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.
Tag Archive for: European Commission
The European Commission is carrying out unannounced inspections at the premises of an unnamed medtech company.
The company’s HIV-focused unit ViiV Healthcare’s cabotegravir long-acting injectable and tablets received the authorization.
The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.
The European Commission said the size of the fine, amounting to 10% of Illumina’s global revenue and the maximum allowed under EU merger rules for such infringements, underscored the seriousness of the offense and aimed to deter such conduct.
The European Commission has contracted pharma companies including Pfizer to reserve capacity to make up to 325 million vaccines per year in case of a future global health emergency.
The approval on Wednesday by the European Commission, which follows a recent endorsement from the European Medicines Agency, comes about a month after the U.S. health regulator gave the drug Arexvy the green light.
British drugmaker GSK on Wednesday warned that the overhaul of laws governing the EU’s pharmaceuticals industry risks forcing companies to invest and innovate elsewhere, which would hurt EU efforts to improve access to medicines.
U.S. drugmaker Pfizer is ready to launch its respiratory syncytial virus (RSV) vaccine for both older adults and pregnant women in the United States and Europe later this year, executives said on Thursday.
Europe will lose out to countries like the U.S. and Japan on new medical research, trials and treatments unless draft rules reforming the European pharmaceutical landscape change, the CEO of Danish drugmaker Novo Nordisk warned on Thursday.
