In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle delivery technology in the Spikevax COVID-19 vaccine.
A therapeutic strategy based on alternative splicing of the MECP2 gene could restore protein levels in Rett syndrome, a neurological disorder caused by mutations in that gene. Scientists at Baylor College of Medicine have successfully tested this approach both in vitro in neurons from Rett patients that produce some functional protein, correcting the altered gene expression and improving neuronal functions, and in vivo in mice.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Abbott, Agios, Ascendis, Biomarin, Innocare, Innovent, Intellia, Merck, Novo Nordisk, Protagonist, Sanofi, Scibase, Takeda, Uniqure.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Bioatla, Blueprint, Celyn, Cullgen, Deephealth, Disc, Gyre, Kairos, Medimaps, Opgen, Pulmatrix, Radiobiotics.
Clinical updates for biopharma and med tech, including data readouts and publications: Aardvark, Abbvie, Bayer, Bioxytran, Celldex, Cogent, DBV, Longbio, Merck, Opus, Rhythm, Roche, Septerna, United, Upstream.
Biopharma and med-tech companies raising money in public or private financings, including: Beone, Defence, Edison, Jazz, Royalty, Sharp, Telo Genomics, Zymeworks.
Vanda Pharmaceuticals Inc. will get to take its argument for twice-rejected jet lag disorder drug Hetlioz (tasimelteon) before the U.S. FDA in a formal evidentiary public hearing, a rare move by the agency that the firm claims underscores the “gravity of the legal and scientific issues” it has raised.
Oddsmakers wasted no time figuring the market chances after Merck & Co. Inc. rolled out data from the phase III Litespark-011 study testing its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), when used with tyrosine kinase inhibitor Lenvima (lenvatinib, Eisai Co.) in advanced renal cell carcinoma.
Quell Therapeutics Ltd. has delivered the first clinical data indicating its chimeric antigen receptor (CAR) T regulatory cell therapy, QEL-001, can enable liver transplant patients to be weaned off long-term immunosuppression.
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