Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more
On May 16, 2023, the US Court of Appeals for the Second Circuit affirmed the Southern District of New York’s order dismissing an action brought by investors of AstraZeneca PLC (AstraZeneca) attempting to hold the company...more
On September 12, 2022, Judge J. Paul Oetken of the United States District Court for the Southern District of New York dismissed with prejudice a putative class action asserting claims under the Securities Exchange Act of 1934...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
U.S. drug giant Merck is shuttering its coronavirus vaccine development “after early trial data showed [its pair of vaccines] failed to generate immune responses comparable to natural infection or existing vaccines.” ...more
Exciting developments are being reported for COVID-19 vaccine candidates - on a daily basis. There are nearly 200 vaccine candidates, with at least 20 in late-stage clinical trials. Of those, the FDA has approved both the...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more
Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more
As a second COVID-19 wave hits Europe, many countries are implementing lockdown restrictions to flatten the curve. The second wave coincides with a pause in two vaccine clinical trials and the emergence of some documented...more
September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca. In line with FDA’s June 2020...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine...more
The “warp speed” race to develop a Covid-19 vaccine has gotten hit with a yellow flag....more
AstraZeneca’s Phase 3 vaccine clinical trials came to a halt this week as the pharmaceutical company works to identify the underlying cause of a case of transverse myelitis emerging in a volunteer. The pause coincided with...more
Food - FDA Released Final Rule on Gluten-Free Labeling – The final rule establishes compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, that use the...more
In Washington: Today, the House will meet for a pro forma session and the Senate will resume consideration of John Badalamenti to be United States District Judge for the Middle District of Florida. The full House will be...more
UPDATE: The Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 was made on March 1, 2021 (see Notice here) and repeals the Interim Order Respecting the Importation and...more
The life sciences industry is facing unprecedented demands due to COVID-19. From front line carers to researchers and scientists, significant efforts are being put towards caring for those suffering from COVID-19 and...more
The Wall Street Journal’s Health Forum convened—virtually—on March 24th during an extraordinary period in global health: the novel coronavirus is threatening populations, overwhelming provider systems, and sending economies...more