United States: Life Sciences, Biotechnology & Nanotechnology

This month, the U.S. Food & Drug Administration (“FDA”) quietly published its Unified Agenda, which includes a proposed rulemaking that — if finalized — would fundamentally reshape the landscape...

Nevada pharmacies, physicians, healthcare facilities and other practitioners engaged in pharmaceutical compounding should closely monitor a significant regulatory proposal issued by the Nevada State Board of Pharmacy.

On June 26, 2026, in Huey v. Anavex Life Sciences Corporation, No. 25-1752, the United States Court of Appeals for the Second Circuit affirmed the district court’s dismissal of a putative class action asserting securities fraud claims where the plaintiff-shareholder failed to plead a plausible causal link between the alleged misrepresentations and the loss in share price, as was necessary to plead loss causation.

A small drafting mistake can have major consequences in patent law. That was the lesson from Enanta Pharmaceuticals, Inc. v. Pfizer Inc., where the Federal Circuit held in a precedential opinion that Enanta’s patent...

Accord BioPharma has secured FDA approval for ENNUMO, its second pegfilgrastim biosimilar referencing Amgen's NEULASTA, positioning the company as the only U.S. provider offering two distinct pegfilgrastim biosimilars alongside a short-acting G-CSF biosimilar. With eight pegfilgrastim biosimilars now approved by the FDA, the competitive landscape for these infection-reducing cancer treatments continues to expand. This approval strengthens Accord's biosimilar portfolio in the oncology supportive care market.

The European Union’s new regulatory framework for plants obtained through certain New Genomic Techniques (NGTs) enters into force today, 16 July 2026.

The FDA has granted interchangeability designation to TRUXIMA® (rituximab-abbs), making it the first rituximab biosimilar to achieve this status in the United States. This milestone allows pharmacists to substitute TRUXIMA® for the reference product RITUXAN® without prescriber intervention, potentially expanding access to this treatment for conditions including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Strategic seed capital works best when investors help founders see what their technology can become - not just what it does today. Dr. Gopal Chopra, founding partner of Validare Capital, shares how his background as a neurosurgeon, entrepreneur and investor informs the firm's approach to early-stage investing, targeting companies that can be built quickly and efficiently with lean teams while addressing critical market needs across life sciences and data analytics.

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