Congratulate AstraZeneca and Nektar Therapeutics. Their oral therapy for opioid-related constipation, Movantek, beat all rival pills to market. And if analysts are correct, that market lead will pay off big time.
Months after clearing the Wearable Artificial Kidney for human clinical trials, the FDA gave medical researchers a green light to begin the first human study of the device in the United States.
As if the merger-happy pharmaceutical industry didn't have enough to worry about, what with the federal government threatening to crack down on companies that flee overseas to lower their taxes, now there's another set of stakeholders protesting these so-called tax inversions: pension funds.
Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United States."
The FDA approved a new opioid-induced constipation treatment from partners AstraZeneca and Nektar Therapeutics, shaking off some safety concerns and green-lighting a drug the two hope can bring in billions.
Next month, the FDA's expert advisers will take another look at Pfizer's stop-smoking drug Chantix. The official agenda: Weigh new data on Chantix's links to psychiatric side effects, and consider changing the black-box warning about those risks.
A court ruling has saddled biodefense specialist Siga Technologies with debts it cannot pay, the company said, and the biotech is filing for bankruptcy in an effort to keep its doors open long enough for an appeal.
Some analysts called it a cheap trick when Forest Laboratories said it would stop making the Alzheimer's drug Namenda this fall so it could push patients to switch to their new long-acting version as generic rivals to the original loom. New York attorney general Eric Schneiderman calls the tactic something else: illegal.
Novo Nordisk bolstered its better-late-than-never case to win FDA approval for a new long-acting insulin, as the drug, Tresiba, met its main goals in a study on children with Type 1 diabetes.
Anxious to prove that U.K. drug regulators aren't as slow and stodgy as they're often accused of being, British officials today announced the first in a new category of experimental drugs to earn the title of "Promising Innovative Medicine."