Weeks into a chaotic vaccine rollout in Europe, AstraZeneca finally has the long-awaited Phase III data it needs to crack open the American market — without the safety scare. How big of a role it might play in the US, though, is less certain.

At the interim analysis, AZD1222 sported a 79% efficacy at preventing symptomatic Covid-19 — a figure squarely in between the 94% or 95% posted by its mRNA rivals and 72% claimed for J&J’s single-shot vaccine. The results were based on 141 symptomatic cases recorded across 32,449 volunteers, who were randomized 2:1 vaccine to placebo, although the breakdown wasn’t disclosed.

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GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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BrainStorm Cell Therapeutics has had a rocky road trying to get its ALS treatment through to the FDA, including a particularly difficult setback after the FDA slapped the company with a refusal to file (RTF) letter in November after it submitted its original BLA in September last year.

But there’s a glimmer of hope for BrainStorm’s ALS treatment, NurOwn – the FDA will hold an advisory committee meeting to discuss the company’s BLA for the treatment, the company announced today.

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A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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