Sanofi’s pompe disease therapy adopted for positive opinion by the European Medicines Agency

FRANCE – The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sanofi’s avalglucosidase alfa,a long-term enzyme replacement therapy for the treatment of people with Pompe disease. CHMP’s positive opinion and recommended indication reflect the robust data from avalglucosidase alfa’s clinical development program. The positive opinion is based on data from the Phase 3 COMET study, which found that avalglucosidase alfa showed clinically meaningful improvements in respiratory function and movement endurance measures in people with late-onset Pompe disease. Avalglucosidase alfa is…

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Diabetes tech market continues to witness an upward trend as more companies are coming up with new innovations

US – Despite the volatility of last year’s economy due to the corona virus pandemic, diabetes technology companies experienced tremendous success. Analysts have been bullish on the market as companies target new patient populations and major product launches have been planned for 2021 with clinicians approving of the same. Recent surveys of healthcare professionals projecting both the use of continuous glucose monitors and insulin pumps to jump in the coming years. While continuous glucose monitoring (CGMs) and insulin pumps are the primary devices in diabetes tech, the space is also…

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Merck and BioMedX set to partner as they strive to bolster their fight against cancer in a new joint cancer research programme

GERMANY – German based pharma company, Merck, and BioMed X, an independent research institute located at the University of Heidelberg in Germany have partnered to focus on their oncology related research. This is the eighth collaboration between the two organizations and is set to explore the role of extrachromosomal DNA (ecDNA) in cancer. BioMedX currently has two other ongoing oncology related programmes focused on DNA damage response and RNA splicing that this new research program is set to compliment. Extrachromosomal DNA (ecDNA) is any DNA that is found off the…

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Sanofi plans to invest in ‘center of excellence’ that focuses on mRNA vaccines

FRANCE- The French pharmaceutical giant Sanofi has announced its plan to invest US$475.4m into a new facility focused on solely on the development and delivery of next-generation mRNA-based vaccines. The new mRNA ‘center of excellence’ is expected to employ approximately 400 new staff members in a bid to integrate end-to-end mRNA vaccine capabilities. This investment will see Sanofi bringing together dedicated research & development, digital and chemistry, manufacturing and controls (CMC) teams, working across sites based in the US and France. “During the COVID-19 pandemic, mRNA technologies demonstrated potential to…

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Sanofi’s and translate bio’s mRNA influenza vaccine now in its first phase clinical trials

US – Sanofi Pasteur, the vaccine global unit of Sanofi and Translate bio, is initiating the first phase clinical trials of its mRNA influenza vaccine. This is a move that proceeds positive preclinical safety and immunogenicity data of the mRNA vaccines which will assess the safety and immunogenicity (immune response) of the monovalent (single-strain) vaccine candidate in up to 280 participants.  The development of this vaccine has been ongoing since a joint venture collaboration between Translate Bio and Sanofi Pasteur that involved an exclusive license agreement that has been ongoing…

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