Lundbeck reaches voluntary agreement with US Department of Justice

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 […]

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, […]

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 […]

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 […]

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 […]

Being part of a fast-paced industry where the technology is constantly evolving is part of what makes life science law an enjoyable challenge, said Attorney Hanna Paloheimo, who oversees the life sciences division at Castrén & Snellman Attorneys of Helsinki. Castrén & Snellman is a full-service business law firm, which provides a wide range of services to its life sciences clients, including intellectual property (IP), contracts, marketing law […]

The European Commission (EC) opens formal investigation into Aspen Pharma’s pricing practices for cancer medicines. The formal investigation address concerns that Aspen Pharma has engaged in excessive pricing concerning five life-saving cancer medicines. The Commission will investigate whether Aspen has abused a dominant market position in breach of EU antitrust rules. “When we get sick, […]