Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast - Discussing the Mission of Black Women's Health Imperative with CEO Linda Goler Blount
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
BLACK HISTORY MONTH | KATHERINE JOHNSON AND CHARLES DREW
Technology in Healthcare
On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more
Recorded at SCbio’s 2024 annual conference, hosts Heather and Matthew welcome Sarah Glaven, a research biologist and the Assistant Director of Biotechnology and Biomanufacturing for The White House Office of Science and...more
As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more
Recorded at NC Life Sciences Organization’s 2023 annual meeting, hosts Heather and Matthew welcome Christine Harhaj, the Senior Director for Pharmaceutical Research and Manufacturers of America (PhRMA). They have an...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more
The U.S. Food and Drug Administration (FDA) recently finalized the guidance “Multiple Endpoints in Clinical Trials,” which advises drug sponsors on how to separate analyses of primary endpoints – which are critical to showing...more
President Joseph Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (EO) on September 12. Under this EO, the president aims to...more
Heightened interest in medical suppliers, contract research organizations and biotech firms resulted in an impressive year for healthcare dealmaking- Dealmaking within the pharma, medical and biotech sector continued from...more
In a one-count complaint for unjust enrichment filed on October 4, 2021—the 70-year anniversary of Henrietta Lacks’ death—the estate of Henrietta Lacks sued Thermo Fisher Scientific, a multibillion-dollar corporation...more
The domestic cat has been the subject of much study, recently involving its genetic structure, genomic DNA sequence, and comparisons with other felines. The first such study was published in 2014, when an international...more
Two articles (Newsweek and Fierce Biotech) describe the new lawsuit by the Henrietta Lacks Estate surrounding the HeLa cell line. The claim is "unjust enrichment," a difficult claim to win, but one that seems to fit this...more
2020 Filings While there was a more than 20 percent decline in the number of securities class actions filed in 2020 (approximately 330 cases) as compared to 2019 (approximately 430 cases), the percentage of cases filed...more
The COVID-19 pandemic has had an immense impact on clinical trials in the US. Many clinical trials have been suspended or stopped due to the demands of the pandemic. Not only does interruption of these trials leave...more
The Fountain of Youth -- an enduring aspiration, particularly as the ravages of age reduce human faculties prior to leading inexorably to death. Reduction in sight is the human faculty that can have the greatest effect on...more
Clinical manifestations of head and neck cancers often occur only after the disease has reached an advanced stage. Development of new technology for earlier diagnosis is of critical importance. Since the nasopharynx, base of...more
Over the past few months, several clients have alerted us to the delayed or discontinued status of their clinical trials due to the COVID-19 pandemic. Studies typically conducted in physicians’ offices, clinics, or hospitals...more
White & Case Technology Newsflash - In line with the increased protectionism around foreign direct investments (FDI) in the past few years, the economic impact of COVID-19 led to a worldwide rapid expansion of existing...more
One of the most interesting and promising areas of medical research today involves the use of T-Cell therapies, which offer hope and promise as a new approach to cancer treatment. It has also made for a robust climate for...more
FDI restrictions have been on the political agenda in Europe and further afield for at least the past year, and following the outbreak of COVID-19 and the changed economic landscape, the approach in jurisdictions across the...more
This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more
On 12 June 2020, the management board of the European Medicines Agency (EMA) announced December 2021 as the date of entry into application of the EU Clinical Trials Information System (CTIS). ...more
For decades, antiviral drugs have been used to combat viral infections, including HIV/AIDS and influenza. Now they are a source of hope in the fight against the COVID-19 pandemic....more
Despite activists’ rhetoric that animal models are not necessary for the advancement of biomedical research and development, the criticality of the continued use of animal models in biomedical research is highlighted by...more