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Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

Shots: The P-III (LUCIDITY) trial assessed avexitide (90mg, SC, QD) vs PBO in 78 adults with Post-Bariatric Hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery  Trial met its 1EP, showing a 55% reduction in the composite rate of Level 2 & Level 3 hypoglycemic events through Wk. 16. All 2EPs were also met, with consistent, highly…
August 18, 2026

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Harbour BioMed Reports NMPA IND Approval for HBM7004 to Treat Solid Tumors

Shots: The NMPA has approved the IND application for HBM7004 for the treatment of advanced solid tumors HBM7004 is a B7H4xCD3 bispecific antibody developed using HBM’s HBICE platform, designed to offer a differentiated cancer immunotherapy approach with potential efficacy & safety benefits  In preclinical studies, HBM7004 induced B7H4-dependent intratumoral T-cell activation & demonstrated strong anti-tumor…
August 18, 2026

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Biocon Secures FDA Approval for Yesintek (Biosimilar, Stelara) 

 Shots:  The US FDA has approved Yesintek 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors, a biosimilar version of Stelara (ustekinumab)  Yesintek is indicated for mod. to sev. plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older, and for mod. to sev. active Crohn’s disease and ulcerative colitis in adults  Yesintek was initially approved in November 2024  Ref: Biocon…
August 18, 2026

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Bio-Thera Partners with Avalon Pharma to Commercialize BAT2406 (Biosimilar, Dupixent) in Saudi Arabia and MENA

 Shots:  Avalon Pharma and Bio-Thera Solutions have signed commercialization and licensing agreements for BAT2406 (dupilumab), a proposed biosimilar of Dupixent, covering Saudi Arabia and the broader MENA region  As per the deal, Bio-Thera will handle BAT2406’s development, manufacturing, and supply, while Avalon Pharma will manage regulatory approvals and commercialization across the licensed territory  BAT2406 is…
August 18, 2026

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AbelZeta Gains FDA IND Clearance for Bispecific CAR-T C-CAR039 in LBCL

Shots: AbelZeta has received FDA clearance for the IND application for C-CAR039 (prizloncabtagene autoleucel), an anti-CD20/CD19 bispecific CAR-T therapy, for r/r large B-cell lymphoma (LBCL) AbelZeta regained global development, regulatory, manufacturing, & commercialization rights to C-CAR039 in Jul 2026 & is working with the FDA to finalize clinical protocols for 3L or later LBCL pts…
August 18, 2026

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LEO Pharma to Acquire Global Rights to Tanabe Pharma’s Dersimelagon for ~$435M

Shots: LEO Pharma has entered into an agreement to acquire worldwide rights to dersimelagon from Tanabe Pharma for the treatment of erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) As per the deal, Tanabe Pharma will receive up to $435M in upfront & near-term milestone payments together with potential downstream milestones and tiered royalties on net…
August 18, 2026

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Innocare Pharma
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InnoCare Pharma Reports NMPA Approval for P-III Trial of Mesutoclax + Azacitidine in Treatment-Naive AML

Shots: Chinese NMPA has approved the P-III trial of mesutoclax (ICP-248) in combination with azacitidine vs venetoclax with azacitidine in elderly or unfit pts with treatment-naïve acute myeloid leukemia (TN AML) At ASCO’26, the combination achieved an 81.8% composite CR rate in evaluable TN AML pts (as of Apr 13, 2026), with 86.5% of responders…
August 18, 2026

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OmniAb and Eli Lilly Partner on New Ion Channel Discovery Program

Shots: OmniAb has entered a global collaboration & license agreement with Eli Lilly for a new ion channel program, leveraging OmniAb’s discovery & screening platform to identify next-generation therapeutics targeting ion channels The therapeutic target and modality remain undisclosed, while OmniAb will contribute its established expertise and technology in ion channel discovery & screening As…
August 17, 2026

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