India’s drug regulatory body to create new database to monitor drug manufacturers

September 27, 2018 The Regulatory Agency (CDSCO) told the Economic Times it is in the process of finalizing the software to be used for the database and will amend its rules and regulations to make it mandatory for manufacturers to regularly put details of their facilities and products into the database. India does not have … Read more

China pushes generics over brands with another round of new pharma policies

September 25, 2018 The package (Chinese) would allow certain qualified generics makers to be designated as high-tech enterprises, a label that comes with a 15% corporate tax rate, compared to 25% for other companies.  The policy also makes clear that China considers compulsory patent licensing a bona fide option during public health emergencies or shortages of … Read more

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