Trump orders overhaul of kidney disease payments and treatment

October 31, 2019 The order also aims to create new payment models for transplants, and hopes to encourage the development of artificial organs — with the goal of doubling the total number of available kidneys by 2030.  Currently, more than 100,000 people are waiting for a potential kidney transplant.  Shares of DaVita and Fresenius Medicare … Read more

Study finds that shortening residents’ hours did not affect doctor performance

October 29, 2019 A move that capped residents’ work hours at 80 hours a week in 2003 did not make a difference in terms of patient mortality within 30 days of being hospitalized, readmissions or inpatient spending, according to the study published in the British Medical Journal (BMJ).  In 2003, the Accreditation Council for Graduate … Read more

AdvaMed Calls for Tweaks to FDA Guidance on Inspections

October 24, 2019 “The current wording of the draft guidance…provides FDA with so much flexibility to deviate from these processes and standards that they are rendered meaningless,” writes AdvaMed Senior Executive Vice President for Technology and Regulatory Affairs Janet Trunzo.  The group seeks revisions that address “this shortcoming” and align with least burdensome principles. AdvaMed … Read more

China’s biotech cash injection suddenly drops as U.S. scrutiny intensifies

October 22, 2019 Regulation is complex, to say the least; however, U.S. and European biotech companies know China is an increasingly important area not just to sell medicines, but to discover and develop them as well.  China, too, has been making a big push in the direction of innovation, and is looking to spend considerable … Read more

Subtle chemical shift reverses pre-diabetes in Merck-partnered mouse trial

October 17, 2019 Summers’ team collaborated with scientists at Merck Research Laboratories to develop a technique for lowering the amount of ceramides in the body.  They accomplished that by shutting down an enzyme called dihydroceramide desaturase 1 (DES1).  That, in turn, shifted two hydrogen atoms from ceramide, crippling the fatty lipid. When the researchers made … Read more

U.S. looks to extradite Chinese researcher in GlaxoSmithKline trade secrets case

October 15, 2019 Swiss authorities arrested Xue in May and are keeping him in custody while they mull the extradition request, Reuters reported.  He is fighting extradition and considered a potential flight risk, according to a Swiss Federal Criminal Court Verdict. Xue’s sister, Yu Xue, worked at GSK’s R&D unit in Pennsylvania from 2006 to 2016, … Read more

Engineered bacteria prime solid tumors for immunotherapy

October 10, 2019 Scientists at Columbia University hope to change that, using another emerging field of science:  synthetic biology.  A team at Columbia Engineering and the University’s Irving Medical Center are engineering bacteria that can deliver immunotherapy drugs straight to solid tumors.  In mice, the strain of bacteria that the researchers made was able to … Read more

Searching exhaled breaths for the chemical signs of multiple sclerosis

October 03, 2019 The goal is to produce a rapid, inexpensive and simple-to-perform diagnostic tool that could help physicians identify the disease, track a patient’s progression and monitor responses to treatment.  The researchers’ preliminary results have highlighted potential signals related to MS, which researchers believe may be linked to changes in the gut microbiome.  They … Read more