Insights and Analysis
Hogan Lovells 2024 M&A Outlook
01 May 2024
Our 10th annual M&A Year in Review features a 2024 M&A Outlook, which provides insights across the key topics that we expect will influence dealmaking in the months to come:...
Publications
News
The use of IVDs as CDx in pharmaceutical clinical trials
30 April 2024
The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for...
News
HRSA issues 340B Program final rule modifying administrative dispute resolution process
19 April 2024
On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative ...
News
2024 Life Sciences & Health Care Horizons
18 April 2024
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...
News
Reduction of EU regulatory data protection, but not as short as the European Commission proposed
12 April 2024
On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as...
News
New Commission Action Plan to boost biotechnology and biomanufacturing in the EU
20 March 2024
Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic ...
News
How to navigate gene editing regulatory hurdles: FDA webinar clarifies newly finalized guidance
14 March 2024
Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory approval necessitate careful consideration of...
News
Transition soon to the EU Clinical Trials Regulation
14 March 2024
Clinical trials in the European Union (EU) that were approved under the former EU Clinical Trials Directive (CTD) will soon need to transition to the current EU Clinical Trials Regulation...
News
Spotlight on the U.S.: Panelists discuss navigating the IRA
04 March 2024
Hogan Lovells is hosting a special webinar series for Life Sciences and Health Care companies based in, or with commercial interests in, the Asia-Pacific (APAC) region. The series shares...
