During his tenure, FDA issued a number of guidance documents outlining regulatory processes and practices that streamline reviews, yet are still dictated by scientific evidence. . . . → Read More: Commentary – Scott Gottlieb’s Legacy
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Clinical trials testing the genome editing technique Crispr for sickle cell disease and beta thalassemia, two inherited blood disorders, enrolled and infused their first patients. . . . → Read More: Trials Underway Testing Crispr for Blood Disorders  Comments are closed  Joint ventures/collaborations, New products  biomedical, biotechnology, Canada, clinical trials, Europe, FDA, genomics, life sciences, pharmaceuticals, stem cells, U.K. 
Food and Drug Administration is releasing for comment regulatory guidance for its review of implanted medical devices that connect human brains to computer systems. . . . → Read More: FDA Drafts Brain-Computer Device Regulatory Guidance One comment - (Comments are closed) Regulations biomedical, clinical trials, computer science, engineering, FDA, life sciences, medical device, physical sciences, preclinical, semiconductors, software 
Spark Therapeutics, a biotechnology company that pioneered gene therapies, is being acquired by drug maker Roche Group in a deal valued at $4.3 billion. . . . → Read More: Gene Therapy Company Acquired in $4.3B Deal One comment - (Comments are closed) Finance biomedical, biotechnology, equity, FDA, genomics, investment, life sciences, merger, pharmaceuticals, university 
A bioinformatics lab developed a prototype system for securely transmitting and storing clinical trial data with blockchain that protects against corrupting trial records. . . . → Read More: Blockchain Prototype Designed for Clinical Trial Data Comments are closed New products, Regulations biomedical, blockchain, clinical trials, computer science, engineering, FDA, life sciences, mathematics, physical sciences, software, university 
An organization advocating for medicines addressing a person’s unique chemical composition rather than disease symptoms says U.S. regulators approved 25 of those drugs in 2018. . . . → Read More: FDA Approves 25 Precision Meds in 2018 One comment - (Comments are closed) Regulations biomarkers, biomedical, biotechnology, cancer, FDA, genomics, life sciences, medical device, pharmaceuticals 
Before we start celebrating the end of injections, we need to deal with a more basic problem facing people with diabetes, namely the rapidly rising cost of insulin. . . . → Read More: Insulin Delivered by Capsule, That’s the Good News Comments are closed Regulations biomedical, clinical trials, economics, FDA, licensing, life sciences, medical device, pharmaceuticals, special, university 
Our friends at Statista reported on a survey on how the shutdown is affecting people in the U.S., this weekend’s infographic. . . . → Read More: Infographic – Americans Affected by Gov’t Shutdown 
A start-up enterprise begun by students at Purdue University developed an iPhone app that detects mild brain injuries by measuring responses of eyes to light. . . . → Read More: Univ. Spin-Off Creates Concussion Detection App Comments are closed New products biomedical, engineering, entrepreneurs, FDA, life sciences, medical device, patent, software, university 
Regulatory review of a drug to prevent allergic reactions to peanuts appears to be delayed by the shutdown of some U.S. government operations. . . . → Read More: Shutdown Delays FDA Peanut Allergy Drug Review Comments are closed Regulations biomedical, biotechnology, clinical trials, FDA, life sciences, pharmaceuticals |
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