Tag Archives: European Medicines Agency

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 »

Week’s opening stock salvo: Cleveland BioLabs, ImmunoGen lead winners; XBiotech, OncoMed crash

Among the top winners and losers in the healthcare sector last week, the following four were standouts and bear watching or acting upon, depending, as always, on one’s risk tolerance…. Read more »

Cempra stock tanks on FDA concerns for lead drug’s side-effects; high hopes still riding on Friday AdCom meeting

Cempra Inc.’s (Chapel Hill NC) experimental drug to treat community-acquired pneumonia, the kind recently suffered by presidential candidate Hillary Clinton, causes a potentially concerning rise in liver enzymes, according to… Read more »