FDA sets new action date for Karyopharm's myeloma candidate selinexor | PhaseBio unveils preliminary results from early-stage ticagrelor trial | EMA opens at temporary Amsterdam headquarters
March 18, 2019
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FDA sets new action date for Karyopharm's myeloma candidate selinexor
The FDA has extended the review period for Karyopharm Therapeutics' new drug application for selinexor for patients with penta-refractory multiple myeloma, with its action date moved from April 6 to July 6. The delay is based on a recommendation made by the agency's Oncologic Drugs Advisory Committee opposing selinexor's accelerated approval.
Targeted Oncology (3/15) 
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Health Care & Policy
PhaseBio unveils preliminary results from early-stage ticagrelor trial
Researchers conducting a small Phase I trial found that an experimental drug could be an antidote to the antiplatelet drug Brilinta, or ticagrelor, showing use of PhaseBio Pharmaceuticals' PB2452 resulted in a reversal of ticagrelor's effects within five minutes that lasted for over 20 hours. The findings were reported in The New England Journal of Medicine.
MedPage Today (free registration) (3/17) 
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EMA opens at temporary Amsterdam headquarters
The European Medicines Agency has begun operating from its temporary Amsterdam headquarters and is expected to house almost 350 staff members there as of today. The agency expects to lose about a quarter of its employees due to the relocation.
FDAnews (3/18) 
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CARsgen to launch trial to assess CAR-T candidate in multiple myeloma
CARsgen Therapeutics announced that clearance from the Chinese National Medical Products Administration for its investigational new drug application for CT053 will allow the firm to begin clinical testing for its chimeric antigen receptor T-cell therapy to treat relapsed or refractory multiple myeloma in China. CARsgen also plans to submit an IND for CT053 for approval by US regulators this year.
Myeloma Research News (3/14) 
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Lexicon doses first patient in biliary tract cancer drug study
The first patient has been dosed in a Phase IIa study for Lexicon Pharmaceuticals' Xermelo, or telotristat ethyl, for the treatment of biliary tract cancer. The company expects to gather topline data next year.
Seeking Alpha (3/15) 
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Cardiology groups issue new guidance on aspirin use for heart disease
The American Heart Association and the American College of Cardiology have revised their recommendations on the use of aspirin for those never diagnosed for heart disease, presenting the updated primary prevention guidelines during a recent ACC conference. The new guidance was based on findings from newer studies that showed an increased risk for bleeding by aspirin users, particularly gastrointestinal bleeding, although the drug is still recommended for prevention of heart attacks in those previously diagnosed with cardiovascular illnesses.
The Wall Street Journal (tiered subscription model) (3/17) 
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Company & Financial News
Merck KGaA to use Iktos' AI technology in drug development
Merck KGaA and Iktos agreed to collaborate to research and develop therapies using the latter's artificial intelligence technology. The technology automatically designs virtual novel molecules with desired activities for treating a particular disease.
Pharmacy Times online (3/15) 
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Food & Agriculture
Japan health ministry to finalize biotech food rules
Finalized rules on biotech foods, including agricultural and marine products, are expected from a Japanese health ministry panel today. The rules would require companies to inform the government about the kind of biotech food they plan to distribute and could allow sales of biotech foods in Japan as early as this summer.
NHK World (Japan) (3/17) 
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Industrial & Environmental
Switching wood formation genes could have applications in biofuels
Scientists from North Carolina State University found that switching wood formation genes on and off could be used in modifying wood properties for biofuels, paper and timber production.
Biofuels Digest (3/17) 
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one of at least 20 plus-size women who hiked Mount Kilimanjaro together from March 2 to 10

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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 bio@smartbrief.com.
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