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Bracco Imaging & Subtle Medical’s AiMIFY Receives the European CE Mark Approval for Enhanced Brain MRI 

Shots: Bracco Imaging & Subtle Medical have received the European MDR CE Mark approval for their AI-powered AiMIFY software for brain MRI; phased commercial availability expected from late 2025 to early 2026 AiMIFY has depicted consistent efficacy across extensive validation data, incl. diverse pts demographics, pathologies, lesion sizes, MRI sequences, scanner vendors, & acquisition orientations…
June 16, 2025

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Merck new
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Merck Receives the US FDA’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The US FDA has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC based on P-III (KEYNOTE-689) trial Trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ± cisplatin vs…
June 16, 2025

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AstraZeneca Partners with CSPC Pharmaceuticals to Identify and Develop Small Molecule Across Chronic Indications

Shots: AstraZeneca & CSPC have partnered to discover & develop pre-clinical candidates for multiple targets across chronic diseases, incl. a pre-clinical oral small molecule for immunological diseases As per the deal, CSPC will receive $110M upfront as well as ~$1.62B in development & ~$3.6B in sales milestones with net sales-based single digit royalties, while AstraZeneca…
June 16, 2025

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Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar & Animal Health. Check out our full report below:   Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN  Read More: Apellis Pharmaceuticals and Sobi  Daiichi Sankyo Reports First Patient…
June 13, 2025

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Merck Animal Health
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Merck Animal Health Reports the CVMP Positive Opinion for Nobivac L6 and Nobivac LoVo L6 Vaccines for Canine Leptospirosis

Shots: The CVMP has recommended Nobivac L6 & Nobivac LoVo L6 for the active immunization of dogs against leptospirosis; EC’s decision expected by Q3’25 The vaccine protects against 6 Leptospira serovars: Canicola, Copenhageni, Bratislava, Bananal/Lianguang, Icterohaemorrhagiae, & Grippotyphosa, preventing mortality, renal carriage, renal lesions, & urinary excretion while reducing infection & clinical signs Nobivac L6…
June 13, 2025

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UreVac
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BioNTech to Acquire CureVac for ~$1.25B

Shots: BioNTech has entered into a definitive purchase agreement to acquire CureVac in an all-stock transaction, strengthening its mRNA tech & capabilities As per the deal, each CureVac share will be exchanged for ~$5.46 in BioNTech ADSs, implying a total equity value of ~$1.25B, with a collar-adjusted exchange ratio (0.04318 if BioNTech’s 10-day VWAP >$126.55; 0.06476…
June 13, 2025

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Elanco
News

The CVMP Adopts Positive Opinion on Elanco’s Zenrelia for Allergic and Atopic Dermatitis in Dogs

Shots: The CVMP has recommended Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs Opinion was based on clinical data demonstrating quality, safety, efficacy, & a favorable benefit-risk profile incl. a non-inferiority study conducted as a part of the EU approval process Elanco plans to…
June 13, 2025

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