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. ...

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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 ...

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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 ...

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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) ...

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FDA needs a competitiveness czar

15 October 2021 - The FDA needs a Deputy Commissioner for Regulatory Competitiveness.  ...

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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 ...

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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.  ...

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Recommendations made by the PBAC – September 2021 intracycle meeting

15 October 2021 - First PBAC recommendation for a new gene therapy. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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