Clinical Trials

The major’s attempt to break into Crohn’s disease and ulcerative colitis has been cut short as a highly competitive market and pipeline, intensified by the entrance of biosimilars, renders further development of brazikumab impractical.

Drug shortages, stable prices and a demand recovery in the US helped drive Aurobindo’s growth in Q4. Meanwhile, the company is developing a biosimilar to Roche/Novartis’s multi-billion product Xolair, as predicted by Scrip earlier. Use of decentralized mode for its Phase III trials is a notable aspect

Chinese biotechs Biokin, Dizal, Junshi and Kelun Biotech are presenting four of the most closely-followed oral reports at ASCO on new clinical results for their candidates for non-small cell lung cancer.

The latest data from a Phase I/II study shows that pegtibatinase can yield a rapid, sustained reduction in homocysteine, the protein behind the underlying cause of the rare disease.

Also, CRO Syneos Health appointed an executive to its newly created DE&I position, while Alterity started a new Phase II study in multiple system atrophy, Antabio dosed the first patients in its Phase I study of an antibiotic for hospital infections, and Structure Therapeutics started a Phase IIa trial of its GLP-1 agonist in obesity and diabetes, with plans for a Phase IIb trial in 2024.

Despite a troubled history of JAK inhibitors in lupus trials, AbbVie’s Rinvoq has hit the mark in a mid-stage study of the condition, shifting focus to a pivotal program that could expand the blockbuster drug’s reach.

Much of the focus on the French major’s MS pipeline has been on the BTK inhibitor tolebrutinib but promising Phase II data on frexalimab have caught the eye.

The drug showed efficacy in hemophilia A and B with no sign of clots, an issue that historically has dogged anticoagulation agents, but it remains unclear whether that advantage will hold.

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.

Investment from big and small players against existing and novel targets is making antibody-drug conjugates one of the fastest-growing fields in oncology, as attested by their presence at the upcoming ASCO meeting.

In this week's podcast edition of Five Must-Know Things: novel BMS drug shows promise in IPF; Novo’s oral semaglutide compares well with injectable in weight loss; Teva looks to innovative brands to return to growth; US setback for Intercept’s NASH drug; and India’s improving environment for clinical trials.

AstraZeneca plans to unveil multiple major data packages, while Servier reveals much-anticipated results in glioma, and ImmunoGen and Novartis will present key pivotal data in women’s cancers.