Pfizer and Valneva Report EMA’s MAA Validation for PF-07307405 Against Lyme Disease

Shots: The EMA has validated the MAA for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application developed in collaboration between Pfizer & Valneva The application is supported by >70% efficacy in the P-III (VALOR) trial, which evaluated PF-07307405 in individuals aged ≥5 years.…

ByRidhi RastogiAugust 14, 2026

NEWS

Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

Shots: Pfizer & Valneva have reported the P-III (VALOR) trial data in pts (≥5yrs.) at high risk of Lyme disease randomized to either PF-07307405 vs saline PBO, with one dose administered at mos. 0, 2, 5-9 followed by a fourth dose 1yr. late In pre-specified analyses, efficacy reached 73.2% at 28 days post-dose 4 &…

ByRidhi RastogiMarch 24, 2026

NEWS

Valneva Obtains Health Canada’s Approval for Ixchiq to Prevent Chikungunya

Shots: Health Canada has approved label expansion for Ixchiq against CHIKV disease in individuals (≥12yrs.) Approval was based on a P-III trial of Ixchiq vs PBO in adolescents over 6mos., which showed a superior high & sustained immune response in 99.1% of participants; data was published in The Lancet Infectious Diseases Additionally, label extension filing…

ByRidhi RastogiAugust 18, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2024

Shots: The third 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 Eli Lilly's acquisition of Morphic Holdings for ~$3.2B This quarter also showcased multiple clinical trial results including Roche's P-I Study Data of CT-996 to treat Obesity Our…

BySaurabh ChaubeyOctober 1, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in November 2023

Shots: The EMA approved 3 BLA while 6 New Chemical Entities with 1 recommendation and 1 acceptance in November 2023, leading to treatments for patients and advances in the healthcare industry In November 2023, the major highlighted drugs were Vyjuvek to Treat Dystrophic Epidermolysis Bullosa (DEB) and Vyvgart with Halozyme’s Enhanze for the treatment of…

BySenior EditorDecember 29, 2023

Pfizer and Valneva Report EMA’s MAA Validation for PF-07307405 Against Lyme Disease

Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

Valneva Obtains Health Canada’s Approval for Ixchiq to Prevent Chikungunya

PharmaShots’ Key Highlights of Third Quarter 2024

Insights+: EMA Marketing Authorization of New Drugs in November 2023

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