Blog

Apple launches Health Records with 39 health systems. How soon will it reach clinical studies?

September 20, 2018 Now patients of 39 health systems covering hundreds of hospitals and clinics can view their Electronic Health Records (EHR) from all participating institutions aggregated together on their iPhone.  It means patients and physicians can better view medical information in the healthcare setting; however, it could also change the clinical trial landscape, according … Read more

Eye implant made from stem cells could halt macular degeneration

September 18, 2018 A team of scientists led by the University of Southern California’s Roski Eye Institute built a retinal implant from embryonic stem cells, and they have early but encouraging evidence from a small clinical trial that it may improve visual functioning in people with advanced dry AMD.  The implant is designed to mimic … Read more

FDA orders mandatory recall for kratom products due to risk of salmonella: Triangle Pharmanaturals refused to cooperate with FDA despite repeated attempts to encourage voluntary recall

September 13, 2018 The FDA is advising consumers to discard the products that are part of the mandatory recall, which include, but are not limited to:  Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red.  The FDA understands that … Read more

India proposes caps on use of imported medical devices

September 11, 2018 Local companies gained preference over foreign businesses under Indian public procurement rules last year.  But those general, pan-industry rules stopped short of stipulating how the “Make in India” promotional agenda would apply to the procurement of medical devices.  A draft document released by the Department of Pharmaceuticals (DoP) has now filled that … Read more

Amazon hires openFDA trailblazer Kass-Hout for healthcare project

September 06, 2018 Details of what Kass-Hout will do at Amazon are scarce.  Based on the comments of an anonymous source, CNBC expects Kass-Hout to take on a healthcare-focused business development role at the online retailer’s Grand Challenge team.  Babak Parviz, who founded Google’s smart contact lens and robotic surgery programs, runs the experimental, Google … Read more

House votes down right-to-try bill

September 04, 2018 If passed, the bill would have enabled terminally ill patients to access unapproved drugs if a doctor and the manufacturer of the medicine agreed.  Today, patients must get the clearance of a doctor, the manufacturer and the FDA.  The rejected legislation would have stripped the FDA of the power to stop patients … Read more

China creates new drug regulator in biggest government overhaul in years

August 30, 2018 Presenting in March before China’s legislative body during an annual conference, the government — known as the State Council — proposed to combine the CFDA with agencies that regulate business registration, quality control, pricing and anti-monopoly efforts into a new department.  “Given the unique characteristics of drug regulation, a separate state drug administration … Read more

FierceBiotech’s rotten tomatoes and ripening fruit 2017

August 28, 2018 This year we are at it again, with a bit of a twist:  We are also looking at fruit that’s come back to ripen once again — namely some companies that topped the rotten leaderboard in 2016 but came back in 2017 smelling of roses.  We are willing to elevate, as well … Read more

Amazon breaks into drug sales with Perrigo’s store-brand OTC medications

August 23, 2018 Amazon rolled out a line of consumer health products, called Basic Care, in August 2017, CNBC reported.  The portfolio — consisting of 60 Perrigo-made treatments — sets Amazon up to put the squeeze on retailers of OTC therapies, giving the Dublin drug-maker a boost in the process. Basic Care does not directly … Read more