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RSS FeedPosted by Michael Wonder on 18 Sep 2020
Highlights from 14-17 September CHMP meeting
18 September 2020 - Seven new medicines recommended for approval. ...
Posted by Michael Wonder on 18 Sep 2020
EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
18 September 2020 - EMA’s CHMP has completed its review of results from the RECOVERY study arm that involved the ...
Posted by Michael Wonder on 17 Sep 2020
Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer
16 September 2020 - Next generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly ...
Posted by Michael Wonder on 17 Sep 2020
ChemoCentryx announces FDA acceptance of the avacopan new drug application for the treatment of ANCA associated vasculitis
17 September 2020 - FDA sets PDUFA goal date of 7 July 2021. ...
Posted by Michael Wonder on 17 Sep 2020
EMA close to finalising guidance for advanced therapies
16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...
Posted by Michael Wonder on 17 Sep 2020
Eton Pharmaceuticals provides update on the FDA review of EM-100
16 September 2020 - Eton Pharmaceuticals reported that its partner has not yet received a communication from the U.S. FDA regarding ...
Posted by Michael Wonder on 17 Sep 2020
Coronavirus vaccine: Donald Trump contradicts CDC director Robert Redfield
17 September 2020 - Donald Trump has issued an extraordinary public rebuke to his own government’s top health official, labelling him ...
Posted by Michael Wonder on 16 Sep 2020
Up is down — pharmaceutical industry caution versus federal acceleration of COVID-19 vaccine approval
15 September 2020 - Nine pharmaceutical company leaders took the unprecedented step on 8 September 2020, of stating that they would ...
Posted by Michael Wonder on 16 Sep 2020
FDA granted paediatric disease designation for OXi-4503
16 September 2020 - Treatment of acute myeloid leukaemia due to genetic mutations that disproportionately affect paediatric patients. ...
Posted by Michael Wonder on 16 Sep 2020
Orphazyme announces U.S. FDA acceptance and priority review of new drug application for arimoclomol for Niemann-Pick disease Type C
16 September 2020 - If approved, arimoclomol would become the first approved therapy in the U.S. for people with Niemann-Pick disease ...
Posted by Michael Wonder on 16 Sep 2020
MediWound announces FDA acceptance of biologics license application for NexoBrid for the treatment of severe thermal burns
16 September 2020 - MediWound today announced that the U.S. FDA has accepted for review its recently submitted biologics license application ...
Posted by Michael Wonder on 16 Sep 2020
EMA validates Bristol Myers Squibb’s type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of malignant pleural mesothelioma
15 September 2020 - Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer ...
Posted by Michael Wonder on 16 Sep 2020
GenSight Biologics submits EU marketing authorisation application for Lumevoq gene therapy to treat vision loss due to Leber hereditary optic neuropathy
15 September 2020 - First marketing authorisation application for a gene therapy treating a mitochondrial disease. ...
Posted by Michael Wonder on 16 Sep 2020
EMA approves label update for Hyqvia (human normal immunoglobulin 10% and recombinant human hyaluronidase), expanding its use to a broader group of patients with secondary immunodeficiencies
15 September 2020 - Takeda today announced that the EMA has approved a label update for Hyqvia (human normal immunoglobulin 10% ...
Posted by Michael Wonder on 16 Sep 2020
Brenzys (etanercept injection) now indicated for the treatment of plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis
15 September 2020 - Brenzys is a biosimilar biologic drug authorised based on its similarity to Enbrel, which is already approved ...