Billionaire investor Icahn, who owns 1.4% of Illumina, launched a proxy battle against the company earlier this month seeking divestment of cancer test developer Grail as the $7.1 billion acquisition cost investors billions of dollars.
The gene therapy has yet to be approved in the U.S. PTC expects to submit a Biologics License Application (BLA) to the FDA in the first half of 2023, the company announced.
In a double data drop yesterday, AbbVie touted two clinical trial wins. Topline data from the Phase III INSPIRE study showed Skyrizi (risankizumab) met its primary and all secondary endpoints in ulcerative colitis and Rinvoq (upadacitinib) aced its Phase II SLEek trial, showing therapeutic potential in systemic lupus erythematosus.
The company said the focus of its drug research would shift away from women’s health, a traditional pillar of Germany’s largest drugmaker, to hone in on neurology, rare diseases and immunology.
Despite positive results Monday from a Phase III trial of KarXT (xanomeline-trospium) and analysts’ recommendations to buy, Karuna Therapeutics’ stock dropped more than 19% in 48 hours this week.
The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.
A California judge’s decision to allow expert testimony linking GSK’s heartburn drug Zantac to cancer wasn’t a surprise, analysts said, though the litigation will likely weigh on the drugmaker’s share price until a trial in the summer.
The deal couples Novo Nordisk’s experience in diabetes with Dewpoint’s discovery and artificial intelligence platform. The companies will work to discover potential molecule drugs against multiple condensate targets.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen’s effect on neurofilament light chain could be a reasonable predictor of clinical benefit.
Sanofi’s asthma drug Dupixent met all targets in a trial to treat “smoker’s lung”, potentially adding billions to the French drugmaker’s growth prospects, but also underscoring a heavy reliance on its bestseller.