The FDA revised the label for Gilenya, Novartis’s multiple-sclerosis treatment, over safety concerns. The regulator said there has been one case of definite progressive multifocal leukoencephalopathy, a rare viral infection in the brain that can cause death, and a second case of probable PML. The label change may generate more attention from physicians and could serve as a point of differentiation for sales reps when comparing Gilenya to other oral multiple-sclerosis drugs, like Biogen’s Tecfidera or Sanofi’s Aubagio, according to Marc Schoenebaum, an analyst with Evercore ISI.
A reporter at The Wall Street Journal visited Havas Worldwide to better understand the creative process behind pharmaceutical TV ads. His findings? The FDA’s Office of Prescription Drug Promotion “approves everything.” Those diagnosed with a particular condition are more likely to positively respond to an ad for a therapy that treats that condition.
Teva’s $40.5 billion acquisition of Allergan’s generic drugs business is in part due to the consolidation occurring among wholesale drug distributors, according to Bloomberg Business. By getting bigger, pharmaceutical companies have more negotiating clout with the distributors that buy generic drugs. The trend toward consolidation is apparent in other sectors of the healthcare industry as well, including insurers and hospitals.
The FDA reissued draft guidance about disclosing risk information in direct-to-consumer ads to include animal health products. The guidance aims to standardize risk information included in DTC ads and make it more understandable to consumers.
Regeneron told investors it plans to offer free samples of Praluent, its newly approved PCSK9 inhibitor, to address slow reimbursement of the cholesterol-lowering drug, according to The Pink Sheet Daily. The company provided few details about the launch of Praluent during an earnings call earlier this week but said payers will likely insist on patients taking the maximum-tolerated dose of statins before providing access to the new drug.