Anticancer

Scrip Asks... What Does 2025 Hold For Biopharma? Part 6: Therapeutic Area Advances

 

Over 140 biopharma leaders share their views on developments to watch for in key therapeutic areas this year. Advances in multiple scientific fields are opening up new avenues for treatment.

UroGen Plots Expansion, Brings In A New Asset

 

The company acquired a next-generation oncolytic virus from IconOVir that it plans to develop as a locally administered therapy for bladder cancer.

Novartis Development Head On The India Hub, AI And Not Doing ‘Me Too’ Stuff In Obesity

 

Novartis president, development and chief medical officer talks about the pivotal role of the development India hub in progressing breakthrough drugs, how AI is delivering gains in the trials arena, driving focus in the R&D engine and the Swiss group’s approach in the obesity space.

2025’s Biggest New Launches

 

Big pharma once again fails to dominate the top 20 expected best sellers from products due for launch this year. Small-to-medium pharma account for nearly half the list, while Vertex has two products in the top five.


Arcus’s Casdatifan Differentiates, But Data Overshadowed By Gilead Opting Out

 
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With new Phase I/Ib results in kidney cancer, the HIF-2a inhibitor outshines Merck’s Welireg, but longtime Arcus partner Gilead decided not to exercise its option for casdatifan.

Alligator Snaps Back Into Shape With Cash And FDA Backing

 
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The Swedish biotech has held positive talks with US regulators about the Phase III design for its pancreatic cancer candidate, mitazalimab. Now it needs to pin down a partner.

Bristol Gives Up On Adjuvant Melanoma For Opdualag With Failed Trial

 
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The checkpoint inhibitor combo missed a recurrence-free survival endpoint in Phase III in post-surgical melanoma. The LAG-3 inhibitor-containing product continues development in lung cancer, however.

AbbVie Deal Unmasks Promise Of Xilio’s T-Cell Engagers

Masked T-cell engagers are a buzzing field, and AbbVie’s investment has given Xilio some much-needed validation and cash as it goes up against rivals.


SpringWorks Gains New Approval Amid Merck KGaA Buyout Talks

 

After coming up blank with its in-house oncology efforts, the German conglomerate is mulling a deal to acquire the US specialist company which has just managed a new drug approval for mirdametinib.

Incyte Points To Niktimvo, Three Near-Term Approvals For Growth

 
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With Jakafi slated to lose US patent protection in 2028, Incyte is looking to GVHD launch product Niktimvo and label expansions for Opzelura, Monjuvi and Zynyz to drive late-decade growth.

10 Clinical Trials To Look Out For In 2025

 

Scrip surveys some of the more interesting Phase III clinical trial readouts expected this year.

Kura/Kyowa Kirin’s Ziftomenib Scores In NPM1m AML, But Differentiation Is Key

 

The company plans to file for accelerated approval with the US FDA next quarter, but there are concerns about how differentiated ziftomenib would be from Syndax’s first in class menin inhibitor.


AstraZeneca’s $80bn Ambition Riding On This Year’s Phase III Readouts

 

The company needs a string of Phase III wins this year to keep on track to reach $80bn revenues in 2030, with analysts still skeptical. Meanwhile, investors were relieved to learn that any fine related to a China corruption probe would be relatively modest.

GSK’s Walmsley Keeps Focus On Long Term Amid Trump And Tariffs Chatter

 
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The CEO has trumpeted the UK giant’s pipeline and potential growth as it aims for £40bn of sales in six years’ time.

New EU Rybrevant Approval Decisions Turn The Screw On Tagrisso

 

A manufacturing inspection issue may have put paid to J&J getting a rapid approval for its subcutaneous version of Rybrevant in the US, but a positive opinion from the CHMP plus an expanded EU approval for the IV version are two recent boosts to a franchise taking aim at Tagrisso’s crown.

Pfizer Quickly Follows Braftovi Accelerated Approval With Confirmatory Data

 

The drug maker announced positive topline PFS results from the Phase III BREAKWATER trial, after ORR data from the trial garnered Braftovi an accelerated approval in December.


Novartis’s Bulto: Kisqali Is Blueprint For More Competitive US Launches

 

Novartis enjoyed exceptional growth in 2024, and its US leader, Victor Bulto, puts that down to greater R&D and commercial co-ordination paying off with drugs such as Kisqali in early breast cancer.

Rakuten Takes Photoimmunotherapy Into Global Phase III Program For Head/Neck Cancer

 
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Oncology-focused venture eyes potential US approval for first-line use as it kicks off expanded development of light-activated therapy.

Cullinan/Taiho’s Zipalertinib Stands To Benefit From A Clear Market

 

The two companies announced positive topline results for the drug in pretreated EGFR exon 20 insertion mutation NSCLC, a market that Takeda vacated in 2023.

Genmab Foundations Firm Amid Share Price Slumps

 
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The Danish drugmaker's stock keeps falling as investors wait to see if Johnson & Johnson will opt in to co-develop a successor to the partners' multiple myeloma big earner Darzalex, but analysts have been heralding Genmab's bright prospects for assets such as Epkinly and Rina-S.