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The FDA has approved the first over-the-counter (OTC) naloxone nasal spray — Emergent BioSolutions’ opioid overdose therapy Narcan, 4 mg — and is encouraging other producers to apply for OTC status. Read More
The White House has laid out “bold goals” to use biomanufacturing breakthroughs to produce at least 25 percent of all active pharmaceutical ingredients (API) for small-molecule drugs in the U.S. within five years. Read More
The Senate Commerce, Science and Transportation Committee has passed a bill that would force pharmacy benefit managers (PBM) to be upfront about their often murky pricing practices and compel them to stop what legislators are calling unfair and deceptive conduct that drives up costs for consumers. Read More
GOTHENBURG, SWEDEN — The FDA correctly approved Biogen’s Aduhelm (aducanumab) in 2021 because the drug met the criteria for disease modification the agency had laid down for Alzheimer’s disease (AD) drug sponsors years before, according to a former FDA employee. Read More
The European Medicines Agency (EMA) reported “remarkable” progress despite the pandemic in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that will encourage innovation — including advances in clinical trials and a new real-world data (RWD) network. Read More
The FDA announced yesterday that its generic drug program has resumed in-person, face-to-face meetings with industry, in a phased-in approach alongside videoconference meetings. Read More