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MAGAZINE

PharmaShots Magazine-May-2026 Edition

Shots: PharmaShots’ May Edition explores how AI is transforming commercial strategies across the healthcare ecosystem by enabling predictive analytics, personalized engagement, dynamic launch planning, and real-time omnichannel optimization while balancing compliance and measurable ROI. The magazine highlights key industry movements shaping global biopharma, including AI-driven drug discovery collaborations, strategic M&A activity, advancements in cell and…
May 14, 2026

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INSIGHTS+

The US FDA New Drug Approvals in April 2026 

Shots:  Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.  Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…
May 12, 2026

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NEWS

CareDx to Acquire Naveris for ~$260M

Shots: CareDx has entered into a definitive agreement to acquire Naveris, extending CareDx’s Precision Medicine Testing Services strategy into specialty oncology As per the deal, CareDx will acquire Naveris for $160M upfront & up to $100M in revenue milestones; closing is expected in Q3’26 Naveris’ liquid biopsy platform uses TTMV DNA to detect viral DNA…
April 29, 2026

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NEWS

X4 Pharmaceuticals’ Xolremdi Receives the EC’s Approval for WHIM Syndrome 

Shots:  The EC has approved Xolremdi (Mavorixafor), under exceptional circumstances, for the treatment of WHIM syndrome  Approval was supported by the global pivotal P-III (4WHIM) trial, PBO-controlled 52-wk study evaluating mavorixafor’s efficacy & safety in pts ≥12 yrs with WHIM syndrome  Xolremdi (PO, QD), a CXCR4 antagonist, is used in pts ≥12 yrs with WHIM syndrome to increase circulating mature neutrophils & lymphocytes  Ref: X4…
April 27, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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INSIGHTS+

The US FDA New Drug Approvals in March 2026 

Shots:  Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact.  Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…
April 14, 2026

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NEWS

Imagene AI Partners with Daiichi Sankyo to Advance Multimodal Biomarker Discovery in Oncology

Imagene AI has entered into a collaboration with Daiichi Sankyo to advance biomarker discovery and response prediction across oncology drug development programs Under the collaboration, Daiichi Sankyo will leverage Imagene’s OI Suite, powered by the CanvOI foundation model, to integrate H&E and IHC whole-slide images with molecular and clinical data to enhance biomarker identification and…
April 10, 2026

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NEWS

DeepCyte Secures $1.5M to Advance AI-Driven Single-Cell Toxicology in Drug Development

Shots: DeepCyte, a techbio startup focused on advancing AI-powered toxicology for drug development, has officially launched with $1.5 million in seed funding, introducing two solutions to help biopharma teams detect, predict, and understand drug toxicity in human cells at single-cell resolution DeepCyte's MetaCore, a high-throughput single-cell metabolomics platform, leverages laser-based sampling and mass spectrometry to…
April 9, 2026

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VIEWPOINTS

Turning Genome Data into Clinical Insight: Jehee Suh of Inocras on AI-Driven Genomics 

Shots:  Inocras is advancing the clinical adoption of whole-genome sequencing (WGS) by transforming it from a research tool into a standardized diagnostic workflow, refining its algorithms through thousands of real-world patient cases to deliver actionable genomic insights in routine care.  Through platforms such as CancerVision, RareVision, and MRDVision, the company integrates deep genomic analytics, AI-driven bioinformatics, and clinical services like genetic counseling and…
March 31, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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