Tag Archives: U.S. Food and Drug Administration

Cempra stock tanks on FDA concerns for lead drug’s side-effects; high hopes still riding on Friday AdCom meeting

Cempra Inc.’s (Chapel Hill NC) experimental drug to treat community-acquired pneumonia, the kind recently suffered by presidential candidate Hillary Clinton, causes a potentially concerning rise in liver enzymes, according to… Read more »

Ariad Pharma’s Slide Continues as Bernie Sanders Seeks Data on Leukemia Drug; Recent Drug Price Hikes Put Company on Familiar Hot Seat

Ariad Pharmaceuticals Inc. (Cambridge MA) continued to plummet Thursday (October 20, 2016) after Vermont Sen. Bernie Sanders and Maryland Rep. Elijah Cummings sent a letter to the company, demanding more information about… Read more »

Johnson & Johnson Tumbles as Pfizer Set to Launch Remicade Biosimilar; Solid 3rd Quarter Doesn’t Quell Market’s Overreaction

Thriving pharmaceutical sales drove stellar quarterly results for Johnson & Johnson (New Brunswick NJ), but the company’s shares fell 3% so far this week on worries that its smash hit,… Read more »

CDC Warns of Infection Risk after Open Heart Surgery; When to Worry

A federal investigation has concluded that a device used during open-heart (open-chest) surgery that infected at least 12 patients at a Pennsylvania hospital last year was probably contaminated at the plant in… Read more »

First Investor Sues Theranos for Fraud; More Likely to Join Queue

A San Francisco-based hedge fund that invested $96.1 million in Palo Alto-based Theranos Inc. is suing the blood-testing company, according to The Wall Street Journal. Partner Fund Management LP invested… Read more »

Theranos Pivots From Blood Tests to New Lab Product; Will “Phoenix” Effort Succeed?

Beleaguered startup Theranos Inc. (Palo Alto CA) will close its blood-testing labs and fire about 340 workers, shifting its focus to an experimental technology following months of run-ins with regulators and… Read more »

Lawmakers Unimpressed with Mylan CEO’s Defense of EpiPen Pricing; Fact that She’s a Senator’s Daughter Not Beneficial

Outraged Republican and Democratic lawmakers on Wednesday grilled the head of pharmaceutical company Mylan NV (Amsterdam) about the significant cost increase of its life-saving EpiPens and the profits for a company with… Read more »

Good News for Mylan after Hellish Week: Another Win in Patent War Over MS Drug; Lawyers on Both Sides Rejoice.

Teva Pharmaceutical Industries Ltd. (Petach Tikva ISR) had a third patent on its top-selling multiple sclerosis drug, Copaxone, invalidated last Thursday by a U.S. agency, a further blow to its… Read more »

Theranos Pulls Zika Test from FDA Review after Problems Flagged; Anyone Else Hear a Death Knell?

Blood-testing firm Theranos Inc. (Palo Alto CA) said it voluntarily withdrew a request to the U.S. Food and Drug Administration for emergency clearance of its new Zika-virus blood test. Theranos… Read more »

Study Suggests Revolutionary Drug Could Benefit Patients with Early Stage Alzheimer’s

A trial of a new Alzheimer’s drug has shown it could benefit patients in the earliest stages of the disease, raising hopes that a treatment for the devastating condition may… Read more »