False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more
On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more
Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more
China’s National Medical Products Administration (NMPA) on November 13, 2024 issued the Interim Provisions on the Administration of the Domestic Responsible Person Designated by Foreign Marketing Authorization Holders (New...more
Inventive deal structures are on the rise within China’s life sciences industry, with the “NewCo” model having garnered significant interest among Chinese pharmaceutical companies in recent years. In 2024, several landmark...more
In recent years, China has introduced significant changes to its Drug Administration Law and corresponding legislation, including the nationwide Market Authorization Holder (MAH) system. These reforms aim to boost foreign...more
On August 9, 2024, China’s State Administration for Market Regulation (SAMR) released a draft of the Anti-Monopoly Guidelines for the Pharmaceutical Sector (hereinafter referred to as the “AMGP”) for public comment. The AMGP...more
GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more
On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab),...more
In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more
In recent years, there has been an uptick in interest in the Chinese market from licensors based predominantly in the U.S., Canada, Europe, and South Korea. Factors encouraging the in-licensing of products to China include...more
On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal...more
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
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...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
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
Shanghai Junshi Biosciences Co. Ltd. and Mabwell Bioscience Co. Ltd. announced that the jointly developed adalimumab biosimilar injection (Junmaikang ®) was officially approved by the Chinese National Medical Products...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
On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab),...more
China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers. This new system will also create a new form of pharmaceutical patent litigation in...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
On 9 February 2021, China's National Intellectual Property Administration ("CNIPA") published its Administrative Adjudication Measures For The Early Resolution Mechanism For Drug Patent Disputes. These Measures are aimed at...more
On January 6, 2021, Everest Medicines (HKEX 1952.HK) announced that the National Medical Products Administration (NMPA) of the People’s Republic of China approved a Clinical Trial Application (CTA) for sacituzumab...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