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RSS FeedPosted by Michael Wonder on 18 Oct 2021
FDA approves Cyltezo, the first interchangeable biosimilar to Humira
18 October 2021 - The U.S. FDA approved the first interchangeable biosimilar product to treat certain inflammatory diseases. ...
Posted by Michael Wonder on 18 Oct 2021
Update on U.S. FDA review of biologics license application for bimekizumab
16 October 2021 - The U.S. FDA has informed UCB via letter that the Agency was unable to complete review of ...
Posted by Michael Wonder on 18 Oct 2021
Novartis applauds Quebec, the first province to list Zolgensma for the treatment of paediatric patients with spinal muscular atrophy
15 October 2021 - Public reimbursement under the Régie de l'assurance maladie du Québec, effective October 20th will apply for children ...
Posted by Michael Wonder on 18 Oct 2021
TGA provisional approval of Roche COVID-19 treatment, casirivimab with imdevimab (Ronapreve)
18 October 2021 - The TGA has provisionally approved the use of the Roche combination therapy, casirivimab + imdevimab (Ronapreve) ...
Posted by Michael Wonder on 17 Oct 2021
FDA needs a competitiveness czar
15 October 2021 - The FDA needs a Deputy Commissioner for Regulatory Competitiveness. ...
Posted by Michael Wonder on 17 Oct 2021
Recent trends in Medicaid spending and use of drugs with US Food and Drug Administration accelerated approval
8 October 2021 - In this cross-sectional study of 216 drugs granted accelerated approval from 1992 through 2020, relative to all ...
Posted by Michael Wonder on 17 Oct 2021
How much does it cost to research and develop a new drug? A systematic review and assessment
15 October 2021 - Debate over the viability of the current commercial research and development model is on-going. ...
Posted by Michael Wonder on 17 Oct 2021
Recommendations made by the PBAC – September 2021 intracycle meeting
15 October 2021 - First PBAC recommendation for a new gene therapy. ...
Posted by Michael Wonder on 17 Oct 2021
Pfizer’s abrocitinib receives positive CHMP opinion for the treatment of adults with moderate to severe atopic dermatitis
15 October 2021 - CHMP also recommends Xeljanz (tofacitinib) approval for the treatment of adults with active ankylosing spondylitis ...
Posted by Michael Wonder on 17 Oct 2021
Merck and Eisai receive positive EU CHMP opinions for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) in two different types of cancer
15 October 2021 - Merck and Eisai today announced that the CHMP of the EMA has adopted positive opinions recommending ...
Posted by Michael Wonder on 16 Oct 2021
Merck receives positive CHMP opinion for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) in individuals 18 years of age and older
15 October 2021 - Merck today announced that the EMA’s CHMP has recommended the approval of Vaxneuvance (Pneumococcal 15 valent ...
Posted by Michael Wonder on 16 Oct 2021
Bristol Myers Squibb receives positive CHMP opinion for Zeposia (ozanimod) as a treatment for adult patients with moderately to severely active ulcerative colitis
15 October 2021 - CHMP recommendation based on positive results from the Phase 3 True North trial, in which Zeposia demonstrated ...
Posted by Michael Wonder on 16 Oct 2021
Janssen receives Positive CHMP opinion for Rybrevant (amivantamab) for the treatment of patients with advanced non-small cell lung cancer with EGFR exon 20 insertion mutations after failure of platinum-based therapy
15 October 2021 - If approved by the European Commission, amivantamab will be the first treatment in the European Union specifically ...
Posted by Michael Wonder on 16 Oct 2021
AbbVie receives CHMP positive opinion for risankizumab (Skyrizi) for the treatment of adults with active psoriatic arthritis in the European Union
15 October 2021 - CHMP positive opinion is based on data from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2. ...
Posted by Michael Wonder on 15 Oct 2021
TLV's web application for TNF inhibitors shows room for savings
15 October 2021 - The TLV, has developed a web application that will show the regions' use of TNF inhibitors ...
Posted by Michael Wonder on 15 Oct 2021
NICE clears Opdivo for resected oesophageal or gastro-oesophageal junction cancer
15 October 2021 - The UK NICE has recommended BMS' Opdivo (nivolumab) as a treatment option for certain resected oesophageal ...