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Commentary – Scott Gottlieb’s Legacy

Scott Gottlieb

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

Trials Underway Testing Crispr for Blood Disorders

Crispr genome edits illustration

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

FDA Drafts Brain-Computer Device Regulatory Guidance

Brain circuits illustration

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

Gene Therapy Company Acquired in $4.3B Deal

Retinal gene therapy

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

Blockchain Prototype Designed for Clinical Trial Data

Network illustration

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

FDA Approves 25 Precision Meds in 2018

Onpattro

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

Insulin Delivered by Capsule, That’s the Good News

Diabetes word cloud

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

Infographic – Americans Affected by Gov’t Shutdown

Chart, survey of shutdown effects

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

Univ. Spin-Off Creates Concussion Detection App

Eye measurements

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

Shutdown Delays FDA Peanut Allergy Drug Review

Closed sign

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