Tag Archives: AstraZeneca PLC

Drug regulators in China, US and Europe out of the gates in 2020 with a whole month’s worth of action.

Slowly at first, then accelerating recently in its domestic and global footprint in drug research and regulation, China and its National Medical Products Administration (NMPA) has been on a tear…. Read more »

In a seeming role-reversal, FDA steps up action over Thanksgiving week while EMA goes on holiday.

Although usually thought of as a well-deserved respite from governmental rulings, the US Food and Drug Administration seized on Thanksgiving week as a demonstration of its zeal to pump out… Read more »

European drug regulator comes out of hibernation in new Dutch headquarters, rivaling the FDA with rulings; well, just for one week.

It may have taken nearly 6 months and perhaps a Fourth of July holiday-shortened work week here in the US, but the European Medicines Agency (EMA) finally issued some new… Read more »

Brexit referendum slowing the European Medicines Agency’s operations to a crawl.

The News: The European Medicines Agency (EMA) recently addressed its concerns for ensuring business continuity and staff retention which had become huge challenges caused by the Brexit referendum. The EMA… Read more »

Liquid biopsy for cancer detection catching on fast. You choose: simple blood test, or invasive solid tissue sample?

The News: Until recently, cancer detection depended on invasive solid tissue sampling that didn’t provide a complete picture. Now, a budding cluster biotechs is making it easier to detect cancer… Read more »

Breakthrough gene editing reported that removes deadly embryonic mutations; biotech licks its chops as stakes are incalculable for ensuing blockbusters.

The News: Scientists have modified human embryos to remove genetic mutations that cause heart failure in otherwise healthy young people in a landmark demonstration of the controversial procedure, The Guardian… Read more »

Update: CDC data say docs still making billions from Pharma, med device companies; my personal take.

The News: It’s been a few years since the US government unveiled its Open Payments (OP) database, a collection of drug and device makers’ payments to healthcare providers. The data-collection… Read more »

Tesaro says it’s for sale, but who can afford it

The News: Just ahead of the year’s biggest download of cancer data, the maker of a closely watched drug has put itself up for sale, according to The Wall Street… Read more »

What’s wrong with Novartis? Actually nothing.

The News: Novartis AG (Basel CHE) has been the subject of widespread and lingering chatter to the effect that its stature among the Big Pharma league players has diminished, and… Read more »