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INSIGHTS+

EMA Marketing Authorization of New Drugs in August 2026

Shots:  The European Commission (EC) approved Daybu (trofinetide) and Hopledo (modified-release levodopa/carbidopa) for neurological disorders, expanding treatment options for Rett syndrome and Parkinson’s disease, respectively.  Daybu was approved for neurobehavioral symptoms of Rett syndrome in patients aged ≥5 years, while Hopledo was approved for adults with Parkinson’s disease and moderate to severe motor fluctuations.  The…
September 15, 2026

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NEWS

QurCan Therapeutics Partners with Eli Lilly to Develop Nucleic Acid Therapies for CNS and PNS Diseases

Shots: QurCan Therapeutics has entered into an exclusive research & collaboration agreement with Eli Lilly for the treatment of diseases of the central nervous system (CNS) and peripheral nervous system (PNS) Lilly & QurCan will collaborate on multiple research programs focused on the development of PLNP-enabled genetic medicines for CNS & PNS delivery, with QurCan…
September 15, 2026

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NEWS

Evotec and Plectonic Partner on Next-Generation T-Cell Engagers for Solid Tumors

Shots: Evotec and Plectonic Biotech have entered a research collaboration to explore a novel immunotherapy approach for solid tumors by combining Plectonic’s programmable Logibody technology with Evotec’s BiTco platform Plectonic’s Logibody uses multi-antigen tumor signatures to selectively activate T cells, while Evotec’s BiTco platform uses a non-blocking CD2 antibody to enhance T-cell activity, tumor killing…
September 2, 2026

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NEWS

Styx Biotechnologies Partner with ZoeNCure Therapeutics to Advance ADC Development

Shots: Styx Biotechnologies has entered into a strategic agreement with ZoeNCure Therapeutics to accelerate selected Styx ADC programs toward first-in-human clinical studies for multiple solid tumor indications The collaboration gives Styx a capital-efficient path to advance selected ADC assets through coordinated preclinical, CMC, regulatory & clinical activities while preserving opportunities for global development & strategic partnering As…
September 2, 2026

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EVENTS

Digi-Tech Pharma & AI 2027 | May 11-12 | London, UK

The pharmaceutical and healthcare industries are entering a new era of technology-led transformation, with artificial intelligence, machine learning, data science, informatics, and advanced data management reshaping how medicines are discovered, developed, and delivered. Against this backdrop, Digi-Tech Pharma & AI 2027 will bring together senior professionals, technology leaders, decision-makers, and innovators from the pharmaceutical, biotechnology,…
August 19, 2026

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EXCLUSIVE

Oncolytics Biotech’s Next Chapter: Jared Kelly on Advancing Pelareorep Toward Approval  

Shots  Pelareorep is gaining regulatory momentum through multiple FDA interactions and Fast Track designations, providing greater clarity around potential registration pathways and shaping Oncolytics’ clinical development and partnership strategy.  REO-033 could mark a pivotal step toward registration as the randomized study in RAS-mutant MSS metastatic colorectal cancer builds on encouraging clinical data and has the potential to become…
August 17, 2026

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INSIGHTS+

The US FDA New Drug Approvals in July 2026 

Shots:  The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.   Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…
August 11, 2026

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EVENTS

Global Clinical Trials Connect 2027 | May 11-12 | London, UK

As clinical trials become increasingly complex and technology-driven, the need for smarter strategies, stronger collaborations, and patient-centric innovation has never been greater. From decentralized clinical trials and artificial intelligence to advanced data management and evolving regulatory frameworks, the clinical research landscape is undergoing a significant transformation. Global Clinical Trials Connect 2027 aims to bring together…
August 6, 2026

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EVENTS

Global Pharma Partnering Summit 2026 | Nov 2–3, 2026 | Hyderabad, India

The pharmaceutical industry is entering a new era where innovation is no longer driven by individual organisations alone. From drug discovery and clinical research to manufacturing, regulatory compliance, digital transformation, and global commercialisation, success increasingly depends on strategic partnerships that combine expertise, technology, and shared ambition. The Global Pharma Partnering Summit 2026 serves as a…
July 31, 2026

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