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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & Biosimilars. Check out our full report below:      Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn's Disease  Read More: Eli Lilly  Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration  Read…
February 14, 2025

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CSL
NEWS

CSL Behring Receives the EC Approval for Andembry as a Prophylactic Treatment of HAE

Shots: EC has approved Andembry for HAE pts (≥12yrs) in 30 EEA states (incl. Iceland, Liechtenstein & Norway) following UK’s MHRA & Australia’s TGA approval in Jan 2025. Although, regulatory review is ongoing for the US, Switzerland, Japan & Canada Approval was based on the P-III (VANGUARD) trial (Data published in The Lancet) assessing Andembry vs PBO & OLE…
February 14, 2025

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Pfizer New
NEWS

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide +…
February 13, 2025

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BridgeBio
NEWS

BridgeBio’s Beyonttra (Acoramidis) Gets the EU approval to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: The EU granted marketing authorization to Beyonttra (acoramidis) to treat wild-type or variant ATTR-CM in adult pts.; launch expected in 1H’25 The approval was supported by the results of P-III (ATTRibute-CM) study of Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts.. It achieved its 1EP, showing a 42% reduced composite ACM &…
February 12, 2025

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SpringWorks Therapeutics
NEWS

SpringWorks Therapeutics Receives US FDA Approval for Gomekli to Treat Neurofibromatosis Type 1 Associated Symptomatic Plexiform Neurofibromas (NF1-PN)

Shots: The US FDA has approved Gomekli for pts (≥2 years) with unresectable NF1-PN based on P-IIb (ReNeu) trial & has also granted RPD PRV to SpringWorks; availability in US market is expected within 2wks; MAA is under EMA review with decision expected in 2025 The P-IIb (ReNeu) study assessed Gomekli(2mg/m^2, BID) in 2 Arms…
February 12, 2025

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Regeneron
NEWS

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The US FDA has accepted resubmitted BLA for linvoseltamab to treat r/r MM in pts who received ≥4L or ≥3L & were unresponsive to the last line (PDUFA: Jul 10, 2025) after resolving third-party fill/finish manufacturing issues; MAA is under EMA review Application was backed by P-I/II (LINKER-MM1) trial data, assessing linvoseltamab (200mg)…
February 12, 2025

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