The European Commission wants to make health data easier to access by 2025 for patients, medics, regulators and researchers in a bid to improve diagnoses, cut unnecessary costs from duplication of medical tests and boost medicine research.
Biogen Inc. decided to withdraw the marketing authorization application for the company’s troubled Alzheimer’s drug aducanumab in Europe after failing to convince the regulator of the product’s benefits.
The head of the World Trade Organization told Reuters on April 14 that negotiations on an intellectual property deal for COVID-19 vaccines were ongoing between the four parties, saying they were seeking to agree on the proposal’s final terms.
PTC Therapeutics Inc. announced that the company completed the Scientific Advisory Group and Oral Explanation meetings for its gene therapy treatment for AADC deficiency (PTC-AADC) with the Committee for Advanced Therapies (CAT).
Gene therapy development is a complex endeavor, with evolving regulations and complicated study logistics. In this article, Premier Research and Premier Consulting explore the regulatory and clinical trial landscape for gene therapy trials and offer strategies for successfully negotiating the challenges of executing these studies.
The United States, European Union, India and South Africa reached a consensus on key elements of a long-sought intellectual property waiver for COVID-19 vaccines, according to a proposed text reviewed by Reuters.
Novavax Inc. delivered just a small fraction of the 2 billion COVID-19 shots the company plans to send around the world in 2022 and has delayed first-quarter shipments in Europe and lower income countries such as the Philippines, public officials involved in their government’s vaccine rollouts told Reuters.
The European Union on December 20 approved the use of Novavax’s COVID-19 vaccine in people 18 years and older, giving a boost to the U.S. biotech after long delays and paving the way for a fifth shot in the EU as the Omicron variant spreads quickly.
EU health agencies recommended that Covid-19 vaccines be mixed and matched for both initial courses and booster doses as the region battles rising cases ahead of Christmas.
Europe crossed 75 million coronavirus cases on December 3, according to a Reuters tally, as the region braces for the new Omicron variant at a time when hospitals in some countries are already strained by the current surge.