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RSS FeedPosted by Michael Wonder on 23 Nov 2020
European Commission approves MenQuadfi, the latest innovation in meningococcal vaccination for individuals 12 months of age and older
23 November 2020 - EC approval based on robust data from seven pivotal Phase 2 and 3 trials involving more than ...
Posted by Michael Wonder on 23 Nov 2020
Alexion receives marketing authorisation from European Commission for new formulation of Ultomiris (ravulizumab) with significantly reduced infusion time
20 November 2020 - The new 100 mg/mL formulation will reduce infusion time by approximately 60%, lessening the burden on patients. ...
Posted by Michael Wonder on 20 Nov 2020
Update on remdesivir - EMA will evaluate new data from Solidarity trial
20 November 2020 - EMA is aware that the World Health Organization has updated its guidelines advising against the use ...
Posted by Michael Wonder on 20 Nov 2020
HMA/EMA statement on approval of vaccines
20 November 2020 - Development and deployment of safe and effective vaccines is seen as an essential element in the management ...
Posted by Michael Wonder on 19 Nov 2020
NICE recommends another medicine for patients with multiple myeloma
18 November 2020 - Recommended for listing in the Cancer Drugs Fund. ...
Posted by Michael Wonder on 19 Nov 2020
Alnylam receives approval for Oxlumo (lumasiran) in the European Union for the treatment of primary hyperoxaluria type 1 in all age groups
19 November 2020 - Oxlumo is the first therapeutic approved for the treatment of primary hyperoxaluria type 1, and the ...
Posted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
Posted by Michael Wonder on 19 Nov 2020
EMA organises public meeting on COVID-19 vaccines
19 November 2020 - EMA will organise a public meeting on 11 December 2020 to inform European citizens about the ...
Posted by Michael Wonder on 19 Nov 2020
Pacira receives European Commission approval for Exparel (bupivacaine liposome injectable suspension) for the treatment of post-surgical pain
18 November 2020 - Approval based on four pivotal studies showing Exparel reduced pain scores and opioid use following surgery. ...
Posted by Michael Wonder on 18 Nov 2020
European Commission approves Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older
18 November 2020 - Contains three times more antigen than standard-dose vaccines. ...
Posted 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
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
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 ...