Tag Archives: European Medicines Agency

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 »

What Brexit Means for the UK’s National Health Service; What We Americans Might Learn

The United Kingdom’s decision to leave the European Union registered a magnitude 9 on the Richter scale across the world as far as I can judge. The economic fallout is… Read more »

Wall Street Ponders Brexit’s Impact on Drug, Biotech Stocks

In a historic vote Thursday, Britain has decided to leave the European Union. And, swallowing hard, financial markets around the world are not taking the news very well. Stateside, the Dow… Read more »