Lilly’s Orforglipron Makes Strong Showing In Diabetic Obesity Population

 

The drugmaker announced topline results from the Phase III ATTAIN-2 trial in overweight/obese patients with type 2 diabetes and plans to file for approval.

Regeneron Plans To File Cemdisiran For gMG But Will Face Tough Market

 

Head of hematology clinical development Andres Sirulnik talked to Scrip about the positive Phase III results for the siRNA medicine.

Novartis Signs Up For BioArctic Blood-Brain Barrier Tech

 
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The Swiss giant is paying $30m upfront for rights to the Swedish firm’s BrainTransporter technology, its second brain-barrier breaching deal in as many months.

US FDA Suspends Valneva’s Ixchiq Based On Four New Serious AE Reports

 
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After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.


Pipeline Watch: Twelve Approvals And Two 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.

Argenx’s Vyvgart Positioned For Broadest Label In Myasthenia Gravis

 

The company reported positive Phase III data in individuals with gMG who are ACHr-Ab seronegative, providing an expansion opportunity.

Pipeline-In-A-Product: A Retrospective On The Development Of Dupixent

 

Dupixent’s success across eight indications is a model other drugmakers would like to replicate. R&D leaders at Sanofi and Regeneron reflect back on the development strategy that built the $15bn product.

Ascletis Confident Oral GLP-1 Challenger Can Best Lilly In Phase II

 

The China-headquartered company expects Phase II results from ASC30 later this year to outperform orforglipron and spark lots of big pharma interest.


Speedy FDA Review Could Save Stealth From Sinking

 
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The agency is expected to give its final verdict on elamipretide by the end of September.

Chinese Biotechs Bet On FDA-Cleared Phase III Trials With First-Mover Potential

 

Ascentage and Biokin are the latest novel drug players from China to progress potential first-in-class molecules into Phase III trials in the US. Meanwhile, Zai Lab is seeking US accelerated approval for its lung cancer candidate.

Ionis’s Dawnzera Becomes First RNA-Targeted HAE Prevention Drug

 
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Dawnzera joins CSL’s recently approved Andembry as new additions to the crowded hereditary angioedema prevention market. It is priced at $57k per dose, but labeling includes four- or eight-week options.

Dynavax Aims To Disrupt GSK’s Shingrix Market With More Tolerable Shingles Vaccine

 
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Phase I/II head-to-head data show Dynavax’s Z-1018 had similar immunogenicity and much improved tolerability versus Shingrix, prompting a move into Part 2 of the study.


Nicox Plots US Submission After Another Phase III Glaucoma Win

 
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The France-headquartered firm’s eye drop has demonstrated efficacy in a second pivotal trial.

Rocket’s Warp Drive Back Online As FDA Lifts Danon Gene Therapy Hold

 

The company took a prophylactic C3 inhibitor out of the immunomodulatory regimen used in its Phase II study of RP-A501, lowered the dose and adjusted its use of eculizumab.

Madrigal Regains Lead With Rezdiffra MASH Approval In EU

 
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Four days after Wegovy became the second approved MASH therapy in the US, Rezdiffra gets the first European approval. Plans are for an initial launch in Germany.

Celldex Bullish On Barzolvolimab Despite Study Miss

 
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All eyes on chronic urticaria after eosinophilic esophagitis disappointment.


BioNTech/BMS Bispecific Shows Early Promise In Small Cell Lung Cancer

 

An updated abstract from the World Conference on Lung Cancer has given analysts confidence in BioNTech’s VEGF-A/PD-L1 bispecific challenger

Discontinuations For Viking’s Oral Obesity Drug VK2735 Scare Investors

 
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Analysts lauded the 13-week weight-reduction rates Viking’s oral dual GLP-1/GIP agonist showed in Phase II, but the firm’s stock tumbled 42% due to high discontinuation rates.

Interest In PTC’s Sephience Launch Overshadows FDA’s Vatiquinone Rejection

 

PTC said it got a complete response letter for the Friedreich’s ataxia drug, with the agency asking for an additional clinical trial.

Boehringer Expands Eyecare Horizons With Palatin Collaboration

 

The German company already had four eye disease candidates in Phase II development and sees promise in Palatin’s novel melanocortin receptor modulators.