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Argenx
NEWS

Argenx Receives the EC’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Shots: The EC has approved Vyvgart (efgartigimod alfa) 1000mg for SC injection as a monotx. for adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior corticosteroid or immunoglobulin treatment in all 30 EEA states The EC approval was based on the ADHERE trial, showing 66.5% (214/322) of VYVGART SC-treated pts showed…
June 23, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 16, 2025 – Jun 20, 2025)   

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:    Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma  Read More: J&J  Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…
June 20, 2025

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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

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NEWS

Partner Therapeutics Reports CHMP’s Positive Opinion for Imreplys to Treat Exposure to Myelosuppressive Doses of Radiation 

Shots:  The CHMP has recommended Imreplys (sargramostim) to treat pts of all ages with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS) following myelosuppressive radiation exposure, across the EU, Norway, Iceland, and Liechtenstein  Sargramostim is a recombinant human GM-CSF produced using yeast (S. cerevisiae) expression technology  In 2018, the same formulation was approved by the US…
June 20, 2025

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NEWS

ExCellThera Reports CHMP’s Positive Opinion for Zemcelpro to Treat Haematological Malignancies

Shots: The CHMP has recommended conditional approval of Zemcelpro in 30 EEA states for adults with haematological malignancies requiring allogeneic HSCT after myeloablative conditioning with no suitable donor; EC’s decision is expected within 2mos. Zemcelpro (UM171 Cell Therapy) was evaluated in P-II trials for pts with high & very high-risk acute leukemias & myelodysplasias with…
June 20, 2025

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Novartis
NEWS

Novartis Reports the Health Canada’s Approval of Kisqali (Ribociclib) for the Treatment of HR+/HER2- Early Breast Cancer

Shots: Health Canada has approved Kisqali (ribociclib) + an aromatase inhibitor (AI) for adj. treatment of adults with HR+/HER2-, stage II-III early breast cancer (EBC) at high risk of recurrence Approval was supported by global P-III (NATALEE) study assessing Kisqali + AI vs AI alone as an adj. treatment of pts (n=5101) with stage II & III…
June 19, 2025

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Gilead
NEWS

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…
June 19, 2025

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