The FDA accepted and granted priority review status to Bristol-Myers Squibb's supplemental biologics license application for Opdivo, or nivolumab, in combination with Yervoy, or ipilimumab, as a treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma, with an action date of April 16, 2018. The application was supported by the results of a late-stage study in which the combination therapy achieved the primary endpoints of improving the objective response rate and overall survival versus use of Sutent, or sunitinib.
The action date for Pfizer's marketing application for Xeljanz, or tofacitinib, was moved by the FDA to June because the agency needed more time to review additional data the company submitted. The drug is being evaluated as a treatment for adult patients with moderate to severe active ulcerative colitis.
Sanofi says it is planning nine regulatory submissions in the next year and a half, including a PD-1 checkpoint inhibitor, cemiplimab, to treat advanced cutaneous squamous cell carcinoma. Another candidate is isatuximab, a treatment for relapsed or refractory multiple myeloma.
An investigational new drug application was filed by Cellectar Biosciences to the FDA for CLR 131, which is intended to treat adolescents and pediatric patients with certain orphan-designated and rare cancers. The proposed early-stage trial will assess the safety and tolerability of the drug candidate.
Preliminary data from two early-stage trials for Servier and Pfizer's chimeric antigen receptor T-cell therapy candidate, UCART19, proved safety and tolerability among pediatric and adult patients with high-risk relapsed or refractory B-cell acute lymphoblastic leukemia participating in the CALM and PALL studies, according to a presentation made at the annual meeting of the American Society of Hematology. Servier gained exclusive global rights for UCART19 from Cellectis in 2015 and is co-developing the treatment with Pfizer.
Johnson & Johnson's Imbruvica, or ibrutinib, was recommended by the National Institute for Health and Care Excellence as a second-line treatment for patients with mantle cell lymphoma. The company agreed to an undisclosed discount off the drug's selling price.
A new freeze-dried powder formulation of Oncaspar, or pegaspargase, has received marketing approval from the European Commission. Shire's lyophilized drug, which is administered together with chemotherapy for patients with acute lymphoblastic leukemia, has a longer shelf life and can last for 24 months, compared with its liquid formulation, and will be sold in Europe in the first half of 2018.
Our broad portfolio of cost-saving programs keeps costs down so companies can reinvest in themselves through untapped research opportunities. Hear how BIO Business Solutions helped one BIO member save on business essentials here.
The Ugandan government and agriculture experts are promoting a fast-maturing, high-yield variety biotech super bean, called NABE15, that can resist drought and possibly give hope to hunger-prone areas of Africa.
Scientists from the US and Germany have developed a way to turn Greek yogurt waste into biofuel. Utilizing bacteria, leftover acids and sugars from the yogurt are turned into molecules that can be used in the production of biofuels.
Learn more about key policy issues affecting biotechnology in Washington, D.C., and state capitals around the country. With the unpredictability of the federal level coupled with the increasingly hostile state legislatures, it is vital that the biotechnology industry amplify its voice on the federal, state and local levels. Become an advocate for biotechnology by joining BIO Action today. Now, more than ever, we need your voice! Text BIO to 52886 or visit BIO's website.
A mind troubled by doubt cannot focus on the course to victory.
Phil Armstrong, writer
The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at firstname.lastname@example.org.