Kelonia Draws Attention With In Vivo CAR-T Myeloma Data

 

The biotech will present data at the upcoming ASH meeting on three patients who achieved PRs or VGPRs with minimal residual disease negativity and no cases of neurotoxicity.

Padcev Sales Set To Soar With Latest US Approval

 
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Terms like ‘game-changing’ and ‘transformational’ are regularly used by pharma companies but the data behind the latest approval for the Padcev/Keytruda combo for adults with muscle- invasive bladder cancer who are ineligible for cisplatin has been heralded by KOLs as exactly that.

UPDATED: Bayer Surprises With Phase III Win For Asundexian In Stroke

 
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Successful stroke data on the oral Factor XIa inhibitor represents the first Phase III success for the class and is a major boost for Bayer’s cardiovascular franchise.

Jefferies 25: Leo Ready To Leap Into More Deals

 
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CEO Christophe Bourdon tells Scrip that the phone is ringing as the Danish drugmaker aims to become ‘the go-to partner for anything in dermatology.’


Jefferies 25: Biotech Leaders Bullish As M&A Heats Up

 

A rush of bigger M&A deals is inspiring renewed confidence in the biotech sector, but US companies are facing up to unprecedented competition from China.

Clinicians Weigh In On Evolution Of MASH Treatment

 
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With Novo Nordisk’s Wegovy joining Madrigal’s Rezdiffra as an FDA-approved MASH treatment, doctors now can choose between direct liver benefits or pursuing weight loss.

Jefferies Conference 2025: Five Themes To Follow

 

The investor event will bring deal-hungry big pharma and biotech execs together but input from the FDA’s unsettled leadership will be missing this year.

MASH Updates: Sagimet, Altimmune, GSK Discuss Development Plans At AASLD

 
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Sagimet may shift focus to later-stage MASH while it lines up Phase III financing. Altimmune expects its dual agonist to show efficacy and tolerability, while GSK is readying efimosfermin as the third FGF21 analog into Phase III for MASH.


Beijing Mabworks Scores World-First Phase III Win In Membranous Nephropathy

 

In a world-first, Beijing Mabworks has scored a Phase III clinical win for its novel anti-CD20 antibody in the treatment of primary membranous nephropathy. However, multiple global contenders including Roche are threatening to come from behind in the race.

Merck & Co.’s Enlicitide Raises The Bar For Oral Lipid Lowering

 

Detailed clinical trial data presented at AHA positions the oral PCSK9 inhibitor on par with injectable drugs on efficacy, but the competitive dynamics remain intense.

Amgen’s ‘Stunning’ VESALIUS Results Could Push Repatha Into The Mainstream

 
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Cardiologists know PCSK9 inhibition is a powerful LDL-lowering tool and now Amgen’s VESALIUS data show it may be worth adding to the primary care physician’s toolbox for prevention of high-risk patients’ first major cardiovascular events.

BIO-Europe: How Europe’s Biopharma Industry Must Respond To Rising Threats

 

There will be no return to normal for the European biopharma sector which needs to turn increasing macro-pressures into opportunities and become leaner and more efficient, experts at BIO-Europe said this week.


How To ‘Shift Left’ With Agentic AI, Balance Compliance And Creativity In MLR Reviews

 
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Experts from UCB, Alnylam, Lantheus and Medtronic deliberated at a recent summit best uses of agentic AI in the MLR review process, its human replaceability quotient and ways to balance creativity with compliance, a significant discussion amid DTC advertising and US FDA scrutiny.

Galien Forum Notebook: AI, Pharma Groupthink Take Center Stage

 

At the annual biopharma confab, biopharma execs shared their thoughts about where artificial intelligence is heading and pharma avoiding following the leader in hot areas.

Novartis Heralds Watershed Ianalumab Data In Sjogren’s

 
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The Swiss major plans to submit the positive results from the NEPTUNUS program to health authorities globally in early 2026.

MFN And Confidential Pricing: What Experts Said

 

Experts at a recent summit discussed the complexities and impact of US MFN pricing from a payer perspective and emphasized the importance of a centralized purchaser of drugs to effectively negotiate prices. The potential rise of 'confidential discounts' in Germany was another key talking point.


How Korean Biotech Can Overcome Investment, Regulatory Hurdles

 
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At recent conferences in Seoul, participants discussed various hurdles for growth in the Korean biotech ecosystem and potential opportunities such as the ongoing collaborations between Korea and Japan.

ESMO 25: What Was Behind Bemarituzumab’s Waning Efficacy In FORTITUDE-101?

 

While Amgen and Zai Labs await the results of a second Phase III trial before filing for approval, some hints as to what might have gone wrong for their FGFR2b-targeting monoclonal antibody in FORTITUDE-101 came with the full data presentation at ESMO this week.

ESMO 25: OS/PFS Win For RemeGen’s Disitamab Vedotin/Toripalimab Combo In 1L Urothelial Carcinoma

 
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RemeGen’s disitamab vedotin in combination with toripalimab significantly improved OS/PFS in Chinese patients with HER2-positive advanced urothelial carcinoma regardless of HER2 expression levels, meaning over 80% of patients with this condition could potentially benefit.

ESMO 25: Immatics Makes An Impact With Stellar Rare Eye Cancer Data

 
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Data presented at the Berlin meeting highlight the potential of the company's cell therapy anzu-cel to redefine the treatment paradigm for uveal melanoma.