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
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…
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…