NEWS

Regeneron and Sanofi Report the US FDA’s Approval of Dupixent for Chronic Spontaneous Urticaria

Shots: The US FDA has approved Dupixent to treat CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program; regulatory review ongoing in EU & other regions Study A & C assessed Dupixent (loading dose then 300mg Q2W; pts weighing <60kg received 200mg)…

April 21, 2025

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Shots: Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adult Clinical study showed strong efficacy and safety of ebdarokimab (135mg) two doses at weeks 0 and 4, with a PASI 75 response rate of 79.4% at 16wks. and ebdarokimab Q12W 77.9% at 52wks. along with significant improvements in patients'…

April 18, 2025

BigHat Biosciences Collaborates with Eli Lilly to Advance AI-Driven Antibody Therapeutics

Shots: BigHat Biosciences and Eli Lilly entered into a strategic collaboration to design and develop next-generation therapeutic antibodies using BigHat’s ML-powered Milliner platform and synthetic biology wet lab The collaboration includes up to two antibody programs and support for BigHat’s internal pipeline, including a next-gen ADC for GI cancers entering the clinic in 2026, with…

April 18, 2025

Endevica Bio Reports the First Patient Dosing in P-II Study Evaluating TCMCB07 (B07)

Shots: Endevica Bio conducting P-II study in collaboration with WuXi Clinical reported the dose administration of B07 in first patient to prevent weight loss in cancer patients diagnosed with stage 4 metastatic colorectal cancer undergoing CT In 2024, Endevica Bio completed its P-I study, with early results showing strong safety and efficacy. In current P-II…

April 18, 2025

Hikma Pharmaceuticals Acquires Novugen’s US FDA ANDA Approved Trametinib

Shots: Hikma has acquired the Novugen's US FDA ANDA approved trametinibtablets and also entered into a commercial agreement with Novugen Under the agreement, Hikma will be responsible for all the US sales and marketing of trametinib while Novugen will manufacture and supply them to Hikma. Furthermore, when product is launched Hikma will have 180 days…

April 18, 2025

The US FDA Accepts sBLA Priority Review for Regeneron’s EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

Shots: Regeneron reported the US FDA acceptance for its priority review of the sBLA by using priority review voucher for EYLEA HD (aflibercept 8 mg) to treat macular edema from retinal vein occlusion (RVO) and to expand dosing to include monthly administration in all approved indications. The US FDA’s expected action date is Aug 19,…

April 18, 2025

Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

Shots: The P-III (ACHIEVE-1) trial assessed orforglipron vs PBO in T2D adults (n=559) having inadequate glycemic control with diet & exercise alone; subjects started at 1mg QD, with dose escalation at every Q4W till assigned doses of 3, 12mg (via 1, 3 & 6mg), or 36mg (via 1, 3, 6, 12, & 24mg) Trial met…

April 18, 2025

Sanofi Enters a ~$1.84B Global License Agreement with Earendil Labs for HXN-1002 & HXN-1003

Shots: Earendil Labs has granted Sanofi exclusive global rights to develop HXN-1002 & HXN-1003 bispecific antibodies for autoimmune & inflammatory bowel diseases As per the deal, Earendil Labs will receive $125M upfront, ~$1.72B in development & commercial milestones, incl. a near-term $50M payment, & tiered royalties ranging from high-single to low-double digits Developed using Earendil…

April 17, 2025

InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

Shots: China’s NMPA has accepted NDA of zurletrectinib (ICP-723) for the treatment of pts (≥12yrs.) with advanced solid tumors having NTRK gene fusions In a registrational trial, zurletrectinib demonstrated favorable safety & strong efficacy, with the ability to overcome acquired resistance to the 1st generation TRK inhibitors in mentioned pts Zurletrectinib is a next-generation pan-TRK inhibitor…

April 17, 2025

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Shots: BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer 37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data Trial showed 25/37…

April 17, 2025

NEWS

Regeneron and Sanofi Report the US FDA’s Approval of Dupixent for Chronic Spontaneous Urticaria

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

BigHat Biosciences Collaborates with Eli Lilly to Advance AI-Driven Antibody Therapeutics

Endevica Bio Reports the First Patient Dosing in P-II Study Evaluating TCMCB07 (B07)

Hikma Pharmaceuticals Acquires Novugen’s US FDA ANDA Approved Trametinib

The US FDA Accepts sBLA Priority Review for Regeneron’s EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

Sanofi Enters a ~$1.84B Global License Agreement with Earendil Labs for HXN-1002 & HXN-1003

InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

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