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RSS FeedPosted by Michael Wonder on 28 Feb 2024
AB Science announces that Health Canada has issued a notice of non-compliance-withdrawal for masitinib in ALS
26 February 2024 - AB Science today announces that Health Canada has issued a notice of non-compliance-withdrawal regarding its new ...
Posted by Michael Wonder on 27 Feb 2024
Theratechnologies receives refusal to file letter for Trogarzo intramuscular method of administration sBLA from FDA
27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s ...
Posted by Michael Wonder on 27 Feb 2024
Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia
27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...
Posted by Michael Wonder on 27 Feb 2024
Etrasimod arginine for the treatment of patients with moderate to severe active ulcerative colitis
27 February 2024 - NICE has published final evidence-based recommendations on the use of etrasimod arginine (Velsipity) for the treatment ...
Posted by Michael Wonder on 26 Feb 2024
Voydeya recommended for approval in the EU by CHMP as add-on treatment to ravulizumab or eculizumab for adults with PNH who have residual haemolytic anaemia
26 February 2024 - Recommendation of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial results. ...
Posted by Michael Wonder on 26 Feb 2024
CSL Vifor and Travere Therapeutics announce sparsentan receives positive CHMP opinion for the treatment of IgA nephropathy
23 February 2024 - Positive CHMP opinion is based on pivotal Phase 3 PROTECT study results. ...
Posted by Michael Wonder on 26 Feb 2024
Highlights from the 19-22 February 2024 CHMP meeting
23 February 2024 - The EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting. ...
Posted by Michael Wonder on 26 Feb 2024
Alvotech and Teva announce US approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high concentration, citrate free biosimilar to Humira
23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...
Posted by Michael Wonder on 24 Feb 2024
Vertex receives CHMP positive opinion for Kalydeco for the treatment of infants with cystic fibrosis ages 1 month and older
23 February 2024 - If approved, Kalydeco will be the first and only medicine approved in Europe to treat the underlying ...
Posted by Michael Wonder on 24 Feb 2024
Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam
23 February 2024 - No clinical safety or efficacy issues identified. ...
Posted by Michael Wonder on 24 Feb 2024
Janssen receives positive CHMP opinion for Carvykti (ciltacabtagene autoleucel) for treatment in earlier lines of relapsed and refractory multiple myeloma
23 February 2024 - Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the ...
Posted by Michael Wonder on 24 Feb 2024
First oral treatment against residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria
23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for Voydeya, the first ...
Posted by Michael Wonder on 24 Feb 2024
New treatment for rare motor neurone disease recommended for approval
23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for a new therapy ...
Posted by Michael Wonder on 24 Feb 2024
Bristol Myers Squibb receives positive CHMP opinion for Reblozyl (luspatercept) for treatment of adults with transfusion-dependent anaemia due to low- to intermediate-risk myelodysplastic syndromes
23 February 2024 - In the pivotal Phase 3 COMMANDS study, Reblozyl nearly doubled the percentage of patients achieving primary ...
Posted by Michael Wonder on 24 Feb 2024
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for the treatment of resectable NSCLC at high risk of recurrence
23 February 2024 - Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. ...