Hookipa Pharma Inc.’s nearly $1 billion collaboration with Roche Holding AG dissolved along with 30% of the company’s staff. The New York-based company said Roche ended the October 2022 deal involving the HB-700 program in treating KRAS mutated cancers but did not say why the agreement fell apart. Leerink Partners analyst Andrew Berens wrote Jan. 29 that the firm spoke to management, which indicated the program was progressing according to plan and that Roche's decision was based more on its own internal pipeline strategy, lessening its focus on oncology after high profile failures vs. the program having issues in development. Read More
Sarepta Therapeutics Inc.’s next-generation peptide-conjugated PMO therapy, SRP-5051 (vesleteplirsen), looks set to stake its claim in the Duchenne muscular dystrophy (DMD) space, as phase II data unveiled dystrophin expression that outperforms first-generation exon-skipping drug Exondys 51 (eteplirsen). The question is what that space might look like in the wake of a U.S. FDA decision whether to expand labeling and convert to full approval Sarepta’s DMD gene therapy, Elevidys (delandistrogene moxeparvovec). Read More
Investigators have identified five cases of so-called iatrogenic Alzheimer’s disease (AD), that is, AD that was acquired as a result of undergoing medical procedures. A team led by University College London scientists reported their findings online in Nature Medicine on Jan. 29, 2024. Read More
In keeping with federal standards for classifying race and ethnicity data, the U.S. FDA issued a draft revision to broaden its 2016 guidance on the collection of such data in clinical trials. Read More
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space. Read More
No subpoena will be needed to force the CEOs of Johnson & Johnson (J&J) and Merck & Co. Inc. to appear before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, as apparently the threat was enough to get the CEOs to agree to testify at a committee hearing on U.S. drug prices. Read More
After raising $20 million in a series B round in December 2022, Aravax Pty Ltd. has raised another $22 million to close out its series B round with $42 million that expands the syndicate with new investors Novartis Venture Fund, Breakthrough Victoria, Uniseed, Unisuper, and Agati Capital. The funds will take the company’s peanut allergy immunotherapy, PVX-108, through phase II trials. Read More
Biopharmas raising money in public or private financings, including: Alto, Ascendis, Checkpoint, Eyconis, Panbela, Redhill, Renovorx, Sirona, Skye and Vera. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Corbus, Cytokinetics, Femasys, Incannex, Orion, Merck, Ultragenyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABL, Cristalia, Debiopharm, Formosa, Gamida Cell, Institut Mérieux, Oxford Biomdica, Pathos, Ractigen, Rain Oncology, Sanofi, Synthekine and Transcode. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 2seventy, Apellis, Bristol Myers Squibb, Eisai, Liquidia, Minoryx, Neuraxpharm, PTC, Regeneron. Read More