Clinical Trials

ASCO: IO Continues Climb To Earlier Use With AstraZeneca’s MATTERHORN, BMS’s NIVOPOSTOP

 

Data presented at ASCO supports use of AZ’s Imfinzi for perioperative gastric cancer and BMS’s Opdivo for adjuvant treatment of head and neck cancer.

Regeneron Buys Tirzepatide-Like Product With Eye On Muscle-Preserving Combinations

 

Regeneron is bringing in its own GIP/GLP-1 agonist, establishing a path to develop proprietary obesity drug combinations with its internal muscle-sparing drugs.

ASCO: DESTINY-Breast09 Strong, But May Need Mature OS Data To Change Practice

 

Data from AstraZeneca/Daiichi’s breast cancer trial showed positive PFS, but some oncologists are waiting for confirmation of statistically significant OS benefit.

Sanofi Plays It Safer With Blueprint Buy After Bumpy 2025

 
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But the French major is still keen on early-stage M&A.


Pipeline Watch: Eight Approvals And Nine Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

BREAKING NEWS: Sanofi Bets $9.5bn To Bag Blueprint

 
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Buy boosts the French major's immunology pipeline.

ASCO: AstraZeneca Changes Management Of Breast Cancer Resistance With SERENA-6

 

AstraZeneca presented data from the SERENA-6 trial that experts said could represent a significant change in how HR+/HER2- breast cancer is treated.

Summit’s Ivonescimab Shows Significance On PFS, But Not Overall Survival

 
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In a study intended to show similar benefit in western patients, PD-1/VEGF-targeting ivonescimab met a progression-free survival endpoint, but missed on OS.


Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
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One Phase III trial hits but a second study misses by a mile.

In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Merck & Co./Daiichi Pull Patritumab Deruxtecan BLA On Disappointing OS

 

Patritumab deruxtecan is the lead antibody drug conjugate in a $22bn deal signed between the two partners, with the decision marking a disappointing setback

Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.


In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
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Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
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Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

InflaRx Stock Sinks As Vilobelimab Fails Phase III Skin Trial

 
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A study of the German biotech's intravenous complement factor C5a antibody for pyoderma gangrenosum was stopped for futility.


Angelini Advances Brain Health Ambitions With GRIN Pact

 
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The Italian drugmaker gets rights to Phase III-ready asset radiprodil.

Sweden’s Hansa Slims Down Ahead of Key Readouts

 
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New CEO Renée Aguiar-Lucander is marking her mark.

Gilead Ready To Go After Hepatitis D Again

 
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Following an FDA complete response in 2022, Gilead is getting ready to refile bulevirtide for hepatitis D. The drug already is approved in the EU, UK and elsewhere.

Progress In The Effort To Improve Outcomes In SCLC

 

Several drug makers are working to bring new advances to small-cell lung cancer, a fast-growing cancer with limited treatment options.