The FDA has finalized its guidance to help drug sponsors develop population pharmacokinetic (PK) analyses used in drug development to fine-tune dosing regimens. Source: Drug Industry Daily

To try to avoid supply chain disruptions based on licensing uncertainties, the FDA has issued a proposed rule on the standards for licensing wholesale drug distributors and third-party logistics providers.…

Biogen might want to add “company headache” to Aduhelm’s adverse event profile. Source: Drug Industry Daily

In a 269-page submission to U.S. Trade Representative, Katherine Tai, the Pharmaceutical Research and Manufacturers of America (PhRMA) spelled out the group’s objections to efforts by the World Health Organization…

A bankruptcy judge in Delaware has green lighted drugmaker Mallinckrodt’s $1.7 billion opioid settlement and chapter 11-exit plan. Source: Drug Industry Daily

Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni fielded questions from lawmakers yesterday on confirmatory trials for drugs that receive FDA’s accelerated approval, during a hearing on reauthorizing…

Four approved COVID-19 therapeutics are reasonably priced, offering not only improved patient outcomes but potentially saving tens of thousands of dollars in hospital costs associated with treating severe disease, according…

The United Nations-backed Medicines Patent Pool (MPP) announced yesterday that it signed an agreement with Cape Town, South Africa-based Afrigen Biologics “to allow Afrigen to establish itself as the global…

Johnson & Johnson (J&J) announced that it’s pulling the plug on atopic dermatitis trials for the drug bermekimab, a move that is costing the company $610 million. Source: Drug Industry…

In an effort to better understand high prices for drugs and diagnostics, a group of doctors has called on the Biden administration to openly share the costs of clinical trials…