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.
Head of hematology clinical development Andres Sirulnik talked to Scrip about the positive Phase III results for the siRNA medicine.
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.
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 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.
The company reported positive Phase III data in individuals with gMG who are ACHr-Ab seronegative, providing an expansion opportunity.
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.
The China-headquartered company expects Phase II results from ASC30 later this year to outperform orforglipron and spark lots of big pharma interest.
The agency is expected to give its final verdict on elamipretide by the end of September.
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.
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.
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.
The France-headquartered firm’s eye drop has demonstrated efficacy in a second pivotal trial.
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.
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.
All eyes on chronic urticaria after eosinophilic esophagitis disappointment.
An updated abstract from the World Conference on Lung Cancer has given analysts confidence in BioNTech’s VEGF-A/PD-L1 bispecific challenger
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.
PTC said it got a complete response letter for the Friedreich’s ataxia drug, with the agency asking for an additional clinical trial.
The German company already had four eye disease candidates in Phase II development and sees promise in Palatin’s novel melanocortin receptor modulators.