Sanofi may make Rx-to-OTC switch history Wednesday. Reuters reports that reviewers at the FDA are leaning in favor of letting the French drug maker’s nasal allergy medication Nasacort AQ become available without a prescription. An advisory panel takes up the issue tomorrow, and if the hay fever med does end up with an approval by the regulator it would be the first OTC intranasal corticosteroid in the US; it’s already an OTC med in 10 other countries. The ultimate decision still lies with the regulator, but advisory panels serve as a pulse point the agency refers to when deciding to reject or approve drugs.
Celgene has added collaboration to its mix. The biotech announced Monday that it was partnering up with Array Biopharma to develop a program “targeting a novel inflammatory pathway.” The deal is costing Celgene $11 million up front, but with the promise of exclusive licensing options. Array stands to gain up to an additional $376 million in milestone payments. As noted by FierceBiotech, this is a small deal for Celgene, which recently spent $100 million for the option to buy Acetylon and its experimental myeloma treatment.
The US Task Force of Preventative Medicine is expected to propose that lung cancer screening be made as routine as mammograms and colonoscopy, reports NPR. The recommendation would give the test a B priority, which, if granted, would mean Medicare and insurers would have to pay for the screening, which costs between $300 and $500. NPR notes that physicians aren’t too happy with the idea, because it could mean high detection rates of conditions that are not a threat to patient health. This same concern pops up in an NYT Well piece that talks about narrowing the definition of what it means to have cancer. In the NYT’s case, the issue is that experts say some labels are simply too broad and cause needless patient worry. NYT’s example: ductal carcinoma in situ, which is a cancer that may precede breast cancer, but is not cancer. “We need a 21st century definition of cancer instead of a 19th century definition of cancer,” the American Cancer Society’s chief medical officer told the paper. The Times says the push to rethink and rename conditions is partly due to “concern among doctors, scientists and patient advocates that hundreds of thousands of men and women are undergoing needless and sometimes disfiguring and harmful treatments for premalignant and cancerous lesions.” Doubling back to the lung cancer screening issue, the task force estimates that its recommended screening could mean 20,000 fewer lung cancer deaths a year.
