- Turns out drugmakers don’t tell the whole truth about FDA rejections (fiercebiotech.com)
When the FDA turns away a potential new treatment, it sends the drug's maker what's called a complete response letter, detailing all the deficiencies that led to the rejection. Those forms aren't public, but most companies issue press releases describing their contents. However, as a new study reveals, there's often a wide gap between the FDA's actual issues and the sponsors' spin.
- On-Label Nasal Naloxone in the Works (medpagetoday.com)
An official formulation of nasal naloxone for reversing opioid overdoses that doesn't have to be used off-label may be on the market soon. Lightlake Therapeutics has opened a rolling submission of the NDA for its nasal naloxone to the FDA, according to a release from the National Institute on Drug Abuse (NIDA), which is partnering with the company to develop the drug.
- Do U.S. biomedical researchers really waste about $28B a year? (fiercebiotechresearch.com)
Researchers have known for years just how sketchy preclinical biomedical research can be. Reports on research projects that can capture headlines around the world are also not infrequently impossible to reproduce. And now a new study has attempted to put a dollar figure on the amount of research produced in the U.S. each year that can't be reproduced.