Tag Archives: U.S. Food and Drug Administration

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 »

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 »

John McCain in Phase 1 trial of Bexion’s solid cancer tumor candidate; Bexion who?

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The News: In late September, the University of New Mexico Comprehensive Cancer Center (UNMCC) announced that the first clinical trials of a new drug that targets solid cancer tumors have… Read more »

MannKind’s 10-year quest for insulin product Afrezza gets last-ditch chance; time to buy, or run?

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The News: Last week, MannKind Corp. (Nasdaq:MNKD) led advancing stocks in the healthcare sector, soaring 151% to $5.03, after saying it won a labeling concession from the FDA on its Afrezza inhalable… Read more »

China’s FDA to accept foreign trial data for accelerated approvals; sounds great, but future enforcement of IP rights poses threat to US Pharma.

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The News: For decades, patients in China have fought to gain access to cutting-edge medicines thanks to bureaucratic delays that have thwarted drug development. Now a sweeping government overhaul of… Read more »

Largely ignored by Trump, Puerto Rico’s hurricane disaster slams island’s pharmaceutical industry; US mainland’s access to crucial medicines could take a big hit.

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The News: Unknown to the vast majority of mainland US citizens, a nightmare scenario stemming from “supply chain instability” is unfolding right now in Puerto Rico. Brought to light by… Read more »