Substantial changes to the European life sciences and healthcare regulatory landscape are expected to reshape the sector. EU regulators have outlined a raft of reforms to modernise regulatory architecture, simplify product...more
The challenging funding environment will likely prompt small- and mid-cap listed life sciences companies to seek financing through private investments in public equity.
Small- and mid-cap life sciences companies typically...more
7/28/2023
/ Capital Raising ,
Convertible Notes ,
Corporate Financing ,
EU ,
Financing ,
Investors ,
Life Sciences ,
PIPEs ,
Private Investment Funds ,
Small and Medium-Sized Enterprises (SMEs) ,
Strategic Planning
The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions.
On March 20,...more
The eleventh edition of The Life Sciences Law Review covers a total of 24 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are...more
Drug Pricing Reform: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022
...more
The regulation aims to harmonise clinical and scientific aspects of HTA to make innovative health technologies more widely available in the EU.
Health technology assessment (HTA) is a multidisciplinary evidence-based...more
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit.
On 26 June 2022, the UK Medicines...more
7/1/2022
/ Consultation ,
Diagnostic Tests ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Proposed Regulation ,
Public Comment ,
Public Health ,
Technology ,
UK ,
UK Brexit
The fertility sector is likely to present growing opportunities for PE as an emerging, multifaceted industry.
The global fertility sector, which has grown significantly in recent years as demand continues to soar, is...more
France is generally known for its high quality and also highly regulated healthcare system. As an EU Member State, France has implemented the EU medicines and medical devices regimes. This chapter should therefore be read in...more
Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more
2/10/2022
/ Clinical Trials ,
Digital Health ,
EU ,
EU Clinical Trials Regulation (CTR) ,
Health Care Providers ,
Joint Venture ,
Life Sciences ,
Mergers ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Standards ,
UK ,
Venture Capital
The once shunned cannabis sector now offers attractive PE opportunities in many jurisdictions.
In years gone by, the prospect of significant PE investment in the cannabis industry would have been unthinkable for many....more
The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals.
A 10-week consultation launched by the UK’s Medicines...more
The agreement provides guidance across several areas for the life sciences sector, though gaps remain.
The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more
3/4/2021
/ Clinical Trials ,
Data Privacy ,
EU ,
Life Sciences ,
Manufacturers ,
Marketing Authorization Application ,
Medical Devices ,
Pharmaceutical Industry ,
Trade Agreements ,
UK ,
UK Brexit