Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
California OHCA Issues Final Regulations Implementing Expanded Health Care Transaction Review Requirements For Private Equity, Hedge Funds, And MSOs
On Friday, California Office of Health Care Affordability (“OHCA”) published proposed final regulations that implement a 2026 law that significantly expanded OHCA’s review authority over health care transactions involving private equity (“PE”) groups, hedge funds, and management services organizations (“MSOs”). Stakeholders involved in California health care transactions should re-assess whether their ongoing or contemplated transactions are implicated by these regulations, because newly covered transactions will need to comply with the 90-day advance notice requirement established in the original OHCA regulations.
United States Healthcare
ST
Simpson Thacher & Bartlett
Article
Congressional Democrats Introduce National Corporate Practice Of Medicine Bill
Democrats in Congress have introduced the Stop Corporate Takeovers of Physicians Act, federal legislation that would establish unprecedented restrictions on physician practice ownership and management services organization structures. Drawing from Oregon's Senate Bill 951, this proposal would create a national framework in an area historically regulated exclusively at the state level, raising critical questions about federal-state interaction and the future of healthcare practice ownership.
United States Healthcare
HK
Holland & Knight
Article
Concierge Medicine And Medical Aesthetics: The Private Equity Playbook For A US$590 Billion Opportunity
Private equity investment in concierge medicine, aesthetic dermatology and medispas has surged due to cash-pay economics, recurring revenue models and fragmented markets ripe for consolidation. However, navigating state-by-state corporate practice of medicine prohibitions, licensure requirements and evolving GLP-1 regulations requires sophisticated legal structuring to protect valuations and enable successful exits.
United States Healthcare
D
Dechert
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Article
BMS And Ono File BPCIA Suit Against Amgen For Nivolumab Biosimilar
Bristol-Myers Squibb and Ono Pharmaceutical have filed a patent infringement lawsuit against Amgen over its proposed nivolumab biosimilar ABP 206, asserting seven patents related to OPDIVO. The complaint follows earlier inter partes review challenges and patent dance negotiations that narrowed the dispute to specific claims covering the antibody sequence, cancer treatment methods, and dosing regimens.
United States IP
GP
Goodwin Procter LLP
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Article
Concierge Medicine And Medical Aesthetics: The Private Equity Playbook For A US$590 Billion Opportunity
Private equity investment in concierge medicine, aesthetic dermatology and medispas has surged due to cash-pay economics, recurring revenue models and fragmented markets ripe for consolidation. However, navigating state-by-state corporate practice of medicine prohibitions, licensure requirements and evolving GLP-1 regulations requires sophisticated legal structuring to protect valuations and enable successful exits.
United States Healthcare
D
Dechert
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Article
Buchanan’s PBM & Pharmacy Practice Group Reduce PBM Audit Findings By 100%
Pharmacy Benefit Manager audits can threaten independent pharmacies with hundreds of thousands of dollars in alleged discrepancies and potential network exclusion. Through meticulous documentation review and strategic legal response, one pharmacy successfully eliminated nearly $400,000 in audit findings. Understanding the critical elements of an effective audit defense can protect pharmacies from unwarranted financial harm and regulatory consequences.
United States Accounting
BI
Buchanan Ingersoll & Rooney PC
Article
BMS And Ono File BPCIA Suit Against Amgen For Nivolumab Biosimilar
Bristol-Myers Squibb and Ono Pharmaceutical have filed a patent infringement lawsuit against Amgen over its proposed nivolumab biosimilar ABP 206, asserting seven patents related to OPDIVO. The complaint follows earlier inter partes review challenges and patent dance negotiations that narrowed the dispute to specific claims covering the antibody sequence, cancer treatment methods, and dosing regimens.
United States IP
GP
Goodwin Procter LLP
Article
Democratic Lawmakers Urge CPSC To Halt NEISS Modernization Efforts And Respond To Detailed Requests For Additional Information
Democratic lawmakers are raising alarms about the Consumer Product Safety Commission's modernization of its injury surveillance system, questioning whether the expanded data collection exceeds legal authority and threatens patient privacy. The controversy centers on NEISS-R's shift from decades of using de-identified data to requesting identifiable emergency room records covering thousands of medical conditions, many unrelated to consumer products. With new commissioners joining CPSC, the future scope and i
United States Government
AP
Arnold & Porter
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