Archive for March 2023
Esperion Sues Daiichi Sankyo Over $300M Milestone Payment
Esperion is suing Daiichi Sankyo over a failure to pay a $300 million milestone payment for the cardiovascular drug Nexletol (bempedoic acid), a treatment for heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. Source: Drug Industry Daily
Read MoreFDA Approves Over-the-Counter Naloxone Nasal Spray
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. Source: Drug Industry Daily
Read MoreCaliff Defends Against Proposed Cuts to FDA’s Budget for Fiscal 2024
If the FDA is forced to go back to fiscal 2022 levels — as House Republicans are proposing — there will be fewer inspections, new drug products won’t get approved and drug companies will flock to other countries, said FDA Commissioner Robert Califf during a fiscal 2024 budget hearing on Wednesday. Source: Drug Industry Daily
Read MoreWhite House Outlines New Drug Manufacturing Goals to Improve Supply Chain
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. Source: Drug Industry Daily
Read MoreFormer FDA Official Says Agency Was Right to Approve Aduhelm
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. Source: Drug Industry Daily
Read MoreEMA Highlights Trial Innovation, Real-World Data Advances in Mid-Point RSS Report
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. Source: Drug Industry Daily
Read MoreBipartisan PBM Transparency Act Advances Out of Committee
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. Source: Drug Industry Daily
Read MoreFDA Generics Program Resumes In-Person Meetings
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. Source: Drug Industry Daily
Read MoreLilly and Roche Collaborate on Blood Test for Early Detection of Alzheimer’s
Roche has teamed up with Eli Lilly to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), an investigational blood-based biomarker test designed to give patients an earlier Alzheimer’s disease diagnosis. Source: Drug Industry Daily
Read MoreCalifornia Judge Says Zantac Single-Plaintiff Lawsuit May Proceed
A California judge has ruled that a lawsuit by one individual against GlaxoSmithKline (GSK) for its heartburn drug, Zantac (ranitidine), may go ahead — potentially setting the stage for other Zantac consumers in the state to have their day in court. Source: Drug Industry Daily
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