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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,…

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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…

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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…

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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…

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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…

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A Promise Made at Six: The Winding Road to Cancer Research

An Interview with Priyanka Joshi, Associate Scientist in Analytical Development Introduction Cancer remains one of the world's greatest healthcare challenges, driving scientists to develop more effective and precise treatment approaches. Among the most promising innovations are cell therapies, which harness the body's own immune system to fight cancer. Behind these advances are scientists working to…

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Key Biosimilars Events of July 2026 

Shots:  July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases.   Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…

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EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…

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The US FDA New Drug Approvals in June 2026 

Shots:  The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment.  Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical…

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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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