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EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia
Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.
Biofabri and Bharat Biotech Sign Technology Transfer Deal for MTBVAC
Biofabri and Bharat Biotech have entered into a technology transfer agreement to enable end-to-end manufacturing of the MTBVAC tuberculosis vaccine candidate, supporting global efforts to expand access to new TB prevention options, particularly in high-burden, low- and middle-income countries.
Biocon Biologics Secures Global Rights to Hulio
The new agreement supersedes the existing collaboration agreement between Biocon Biologics and Fujifilm Kyowa Kirin Biologics (FKB) for biosimilar Adalimumab, under which Biocon Biologics only had commercialisation rights.
Pluri and Remedy Cell Expand Partnership with Clinical-Grade Manufacturing Success
The duo have integrated Remedy Cell’s proprietary manufacturing process into Pluri’s GMP facility, completed GMP training and qualification for Remedy Cell’s manufacturing team, conducted engineering runs to validate process robustness and scalability, and produced multiple clinical-grade batches of Remedy Cell's lead candidate.
Bayer Secures Japanese Approval for Finerenone
Bayer has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with chronic heart failure with mildly reduced or preserved Left Ventricular Ejection Fraction (LVEF).
Glenmark Launches Epinephrine Injection Multi-Dose Vial
Glenmark has introduced its Epinephrine Injection USP, 1?mg/mL, 30?mg/30?mL multiple-dose vial, which is bioequivalent and therapeutically equivalent to the reference drug by BPI Labs, LLC (NDA 205029), offering a reliable alternative for patients and healthcare providers.
Amneal Gains US FDA Approval for Prolia and XGEVA Denosumab Biosimilars
The US FDA approvals for Prolia and XGEVA denosumab biosimilars strengthen Amneal’s growing biosimilars portfolio, with the company planning to commercialise six biosimilars across eight presentations by 2027.
US FDA Approves Wegovy by Novo Nordisk as first Oral GLP-1 for Weight Loss
Wegovy’s approval is supported by phase III OASIS 4 trial data showing a mean weight loss of 16.6 percent, with the oral GLP-1 indicated for long-term weight management and reduction of major adverse cardiovascular events, and Novo Nordisk planning a US launch in early January 2026.
Rectify and Boehringer Ingelheim Collaborate to Advance First-in-class CKD Treatments
The collaboration will focus on accelerating the development of first-in-class oral small-molecule therapies for chronic kidney disease and other conditions, leveraging Rectify’s ABCC6-targeting platform designed to reduce pathological calcification.
Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer
The US FDA has granted Breakthrough Therapy Designation to Enhertu for use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer, marking the tenth such designation for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, supported by phase III DESTINY-Breast05 trial results.
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