Tag Archives: U.S. Food and Drug Administration

GlycoMimetics gets Breakthrough title; stock explodes but what’s next?

The News: GlycoMimetics Inc. (Rockville MD) soared Thursday (May 18, 2017), up 99% to $10.67. The unforeseen blastoff followed Tuesday (May 16, 2017) night’s announcement that the company’s clinical-stage acute… Read more »

Akebia surges on anemia drug deal; is a much bigger breakout looming?

The News: Akebia Therapeutics Inc. (Cambridge MA) leaped 18% Tuesday (May 16, 2017) sparked by news the fledgling dialysis treatment developer and Swiss backer Vifor Pharma Group Ltd. (Glattburg) agreed… Read more »

Glaxo dodges another Advair punch as second generic attempt crashes; Big Pharma’s plight highlights new world order for competition and innovation

The News: GlaxoSmithKline PLC is likely to escape generic competition to its blockbuster lung drug Advair in the US this year, after a second application for a cut-price equivalent form… Read more »

Senate confirms Gottlieb as FDA chief; former FDA tour, industry ties signal solid choice despite Dems’ jabs

The News: The US Senate voted 57 to 42 on Tuesday (May 9, 2017) to confirm Scott Gottlieb, MD, as Food and Drug Administration (FDA) Commissioner. Gottlieb, who was nominated by… Read more »

Novartis 1Q results remain insomnia cure; investors plead for something, anything to get excited about

The News: Novartis AG shares moved higher Tuesday (April 25, 2017) after the pharmaceuticals group clung to full-year earnings targets and barely beat analysts’ estimates for first-quarter earnings. The Swiss… Read more »

Healthcare stocks have rough week as TherapeuticsMD, NantHealth fall flat; but Neurocrine, Tocagen shine

TherapeuticsMD Inc.(NYSE: TXMD) led a large contingent of stocks performing faceplants among the healthcare ranks. The clinical-stage biotech company focused on women’s health, plummeted $2.19, or 28%, to $7.70 in… Read more »

Mylan’s EpiPen profitable despite recalls, lawsuits; stock price immune to ethics rants

Mylan NV (Amsterdam) is facing a new class-action lawsuit related to the price hikes of it EpiPen devices. The lawsuit was filed in federal court in Tacoma, Washington on Monday… Read more »

Week’s opening stock salvo: Esperion, Nektar, CytomX soar; Aevi Genomic thrashed

Esperion Therapeutics Inc. (Nasdaq: ESPR) stock recently recovered big time from last Amgen-induced beat down to touch an 18-month high after the company outlined its path to FDA approval for its… Read more »

Health sector’s biggest winners & losers as of March 17, 2017

Seres Therapeutics Inc. (Nasdaq: MCRB) led advancing issues, soaring $2.71, or 29% for the week, to $12.04. The small microbiome-therapeutics platform company released its fourth-quarter results earlier Thursday (March 16,… Read more »

Trump and pharma execs make nice; what, Sen. Sanders too?

The News: Last week (January 30, 2017), President Trump promised some of the nation’s top drug-company executives in a meeting at the White House that he would shrink Food and… Read more »