Topic:

Regulatory

Latest Headlines

Latest Headlines

Alere earns FDA clearance for rapid diagnostic of Strep A

Alere announced FDA clearance of its Alere i Strep A test to detect Strep A bacteria in 8 minutes or less using throat swab specimens.

Shire could use boost from adult ADHD med to hit $10B goal

Shire has said it's targeting $10 billion in sales by 2020, with $3 billion of that coming from its current pipeline. Now, it looks like an ADHD product waiting in the wings could be ready in time to help it get there.

Clovis one-ups AstraZeneca with a 'breakthrough' tag for its cancer drug

Clovis Oncology picked up the FDA's coveted breakthrough therapy designation for its in-development ovarian cancer treatment, securing a speedy review and notching an honor denied to rival AstraZeneca and its similar drug.

Baxter recalls more than half a million units of saline

A manufacturing problem has led Baxter to recall more saline, this time nearly 600,000 units. Manufacturing problems by all the major producers have resulted in a shortage that has gone on for well over a year now, leading hospitals to rethink their use of a product they once took for granted.

Draft of China's proposed stem cell research guidelines out for comment

China has published a draft of proposed guidance on stem cell research and will accept comments on the document until April 10.

South Korea struggles with healthcare needs of elderly

South Korea has a wealth of statistics about the near future of healthcare needs in the country, but no apparent solutions for how to deal with an elderly population about to drain its coffers.

India's Aurobindo files fraud lawsuit against Natrol former owners

India's Aurobindo Pharma is involved in a complicated legal row over Natrol Inc., a vitamin and health products company it bought out of a U.S. bankruptcy proceeding last year for  $132.5 million.

FDA releases guidance on abuse-deterrent opioid formulations

To prepare for a wave of opioid candidates in the pipeline, including Pfizer's abuse-deterring, extended-release opioid capsules, the FDA has finalized guidance on the evaluation and labeling of abuse-deterrent opioids.

North Carolina compounder is closed and its products are recalled

For more than two years, the FDA has been very clear about the standards its expects U.S. drug compounders to maintain and the very harsh penalties that can await those who don't comply. But some still haven't heeded the message, and last week North Carolina authorities closed one and the FDA warned providers not to use any of its products.

Amgen CEO Bradway collects a $14M pay package on record-breaking revenue

In a year when several of his peers won big payoffs for one extraordinary reason or another, Amgen CEO Robert Bradway earned just about as much as he had the previous year, give or take a few hundred thousand. Small comfort--though some comfort, perhaps--to the thousands of employees facing job cuts as Amgen prepares for biosimilar competition to its top-selling meds.