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The U.S. government filed an appeal of a jury’s recent decision in the CDC patent infringement case involving Gilead’s HIV-prevention regimen, seeking $1 billion in compensation against Gilead’s $10 billion in revenue from the drugs. Read More
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
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
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formal dispute resolution (FDR) procedures on how to appeal a final order for OTC monograph drugs are outlined in a draft guidance the FDA released on Thursday.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
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
To better understand the performance of the in vitro diagnostic tests used to identify the right treatment for cancer patients, the FDA has begun a pilot project for CDER-regulated oncology drugs and the corresponding clinical assays. Read More
Bristol Myers Squibb (BMS) filed suit against HHS and CMS over the Inflation Reduction Act (IRA) claiming that the drug price negotiation program violates the Constitution by “forcing pharmaceutical companies to turn over their most successful and innovative products at a huge discount.” Read More
The FDA’s list of regulations it plans to propose or finalize in the next 12 months, released Tuesday, includes more than 30 proposed and final rules related to drug, device and biologics products. Target release dates vary by rule. Read More