Gentibio Inc. has raised $157 million to develop its engineered regulatory T cells (Tregs), setting itself a target to cure type 1 diabetes and treat other diseases caused by the immune system. Boston-based Gentibio launched in August last year with $20 million seed funding from Orbimed, Novartis Venture Fund and RA Capital. Those investors stayed on into the next round, which was led by Matrix Capital Management with participation by Avidity Partners and JDRF T1D Fund. Read More
Fibrogen Inc. was braced for receiving a complete response letter (CRL) and it got one. The FDA suggested it would not approve roxadustat’s NDA for treating anemia of chronic kidney disease until more clinical work is conducted. In July, the FDA’s Cardiovascular and Renal Drugs Advisory Committee said basically the same thing as it voted 13-1 against approval for the nondialysis population and 12-2 against approval for patients on dialysis unless more trial data are submitted. Read More
Shares of Cohbar Inc. (NASDAQ:CWBR) hit a 52-week high on Aug. 11 following news that a mitochondrial peptide analogue it is testing for the potential treatment of nonalcoholic steatohepatitis (NASH) and obesity, CB-4211, delivered "robust" improvements in key biomarkers of liver damage and glucose levels vs. placebo during a small phase Ia/Ib study. Read More
Contrary to the broader markets, BioWorld’s Cancer Index is down by 22% this year, losing more than 7% throughout the month of July, despite oncology driving several high-money deals and accounting for 38%, the lion’s share, of financings. Both the Nasdaq Biotech Index and the Dow Jones Industrial Average are tracking similarly for the year, and are up by 13.2% and 15.2%, respectively, as of Aug. 10. Read More
LONDON – Stopping people under 40 from receiving Astrazeneca plc’s COVID-19 vaccine has put an end to the serious blood-clotting syndrome associated with the product, with no new cases in the U.K. for the past four weeks, according to an expert panel of hematologists. Read More
The FDA’s latest version of the intended use rule is a complex, 61-page document that cleaned up a few things from the previous version and added a phrase or two to the regulatory lexicon. Randy Prebula, a partner in the D.C. office of Hogan Lovells U.S. LLP, told BioWorld that while the FDA left itself some wiggle room by avoiding a prescriptive use of language in the rule, the final rule is unlikely to be the final word on the intended use question. Read More
New hires and promotions in the biopharma industry, including: Aeon, Algernon, Be, Blue Water, Immunetune, Insilico, Intrommune, Lqt, Makana, Rakuten, Sesen, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Belief, Dermavant, Fibrogen, GW, Innocare, Lantern, Merck, Phasebio, Reata, Roivant, SFJ. Read More
