Life Sciences
Top stories summarized by our editors
3/18/2019

As part of its March report to Congress, the Medicare Payment Advisory Commission proposed increasing payments to acute-care hospitals by 2%, rather than the 2.8% hike expected under existing law, with the remaining 0.8% to be used to reward participants under a single quality incentive program. Amid concerns that hospitals are losing money under Medicare, the panel also proposed eliminating $1 billion in penalties incurred by hospitals annually under two penalty-only incentive programs and replacing the four current incentive programs with a single program.

3/18/2019

Legacy Pharmaceutical Packaging is recalling an additional 43 lots of blood pressure drug losartan due to trace amounts of a possible carcinogen. This recall follows other recent recalls of losartan tablets for the presence of potential carcinogens.

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losartan
3/18/2019

Fresenius Medical Care's computer-assisted ultrafiltration control software, designed for improving fluid management in hemodialysis, has obtained breakthrough device designation from the FDA. The software is being developed for use in a dialysis machine embedded with intelligent diagnostics that can give computer-assisted recommendations for meeting target relative blood volume levels.

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MassDevice (Boston)
3/18/2019

Becton Dickinson has obtained premarket approval from the FDA for its Venovo venous stent, which is intended for treating symptomatic nonthrombotic and post-thrombotic iliofemoral lesions.

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FDAnews
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FDA, Becton Dickinson
3/18/2019

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.

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FDAnews
3/18/2019

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.

3/18/2019

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.

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Myeloma Research News
3/18/2019

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.

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Seeking Alpha
3/18/2019

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.

3/18/2019

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.

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Pharmacy Times online
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Merck KGaA, Iktos, Iktos