Five things for pharma marketers to know: Tuesday, February 23, 2016
1. The Senate cleared the appointment of Dr. Robert Califf as FDA commissioner in a 80-6 vote on Monday. The vote ended months of debate about whether to approve the nomination. A confirmation vote may take place today. (AP)
2. Sanofi said the FDA accepted a new drug application for its experimental combination of Lantus (insulin glargine) and Lyxumia (lixisenatide). The drugmaker, which redeemed a priority review voucher with the submission, said the regulator is expected to make a decision about the therapy in August.
3. The FDA approved UCB's Briviact, an add- on therapy for patients with epilepsy. Clinical studies found that the drug, when taken with other medications, can be effective in reducing the frequency of seizures.
4. The FDA is investigating whether a blood-testing device malfunctioned and compromised the results of a clinical trial that led to the approval of Johnson & Johnson's Xarelto, a blockbuster anticlotting drug. Researchers who oversaw the trial said the device did not affect the outcome of the trial, which was led by Califf, Obama's nominee for FDA commissioner. (NYT)
5. CVS Health said that changes it made to its formularies as well as increasing the number of drugs that require prior authorization helped limit growth of prescription drug spending to only 5% in 2015, compared to an 11% hike in 2014. (AP)