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The Orphan Drug Act should give Jazz Pharmaceuticals the full seven years of exclusivity for its blockbuster narcolepsy drug, Xywav, says Jazz in its suit against the FDA, claiming the agency’s approval of a competitor drug, Lumryz, is unlawful. Read More
Over the past week, the FDA issued final guidance on oncology drug products used with certain in vitro diagnostic tests and draft guidance on formal dispute resolution and administrative hearings procedures. Read More
Addressing growing interest in the therapeutic potential of psychedelic drugs, the FDA has published a draft guidance noting multiple unique considerations for psychedelic drug development programs and challenges in designing trials. Read More
The FTC has filed an amicus brief urging a U.S. appeals court to side with the plaintiffs in a case that alleges Forest Laboratories paid several generics producers millions of dollars to drop a patent challenge for Forest’s hypertension drug Bystolic (nebivolol). Read More
PhRMA joined the constitutional showdown over the Inflation Reduction Act (IRA) by filing a complaint on Wednesday in the U.S. District Court for the Western District of Texas. Read More
This month, our review of recent clinical trial results features Rinvoq’s sustained remission in almost half of Crohn’s disease patients, Novo Nordisk’s semaglutide showing significant patient weight loss, and improved insulin and fasting glucose levels in a phase 2B study of Akero Therapeutics’ human fusion protein efruxifermin.Read More
CDER formal dispute resolution (FDR) procedures on how to appeal a final order for OTC monograph drugs are outlined in a draft guidance the FDA released on Thursday. Read More
Heavy reliance on foreign manufacturing for essential medicines is at the root of FDA concerns over supply chain and drug shortages, according to a report from the FDA Office of Pharmaceutical Quality (OPQ) that shows 82 percent of API and 57 percent of finished dosage form manufacturing sites are outside the U.S. Read More
Following multiple years of development, the streamlined version of the ClinicalTrials.gov website officially launched Wednesday, providing users with a revised, simplified layout intended to enhance efficiency and usability. Read More
The International Council for Harmonisation’s (ICH) governing group announced earlier this month it will begin work on new guidelines in three areas: patient preference, nonclinical safety evaluation for oligonucleotide-based therapies and bioequivalence for modified-release products. Read More