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
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
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
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
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
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
On March 18, the Food and Drug Administration (FDA) issued guidance in recognition of the extraordinary challenges that have impacted ongoing medical research in light of the coronavirus pandemic. “FDA Guidance on Conduct of...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more
Takeda Pharmaceutical Company, a Japan-based global pharmaceutical company, recently announced an agreement with BioSurfaces Inc., a small Massachusetts research company, to research the development of medical devices for the...more
The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more
Lest anyone think that Myriad Genetics is the only patentee asserting rights in patents having claims to isolated DNA molecules or other biological molecules, St. Jude's Children's Research Hospital, Inc. has sued Novartis...more
Introduction - In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the...more
In a paper published in March in the journal Genome Medicine, Dr. Jeffrey Rosenfeld of the University of Medicine & Dentistry of New Jersey and Dr. Christopher Mason of Cornell University contended that due to the...more
Big Pharma and academia cement big deals in the quest for bigger prizes - With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more