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

FDA clears seizure-detecting wearable for epilepsy patients

August 07, 2018 Embrace looks like other smart-watches and activity trackers and shares some of their features.  The key difference is Embrace pairs its gyroscope, accelerometer and thermometer with an electrodermal activity (EDA) sensor and an algorithm that analyzes the data stream for signs the wearer is suffering a seizure.  EDA indicates whether a person is … Read more

Apple eyes FDA approval filing for investigational heart device

August 03, 2018 Full details of what Apple is planning have yet to emerge but its disclosures to participants in the study have sketched an outline of its intentions.  The latest communication from Apple gave participants in the ResearchKit study informed consent documents to sign ahead of the initiation of data collection.  A section of … Read more

Ohio State researchers find pacemaker-like device reduces Alzheimer’s effects

August 01, 2018 In a study published in the Journal of Alzheimer’s Disease, the researchers said they implanted thin electrical wires into the frontal lobes of patients with Alzheimer’s disease to see if using a brain pacemaker could improve cognitive, behavioral and functional abilities in patients with this form of dementia.  They found that using DBS … Read more