Clinical Trials
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Structure Emerges In Obesity Race With Oral GLP-1 Agonist
Early-stage data with Structure’s oral GSBR-1290 shows weight loss of 4.9% at four weeks, which appears to top Lilly’s oral GLP-1 data in a Phase Ia trial.

ViiV In It For The Long Haul In HIV Market Battle With Gilead
The GSK-led joint venture has taken the lead in long-acting HIV treatment and prevention but has put back timelines on a key self-administered candidate.

Bionomics Posts Positive Data In PTSD With Struggling Anxiety Drug
After failing in a Phase II trial in social anxiety disorder, Bionomics thinks mid-stage data for BNC210 in post-traumatic stress disorder may now position the drug as a novel therapy for PTSD.

J&J’s Rybrevant Results Provide Encouragement After Interim Analysis Sparked Jitters
The company announced topline results for MARIPOSA in EGFR-mutant NSCLC, showing positive progression-free survival and a favorable trend on overall survival.

Gilead And AbbVie Are Not The Only Ones Re-Thinking CD47 Immunotherapies
CD47 was once seen as one of the hottest properties in immunotherapy, but multiple setbacks have tempered enthusiasm for targeting the ‘don’t eat me’ cell surface protein. I-Mab and Gilead are just two casualties.

Achieve Life Sciences Believes It Has The New Chantix
Armed with an old drug and new data, the group is aiming to revitalize the smoking cessation market.

Ex-Novartis John Tsai Takes The Reins At Cardiovascular-Focused Forcefield Therapeutics
The ex-chief medical officer at Novartis is now CEO at the UK-based biotech, which he he told Scrip could have a ‘transformational’ therapy to protect patients after a heart attack.

The Game Looks Up For Galecto
The Boston-based biotech is weighing up its options as the fall-out from its failed IPF candidate casts a shadow over Galecto’s future.

Ionis Closer To First Wholly-Owned Drug Launch With Olezarsen Phase III Success
Ionis will seek US and EU approvals to treat familial chylomicronemia syndrome in the first half of 2024. Phase III data in the larger severe hypertriglyceridemia indication are due in late 2024 or early 2025.

Biopharma’s Must-Know Q4 Catalysts
Cytokinetics has a lot riding on the upcoming Phase III readout for aficamten, and crunch time is coming for plenty of other groups, too.

Pierre Fabre Continues Oncology R&D Push
The French firm has followed up its recent acquisition of Swiss lung cancer specialist Vertical Bio by signing a pact with Vernalis.

Novartis’s Lutathera To Be First Radiopharmaceutical In Frontline Use After Trial Success
The Swiss pharma giant is building momentum in radiopharmaceuticals by racking up positive pivotal trial data and overcoming manufacturing bottlenecks.

Pipeline Watch: Nine Approvals And Nine Phase III Trial Updates
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.

What Opdivo Has To Beat In Perioperative Lung Cancer
A positive showing by Bristol Myers Squibb’s checkpoint inhibitor Opdivo in non-small cell lung cancer could broaden its use, though much depends on the magnitude of the hit.

Seagen, Astellas Data Support Broader Indication For Padcev/Keytruda Combo
With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval.

Two LEAPs Behind: Merck/Eisai Post Pair Of Failures Of Keytruda/Lenvima Combo
The announcement that LEAP-006 and LEAP-008, both in non-small cell lung cancer, did not meet their primary endpoints adds to a string of failures for the combination.
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