This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below: Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Read More: Daiichi Sankyo and Merck Gilead…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below: Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas Read More: Arcus Biosciences HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib…
Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography
Shots:Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15, 2025Breast imaging AI was evaluated in the PRAIM study of 460,000 women across Germany, which demonstrated significant improvements in cancer detection &…
Shots:The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophreniaTrial met its 1EP with 6.8 vs 4.2-point improvement in negative symptom severity on the CAINS-MAP at 16wks., achieving a Cohen’s D of -0.36; most…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below: AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer Read More: AstraZeneca and Daiichi Sankyo AstraZeneca Reports P-III (Bax24) Trial Data on…
Shots:The US FDA has granted 510(k) clearance to Bunkerhill MAC algorithm for the detection & quantification of mitral annular calcification (MAC)Bunkerhill MAC, developed & tested using data from 25+ academic centers incl. Emory, Thomas Jefferson, & UCSF, automatically identify & quantify MAC on routine non-gated chest CTs using AI to standardize MAC detection &…
Shots:Roche & KlinRisk have received CE-mark approval for the AI-based Kidney Klinrisk Algorithm to assess progressive kidney function decline, integrated into the navify Algorithm SuiteThe chronic kidney disease algorithm panel combines the new Klinrisk Algorithm for early risk assessment with the CE-marked KFRE Algorithm for later disease stages, supporting care across the full…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below: Daiichi Sankyo & AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer Read More: Daiichi Sankyo & AstraZeneca Merck Presents P-III (HYPERION) Trial Data…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A and Biosimilars. Check out our full report below: Roche Reports P-III (evERA Breast Cancer) Trial Data on Giredestrant + Everolimus for ER-Positive Breast CancerRead More: RocheBMS Reports the P-III (EXCALIBER-RRMM) Trial Data of Iberdomide Regimen to Treat…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and DigiHealth. Check out our full report below: AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC Read More: AstraZeneca Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L…

