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EVENTS

Evolution Summit 2027 | January 19-20 | Four Seasons Hotel Westlake Village, CA

The Evolution Summit will take place 19-20 January 2027 at the Four Seasons Hotel in Westlake Village, California. This invitation-only summit brings together senior clinical development leaders to benchmark strategies for strengthening trial execution, accelerating development timelines and navigating the evolving regulatory and technology landscape. The program covers AI implementation in clinical operations, ICH E6(R3)…
12 hours ago

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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

Evinova Partners with Lothar Medical to Advance Respiratory Clinical Trials Globally

Shots: Evinova has partnered with Lothar Medical to integrate Lothar’s respiratory device with Evinova’s Unified Trial Solution, supporting connected, data-rich respiratory clinical trials globally Lothar’s 3-in-1 device combines FeNO, spirometry & oscillometry, while Evinova’s GxP-validated platform helps streamline traditional, hybrid & DCTs across 4,000+ sites in 54 countries The partnership aims to accelerate patient recruitment…
September 7, 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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INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2026    

Shots:  The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.  EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…
August 18, 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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