Blog
RSS FeedPosted by Michael Wonder on 18 Sep 2020
CHMP recommends approval of Lilly's baricitinib for the treatment of adults with moderate to severe atopic dermatitis
18 September 2020 - Positive opinion is the first regulatory action for baricitinib as an atopic dermatitis medicine. ...
Posted 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
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 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 15 Sep 2020
Apellis announces submission of pegcetacoplan marketing applications to FDA and EMA for patients with PNH
15 September 2020 - -- Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the ...
Posted by Michael Wonder on 15 Sep 2020
European Medicines Agency approves safety label update for Novartis Beovu
14 September 2020 - Novartis worked with the EMA to update the Beovu (brolucizumab) label to guide physicians in their treatment ...
Posted by Michael Wonder on 15 Sep 2020
Vertex announces European Medicines Agency type II variation marketing authorisation application validation for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in people with one copy of the F508del mutation
14 September 2020 - Vertex Pharmaceuticals today announced the EMA has validated a type II variation marketing authorisation application for ...
Posted by Michael Wonder on 14 Sep 2020
EMA publishes agenda for 14-17 September CHMP meeting
14 September 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 14 Sep 2020
Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
14 September 2020 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...
Posted by Michael Wonder on 10 Sep 2020
EU review extended for BioMarin's gene therapy Valrox
10 September 2020 - European regulators have requested more data to review the marketing application for BioMarin's haemophilia A gene ...
Posted by Michael Wonder on 09 Sep 2020
Ascendis Pharma submits marketing authorisation application to the EMA for TransCon hGH for the treatment of paediatric growth hormone deficiency
8 September 2020 - Ascendis Pharma announced today the submission of a marketing authorisation application to the EMA seeking approval for ...
Posted by Michael Wonder on 08 Sep 2020
Janssen announces European Commission decision for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
7 September 2020 - Patients who were new to chronic lymphocytic leukaemia treatment lived longer without disease progression with the Imbruvica ...