AMRX News & Events

The U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative "designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain." The following companies have been selected to participate in the pilot: Amneal Pharmaceutical - Amneal's facility in Long Island, NY will manufacture small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases; Cellares Corp. - Cellares's facility in Bridgewater, NJ will manufacture cell-based gene therapy products for oncology and hematology diseases; Eli Lilly and Company - Eli Lilly's facility in Lebanon, IN will manufacture drug substance in support of the company's existing and future medicines; FUJIFILM Biotechnologies - FUJIFILM's facility in Holly Springs, NC will support commercial-scale cell culture biomanufacturing; Kriya Therapeutics - Kriya's facility in Durham, NC will manufacture AAV-based gene therapy products to address chronic disease conditions; Kyowa Kirin - Kyowa's facility in Sanford, NC will manufacture biotechnology drug substance for rare diseases; Regeneron Pharmaceuticals - Regeneron's facility in Saratoga Springs, NY will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases."

Eli Lilly (LLY), Regeneron (REGN), Amneal (AMRX), Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are the first companies that will participate in the FDA's PreCheck pilot program, which will allow regulators to start reviewing new manufacturing facilities while they're under construction to catch and correct any issues, according to CNBC's Angelica Peebles, citing FDA spokesperson Benjamin Nichols.

Zambon and Amneal Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, or CHMP, has adopted an opinion recommending the granting of a marketing authorization by the European Medicines Agency, or EMA, for Hopledo for the treatment of adult patients with Parkinson's disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatment regimens.

Amneal Pharmaceuticals announced new interim results from its ongoing Phase 4 ELEVATE-PD study, which are being presented at the Advanced Therapeutics in Movement & Related Disorders, or ATRMD, 2026 Congress on June 5. The entire study population evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to Crexont extended-release capsules, regardless of whether patients switched from immediate-release carbidopa/levodopa, IR CD/LD plus a COMT inhibitor, or Rytary extended-release capsules. These interim findings build on the established efficacy and safety profile of Crexont demonstrated in the Phase 3 RISE-PD trial, and reflected in the FDA-approved prescribing information. After patients switched from prior therapies, treatment with Crexont delivered meaningful increases in "Good On" time, reductions in "Off" time, and improved motor symptom control. Patients switching from Rytary achieved consistent gains in continuous "Good On" intervals, the length of uninterrupted time patients experience "Good On." The most common adverse events in the study were dizziness, fall, nausea, dyskinesia, hallucination and headache.