Tag Archives: U.S. Food and Drug Administration

All three of the world’s major drug regulators have busy week despite heat waves, political chaos. You know; the usual.

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Last week was a rare case where the world’s leading drugs and devices regulators were all in action simultaneously. The US Food and Drug Administration (FDA), the European Medicines Agency… Read more »

European drug regulator comes out of hibernation in new Dutch headquarters, rivaling the FDA with rulings; well, just for one week.

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It may have taken nearly 6 months and perhaps a Fourth of July holiday-shortened work week here in the US, but the European Medicines Agency (EMA) finally issued some new… Read more »

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).

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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 »