medical devices
14 August 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products ...
Posted by Michael Wonder on 16 Aug 2020
Australia 'close' to gaining access to Oxford's promising COVID-19 vaccine
16 August 2020 - The Morrison government is close to striking an international deal to domestically produce a vaccine to ...
Posted by Michael Wonder on 15 Aug 2020
FDA approves Genentech’s Enspryng for neuromyelitis optica spectrum disorder
14 August 2020 - First and only FDA approved subcutaneous treatment option for anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder that ...
Posted by Michael Wonder on 15 Aug 2020
Valuing innovative drugs based on their cost of manufacturing will prolong the COVID-19 pandemic
14 August 2020 - The value of innovative medicines has absolutely nothing to do with its cost of production. Yet, ...
Posted by Michael Wonder on 14 Aug 2020
ANTI-PD-1/CTLA-4 bi-specific antibody (AK104) of Akeso granted FDA fast track designation for recurrent and metastatic cervical cancer
13 August 2020 - Akeso today announced that the U.S. FDA has granted fast track designation for AK104, a novel anti-PD-1/CTLA-4 ...
Posted by Michael Wonder on 13 Aug 2020
European Medicines Agency validates BioMarin's marketing authorisation application for vosoritide to treat children with achondroplasia
13 August 2020 - Potential first medicine to treat achondroplasia in EU. ...
Posted by Michael Wonder on 13 Aug 2020
Drug prices fall in Switzerland but generics remain expensive
13 August 2020 - Switzerland is narrowing the gap with other European countries when it comes to the cost of medicines. ...
Posted by Michael Wonder on 13 Aug 2020
4D Molecular Therapeutics receives FDA fast track designation for 4D-310 gene therapy for treatment of Fabry disease
13 August 2020 - 4D Molecular Therapeutics announced that the U.S. FDA has granted fast track designation to 4D-310 for ...