GOTHENBURG, SWEDEN — The approval of two Alzheimer’s disease-modifying therapies is giving the field a much-needed shot in the arm, experts said during a panel discussion at the Alzheimer’s and Parkinson’s Disease 2023 meeting. Read More

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. Read More

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. Read More

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