Legal Advice article - May 22, 2024
Drug Development Professionals and Legalese – A Love Story
It used to be canon that to work in drug development, one must be a scientist of some kind. In the last couple of decades we, as an industry, learned that this was true no longer. The average drug development Subject Matter Expert (SME), regardless of scientific training, had to become almost so technically savvy as […]
Legal Advice - May 3, 2023
Advancing transactions in the life science space
Hanneke Later-Nijland is an attorney-at-law and a trained pharmacist from the Netherlands who recently launched The Genotype Network, a network for corporate and regulatory lawyers specialized in life sciences. Describe the purpose of the network? “The purpose is to add value, and more specifically to advance transactions in the life science space in every aspect, […]
Clinical Trials - April 28, 2022
Macchiarini on trial in Sweden
Paolo Macchiarini who made headlines for pioneering surgery is charged with aggravated assault over procedure. Macchiarini has gone on trial in Sweden charged with aggravated assault, 11 years after he first performed experimental transplants of synthetic windpipes on patients. The trial centres on three transplants Macchiarini performed between 2011 and 2013, when a synthetic windpipe […]
Biotech Business - September 20, 2019
Biosimilars: Opportunities & Challenges
The development and use of biosimilars continues to grow in the Nordic countries, as well as the rest of Europe, and experts are excited about their potential. But there is a thicket of legal issues and regulations that companies have to navigate to get their drugs to the market. A biosimilar is almost identical to […]
Legal Advice article - May 14, 2019
Dignitana efforts prompt landmark legislation
The company announces that HB3984, the bill providing coverage for scalp cooling that the company initiated in February with Texas State legislators, was passed in the Texas House of Representatives on Friday. The Bill now moves to the Senate where it will be introduced by Sen. Angela Paxton. Once passed in the Senate, the Bill […]
Legal Advice article - June 7, 2018
Lundbeck reaches voluntary agreement with US Department of Justice
H. Lundbeck announces that its U.S. subsidiary Lundbeck LLC has reached an agreement in principle to resolve the U.S. Department of Justice (DOJ) investigation related to Lundbeck LLC’s relationship with and donations to independent patient assistance charitable foundations. As part of the agreement, Lundbeck LLC will pay DOJ USD 52.6 million (approximately DKK 336 million). […]
