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FDA’s Real-Time Oncology Review (RTOR) program shaved about two months off the average approval time for cancer therapeutics Genentech has submitted through the program, said Grace Gao, regulatory affairs program manager for Hoffmann-La Roche/Genentech, sharing new data at the annual meeting of the Regulatory Affairs Professionals Society in Phoenix this week. Read More
All people are not the same. While glaringly obvious, that truth is often ignored in clinical trials. And fixing that problem requires companies to understand and overcome a myriad of barriers, according to a panel discussion held at the annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix this week. Read More
Novartis has posted positive late-stage results for people with advanced liver cancer this week, while Amgen’s trial on a form of non-small cell lung cancer (NSCLC) caused by a genetic mutation also produced hopeful outcomes. So did a Novartis trial focused on a painful skin condition. Read More
The National Institutes of Health (NIH) has begun enrolling adults and children in a phase 3 clinical trial to test the effectiveness of the smallpox antiviral TPOXX (tecovirimat) on monkeypox. Read More
Merck’s blockbuster drug Keytruda (pembrolizumab) may be approved to treat 17 different kinds of cancer, but the monoclonal antibody doesn’t always hit it out of the park. Read More
Last week’s Paris meeting of the European Society of Medical Oncology (ESMO) featured a hit and a miss in renal cell cancer and some good news for elderly patients who can’t take platinum-based chemo regimens for non-small cell lung cancer (NSCL). Read More
Regeneron and Bayer’s blockbuster Eylea (aflibercept) given in three- or four-month intervals demonstrated efficacy against two major eye diseases in a pair of late-stage studies, giving the drugmakers an edge in an increasingly competitive market. Read More
Two late-breaking phase 3 studies highlighted advances in breast and colorectal cancer at the annual meeting of the European Society of Medical Oncology in Paris this week. Read More
UCB Pharma is going big with open-label extension data showing that almost 90 percent of plaque psoriasis patients who responded to Bimzelx (bimekizumab) maintained clear skin after three years of treatment. Read More
Sarepta Therapeutics’ trial of its Duchenne muscular dystrophy drug candidate is back on track four months after the FDA stopped it when a trial participant experienced a serious adverse event (SAE) that could have been life-threatening. Read More