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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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Q2 in Review: Pharma’s Dealmaking Surge, a Wave of FDA Approvals, and AI’s Deepening Footprint 

A PharmaShots Quarterly Analysis  Q2 was one of the most active quarters in recent memory for the pharmaceutical and biotech industry. Big Pharma leaned hard into M&A and licensing to refill pipelines, the FDA cleared a broad slate of new therapies, and AI-native partnerships continued to reshape how drugs get discovered. Below, we break down the quarter…

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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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Pharma Market Access Conferences 2026: Where Commercial Teams Meet the Decision-Makers

The pharma market access conferences worth a commercial team's time in 2026 share one trait: they put market access, HEOR, and medical affairs leaders in the same room as the payers and health system executives who actually control access.   Reaching prescribers is not the same as winning system adoption, and the events below are where that second, harder conversation…

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The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…

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Key Biosimilars Events of May 2026 

Shots:  May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.  Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.  Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…

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Advancing HES Care with AstraZeneca’s FASENRA: Insights from James Teague & Princess U. Ogbogu

Shots:  Could a targeted biologic therapy help address the longstanding unmet needs in hypereosinophilic syndrome (HES)? AstraZeneca’s FASENRA has now received US approval for HES, introducing a once-monthly treatment option for patients living with this rare and often underdiagnosed eosinophilic disorder  Results from the Phase III NATRON trial showed that FASENRA reduced the risk of first HES flare by 65% vs placebo,…

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