Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
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 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
On March 31, 2023, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved MAILISHU, a denosumab biosimilar, for the treatment of osteoporosis in postmenopausal women at high risk of...more
This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab). BAT1806 is approved for the treatment of rheumatoid...more
Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of...more
On December 24th, 2021, Innovent Biologics announced that China’s National Medical Products Administration had accepted its Supplemental New Drug Application (sNDA) for TYVYT®, a sintilimab plus bevacizumab biosimilar...more
Innovent Biologics, Inc. announced that the National Medical Products Administration of China (“NMPA”) approved its supplemental New Drug Application for TYVYT®, a sintilimab injection, in combination with BYVASDA®, a...more
Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid arthritis, ankylosing spondylitis, and...more
The past few weeks have seen the following biosimilar developments in China: ..On December 16, 2019, Qilu Pharmaceutical received approval in China for ANKADA, a biosimilar to AVASTIN (bevacizumab). ANKADA has been...more
Guangzhou-based biopharmaceutical company Bio-Thera Solutions recently announced that the China National Drug Administration has accepted for review the BLA for BAT1406, a proposed Humira® (adalimumab) biosimilar. Bio-Thera...more
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good...more
On December 20, 2017, the China Food and Drug Administration (“CFDA“) released two draft documents for public comment: (1) Conditional Approval for Urgently Needed Drugs Technical Guidance (the “Draft Conditional Approval...more
On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more
Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...more
JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that JHL...more