FDA’s top cancer specialist is already waving a red flag at sintilimab, saying the Eli Lilly-licensed Chinese oncology drug — scheduled for review by an FDA advisory committee this week…
The FDA needs to hire more investigators to conduct overseas inspections to reverse a decline in foreign site visits, the Government Accountability Office (GAO) said in a report released yesterday.…
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
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
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…