NEWS

Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca have reported topline P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± pertuzumab vs taxane, trastuzumab & pertuzumab (THP) as a 1L treatment of HER2+ metastatic breast cancer pts (n=1157) Enhertu + pertuzumab showed improved PFS (1EP), with PFS benefit observed across all pre-specified subgroups during interim analysis; OS (2EP) remain immature…

April 21, 2025

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep…

April 21, 2025

Ollin Biosciences Signs a ~$440M Licensing Agreement with VelaVigo Bio for VBS-102

Shots: VelaVigo Bio has granted Ollin Biosciences an exclusive license to develop, manufacture & commercialize VBS-102 worldwide, except Greater China, where VelaVigo will maintain its rights As per the deal, VelaVigo will receive an upfront payment along with development, regulatory, & commercial milestones in cash & equity, making an aggregate of ~$440M, plus tiered royalties…

April 21, 2025

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

NEWS

Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Ollin Biosciences Signs a ~$440M Licensing Agreement with VelaVigo Bio for VBS-102

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

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