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Key Biosimilars Events of June 2026 

Shots:  June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC),  and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology,  ophthalmology,  oncology, osteoporosis, and reproductive medicine.  Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.  Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.  Celltrion Seeks…

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Astex Pharmaceuticals Partners with Genentech for Breast Cancer Therapy Program in a Deal Worth Over $490M

Shots: Astex has entered into an exclusive, worldwide research collaboration & license agreement with Genentech to identify small molecules with selective inhibitory activity for the treatment for breast cancer Astex will license compounds from its breast cancer discovery program to Genentech and jointly optimize lead compounds through preclinical candidate selection, after which Genentech will lead…

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Q2 in Review: Pharma’s Dealmaking Surge, a Wave of FDA Approvals, and AI’s Deepening Footprint 

A PharmaShots Quarterly Analysis  Q2 was one of the most active quarters in recent memory for the pharmaceutical and biotech industry. Big Pharma leaned hard into M&A and licensing to refill pipelines, the FDA cleared a broad slate of new therapies, and AI-native partnerships continued to reshape how drugs get discovered. Below, we break down the quarter…

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CXO Talks Podcast | The Road to Acquisition: Oncolytics’ CEO Jared Kelly on Clinical Data, IP & Pharma Partnerships

Shots: In an engaging conversation with PharmaShots CXO Talks, Jared Kelly, CEO & Director of Oncolytics Biotech, shared insights from his experience leading corporate strategy at Ambrx and contributing to its $2B acquisition by Johnson & Johnson, offering a practical perspective on what makes biotech companies attractive acquisition targets. Kelly explained why successful biotech acquisitions…

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Voro Therapeutics and Alloy Therapeutics Partner on Next-Generation T-Cell Engagers

Shots: Voro Therapeutics & Alloy Therapeutics have entered into a strategic research collaboration to discover and develop next-generation masked T-cell engager (TCE) therapies Partnership will combine Voro’s PrimeBody platform with Alloy’s optimized CD3 antibodies & multispecific engineering capabilities to develop novel immunotherapies designed to selectively activate immune responses within tumors PrimeBody is designed to unlock difficult-to-target…

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LabGenius Therapeutics and LG Chem Collaborate to Develop an AI/ML-Designed Tumour-Targeting Antibody

Shots: LabGenius has entered into a multi-year research collaboration, option & licensing agreement with LG Chem to identify next-generation multispecific antibodies for difficult-to-treat cancers, leveraging LabGenius’ AI/ML-driven antibody discovery platform, EVA As per the licensing deal, LabGenius will lead preclinical research, incl. in vitro efficacy studies, after which LG Chem will conduct further preclinical development, incl.…

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PharmaShots Magazine-June-2026 Edition

Shots: This edition explores Digital Vigilance: AI Enhancing Post-Market Safety Monitoring, highlighting how artificial intelligence, real-world data, and digital listening technologies are transforming pharmacovigilance into a proactive, predictive, and patient-centric discipline. Through expert perspectives, cover stories, and regulatory insights, we examine the opportunities and challenges of AI-driven safety surveillance—from social media signal detection and real-world…

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The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…

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Jared Kelly on Immune Priming & Survival Outcomes: Oncolytics Biotech’s Vision for Pelareorep

Shots:  Oncolytics Biotech is advancing pelareorep beyond the traditional standalone therapy model, positioning the platform as a potential immune-priming backbone capable of enhancing immunotherapies, checkpoint inhibitors, chemotherapies, and other oncology treatments across multiple difficult-to-treat tumor settings.  The company continues generating growing survival and immune-engagement data across colorectal, pancreatic, and anal cancers, while emphasizing pelareorep’s potential to “turn cold tumors…

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