… a major change to the Regulation is needed to prevent shortages of life-saving medical devices… Background On Friday 9 December 2022, the European Commission proposed to extend the transition deadline in the Medical Device Regulation (EU) 2017/745 (MDR). According to the European Commissioner for Health and Food Safety, Stella…
The Unified Patent Court (“UPC”) is set to begin on June 1, 2023. Under the UPC framework, a single court proceeding could result in simultaneous revocation of European Patents across multiple European Union (“EU”) countries, including France and Germany. A three-month “Sunrise Period” is set to begin March 1, 2023….
Goodwin’s Financial Restructuring partner Simon Thomas and counsel Oonagh Steel, with contributions from Life Sciences partners Sophie McGrath, Andrew Harrow and Tim Worden, have recently published a piece of thougtht leadership titled “Restructuring and insolvency in the life sciences sector: Q&A” The Q&A discusses the sector-specific issues and risks that…
In Europe, life sciences deals increased over the last few years with a strong acceleration in 2021. As a result, the market wonders whether this is just a pick or rather a steady trend which will impact our market in the future as well. Analyzing the reasons of such growth…
Companies often use equity incentives to reward key members of their workforce and attract and retain the best talent. In the UK, companies have typically granted EMI options (a government‑backed, tax-advantageous share option) or unapproved options. However, where a company is unable to grant EMI options (for example, because the…
COVID-19 put into perspective the importance of the pharma industry to the global economy. Goodwin London Life Sciences partner Andrew Harrow reflects on 2020’s impact on the pharma sector, particularly biotech, and discusses what 2021 might look like for industry deals and investment. Full article here.
What is an accelerator? An accelerator is an entity that provides a fixed-term, cohort-based program designed to accelerate growth and support disruptive and innovative early-stage businesses. They can be generalist or specialist and are located all around the world. Who are they? Probably the most well-known accelerator is Y Combinator…
…the essential criterion for being classified as a medical device is the software’s medical objective… Background Relying on an unregulated app or piece of standalone software to provide a diagnosis or recommend treatment could have potentially life-threatening consequences. In June 2020, the UK’s medical devices regulator, the Medicines and Healthcare…
Life sciences companies often turn to geographical licensing to realise the maximum value from their assets, and to ensure their products reach markets worldwide, particularly where they do not have a global footprint. In the context of a collaboration agreement, the owner of certain intellectual property rights may collaborate with…
In recent years, equity (or investment-based) crowdfunding has been growing as an alternative source of funding for early stage biotech companies. This is due to the increasing availability of capital and willingness of the general public to invest in innovative companies, the potential speed and efficiency gains for companies compared…
