In an indication that has proved difficult for biopharma to conquer, Regulus Therapeutics Inc. disclosed further positive data from its ongoing phase Ib study testing RGLS-8429 in autosomal dominant polycystic kidney disease and laid out its plans to move straight into a phase III trial later this year, with the potential for an accelerated U.S. approval.
In a U.S. Senate Finance Committee confirmation hearing marked by shouted protests, outbursts of applause and tense exchanges on several issues, including ones beyond the reach of the Department of Health and Human Services (HHS), Robert F. Kennedy Jr. (RFK) tried to present himself as someone who follows the science, not a conspiracy theorist or anti-vaxxer.
False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts. However, the report added that the total dollar value of these cases is in line with historical norms, suggesting that the average recovery amount has tapered off significantly.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioage, Humacyte, Invisishield, Neurocrine, Pluristyx, RLS, Takeda, Telix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atai, Genentech, Inbrain, Intensity, ITM, Leap, Kashiv, Roche, Sab.
New hires and promotions in the biopharma industry, including: Allogene, Alumis, Beximco, Clarametyx, Commit, Concerto, OS Therapies, Precision, Roche, Scholar Rock.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Beacon, CSL, Daiichi, GSK, March Biosciences, Saol, Seed.
A former regional sales director at Lantheus Holdings Inc. is the latest biopharma official to settle insider trading charges with the U.S. SEC. As part of the settlement, John Heropoulos agreed to disgorge nearly $61,000, an equal amount in civil penalties and more than $10,000 in prejudgment interest, according to the SEC.
Harness Therapeutics Ltd. has raised fresh financing to further develop its technology for upregulating the translation of mRNA into proteins, and in particular to take on a previously undruggable target in Huntington’s disease.
RSS
