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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu + Perjeta to Treat HER2 Positive Metastatic Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1L treatment of patients with HER2+ positive unresectable or metastatic breast cancer. MAA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer…
January 19, 2026

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Telix Pharmaceuticals
NEWS

Telix Reports First US Patient Dosing in the P-III Trial of Illuccix and Gozellix, for the Diagnosis of Prostate Cancer

Shots: The company has reported dosing of the first patient in the US  P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting Building…
January 19, 2026

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NEWS

D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
January 19, 2026

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NEWS

AstraZeneca Secures China Rights to AbelZeta’s GPC3 Armored CAR-T Therapy for Solid Tumor

Shots: AstraZeneca to acquire AbelZeta’s 50% stake in the China development & commercialization rights to C-CAR031, securing full global rights to develop, manufacture, & commercialize C-CAR031 worldwide Under a prior agreement, AstraZeneca secured global rights to develop, manufacture, & commercialize C-CAR031 outside China, while AbelZeta remains eligible for additional development milestones & royalties tied to…
January 19, 2026

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NEWS

Insilico Medicine and Servier Enter ~$888M R&D Alliance to Advance Novel Oncology Therapies

Shots: Insilico Medicine has entered into a multi-year R&D collaboration with Servier to identify & develop novel oncology therapeutics for challenging targets using Insilico's Pharma.AI As per the deal, Servier will share R&D costs &, upon successful identification of potential candidates, assume responsibility for clinical validation, regulatory engagement, & global commercialization of the resulting oncology drug candidates…
January 5, 2026

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INSIGHTS+

The 2025 Playbook: Industry Trends Shaping the Future of Biopharma 

Shots:  2025 marked a decisive inflection point for the global life sciences and biopharma industry. After several years defined by experimentation, abundant capital, and expansive innovation narratives, the industry entered a phase of disciplined execution.   Strategies were stress-tested, science was closely scrutinized, and only programs with clear biological rationale and operational readiness advanced.  Rather than…
December 31, 2025

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NEWS

Polpharma Biologics and Libbs Farmacêutica Enter into a Licensing Agreement for an Autoimmune Biosimilar 

 Shots:  Polpharma Biologics has signed a licensing agreement with Brazil-based Libbs Farmacêutica for an autoimmune biosimilar  Under this strategic partnership, Polpharma Biologics is fully responsible for the development and manufacturing of the product  Libbs will exclusively handle the product’s commercialization, marketing, and distribution in the Brazilian market  Ref: Polpharma Biologics | Image: Polpharma Biologics | Press Release Related News:- Polpharma Biologics Launches…
December 10, 2025

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INSIGHTS+

The US FDA New Drug Approvals in November 2025 

Shots:  Innovation surged in November, with cutting-edge science and strategic collaborations reshaping the drug development landscape across oncology, renal disease, hereditary conditions, and more  The US FDA cleared five standout therapies, including Bayer’s Hyrnuo (Sevabertinib), UCB’s Kygevvi (Doxecitine + Doxribtimine), and Arrowhead’s Redemplo, underscoring a month of meaningful clinical progress  November 2025 closed with five approvals, matching last year’s total, signaling sustained momentum and a steady…
December 9, 2025

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