Will Facebook’s data-scraping woes bleed into healthcare and pharma?

October 16, 2018 Probably not, said several industry experts interviewed by FiercePharma, although Pharmas should still keep an eye on the controversy. Cambridge Analytica’s mishandling of data collected in apps spurred Congress to hold hearings with Facebook CEO Mark Zuckerberg in the first part of April 2018.  That app-oriented issue does not apply to pharma … Read more

FDA launches criminal investigation into rogue herpes vaccine research

October 11, 2018 SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an Institutional Review Board (IRB). According to four people with knowledge about … Read more

Trump tariffs threatens to cost medical device industry billions

October 04, 2018 The action could have negative consequences for medical device manufacturers and the patients who use their products.  Chinese-made products account for a significant minority of devices imported into the U.S. Some of the imported devices come from Chinese companies.  Others are manufactured by Western companies with operations in China. Estimates of the … Read more

CVS develops medical device to corner home dialysis market

October 02, 2018 Woonsocket, Rhode Island-based CVS established itself as a national brand through its pharmacies; however, over the past decade or so it has broadened its scope, notably by merging with pharmacy benefit manager (PBM) Caremark Rx and striking a deal to buy insurer Aetna.  Now, CVS is moving onto turf traditionally colonized by … Read more

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