Insights on Life Sciences
507 total results. Page 2 of 21.
Peptides remain one of the hottest topics in the drug industry, and many therapeutic peptides offered for sale today have been compounded.
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.
On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”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.
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.
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.
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.
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.
Everyone is talking about peptides. Your doctor, your trainer, that guy at the dinner party who swears that BPC-157 rebuilt his knee — peptides have officially entered the zeitgeist. But for every breathless testimonial, there is a thicket of regulations that most market participants barely understand.
On April 18, President Trump signed an executive order (EO) directing multiple federal agencies to accelerate research and expand access to psychedelic drugs as potential treatments for serious mental health conditions. The EO represents a notable shift in federal policy toward psychedelic substances and their potential therapeutic use.
The Federal Trade Commission (FTC) is signaling that health care and life sciences companies should expect heightened regulatory scrutiny related to consumer protection and competition.