Tag Archives: U.S. Food and Drug Administration

Close (but not too close) encounters with God confer mental health benefits, say researchers at Johns Hopkins. This definitely isn’t your typical medical article.

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The News: Profound religious experiences are linked to lasting mental health benefits, new research suggests. In a survey study of more than 4000 individuals, those who reported having profound personal… Read more »

FDA clears psilocybin for testing as breakthrough therapy

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UPDATE: FDA permits psilocybin to be tested for refractory depression; grants Breakthrough Therapy designation for magic mushrooms psychedelic compound. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy… Read more »

October wraps up healthcare IPOs with another strong week as 2018 biotech explosion still on record pace.

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The News: The Wall Street Journal reports that the pace of biotech IPOs in on track for a near-record year, although many are riskier due to being in earlier stages of development…. Read more »

Stodgy Johns Hopkins wants FDA to clear psilocybin mushrooms for depression. Here’s what you need to know (or recall) about the differences between magic shrooms and, say, LSD.

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The News: Researchers from Johns Hopkins University (Baltimore) have recommended that psilocybin, the active compound in hallucinogenic mushrooms, be reclassified for medical use, potentially paving the way for the psychedelic… Read more »

Insys attempting “Phoenix” impersonation as key Q1 earnings slated for Tuesday. Analysts say Buy, but is now the time?

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The News: A former Insys Therapeutics Inc. (Chandler AZ) sales representative was recently sentenced to six months of home confinement after admitting that she participated in a scheme to pay… Read more »

Biotech IPO tsunami continues even as stocks sag following FDA chief’s drug-price rant.

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The News: US Food and Drug Administration chief Scott Gottlieb on Thursday (May 3, 2018) questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law,… Read more »

Study says central hearing loss may affect memory, also signal cognitive decline–an early indicator of possible dementia. Wake up, Medicare (and other insurers).

      No Comments on Study says central hearing loss may affect memory, also signal cognitive decline–an early indicator of possible dementia. Wake up, Medicare (and other insurers).

The News: Hearing loss is a common part of aging, but for some people, it may be a sign of far more serious neurological problems. Researchers in Italy examined two… Read more »

South Korea’s Celltrion Inc. (Incheon) gets EU green light for Herceptin biosimilar

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The News: Celltrion Inc. said on February 14, 2018 that it has received approval to sell its replica version of Roche Holding AG’s (Basel CHE) breast-cancer blockbuster Herceptin in Europe…. Read more »

Investor alert: Pear Therapeutics hauls-in $50 million Series B after FDA clears first-ever mobile app for substance abuse therapy. What would Warren Buffet think?

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The News: The US Food and Drug Administration (FDA) recently cleared for marketing the first prescription mobile medical application to help treat substance use disorders (SUDs) involving alcohol, cocaine, marijuana,… Read more »

FDA warns against unproven medical claims for marijuana. “Prohibition” didn’t work, remember?

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The News: Four companies selling dozens of various marijuana-derived dietary supplements have been officially warned by the US Food and Drug Administration to stop plugging their products as cures for… Read more »