Nov 21

Notizia

EMA to relocate to Amsterdam by March 2019

Results of the Monday’s vote for the European Medicines Agency relocation led to the emergence of Amsterdam as the new headquarters, beating the other finalists Milan and Copenhagen. Nineteen European Union member states submitted proposals for the EMA headquarters, and Milan and Amsterdam resulted in a tie of 13 votes each, which came after the talks of Brexit forced the organization to relocate from London. Out of 19, Milan, Copenhagen and Amsterdam were the finalist cities after the first round of voting. But shortly after, Copenhagen was out of the running. It wasn’t too long until the final round of voting ended in a draw, and Amsterdam was victorious in a drawing of lots. The EMA headquarters will bring an agency that employs nearly 900 staffers and an estimated economic lift of €1 billion, while transforming the city into a global medical and pharmaceutical hub.

Blockbuster-boosting data for Hemlibra, Tecentriq improve Roche’s prospects

Two of Roche’s new generation of drugs—including the just-approved hemophilia therapy Hemlibra—racked up new data on Nov 20 that bolster their case for blockbuster sales. In the long-awaited Haven 3 study in a broad group of hemophilia A patients, Hemlibra delivered “clinically meaningful” reductions in the number of treated bleeds, when used as a prophylactic treatment. Those reductions were seen in patients using Hemlibra as a preventive, compard with those who weren’t using preventive treatment at all. Meanwhile, Roche’s checkpoint inhibitor Tecentriq hit its study goal in previously untreated lung cancer patients. As an add-on to chemo and its older therapy Avastin, Tecentriq beat chemo and Avastin alone at preventing the cancer’s advance, the company said. As for prolonging patients’ lives, the data are “encouraging”. Details of both studies aren’t yet public, and the lung cancer study hasn’t yet fully wrapped up, but the results stand to expand use of both drugs.

Court Settlement Delays Amgen’s Humira Biosimilar for Five Years in U.S.

The settlement of a court battle means that the launch of Amgen’s biosimilar version of adalimumab (Humira, AbbVie) will be delayed in the United States by more than five years. The two companies announced that they have reached a global settlement to resolve all pending litigation regarding the Amgen biosimilar, known as Amjevita in the U.S. and as Amgevita in some other nations. Under terms of the agreement, AbbVie will grant nonexclusive patent licenses for the use and sale of Amgevita/Amjevita worldwide, on a country-by-country basis, and the companies have agreed to dismiss all pending litigation. Amgen expects to launch Amgevita in Europe on October 16, 2018, and Amjevita in the United States on January 31, 2023. AbbVie said the patent-license periods would begin on other dates in various countries.

Purdue Pharma proposes to settle opioid lawsuit

Facing a rash of lawsuits claiming aggressive opioid marketing led to a nationwide epidemic, Purdue Pharma is initiating settlement talks. The privately held company, which makes Oxycontin and faces legal heat along with other prominent opioid drugmakers, is proposing a global settlement. Along with Endo International, Johnson & Johnson’s Janssen, Teva Pharmaceutical and Allergan, Purdue Pharma is named in an opioid marketing investigation by attorneys general from 39 states. The effort initially focused on Purdue, but investigators expanded their probe in September, homing in on some other big names in the pharmaceutical business. In unveiling the broadened probe, Connecticut Attorney General George Jepsen said officials are open to settlement talks.

 

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