Research over the past decade has shown embryonic stem cells can undergo many disparate aspects of mammalian embryogenesis in vitro. But without the support of extra-embryonic stem cells that go on to form the placenta and yolk sac, development stalls. Now, two groups of researchers, led by scientists at the Weizmann Institute in Israel and Cambridge University, U.K., have taken the in vitro development of whole mouse embryos further, by adding or inducing the differentiation of trophoblast cells and extra-embryonic endoderm stem cells. Read More
As Novartis AG works to streamline the company and finalized a long-considered plan to separate its Sandoz Inc. business by creating a standalone company, it temporarily stopped dosing in a study of branaplam for treating Huntington’s disease. Several findings from the phase IIb study suggested the presence of peripheral neuropathy in some participants. An independent data monitoring committee recommended the dosing halt but fell short of recommending the study be terminated. The VIBRANT-HD steering committee agreed with the committee’s recommendation. Read More
A phase II trial this week showed that combining the diabetes drug semaglutide (Novo Nordisk A/S) with a fixed-dose combination of Cagrisema (cagrilintide/semaglutide) led to “numerically higher” reductions in both HbA1c and body weight than either component alone. And on the preclinical side, researchers from the Novo Nordisk Research Center and the Helmholtz Diabetes Center reported that linking the dual PPAR activator tesaglitazar to GLP-1 improved glucose control in male mice. Both bits of news illustrate that GLP-1R agonists, which are also called incretin mimetics and GLP-1 analogs, are likely to continue their success across multiple areas of medical care. Read More
3T Biosciences Inc. raised $40 million in a series A funding round to take forward a platform for identifying novel T-cell receptors (TCR) and their targets, which is based on the work of scientific co-founder K. Christopher Garcia of Stanford University. Read More
As the PDUFA date looms for Bristol Myers Squibb Co. with its candidate, deucravacitinib, for psoriasis, others – notably Dice Therapeutics Inc. – strive for new solutions to the skin disease, which has remained problematic for many patients despite approvals of multiple drugs in various classes. Read More
It’s that time of year when the U.S. Trade Representative asks for help as it prepares its list of notorious markets for counterfeiting and piracy. While it’s not exhaustive, the annual list is composed of online and physical markets around the world that deal in commercial-scale counterfeiting and piracy across all sectors, including biopharma and med tech. Read More
Interim analysis of a phase III trial testing a single dose of Pfizer Inc.'s bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in older adults has revealed efficacy good enough to support a planned BLA submission for the vaccine to the U.S. FDA in fall 2022, the company said. Preparation for further submissions to other regulatory agencies are underway. Read More
U.S. FDA approvals in 2022 are down by more than 30%, while new molecular entity approvals have been cut in half. So far this year, the U.S. FDA has approved 93 drugs and biologics, including expansions into new indications. In comparison with each of the last three years, it is a significant drop. There were 136 approvals in 2021, 143 in 2020 and 134 in 2019 announced by the end of August. Read More
A dozen years after the Dodd-Frank Act was signed into U.S. law, the SEC adopted a final rule Aug. 25 implementing the law’s so-called “pay-vs.-performance” provisions related to executive compensation. Read More
In an effort to keep up with the advances being made in manufacturing technologies, the European Commission (EC) is updating its 2007 technical guidance on good manufacturing practices for sterile drugs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Annovis, Apellis, Arthrosi, Innovent, Ranok, Regenacy. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ainos, Can-Fite, Enlivex, Innocare, Janssen, Keymed, Moderna, Pfizer, Tachyon, Valneva. Read More
