Tag Archives: European Medicines Agency

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 »

All three of the world’s major drug regulators have busy week despite heat waves, political chaos. You know; the usual.

Last week was a rare case where the world’s leading drugs and devices regulators were all in action simultaneously. The US Food and Drug Administration (FDA), the European Medicines Agency… 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 »

Update: Where does Brexit leave European pharma, now that the EU has excluded the UK from drug approvals?

A European decision to exclude Britain from the EU’s drug approval system from beginning 30, 2019–the day after Brexit–has raised alarm among drugmakers, who fear the abrupt change could disrupt… Read more »

FDA warns against unproven medical claims for marijuana. “Prohibition” didn’t work, remember?

The News: Four companies selling dozens of various marijuana-derived dietary supplements have been officially warned by the US Food and Drug Administration to stop plugging their products as cures for… Read more »

Alarming study concludes most new, pricey cancer drugs don’t work; why are we just hearing about this?

The News: Researchers said only half of the cancer drugs approved by European regulators in the past few years have shown to help patients. Many of the drugs were approved… Read more »

FDA chief Gottlieb makes good on promise to increase drug price competition; will expedite review of generics

The Food and Drug Administration on Tuesday (June 27, 2017) moved to try to spur more competition in the market for generic drugs, an effort aimed at driving down prices. In… Read more »

Abbvie’s biosimilar fight over Humira patent highlights differences between EU and US regulatory mindsets

The News: Coherus BioSciences Inc. (Redwood City CA) last week announced that the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office ruled in the company’s… Read more »