Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
The Force is Strong with this One – Success and Paying it Forward with Co-Founder of ChannelAdvisor and Spiffy Scot Wingo
No Password Required: President at Constellation Cyber, Former FBI Translator, and Finder of Non-Magical Mushrooms
Hosted Payload Episode 10: Jeanine Poltronieri/For All Mankind (Season 1)
Hosted Payload Episode 9: Danielle Pineres/First Man
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Hosted Payload Episode 8: Priya Venkat / A Million Miles Away
Leading the Lead Revolution With the Consortium for Battery Innovation — Battery + Storage Podcast
Market Leader's Podcast Episode 84: “Change Agent: Establishing True Innovation Goals Within a Law Firm,” with Roberto Pont
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 159: Bob Quinn, Executive Director, and Adrianne Grimes, Director of Marketing and Comms, SCRA
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Is Quiet Quitting the New Workplace Phenomenon?
Remaining Innovative in the Battery Storage Space With Electrovaya CEO Dr. Raj Dasgupta - Battery + Storage Podcast
Video: Health Care's Past, Present, and Future - Diagnosing Health Care Podcast
Innovation in Compliance - Innovation as a Process with Stephen Shapiro
Taking the Pulse, A Health Care & Life Sciences Video Podcast | Episode 109: Kelly Calabria, President and CEO of Foundation for Health Leadership & Innovation
Innovation in the Business of Law | Rocky Dhir | Texas Appellate Law Podcast
Guidepost in Motion: Off The Chain Part 2 Innovations and Best Practices in Crypto and Blockchain
Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren welcome Dr. Ehsan Samei and Dr. Susan Halabi, leaders of the new Triangle CERSI, which stands for the Center of Excellence in Regulatory...more
Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...more
On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order...more
Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...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
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more
The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more
On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s...more
20 years or five months? On March 8, 2019, nearly 20 years after AquaBounty Technology discovered a novel approach to increase the growth of Atlantic salmon, the U.S. Food and Drug Administration (FDA) finally “deactivated”...more
The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Plan to “Advance Plant, Animal Biotechnology Innovation” - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement announcing the...more
On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...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
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more