Tag Archive for: European Commission

The European Commission on Monday approved Biogen’s Skyclarys (omaveloxolone) for the treatment of the rare genetic disorder Friedrich’s ataxia in patients aged 16 years and above.

The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.

While the patent for Biogen’s drug has expired in the United States, it had scored a win in Europe in March.

It is the biggest change to existing medical laws in two decades, aiming to ensure all Europeans have access to innovative treatments and drugs.

Europe’s medicines regulator said on Friday its human medicines committee had recommended Eli Lilly’s diabetes drug Mounjaro also be approved as a weight-loss treatment.

A major pharmaceutical rules overhaul, proposed by the European Commission in April, could see Europe’s share in global research and development contract by a third to 21% by 2040 translating to 2 billion euros ($2.15 billion) per year in lost investment, industry group EFPIA said today.

The European Commission said the deal would not significantly reduce competition in the 27-country European Union nor would it have a negative impact on prices.

Regulators on both sides of the Atlantic have stepped up their scrutiny into the pharmaceutical industry to ensure that smaller innovative companies can compete with bigger rivals and that prices for drugs and products remain affordable.

An order from EU competition regulators for Illumina to sell cancer detection test maker Grail could come as early as next week, the Financial Times reported on Monday, citing people with knowledge of the matter.

The move underscores increasing regulatory scrutiny on both sides of the Atlantic of the pharmaceutical industry to ensure that companies continue to innovate and offer products and services at affordable prices without being squeezed out by bigger rivals.