Novartis’s Cosentyx Suffers Rare Phase III Fail

 
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Multi-blockbuster falls short in a giant cell arteritis study.

In Brief: Organon To Pull Plug On OG-6219 Program After Phase II Endometriosis Trial Failure

 

Once hailed as a potential game changer, OG-6219 gets the axe after failing in a Phase II endometriosis-related pain trial.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

Beyond AI Hype: Tokyo-1’s Real Answer On How To Innovate Pharma R&D

 
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Bringing supercomputing power to bear on large-scale calculations for pharma R&D, Tokyo-based Xeureka explains the practical use of AI to empower innovation beyond the hype.


In Brief: Atai-Beckley Deal Marches On After Phase II Psychedelic Win

 
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The psychedelic therapy firms pass a key condition for their planned merger after the antidepressant BPL-003 meets the main endpoints of a Phase IIb trial.

BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
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The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

BlissBio Goes Solo On HER2-Targeting ADC After Eisai Exit

 

BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.


Watch This Space: Miltenyi‘s ‘Brain-To-Vein,’ Point-Of-Care CAR-T Efforts In India

 

From a letter of intent with BIRAC sealed at BIO 2025 to supporting Immuneel’s CAR-T efforts and a study for point-of-care manufactured anti-CD19 CAR-T cell therapy, Miltenyi Biotec is moving on multiple fronts in India. The German group also expects to advance its own CAR-T candidates.

Decentralized Trials Enroll Larger, More Diverse Patient Populations

 

A new study by Tufts CSDD performed a deep dive into use of decentralized clinical trial techniques, but one of the study’s authors said DCTs have been dialed back.

Protagonist Hopes To Come From Behind In Obesity With Oral Triple Agonist

 

The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.

In Brief: Sanofi Cements Support For Adagene

 
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Deal Snapshot: The French drugmaker has been shifting its investments away from cancer to focus on immunology and inflammation but it continues to seek out interesting early-stage oncology assets.


In Vivo CAR-T Interest Grows With AbbVie Acquisition

 

Acquiring Capstan gives AbbVie a stake in two competing in vivo CAR-T delivery platforms, with the field's first readouts expected in 2026.

Moderna Posts Phase III Efficacy Data For Flu Vaccine

 
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With positive relative efficacy data for its mRNA seasonal flu shot, Moderna hopes to file mRNA-1010 for US approval and refile a COVID-19/flu combo shot that it withdrew in May.

Unicycive Gets FDA CRL For OLC As Cash Runs Tight

 

The complete response letter for oxylanthanum carbonate is due to a third-party manufacturing issue and is not related to safety or efficacy, the company said.

Pipeline Watch: Eleven Approvals And ADA Readouts Dominate

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.


Altimmune’s Phase IIb MASH Data Send Share Price Plunging

 
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Altimmune’s stock price did not recover on June 27, after a 57% dip the day before, despite efforts to position pemvidutide as both resolving MASH and offering weight loss.

What Incyte Investors Expect From New CEO Bill Meury

 

Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
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Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Veru’s Enobosarm Market Potential Enhanced By New Obesity Data

 
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The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.