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Roche

Roche Receives the Health Canada Approval for Gazyva to Treat Active Lupus Nephritis

Shots: Health Canada has approved Gazyva (obinutuzumab) for adults with active lupus nephritis receiving standard therapy Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC. Gazyva’s safety profile was consistent with its well-established profile from haematology-oncology indications Gazyva is…

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Neurocrine Biosciences Initiates P-II Study of NBI-1065890 to Treat Tardive Dyskinesia (TD) in Adults

Shots: Neurocrine Biosciences has initiated a P-II study of investigational NBI-1065890 in adults with TD P-II study of NBI-1065890 will enroll ~100 adults with TD, evaluating efficacy, safety, and tolerability, with the 1EP being change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score at Wk 8 NBI-1065890 is a selective oral VMAT2 inhibitor…

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MS Pharma enters an exclusive biosimilar partnership with Hetero 

Shots:  MS Pharma has signed a strategic partnership with Hetero to localize five established biosimilars across key areas, including oncology, immunology, and hematology, in the MENA region  The exclusive agreement will be implemented through El Kendi (MS Pharma Group’s Algeria affiliate) and Hetero Biopharma, a subsidiary of Hetero Group  This marks Hetero’s first local partnership in Algeria, supporting…

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2025 EMA Drug Approvals Outlook: A Year of Intentional, Biology Led Medicine Across Europe 

Shots:  EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion  Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…

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Zydus Lifesciences Launches Tishtha (Biosimilar, Opdivo) in India 

    Shots:  Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India  Tishtha will be available in 100 mg and 40 mg strengths  Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma   Ref: Zydus  | Image: Zydus |  Press Release  Related News: Shanghai Henlius Receives the US FDA…

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EMA Marketing Authorization of New Drugs in December 2025   

Shots:  Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact.  In December 2025, the EMA…

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Daiichi Sankyo

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…

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Telix Pharmaceuticals

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…

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