Clinical Trials

A Phase IIb trial testing Cartesian’s autologous mRNA-engineered CAR-T therapy for the treatment of generalized myasthenia gravis (MG) met the primary endpoint.

BMS may have ditched an antibody-drug conjugate partnership with Eisai, but the Phase II pipeline for ADCs remains strong across the industry.

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.

In this week's podcast edition of Five Must-Know Things: global CEO remuneration; another late-stage loss for Merch KgaA; deals shift to smaller M&A, partnering; Bayer’s Parkinson’s bets bear fruit; and India looks to innovate CAR-T models.

An analysis of new ADCs in Phase III studies shows the difficulties, and possible rewards, of developing these drugs.

Phase IIb data for Auxora in an acute pancreatitis subpopulation is expected to set up the CRAC channel inhibitor for Phase III in that indication while suggesting positive read-through for AKI.

Parexel’s chief strategy officer Kushal Gohil, Clinical EVP Stephen Pyke and India head Sanjay Vyas share thoughts on possible hurdles to, and the cascading impact of obesity treatments, GenAI progress and the opportunities and challenges of real-world data in India, in the second of this two-part interview with Scrip.

Positive clinical outcomes for Hengrui and Innovent/Lilly’s obesity candidates presented at ADA were based on trials that enrolled Chinese subjects and were characterized by fewer women and less severe obesity than similar Western studies. Even so, some of the data appear to stack up well against western rival drugs.

Five years after a Phase III failure, Savara reports pivotal data supporting approval of molgramostim as the first drug for autoimmune pulmonary alveolar proteinosis.

The success in the NIAGRA bladder cancer study is welcome, but another failure in NSCLC means AstraZeneca has more riding on the AEGEAN study, with an FDA advisory board to review the lung cancer data due shortly.

A new muscle-building front is opening in the fight against obesity, with Lilly among the leaders. But it plans to remain tight-lipped on upcoming Phase II data for its myostatin inhibitor in combination with Novo’s Wegovy for fear of playing into the hands of its rival.

The German major is kicking off Phase II trials for a cell therapy and a gene therapy that could be gamechangers for the progressive neurodegenerative disorder that affects more than 10 million people worldwide.

In this Chinese-language podcast episode, "Angus" Shipo Xie, a lawyer at Han Kun Law, joins Brian Yang to discuss the implications of China's updated Data Overseas Transfer rules issued in late March. Dexter Yan explains clinical data released by Hutchmed, Jiangsu Hengrui and Innovent Bio at the recent EHA and ADA annual conferences.

The biotech said it plans to engage with regulators before the end of the year for the Takeda-partnered antisense oligonucleotide, WVE-003, to discuss a pivotal trial that would support accelerated approval.

After the Phase III failure of xevinapant, the German group will need to cut deals and do better in a rare cancer if it is to turn its fortunes around.

The company posted positive results from the HELIOS-B trial in patients with ATTR-CM, which represents a much larger population than the approved hATTR-PN indication.