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RSS FeedPosted by Michael Wonder on 16 Nov 2020
CHMP adopted positive opinion for Elzonris (tagraxofusp) for the treatment of blastic plasmacytoid dendritic cell neoplasm
13 November 2020 - The CHMP recommended approval of Elzonris for the first line treatment of adult patients with blastic plasmacytoid ...
Posted by Michael Wonder on 16 Nov 2020
CHMP recommends EU approval of Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2 positive breast cancer
13 November 2020 - Phesgo offers faster and less invasive delivery of standard of care treatment with Perjeta and Herceptin, under ...
Posted by Michael Wonder on 16 Nov 2020
Swissmedic begins rolling review of Moderna’s mRNA vaccine against COVID-19 (mRNA-1273)
13 November 2020 - Moderna completed enrolment of its Phase 3 COVE study of mRNA-1273 on October 22. ...
Posted by Michael Wonder on 16 Nov 2020
The CHMP has adopted a negative opinion for emapalumab in Europe for the treatment of primary HLH
13 November 2020 - Sobi today announced that the CHMP has adopted a negative opinion recommending a refusal of the ...
Posted by Michael Wonder on 16 Nov 2020
Emer Cooke takes office as head of EMA
16 November 2020 - Emer Cooke has begun her mandate as Executive Director of the European Medicines Agency today. ...
Posted by Michael Wonder on 16 Nov 2020
Adamis Pharmaceuticals receives a complete response letter from the FDA regarding Zimhi
16 November 2020 - Adamis Pharmaceuticals today announced that after the close of business and the U.S. markets on 13 ...
Posted by Michael Wonder on 16 Nov 2020
EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain
16 November 2020 - EMA’s CHMP has started a ‘rolling review’ of data on a vaccine for COVID-19 known as ...
Posted by Michael Wonder on 16 Nov 2020
Eisai receives approval for indication expansion of anti-epileptic agent Fycompa for use in paediatric patients
16 November 2020 - Eisai announced that it has been received approval from the European Commission for the use of its ...
Posted by Michael Wonder on 16 Nov 2020
Aerie Pharmaceuticals receives positive CHMP opinion for Roclanda in the European Union
13 November 2020 - European Commission Decision Anticipated in Approximately Two Months. ...
Posted by Michael Wonder on 15 Nov 2020
Insmed receives Priority Medicines (PRIME) designation from EMA for brensocatib in patients with non-cystic fibrosis bronchiectasis
13 November 2020 - Insmed today announced that the EMA has granted Priority Medicines (PRIME) designation to brensocatib for the ...
Posted by Michael Wonder on 15 Nov 2020
CHMP recommends EU approval of Roche’s Xofluza (baloxavir marboxil) for the treatment of influenza
13 November 2020 - One-dose, oral Xofluza has been recommended for approval for the treatment of uncomplicated influenza in patients aged ...
Posted by Michael Wonder on 15 Nov 2020
Agilent receives expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple negative breast cancer
13 November 2020 - Announcement marks the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained approval in the ...
Posted by Michael Wonder on 15 Nov 2020
Vaccines including for COVID-19 will be made in new Australian plant
15 November 2020 - A state-of-the-art facility focusing on producing vaccines for things like COVID-19 and snake bites will be built ...
Posted by Michael Wonder on 14 Nov 2020
FDA issues complete response letter for sutimlimab, an investigational treatment for haemolysis in adults with cold agglutinin disease
14 November 2020 - Complete response letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility. ...
Posted by Michael Wonder on 13 Nov 2020
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the treatment of post-operative pain
13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, ...