Skip to content Skip to footer
Subscribe Now
Merck new
NEWS

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

Shots: The CHMP has recommended Enflonsia to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season, with potential approval valid in all 30 EEA states Opinion was based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk…
September 22, 2025

Read more

Roche
NEWS

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Shots: The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…
August 7, 2025

Read more

NEWS

Sanofi to Acquire Vicebio for ~$1.6B

Shots: Sanofi has entered into an agreement to acquire Vicebio, expanding its respiratory vaccines pipeline & capabilities with Vicebio’s vaccine candidates (VXB-241 & VXB-251) & Molecular Clamp tech As per the deal, Vicebio will receive $1.15B upfront & ~$450M in development & regulatory milestones; closing is expected in Q4’25 Molecular Clamp tech stabilizes viral proteins…
July 22, 2025

Read more

NEWS

GSK Reports the US FDA’s Application Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has accepted application of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs.; FDA decision is anticipated H1’26. GSK is also seeking expanded RSV vaccine indications in other regions, incl. the EEA & Japan Submission was based on P-IIIb trial (n=1458) assessing immune response & safety…
July 14, 2025

Read more

GSK New
NEWS

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…
June 20, 2025

Read more

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

Read more

Viewpoints_Dr. Bill La Via
VIEWPOINTS

Dr. Bill La Via, Medical Director at Sanofi Shares Insights from the Findings that Support the Need of Protecting Infants from Respiratory Syncytial Virus (RSV)

Shots: Bill spoke about Respiratory Syncytial Virus and how it can severely affect infants' health Bill also talked about the 14 studies on RSV published in the Journal of Infectious Diseases (JID) The interview gives an understanding of how Sanofi’s vision to develop innovative solutions to help reduce the burden of RSV on infants, families,…
November 9, 2022

Read more

PharmaShots Interview Jon Heinrichs of Sanofi Pasteur & Tonya Villafana of AstraZeneca Shares Insights on Nirsevimab in Healthy Infants Born at Term or Late Preterm
VIEWPOINTS

PharmaShots Interview: Jon Heinrichs of Sanofi Pasteur & Tonya Villafana of AstraZeneca Shares Insights on Nirsevimab in Healthy Infants Born at Term or Late Preterm

In an interview with PharmaShots, Jon Heinrichs, Associate, Vice President, and the Head of Innovation and Emerging Sciences at Sanofi Pasteur & Tonya Villafana, Vice President, Global Franchise Head, Infection at AstraZeneca share their views on the data of Nirsevimab in P-III (MELODY) trial to protect infants against Respiratory Syncytial Virus Shots: The P-III (MELODY) trial evaluates nirsevimab (50/100mg, IM) vs…
April 19, 2022

Read more