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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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Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2006-2025) 

Shots:  PharmaShots' latest report chronicles the transformation of the global biopharma industry from 2006–2025, highlighting how innovation, strategic M&A, AI adoption, and evolving commercialization strategies have reshaped the competitive landscape while companies navigated patent cliffs, pricing pressures, and shifting market dynamics.   The report tracks the rise and fall of leading biopharma companies over two decades driven by…

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PharmaShots Magazine-July-2026 Edition

Shots: This edition explores AI-Powered Pharmaceutical Logistics, highlighting how artificial intelligence, predictive analytics, robotics, IoT, and digital twins are transforming pharmaceutical supply chains into intelligent, resilient, and patient-centric networks that optimize forecasting, manufacturing, warehousing, and global distribution. Through expert perspectives, feature stories, and regulatory insights, we examine the opportunities and challenges of AI-enabled pharmaceutical logistics—from…

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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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Redefining Asthma Care: Caterina Brindicci and James Teague on Breztri Aerosphere’s US Approval and the Future of Triple Therapy  

Shots  Breztri Aerosphere became the first and only fixed-dose triple-combination maintenance therapy approved in the US for asthma patients aged 12 years and older, expanding beyond COPD and reinforcing the role of single-inhaler triple therapy in advancing asthma care.  The approval strengthens AstraZeneca’s respiratory portfolio and long-term vision of transforming care beyond symptom control, with additional regulatory reviews…

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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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EMA Marketing Authorization of New Drugs in May 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.  CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…

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