Following initial approvals for rheumatic diseases, Bristol Myers Squibb Co.'s Orencia (abatacept) has become the first FDA-approved drug for the prevention of acute graft-vs.-host disease (aGVHD), in combination with calcineurin inhibitors and methotrexate, both types of immunosuppressants. Read More
Calliditas Therapeutics AB expects its oral version of budesonide to be available early in the first quarter of 2022, following FDA approval for treating patients with progressive kidney disease primary immunoglobulin A nephropathy (IgAN). Branded Tarpeyo, the delayed-release capsules were cleared for use in reducing proteinuria in adults with primary IgAN at risk of rapid disease progression, usually determined as a protein-to-creatinine ration (UPCR) of 1.5 g/g or less. Read More
In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older. Read More
DUBLIN – Anaveon AG raised CHF110 million (US$119.5 million) in a series B round to accelerate development of its interleukin-2 (IL-2) agonist ANV-419, which is currently undergoing a phase I/II trial. “We are putting our compound into multiple clinical trials and multiple indications in parallel,” CEO and co-founder Andreas Katopodis told BioWorld. Read More
Wall Street didn’t much like Uniqure NV’s decision to hold off reporting efficacy measures in the phase I/II trial with one-time gene therapy AMT-130 for the treatment of Huntington’s disease (HD), but safety findings proved encouraging and analysts held out hope. Read More
Anheart Therapeutics Co. Ltd. raised $61 million in a series B round to support the development of a slate of precision oncology pipeline in-licensed by the company from Daiichi Sankyo Co. Ltd. Toward that end, funds will support phase II testing of the Hangzhou, China-based firm’s lead asset, the ROS1 inhibitor taletrectinib, for the potential treatment of non-small-cell lung cancer. Read More
There are many companies using artificial intelligence to aid drug development, with a seemingly overwhelming number of “world firsts” being claimed in this quickly evolving field. After signing a three-year neurology drug development deal with Eli Lilly and Co. worth up to $706 million in July, Verge Genomics is also making waves and just raised $98 million in series B financing to support development of its own AI drug development technology. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology annual meeting, including: Beyondspring, Coimmune, Geron, JW, Novartis, Oncolytic, Oncternal, Oric, Oryzon, Ose, Pfizer, Poseida, Precigen, Rheos, Roche, Rocket, Sangamo, Sanofi, Seagen, Secura, Sierra, Syndax, Talaris, Tessa, TG, Viracta, Wugen, Xencor. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 60 Degrees, Aerovate, Amgen, Arthrosi, Artax, Bioxcel, City of Hope, Eiger, Eli Lilly, Enbiotix, Exelixis, Geovax, GSK, Idera, Jazz, Nektar, NFL, Pharma Two, Polyphor, Recce, Sanofi, Sumitomo, Travere, Ultimovacs, Varmx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Boehringer, CSL, Everest, Fate, I-Mab, Incyte, J&J, Laurent, Merck, Nuvation, Sapience, Sobi. Read More
