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

Algorithm grades NASH from MRI scans in clinical study

August 16, 2018 NASH (*) has emerged as a concern for healthcare systems and a major opportunity for drug developers in recent years.  The condition, a severe form of fatty liver disease, can arise as a comorbidity in people suffering from obesity and type 2 diabetes and can lead to cirrhosis.  Drug developers including Intercept and … Read more

Abbott, J&J tell FDA how to save the industry hundreds of millions of dollars

August 14, 2018 Officials at the FDA asked for insights into how the Agency can streamline its regulations late last year.  Now, with the comment period closed, the FDA has published details of how companies and trade groups want it to repeal, replace and modify its regulations. The feedback spans multiple areas of device regulation … Read more

Algorithm identifies people with diabetes in Apple Watch heart data

August 09, 2018 Cardiogram, an Apple Watch app developer, ran a study on 14,011 of its users in conjunction with researchers at UCSF (University of California/San Francisco).  After using data on some of the participants to train a deep neural network, called DeepHeart, the team tested the algorithm on results from the remaining cohort of … Read more