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Positive Phase III results from the SANOVO and SAFFRON studies with Orpathys raise several sequencing and usage considerations.

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When it’s time to look for a fill-finish CDMO, the transition to GMP filling is not just a scale issue — it’s a regulatory, technical, and operational shift.

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Lunit and Summit Therapeutics have entered a research agreement to assess the Lunit SCOPE IO AI pathology platform for analysing the tumour microenvironment across immuno-oncology programmes evaluating ivonescimab.

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Pathos AI has secured $237m in a Series E round to expand its clinical oncology pipeline and scale its AI drug development platform.

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British biotech generally raised more across public and private markets in Q3 2026, despite an overall downturn in the flow of VC more generally into the UK.
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PharmaShots
Oct 27, 2026, 5:56 AM
Shots: The US FDA has granted BTD to Sumitomo Pharma America’s enzomenib (DSP-5336) for treating pts with R/R acute leukemia with KMT2A rearrangement Enzomenib is being evaluated as monotx in the registrational P-II (Horizen-1) study in R/R acute leukemia with KMT2A rearrangement or NPM1 mutation & in combination with SoC regimens in newly diagnosed &… The post Sumitomo Pharma America’s Enzomenib (DSP-5336) Receives the US FDA’s Breakthrough Therapy Designation for R/R KMT2A-Rearranged Acute Leukemia appeared first on PharmaShots.
PharmaShots
Oct 27, 2026, 5:53 AM
Shots: Regeneron reported ~4yr follow-up data from the P-III (C-POST) trial of Libtayo (cemiplimab) vs PBO as adjuvant treatment in pts (n=415) with CSCC at high risk of recurrence after surgery & radiation; presented as a late-breaking rapid oral at ESMO 2026 At a median follow-up of 44mos, Libtayo showed a 37% reduction in risk… The post Regeneron Reports Longer-Term P-III (C-POST) Trial Data of Adjuvant Libtayo (Cemiplimab) for High-Risk Cutaneous Squamous Cell Carcinoma at ESMO 2026 appeared first on PharmaShots.
PharmaShots
Oct 27, 2026, 5:27 AM
Shots: BioNTech & DualityBio reported topline P-III (DYNASTY-Breast02) results of trastuzumab pamirtecan (BNT323/DB-1303) vs investigator’s choice CT in CT-naïve pts (n=541) with HR+/HER2-low mBC who progressed on ET The trial met its 1EP with a statistically significant but modest PFS improvement, while OS data were immature at the interim analysis; ILD rates were higher than… The post BioNTech and DualityBio Report Topline P-III (DYNASTY-Breast02) Trial Results of Trastuzumab Pamirtecan for HR+/HER2-Low Metastatic Breast Cancer appeared first on PharmaShots.
PharmaShots
Oct 27, 2026, 4:54 AM
Shots: Bayer reported interim P-III (DASL-HiCaP) data of Nubeqa (darolutamide, 600mg BID) vs PBO, each + ADT & locoregional RT for 96wks, in pts (n=1,106) with prostate cancer at high risk of recurrence; presented as LBA4 at ESMO 2026 Presidential Symposium At a median follow-up of 3.8yrs, Nubeqa reduced risk of metastasis or death by… The post Bayer Reports P-III (DASL-HiCaP) Trial Data of Nubeqa (Darolutamide) + ADT and Radiation Therapy for High-Risk Prostate Cancer at ESMO 2026 appeared first on PharmaShots.
ET Pharma
Oct 27, 2026, 1:39 AM
US District Judge Zahid Quraishi in Trenton, New Jersey, said Novo Nordisk did not deserve a preliminary injunction, having failed to show that Eli Lilly's ads threatened sales, undermined its goodwill, or caused lasting damage to its clinical reputation.
Pharma Tech
Oct 26, 2026, 3:52 PM
Positive Phase III results from the SANOVO and SAFFRON studies with Orpathys raise several sequencing and usage considerations.
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Novartis back on track for growth in third quarter SWI swissinfo.ch
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Drug Manufacturing Plant Setup Cost in India IMARC Group
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The In Silico Drug Discovery Market is Expected to Grow Rapidly at a 13.1% CAGR Through 2030 EIN Presswire
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Nanocarriers Market Analysis Report Examining Demand Patterns and Competitive Landscape EIN News
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Why Biotech Needs Partners—and an Informed Public TechNode
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Oct 27, 2026, 5:00 AM
Can French drugmaker Sanofi fix its pipeline? Financial Times
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