More than a decade after first approving Actemra (tocilizumab) for the treatment of rheumatoid arthritis, the FDA has added a sixth use to its label: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays. A final guidance the FDA released in November suggests that the days of ignoring segments of the intended treatment population until safety signals flare in real-world use are coming to an end.
The U.S. NIH’s Feb. 17 announcement that it’s funding a study of the effects of remdesivir in treating COVID-19 in pregnant women is welcome news, but it begs the question of why it took so long given the risk of more severe disease in that population.
Aside from its place in the history books as a global pandemic that nearly locked down the world, COVID-19 could have a lasting, more positive legacy of finally opening U.S. biopharmaceutical clinical trials to greater diversity.
Cambridge, Mass.-based Relay Therapeutics Inc. has signed a lucrative worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development and commercialization of its compound, RLY-1971, a potent inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2) that is being investigated in a phase I dose-escalation study in patients with advanced or metastatic solid tumors.
The latest global regulatory news, changes and updates affecting biopharma, including: HIV trial networks streamlined; Grants to advance use of RWD, RWE; GAO, National Academies, report on AI in health care; ICER not sold on roxadustat; Teva, Cephalon latest EC targets; Hungary looks to Russian vaccine.
The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
DUBLIN – Shares in AC Immune SA were off more than 40% Sept. 23 on news that its tau-directed antibody, semorinemab, which is partnered with Genentech, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease.
LONDON - Scenic Biotech BV has signed up Genentech as first partner for its high-throughput platform for identifying genetic modifiers that can suppress or even completely block the effect of a disease-causing mutated gene, as starting points for drug discovery and development. Under the terms of the agreement, Scenic will identify modifiers in undisclosed therapeutic areas, with Genentech, part of the Roche Group, having an option to take multiple targets into development.
