Priority review status granted to BMS' kidney cancer combo drug | PDUFA date of Pfizer's ulcerative colitis drug extended by FDA | Sanofi immunotherapy drugs among upcoming regulatory submissions
December 15, 2017
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Priority review status granted to BMS' kidney cancer combo drug
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.
BioCentury (12/14) 
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Health Care & Policy
PDUFA date of Pfizer's ulcerative colitis drug extended by FDA
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.
Seeking Alpha (free registration) (12/13) 
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Sanofi immunotherapy drugs among upcoming regulatory submissions
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.
Genetic Engineering & Biotechnology News (12/13) 
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Cellectar seeks FDA nod for rare, orphan-designated cancer drug
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.
Seeking Alpha (free registration) (12/14) 
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Servier, Pfizer report on preliminary data for 2 early-stage UCART19 trials
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.
Reuters (12/13),  Seeking Alpha (free registration) (12/13) 
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NICE reverses decision, recommends J&J's mantle cell lymphoma therapy
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.
Seeking Alpha (free registration) (12/14) 
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Shire's Oncaspar gains European marketing approval for new formulation
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.
Seeking Alpha (free registration) (12/13) 
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Company & Financial News
Funding round pulls in $63M for Relay
A round of Series B funding brought in $63 million for Relay Therapeutics. The company plans to launch a clinical testing of an oncology program in 2019.
BioCentury (12/14) 
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Food & Agriculture
Africa given new hope against famine with biotech beans
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.
The Hindu (India)/The Associated Press (12/4) 
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Industrial & Environmental
Biofuel produced from Greek yogurt waste
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.
Biofuels Digest (12/14) 
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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
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