Shots:
The EC has approved Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with unresectable or metastatic HER2+ (IHC 3+ or ISH+) breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157)
Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior…
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,…
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…
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…
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…
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…
Shots:
The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157)
Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…
Shots:
The US FDA has granted Fast Track designation to Lu AH69593 for the treatment of patients with narcolepsy
Lu AH69593 is a small-molecule orexin 2 receptor agonist being developed by Lundbeck for narcolepsy to regulate arousal, wakefulness, & sleep-wake stability
Lu AH69593 is being evaluated in a P-Ib clinical program, with Lundbeck continuing to…
Shots:
In a thought-provoking conversation with PharmaShots CXO Talks, Venkat Nelabhotla, Co-Founder, President & CEO of Vyome Holdings, discussed how disciplined execution, strategic capital allocation, and focused innovation are shaping the company's approach to developing therapies for high unmet medical needs while strengthening the US–India biotech innovation corridor.
Venkat highlighted Vyome's strategy of leveraging drug…
Shots:
Insilico has entered into a multi-target strategic alliance with Bora to combine its Pharma.AI platform with Bora's expertise in drug development, manufacturing, quality, & commercialization
Insilico will provide end-to-end AI solutions and R&D strategies to accelerate Bora’s AI- & automation-driven drug discovery & development, with plans to expand AI across development planning, process optimization,…

