Australia, the not-so-secret destination for pharma and biotech clinical trials

October 30, 2018 To capitalize both on that growth and its available resources, the Government of Australia began offering tax incentives to attract more global drug developers to the country to conduct early stage clinical trials, as well as build on the research excellence and drug development infrastructure in the country. “From a regulatory aspect, … Read more

FDA plans to launch ‘Pre Cert 1.0’ by the end of 2018, issues working model for digital health regulation

October 25, 2018 Dubbed “Pre Cert 1.0,” the program will be the first formal iteration of a pilot project launched with nine companies last September.  The Agency plans to build the program using a working model and an updated roadmap, released in April, that evaluates each manufacturer’s transparency, culture of quality and organizational excellence rather … Read more

Everyone Hates the Open-Plan Office. It Doesn’t Have to Be That Way

October 23, 2018 Almost three-quarters (3/4) of U.S. offices are designed with an open desk plan.  Microsoft Corp. has one; so does Etsy Inc.; even the General Services Administration (GSA), the government’s landlord, is pitching a wall-free model to federal agencies. Employers love open plans because they save money — you can cram a lot … Read more

FDA puts incentivization of device safety R&D, cybersecurity defenses on action plan

October 19, 2018 The 17-page document is split up into five sections that address the aforementioned topics plus the creation of a patient safety net, integration of pre and postmarket oversight and steps the FDA could take to intervene faster when safety threats arise.  Collectively, the proposals are intended to ensure technological advances translate into … Read more

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