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VIEWPOINTS

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…
July 6, 2026

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NEWS

Orion Pharma Expands Partnership with Shilpa Medicare for Nivolumab Biosimilar in the EU 

Shots:  Orion Pharma has entered into an agreement with Shilpa Biologicals to co-develop and supply IV nivolumab biosimilar across Europe  As per the deal, Orion will gain exclusive rights to register, market, distribute & sell the nivolumab biosimilar across the EU, while Shilpa Biologicals will lead product development, exclusively manufacture & supply the product, and receive development &…
July 6, 2026

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CXO TALKS

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…
June 24, 2026

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NEWS

XtalPi Secures Over $400M Partnership to Develop GPCR-Targeted Small Molecule Therapy

Shots: XtalPi has entered into a strategic partnership with a biopharmaceutical company to develop an oral small molecule against G protein-coupled receptor XtalPi will leverage its structure-based drug design platform, combining quantum physics, generative AI, large-scale automated chemical synthesis orchestrated by a multi-agent system to accelerate Design-Make-Test-Analyze (DMTA) cycles As per the deal, XtalPi will receive…
June 11, 2026

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INSIGHTS+

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,…
June 2, 2026

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NEWS

Wockhardt Receives US FDA Approval for Zaynich to Treat cUTI Including Pyelonephritis 

Shots:  The US FDA has approved Zaynich (Cefepime and Zidebactam) for treating adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria  Approval was based on a P-III (ENHANCE-1) trial in 530 adults with cUTI or acute pyelonephritis across 64 global sites, where Zaynich demonstrated superior clinical and microbiological response rates vs. meropenem (89.0% vs. 68.4%) and was generally well tolerated  Zaynich is an injectable…
May 29, 2026

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NEWS

Novartis Receives the CHMP Positive Opinion of Vijoice for PROS Disorders 

Shots:  The CHMP has recommended Vijoice (alpelisib) for pts (age≥2 yrs) with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders who require systemic therapy  EMA’s recommendation is supported by a retrospective study of 57 PROS pts (age≥2 yrs) treated with alpelisib through a compassionate use program. Pts achieving at least a 20% reduction in the size of 1–3 abnormal growths or tumours after 24 wks, based…
May 21, 2026

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Boehringer Ingelheim
NEWS

Boehringer Ingelheim Receives the CHMP Positive Opinion of Jascayd for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) 

Shots:  The CHMP has recommended Jascayd (nerandomilast) for the treatment of adults with IPF and PPF  Opinion was supported by the P-III (FIBRONEER-IPF and FIBRONEER-ILD) trials; both trials met their 1EPs, showing nerandomilast slowed lung function decline vs PBO through Wk-52. Nerandomilast also demonstrated a favorable safety/tolerability profile, with no liver monitoring requirement and PBO-like discontinuation rates as monotx.   Jascayd (PO, BID) is a PDE4B inhibitor with antifibrotic and…
May 21, 2026

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INSIGHTS+

The US FDA New Drug Approvals in April 2026 

Shots:  Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.  Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…
May 12, 2026

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