Interim findings that Sanofi SA's venglustat is unlikely to provide a meaningful benefit to people with autosomal dominant polycystic kidney disease (ADPKD) have caused the company to halt a phase II/III study of the candidate. Testing continues in other rare diseases, but the exit could be a boon for Otsuka Pharmaceutical Co. Ltd.'s Jynarque (tolvaptan), its generic competitors and ascendant novel ADPKD programs still underway.
Trading in shares in AB Science SA was suspended Tuesday after a safety signal prompted a voluntary hold on two late-stage clinical studies of its masitinib, in mastocytosis and amyotrophic lateral sclerosis, respectively.
DUBLIN – Shares in Santhera Pharmaceuticals Holding AG surged by as much as 71% June 1 on news that the high-dose arm of a phase IIb pivotal trial of vamorolone hit the primary endpoint of an improvement vs. placebo in the time-to-stand velocity attained by ambulatory boys with Duchenne muscular dystrophy (DMD).
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Chiasma, Cstone, Eqrx, Omeros, Tetra, Turning Point, Zai Lab.
HONG KONG – Following a wave of concern about the efficacy of two COVID-19 vaccine candidates developed by China National Pharmaceutical Group (Sinopharm), interim analysis of an ongoing phase III trial, published May 26 in the Journal of the American Medical Association, has shown that adults receiving at least one dose of either of the company’s two inactivated SARS-CoV-2 vaccines had significantly reduced the risk of symptomatic COVID-19.