The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU.

DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”

PERTH, Australia – Australia attracted international attention in July when a Federal Court ruled that artificial intelligence can be named as the inventor of a patent. In Thaler v. Commissioner of Patents, Federal Court Justice Jonathan Beach ruled that under Australian patent law, inventors don’t necessarily have to be human. The decision challenges the assumption that only human beings can be inventors. Beach did rule, however, that an AI system cannot apply for a patent or receive a patent.

LONDON – New figures underline the devastating effect the pandemic is having on cancer clinical research, with recruitment to U.K. studies falling by 60%. A total of 27,734 patients were recruited in 2020/21, compared to an average of 67,057 in the three years previously. Over those three years, recruitment had been on the rise, going from 61,810 in 2017/18 to 71,709 in 2019/20, according to figures compiled by the Institute of Cancer Research in London.

The rise of large national health care systems, mainly in Europe, has created an ongoing tension with the free market ethos of the pharma industry. After years of painstaking and costly research, drug makers want that moment when they can reap the rewards for their hard work bringing an innovative new therapy to the market. But in countries in Europe and beyond where there are national health care systems with stringent cost constraints, it’s not feasible to meet these price demands, at least without some form of rationing to keep down expenditure.

Swedish Orphan Biovitrum AB shares (STO:SOBI) fell 25% Dec. 3 as investors behind Agnafit Bidco AB, previously poised to pay about SEK72.17 billion (US$7.97 billion) for the company, withdrew their bid as shares tendered fell just short of the 90% needed to complete the deal. The bid was seen as likely to succeed after Investor AB, which owns 35% of the capital and votes in the company, commonly called Sobi, supported it. However, with only 87.3% of outstanding shares tendered as of Dec. 3, Agnafit decided to drop the offer, foregoing further extension of the acceptance period, which was earlier extended by ten days to Nov. 26 in hopes of collecting enough support.

LONDON – Each of six different COVID-19 vaccines given as booster doses were safe and increased immunity when administered after two doses of either Pfizer Inc.’s or Astrazeneca plc’s vaccine, according to the latest data from the U.K. Cov-Boost trial.