FDA draft guidance looks set to clear up what types of apps require its approval. MobiHealth News reports that the new guidance comes down to what the regulator considers a wellness app as opposed to a health app. MobiHealth says that wellness items would not “make any reference to diseases or conditions” and veer into broad-stroke categories, like weight management, while health apps would refer to a specific disease or condition and claim that they may help users live better using their app.
Colorado’s state lawmakers are giving biosimilar-swap legislation a second look. The Denver Business Journal reports that Senate Bill 71 revisits a proposal the legislature rejected two years ago, and which would allow pharmacists to substitute a biosimilar for a branded biologic. The Denver publication notes that the legislation died over a provision that would allow a substitution only if a doctor gave the OK. Branded biologics maker Amgen supported this language, but biosim maker Sandoz was against it, saying it could curtail substitutions. Pressure for a swapping framework is increasing, now that an FDA panel has endorsed a biosimilar version of Amgen’s Neupogen.
Janssen’s three-month antipsychotic Invega Sustenna (paliperidone palmitate) has wrangled a priority review designation. The Johnson & Johnson subsidiary said in a statement Monday that an approval would make the drug “the first and only long-acting atypical antipsychotic” that requires just four doses a year.
ZMapp’s experimental Ebola vaccine may be ready for testing in West Africa by next month. The Wall Street Journal reports that although the drug has been used in infected patients, supplies ran out before it could be used in human clinical trials and assessed for safety and efficacy. GSK and Merck also expect to begin human clinical trials of their Ebola vaccines next month, joining Johnson & Johnson, which has already started its human trials.
BioMarin Pharmaceutical’s CEO clinical trial data presentation at last week’s JPMorgan conference has Sarepta’s CEO fuming. The Wall Street Journal reports that the anger hinges on BioMarin’s use of Sarepta data in contrast to data for its own Duchenne muscular dystrophy drug, even though there has not been a clinical trial in which the drugs were compared against each other. The Journal notes that the presentation “could have been interpreted as a direct comparison,” in which case the walking data – a measure of a treatment’s impact– would appear to favor BioMarin’s pipeline treatment. The Journal reports that Sarepta tried to clarify the information in its own presentation.
ICYMI: Aetna has sided with Gilead in the hepatitis C competition that has divided the payer space largely into Gilead or AbbVie camps. Aetna’s move, as reported by the San Jose Mercury News, aligns it with CVS/Caremark, whereas Express Scripts has opted to give AbbVie’s Viekira Pak. SJMN reports that Aetna’s decision could have an impact on the 10.8 million patients it covers, but that eligible patients will not have immediate access to AbbVie’s cocktail. Instead, Aetna will use a step-therapy process in which patients must use older medications before AbbVie’s. Although some PBMs have taken an all-or-nothing approach, Prime Therapeutics announced last week that it will fill both Gilead and AbbVie prescriptions because both drugmakers offered what the company described as a “substantial reduction in the net price.”