Day: June 28, 2021

Two of the Largest Global Insurance Companies Select Award-Winning CCM Solution Quadient Inspire Paris, June 28, 2021 Quadient (Euronext Paris: QDT), a leader in helping businesses create meaningful customer connections through digital and physical channels, announced today that it has secured two of the largest insurance companies in the USA and France this month. Both organizations have selected Quadient Inspire, the leading Customer Communications Management (CCM) solution. In the United States, one of the top three U.S. property and casualty insurance firms has decided to adopt Quadient’s award-winning CCM solution as their platform for all claims communications. This contract is one of the largest deals in the CCM industry in the past 5 years, and contributes to solidify Quadient’s market leadership position, with now three of the...

Co-primary endpoint of the study objective response rate (ORR) was not met The board of directors is undergoing a strategic assessment regarding the future of the companyALLSCHWIL, Switzerland, June 28, 2021 (GLOBE NEWSWIRE) — Polyphor AG (SIX: POLN), a research driven clinical stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance today announced that its global Phase III study, FORTRESS, evaluating balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2 negative, locally recurrent or metastatic breast cancer, did not meet its co-primary endpoint. At the primary analysis, balixafortide plus eribulin showed no improvement in the objective response rate (ORR) compared with eribulin alone (13.0% versus...

Dupixent® (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitisDupixent is the first and only available systemic treatment for atopic dermatitis that has been studied in adults for up to 3 years in a Phase 3 trialPARIS and TARRYTOWN, N.Y. – June 28, 2021– Long-term safety data from a study of adults with moderate-to-severe atopic dermatitis treated with Dupixent will be added to the Dupixent Summary of Product Characteristics (SmPC) following a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Data from a single-arm Phase 3 open label extension (OLE) trial showed the long-term safety profile in adults with moderate-to-severe atopic dermatitis treated with Dupixent and observed up to...

Basel, June 28, 2021 — Novartis announced today the appointment of Rob Kowalski, Pharm.D., Global Head Regulatory Affairs and US Head of Drug Development as Chief People & Organization Officer. He will report to Vas Narasimhan, M.D., CEO of Novartis and become a member of the Executive Committee of Novartis (ECN), effective September 1, 2021. Steven Baert, currently Chief People & Organization Officer, will step down from the Executive Committee of Novartis, effective June 30, 2021 after 15 years with the company and almost 8 years in position. Vicki Rawlinson, US Head People & Organization will lead the function ad-interim until Dr. Kowalski takes over. Dr. Kowalski is a senior drug development and regulatory executive with over 25 years of industry experience. He has successfully built and led Global Regulatory Affairs,...

Orphazyme A/SCompany announcement        No. 20/2021Inside informationCompany Registration No. 32266355–Significant headcount reduction of global workforce to free resources– -Changes to the Board of Directors- –Outlook for 2021 reiterated– Copenhagen – June 28, 2021 – Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announced a restructuring intended to enable the company to advance its corporate strategy and the development of arimoclomol for Niemann-Pick disease type C (NPC). The resulting cost savings include an approximate two thirds reduction in our global workforce. Orphazyme remains committed to pursuing regulatory approval in Europe and assessing a path forward for arimoclomol in the U.S. following receipt of a Complete Response Letter from the U.S. Food and Drug Administration...