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Biogen’s investigational drug for SOD1 amyotrophic lateral sclerosis (ALS), tofersen, has delivered more promising results in an extension study published in the New England Journal of Medicine. Read More
Merck has found a way forward for its stalled oral antiretroviral islatravir, using a lower, 0.75 mg dose in three newly launched phase 3 trials and in a previously paused phase 2 trial that has been languishing under a clinical hold after patients developed decreases in total lymphocyte and CD4+ T-cells. Read More
After a series of rejections, the FDA has finally approved Mallinckrodt’s Terlivaz (terlipressin) for treating adults suffering from hepatorenal syndrome (HRS), a life-threatening condition involving rapid reduction in kidney function. Read More
A spate of phase 3 data hit the wires this week. Here’s a brief look at the numbers from Alexion, Merck, AstraZeneca and Bristol Myers Squibb. Read More
Filing for hundreds of additional patents for drugs already approved by the FDA in order to fend off market entry by generics and biosimilars is the key strategy among many drugmakers for keeping their drug prices high, the Initiative for Medicines, Access & Knowledge (I-MAK) says in its new report. Read More
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