Japan approval for BTK inhibitor marks new indication but in a small niche market, while another clearance may help extend Latuda's commercial life.

Novartis’s AveXis unit has received a CHMP nod for the spinal muscular atrophy gene therapy at its latest meeting, sending it on the final steps to market in the EU.

Zeposia, one of three Celgene candidates central to last year’s merger with BMS, obtains US FDA approval in relapsing MS. BMS, however, will delay the launch due to the COVID-19 pandemic.

Novel antibody-drug conjugate receives approval in Japan for second-line breast cancer, providing another push to Japanese firm’s strategic plan to build up its oncology operations.

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 CLL market segment in the EU will now include a first-line combination therapy of AbbVie’s venetoclax and Roche’s obinutuzumab, which has recently been approved by the European Commission.

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.

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.

Cadila Healthcare has received the first approval globally, in India, for a NASH therapy, after the national regulator cleared its candidate saroglitazar. The company also expects to begin Phase III trials in the US in the second quarter of fiscal 2021.