Tenapanor approved for IBS-C as Ibsrela, but Ardelyx is still seeking a commercial partner for that indication – and is maintaining focus on same molecule in hyperphosphatemia.

Sanofi sells Indian facility to Zentiva, a key customer for products made at the site, and hopes to make up for the earnings gap through a renewed push for its “core activities and brands.”

BioNTech has plenty of cash and is gearing up for an IPO, but money from a Hong Kong investor is in limbo. Plus, Satsuma and SpringWorks bring US IPO total to 34 this year, Fate's FOPO raises $150.5m and Pharvaris brings in $66m.

Asia-focused PE firm PAG has purchased a majority stake in Hisun BioRay, the biotech division of Chinese state-owned generic company Zhejiang Hisun Pharmaceutical, for $540m, boosting its presence in a nascent, fast-growing segment of the country’s drug industry.

Celiac disease specialist Sitari was the first company formed under the six-year collaboration. Three were shut down and Avalon controls the other four, which aren't compatible with GSK's new R&D focus.

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

More than two years after EU approval, BioMarin and the National Health Service have agreed pricing for the ultra-rare disease therapy, Brineura, allowing it to be publicly funded while further clinical data are collected as part of a managed access agreement.

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Novartis/Spark’s gene therapy Luxturna has been OKd for NHS use by NICE in record time thanks to early engagement and close collaboration between the two parties. 

The company's proteasome inhibitor reduced the risk of death in combination with J&J's CD38 inhibitor in a Phase III trial. A day earlier, Amgen reported clinical holds on its Phase I MCL-1 inhibitors due to cardiac safety.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

In a further positive step for its oncology ambitions, Japanese company files first submission for promising lead antibody-drug conjugate, partnered globally with AstraZeneca, while other pipeline ADCs mark development progress.