Ferring Pharmaceuticals A/S has notched another U.S. FDA approval, this time for a bladder cancer treatment, Adstiladrin (nadofaragene firadenovec). The non-replicating adenovirus vector-based gene therapy’s approval comes only weeks after the FDA’s Nov. 30 approval of the privately held company’s Rebyota (fecal microbiota, live), the first fecal microbiota treatment in the U.S. Adstiladrin is another landmark, as the first FDA-approved gene therapy to treat high-risk, non-muscle-invasive bladder cancer. Saint-Prex, Switzerland-based Ferring said it anticipates the product becoming commercially available in the U.S. in the second half of 2023. Read More
“Far superior to what almost anyone expected,” was how H.C. Wainwright analyst Ed Arce described the top-line readout for Madrigal Pharmaceuticals Inc.’s phase III study of resmetirom, which hit both of its dual endpoints in patients with nonalcoholic steatohepatitis (NASH) and is expected to form the basis of an accelerated approval application to the U.S. FDA in the first half of 2023. Read More
In a show of commitment to Innate Pharma SA’s antibody-based natural killer cell engager therapeutics (Anket) platform, longstanding partner Sanofi SA is paying €25 million (US$26.5 million) up front and could pay up to €1.35 billion more in preclinical, clinical, regulatory, and commercial milestones for up to three development programs. Innate also stands to receive royalties on eventual product sales. Read More
Dialing down the immune response remains at the heart of myriad drug development efforts in autoimmune disease. Targeting cytokines, such as tumor necrosis factor alpha or interleukin-12 (IL-12) and IL-23, IL-6, or IL-17, or modulating immune cell trafficking by targeting sphingosine-1-phosphate receptor or integrins, are therapeutic mainstays. But chronic immunosuppression and all its attendant safety concerns is the price that many autoimmune disease patients pay to remain in remission. Read More
New hires and promotions in the biopharma industry, including: ADC, Aruna, Atara, Black Diamond, Carcell, Catalent, Crispr, Fortress, Frequency, Ideay, Mirum, Scpharmaceuticals, Septerna, Taysha Gene, Vaxart. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aelis, Astellas, Bioved, Cerevel, Equillium, Krystal, Mimivax, Ocugen, Palisade, Skye, Synaptogenix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alexbio, Amicus, Apellis, Boehringer Ingelheim, CSL Behring, Eli Lilly, Jacobio, Miromatrix, Moderna, Ocugen, Roche, Regeneron, Sanofi, Uniqure, Y-Mabs. Read More
