Deal for preclinical asset adds an anti-fibrotic mechanism to Novartis’ NASH program. Pliant produced preclinical data showing strong anti-fibrotic effect.

The chairman of Sofinnova Partners told Scrip his newly launched biotech start-up fund aims to profit from Europe’s top science, relatively realistic asset prices, and geopolitical position between the US and China. 

The US FDA cleared the combination in just three months for patients with the most common genetic mutation. Company sets price above double regimen Symdeko, but in line with trailblazer Kalydeco.

Following quickly on a Bristol trial failure with Opdivo in first-line HCC, Roche’s PD-L1 inhibitor looks poised to be the first immunotherapy approved in the setting, with plans for US, EU and China filings.

The New York biotech announces option deals with two universities, asset license from CBM BioPharma. Bayer inks research collaborations with Japan’s RiKen and with a pair of Boston research hospitals.

Farxiga, with a new indication to prevent hospitalization for heart failure in type 2 diabetes patients, is the first drug among the SGLT2 class to gain this indication outside of diabetics with renal disease.

Novartis’s investigational oral therapy for asthma fell at the first Phase III hurdle but pivotal studies in severe disease will be key to prospects.

The company expects to file an NDA for tucatinib in the first quarter after a pivotal trial showed a significant improvement in PFS and OS for patients with advanced or metastatic HER2-positive breast cancer, including those with brain metastases.

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.