Insights on Life Sciences
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Welcome to the July 2026 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.
On July 16, the Centers for Medicare & Medicaid Services (CMS) published the 2027 Physician Fee Schedule (PFS) proposed rule. Among other provisions, CMS has now proposed to convert a previously voluntary filing to a mandatory submission: requiring 340B Covered Entities to submit Part D claims data to the Medicare Part D Claims Data 340B Repository beginning in 2027.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Peptides remain one of the hottest topics in the drug industry, and many therapeutic peptides offered for sale today have been compounded.
Headlines that Matter for Companies and Executives in Regulated Industries
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules, the Physician Fee Schedule (PFS) proposed rule and the Hospital Outpatient Prospective Payment System (HOPPS) proposed rule, that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”
On June 4, the US Supreme Court issued a unanimous decision authored by Justice Ketanji Brown Jackson in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24–889, delivering a significant win for generic pharmaceutical manufacturers seeking US Food and Drug Administration (FDA) approval for drugs with multiple indications.
Headlines that Matter for Companies and Executives in Regulated Industries
ArentFox Schiff is pleased to announce that 68 attorneys were recognized as leaders in their field and 25 practices spanning the firm’s litigation, regulatory, and transactional capabilities, as well as key industries, were ranked among the best in the country in the 2026 edition of Chambers USA: America’s Leading Lawyers for Business.
Forget science fiction — the race to connect computers directly to the human brain is already underway, and it is accelerating. In recent months, neurotechnology companies have expanded human clinical trials and attracted substantial investment.
Headlines that Matter for Companies and Executives in Regulated Industries
ArentFox Schiff’s Gayland Hethcoat on navigating the line between wellness and medical devices in the longevity era.
On April 29, the US Food and Drug Administration (FDA) published a Request for Information (RFI) seeking public comment on a proposed pilot program to test the use of artificial intelligence (AI) in early-stage clinical trials for drugs and biologics. Comments are due June 29.
Headlines that Matter for Companies and Executives in Regulated Industries
ArentFox Schiff is pleased to announce that Partners Craig Gelfound and Ehsun Forghany have been named among Daily Journal’s 2026 Top Intellectual Property Lawyers, an annual list recognizing California-based attorneys whose achievements over the past year have significantly influenced the field.
Headlines that Matter for Companies and Executives in Regulated Industries
On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining regulatory pathway for large-scale compounding of these popular GLP-1 receptor agonists by 503B outsourcing facilities.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries