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RSS FeedPosted by Michael Wonder on 04 Jun 2021
FDA authorises lower 1,200 mg intravenous and subcutaneous dose of Regen-COV (casirivimab and imevimab) antibody cocktail to treat patients with COVID-19
4 June 2021 - EUA supported by pivotal Phase 3 data showing 1,200 mg dose reduced risk of hospitalisation or death ...
Posted by Michael Wonder on 04 Jun 2021
NICE turns down GSK's IV Benlysta for systemic lupus
4 June 2021 - NICE has rejected NHS funding for an intravenous formulation of GlaxoSmithKline's Benlysta (belimumab) as an add-on ...
Posted by Michael Wonder on 04 Jun 2021
Advancing international collaboration on COVID-19 real world evidence and observational studies
4 June 2021 - Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation ...
Posted by Michael Wonder on 03 Jun 2021
The big pharma firm that saw the future
3 June 2021 - Long ago Roche bet on personalised health care. Now its time has come. ...
Posted by Michael Wonder on 03 Jun 2021
Biden health official 'taking a look' at Trump drug pricing proposal
3 June 2021 - A key Biden administration health official said Thursday that she is "taking a look" at one ...
Posted by Michael Wonder on 03 Jun 2021
EU regulators develop recommendations to forecast demand of medicines
3 June 2021 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events has adopted a ...
Posted by Michael Wonder on 03 Jun 2021
U.S. FDA accepts PharmaEssentia’s BLA resubmission for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera
3 June 2021 - FDA assigns a new PDUFA action date of 13 November 2021. ...
Posted by Michael Wonder on 03 Jun 2021
Dermavant submits new drug application to FDA for tapinarof cream for the treatment of adults with plaque psoriasis
3 June 2021 - New drug application is supported by positive data from the Phase 3 PSOARING 1 and PSOARING 2 ...
Posted by Michael Wonder on 03 Jun 2021
Protagonist Therapeutics receives FDA breakthrough therapy designation for rusfertide in polycythemia vera
3 June 2021 - Designation further validates registrational path for rusfertide in polycythemia vera and facilitates potentially expedited development and review. ...
Posted by Michael Wonder on 03 Jun 2021
Most Americans support Medicare negotiation despite claims it would hurt innovation
3 June 2021 - A new West Health/Gallup survey finds nearly all Democrats (97%) and the majority of Republicans (61%) support ...
Posted by Michael Wonder on 03 Jun 2021
'We're not just all about the money' — PHARMAC defends why it still won't fund drug for rare children's disorder
3 June 2021 - Under-fire PHARMAC is defending the way it funds New Zealand's drugs, with the agency's director of operations, ...
Posted by Michael Wonder on 03 Jun 2021
FDA grants priority review for new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa
3 June 2021 - PDUFA date of 30 November 2021 set for Oleogel-S10. ...
Posted by Michael Wonder on 03 Jun 2021
Quebec extends public reimbursement of Dupixent (dupilumab) for the treatment of moderate to severe atopic dermatitis to include adolescents
1 June 2021 - Public reimbursement under the Régie de l'assurance maladie du Québec will now apply for Canadians aged ...
Posted by Michael Wonder on 03 Jun 2021
Health Canada accepts new drug submission for Reduvo as a treatment for patients with chemotherapy-induced nausea and vomiting
2 June 2021 - Tetra Bio-Pharma announced today that Health Canada has accepted its new drug submission for Reduvo and has ...
Posted by Michael Wonder on 02 Jun 2021
FDA approves pricey pill to treat vaginal yeast infections
2 June 2021 - Regulators OK’d a new anti-fungal treatment, but critics say it is unneeded and costs too much. ...