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INSIGHTS+

Disease of the Month – Hemolytic uremic syndrome 

Shots:  Hemolytic uremic syndrome (HUS) is a serious, potentially life-threatening condition in which damage to the small blood vessels in the kidneys interferes with their ability to function properly  With the Disease of Month report, we break down complex medical topics into clear, meaningful insights for global readers. By highlighting conditions that impact communities worldwide, we aim to keep our readers informed,…
14 hours ago

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INSIGHTS+

EMA Marketing Authorization of New Drugs in November 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks  In…
December 16, 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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NEWS

Immutep Collaborates with Dr. Reddy’s to Develop & Commercialize Eftilagimod Alfa

Shots: Immutep and Dr. Reddy’s Laboratories have entered into a strategic collaboration and exclusive licensing agreement to develop and commercialize Eftilagimod Alfa (efti) across all countries outside North America, Europe, Japan, and Greater China As per the deal, Immutep will receive a $20M (~AUD 30.2M) upfront payment from Dr. Reddy’s, plus potential milestone payments of up…
December 9, 2025

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NEWS

Mirum Pharmaceuticals to Acquire Bluejay Therapeutics, Strengthening Rare Disease Portfolio

Shots: Mirum Pharmaceuticals has entered into an agreement to acquire Bluejay Therapeutics, gaining global rights to brelovitug with Breakthrough Therapy and PRIME designations, and expanding Mirum’s rare liver disease portfolio As per the deal, Mirum will acquire all Bluejay shares for $250M in cash and $370M in Mirum stock, plus up to $200M in sales-based…
December 9, 2025

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Incyte
NEWS

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025 

Shots: Incyte reported updated data from two P-I trials showing the safety, tolerability, and efficacy of INCA033989 (INCA33989-101 and INCA33989-102) in 455 adults(age≥18) with mutCALR-positive MPNs, including ET & MF, findings were presented at ASH'25 In ET pts receiving higher starting doses of INCA033989 (400–2,500 mg; n=30), 90% achieved a HR, including 83.3% with CHR…
December 9, 2025

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INSIGHTS+

Key Biosimilars Events of November 2025  

Shots:        Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma  Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…
December 2, 2025

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