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INSIGHTS+

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…
3 days ago

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INSIGHTS+

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…
July 7, 2026

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NEWS

Inocras and AimedBio Collaborate on Precision Oncology and ADC Development

Shots: Inocras and AimedBio have partnered to integrate Inocras’ whole-genome sequencing (WGS) platform into AimedBio’s ADC clinical programs, alongside AimedBio’s strategic equity investment in Inocras As per the deal, AimedBio will use Inocras’ WGS, cancer intelligence platform, & multi-omics analyses across its ADC trials to enable biomarker discovery, patient selection, and novel target identification The…
July 2, 2026

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CXO TALKS

CXO Talks Podcast | The Road to Acquisition: Oncolytics’ CEO Jared Kelly on Clinical Data, IP & Pharma Partnerships

What does it really take for a biotech company to become an attractive acquisition target? In this episode of PharmaShots CXO Talks, Jared Kelly, CEO & Director of Oncolytics Biotech, shares an insider's perspective shaped by years of experience in biotech transactions, corporate strategy, and business development. Before joining Oncolytics, Kelly served as Head of…
June 24, 2026

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INSIGHTS+

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,…
June 23, 2026

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VIEWPOINTS

Judith Greciet on Targeting Iron Dysregulation: PulseSight’s Next-Generation Approach to Geographic Atrophy  

Shots:  PulseSight Therapeutics is advancing a novel approach to Geographic Atrophy (GA) with PST-611, a first-in-class non-viral gene therapy designed to restore iron homeostasis by targeting transferrin biology—an upstream driver of retinal degeneration.  At ARVO 2026, PST-611 delivered encouraging Phase I results, demonstrating an excellent safety and tolerability profile, stable visual acuity, and early signals of potential functional…
June 22, 2026

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NEWS

MoonLake Reports Positive Week 52 P-III (VELA) Data for Sonelokimab in Hidradenitis Suppurativa (HS)

Shots: MoonLake Immunotherapeutics reported positive 52 Wks. (n=396) results from the P-III (VELA-1) and (VELA-2) studies, demonstrating durable efficacy of sonelokimab in adults with moderate-to-severe HS At Week 52, 67.2% of pts. achieved HiSCR75, 33.1% achieved HiSCR100, and 26.0% reached inflammatory remission (IHS4-100). Sonelokimab also showed substantial improvements in quality of life and pain reduction,…
June 22, 2026

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NEWS

CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx) 

Shots:  The Chinese NMPA has accepted the marketing application for its secukinumab injection, a biosimilar version of Cosentyx, submitted as a Class 3.3 therapeutic biologic  The marketing authorization application is supported by a P-I PK similarity study in healthy volunteers and a P-III equivalence study in psoriasis pts, demonstrating that the product is highly similar to Cosentyx in efficacy, safety, PK, and immunogenicity. Detailed results will be…
June 18, 2026

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Bayer
NEWS

Bayer Reports the US FDA Approval of Ambelvist to Enhance MRI Detection of Lesions 

Shots:  The US FDA has approved Ambelvist (gadoquatrane) for contrast-enhanced MRI to detect lesions with abnormal vascularity in the CNS and other body regions in adults and pediatric patients, including term neonates  Approval was supported by the global P-III (QUANTI) studies, which demonstrated that Ambelvist improved lesion visualization at a lower gadolinium dose (0.04 mmol Gd/kg) while providing diagnostic performance…
June 12, 2026

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