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NEWS

Recordati and Moderna Collaborate To Develop And Commercialize mRNA 3927 in a ~$160M Deal

Shots: Recordati has entered into a collaboration & license deal with Moderna to develop & commercialize mRNA-3927 globally for the treatment of propionic acidemia As per the deal, Moderna will continue to co-develop mRNA-3927 with Recordati, while Recordati will lead global commercialization if approved. In exchange, Moderna will receive $50M upfront, ~$110M in development &…
January 30, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2025   

Shots:  Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact.  In December 2025, the EMA…
January 20, 2026

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Moderna
NEWS

Moderna Reports the CHMP Positive Opinion on mNEXSPIKE to Protect Against COVID-19 

 Shots:  The CHMP has recommended mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (age≥12 yrs)  Opinion was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (age ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination  The trial met its 1EP with mNEXSPIKE showing 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in…
December 11, 2025

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TOP 20

Top 20 R&D Spending Biopharma Companies of 2025  

Shots:  Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being  The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…
August 21, 2025

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Top 20 Vaccines of 2025
TOP 20

Top 20 Vaccines of 2025 

Shots:  Vaccines play a critical role in combating infectious diseases by stimulating antibody production and establishing immune memory. Biopharma companies around the globe continue to drive innovation in vaccine development, targeting both infectious and preventable diseases  The global vaccine market was valued at $87.75B in 2024 and is projected to reach $151.96B by 2033, reflecting…
July 17, 2025

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Moderna
NEWS

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…
June 13, 2025

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Moderna
NEWS

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…
June 3, 2025

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Top 20 Biopharma Deal Termination 2024
TOP 20

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…
May 14, 2025

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NEWS

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…
August 23, 2024

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PharmaShots' Key Highlights of Second Quarter 2024
INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2024

Shots: The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9B This quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…
July 2, 2024

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