NEWS

Novocure Reports CE Mark Approval of Optune Lua for Metastatic NSCLC (mNSCLC)

Shots: Novocure has reported CE Mark approval of Optune Lua for mNSCLC adults progressed on Pt-based regimen based on P-III (LUNAR) trial assessing the treatment vs PD-1/PD-L1 inhibitors/docetaxel alone; launch in Germany is expected in coming wks. Trial showed improved OS (1EP), with an mOS of 13.2 vs 9.9mos. with treatment vs PD-1/PD-L1 inhibitors/docetaxel, 18.5…

April 22, 2025

HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

Shots: China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapies Preclinical studies of K1, K2, & their combination showed…

April 21, 2025

GC Cell Partners with DAAN Biotherapeutics for Tumor Antigen-Specific Antibody Sequence

Shots: DAAN Biotherapeutics & GC Cell have entered into an exclusive technology transfer agreement for tumor antigen-specific antibody sequence As per the agreement, DAAN has granted GC Cell exclusive rights to use its antibody sequence, which targets a protein highly overexpressed in major solid tumors, for research & development of CAR-T & CAR-NK therapies Financial terms of…

April 21, 2025

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

NEWS

Novocure Reports CE Mark Approval of Optune Lua for Metastatic NSCLC (mNSCLC)

HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

GC Cell Partners with DAAN Biotherapeutics for Tumor Antigen-Specific Antibody Sequence

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)

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