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Exparel (bupivacaine liposome injectable suspension) / PaciraPACIRA RECEIVES POSITIVE CHMP OPINION FOR EXPAREL (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION) FOR THE TREATMENT OF POSTSURGICAL PAIN (Pacira Pharmaceuticals Press Release) - Sep 18, 2020 - "Pacira BioSciences, Inc....today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for EXPAREL for postsurgical analgesia....The European Commission will review the CHMP opinion and is expected to adopt a final decision in November 2020. The decision will be applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein." Nyvepria (pegfilgrastim-apgf) / PfizerEuropean advisory group back Pfizer's Neulasta biosimilar (SeekingAlpha) - Sep 18, 2020 - "The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Pfizer's (NYSE:PFE) Nyvepria (pegfilgrastim), a biosimilar to Amgen's (NASDAQ:AMGN) Neulasta." Zejula (niraparib) / GSK, ZAI Lab, J&J, TakedaEuropean advisory group backs expanded use of Glaxo's Zejula (SeekingAlpha) - Sep 18, 2020 - "The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of GlaxoSmithKline's (GSK +0.0%) Zejula (niraparib) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemo." Tecentriq (atezolizumab) / Roche; Avastin (bevacizumab) / RocheRoche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer (GlobeNewswire) - Sep 18, 2020 - "Roche...announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy...The recommendation from the CHMP is based on results from the Phase III IMbrave150 study..." Olumiant (baricitinib) / Incyte, Eli Lilly, University of ColoradoCHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis (PRNewswire) - Sep 18, 2020 - "Eli Lilly and Company...announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy....A final decision is expected from the European Commission in the next one-two months....The positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies..."
