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Moderna

Moderna’s mRESVIA Receives the US FDA’s Approval for Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved mRESVIA (mRNA-1345) to prevent lower respiratory tract disease caused by RSV in individuals (18-59yrs.) at risk; expected to be available in US for the 2025–2026 respiratory virus season Approval was based on P-III trial assessing safety & immunogenicity of mRESVIA in adults (18-59yrs.) at increased risk for RSV-associated lower…

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Moderna

Moderna’s mNEXSPIKE Receives the US FDA’s Approval to Protect Against COVID-19

Shots: The US FDA has approved mNEXSPIKE (mRNA-1283) for active immunization against COVID-19 in individuals (≥12yrs.) with ≥1 underlying risk factor as defined by Centers for Disease Control and Prevention; regulatory review is ongoing in other regions Approval was based on P-III (NextCOVE) trial assessing mNEXSPIKE (10 or 50μg) vs Spikevax (mRNA-1273) in ~11,400 subjects…

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Top 20 Biopharma Deal Termination 2024

Top 20 Biopharma Deal Terminations of 2024

Shots:  In the Biopharma industry, navigating M&A and licensing deals is challenging due to strict antitrust laws and shifting regulations. When these pressures create significant risks, nullifying or restructuring existing agreements can be the most rational and strategic response  In 2024, the termination of the $4.45B deal between Adaptimmune and Genentech became a major talking…

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Moderna’s mRESVIA (mRNA-1345) Vaccine Gains the EC’s Approval to Prevent Lower Respiratory Tract Disease (LTRD) 

Shots:    The EC’s approval of mRESVIA (mRNA-1345) vaccine to prevent LTRD due to RSV infection among adults was supported by P-III (ConquerRSV) trial in adults (n=37,000; ≥60yrs.) & is valid across EU plus as Iceland, Liechtenstein & Norway  Primary analysis (3.7mos. median follow-up) depicted vaccine efficacy (VE) of 83.7%, published in the NEJM. Supplementary analysis…

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Moderna’s mResvia (mRNA-1345) Gains the CHMP’s Positive Opinion to Prevent Lower Respiratory Tract Disease (LTRD) 

Shots:  The CHMP’s positive opinion of mRESVIA to prevent lower respiratory tract disease (LTRD) due to RSV infection based on the P-III (ConquerRSV) study in adults (n=37,000; ≥60yrs.)  Primary analysis (3.7mos. median follow-up) showed vaccine efficacy (VE) of 83.7%, published in the NEJM. Supplementary analysis (8.6mos. median follow-up) showed sustained VE of 63.3% against RSV-LRTD…

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Spending on R&D Top 20 2022

Top 20 Companies Spending on R&D in 2022

Shots: R&D (Research and Development) in the biopharma industry lays the foundation stone of innovative drugs. A robust R&D bolstered with new-age technological advances assures long-term sustainability in the future market With a global expenditure of $238B in 2022, the figures are anticipated to reach $285B by 2028. In 2022, AbbVie ranked the top among…

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Companies Spending on R&D Top 20 2022

Top 20 Companies Spending on R&D in 2022

Shots: R&D (Research and Development) in the biopharma industry lays the foundation stone of innovative drugs. A robust R&D bolstered with new-age technological advances assures long-term sustainability in the future market With a global expenditure of $238B in 2022, the figures are anticipated to reach $285B by 2028. In 2022, AbbVie ranked the top among…

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