Tag Archives: U.S. Food and Drug Administration

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 »

Cost of New Cholesterol Drugs Unsustainable Says JAMA Study; Ensuing Debate Rages

A new study from the University of California, San Francisco, using computer models of cardiovascular disease in American adults concludes that the price of a promising new class of cholesterol-lowering… Read more »

DEA Ignores the Evidence; Keeps Marijuana on Parity with Heroin

In a long-awaited announcement, the U.S. Drug Enforcement Administration denied requests to loosen the classification of marijuana as a dangerous drug with no medical use. The decision, reported by Reuters,… Read more »

Bristol-Myers’ Opdivo Fails in Key Lung-Cancer Study; Shares Plunge, as Do Patients’ Hopes

A cancer drug’s surprise failure in a clinical trial erased $20 billion from Bristol-Myers Squibb Co.’s (New York City) market value Friday, and raised serious questions about one of the industry’s… Read more »

FDA Approves New Treatment for Opioid Addiction

Federal health officials on Thursday approved an innovative new option for Americans struggling with addiction to heroin and painkillers: a drug-oozing implant that curbs craving and withdrawal symptoms for six… Read more »

U.S. Lawmakers Approve Bill to Provide Financial Incentives to Companies Developing Treatments for the Zika Virus

U.S. lawmakers last week approved a bill to provide financial incentives to companies developing treatments for the Zika virus, sending the measure on to the White House for President Barack… Read more »