Trending News Today: FDA Declines to Approve ALS Treatment

Officials with the FDA declined to approve BioHaven’s treatment riluzole (Nurtec) for amyotrophic lateral sclerosis (ALS), the company announced in a press release. According to the release, the FDA issued a complete response letter for the 505b(2) application, citing issues with the active pharmaceutical ingredient (API) used in the 2017 bioequivalence study. BioHaven said the API is now being sourced from another supplier and the company will work with the FDA to develop a timely path forward.
 
Newly-published opioid data show that 76 billion prescription painkillers were manufactured and shipped to pharmacies across the United States between 2006 and 2012, the Washington Post reported. According to the article, the Washington Post looked at approximately 380 million transactions from the Drug Enforcement Administration’s database and analyzed shipments of oxycodone and hydrocodone pills, which account for three-quarters of the total opioid pill shipments to pharmacies. The available data are intended to help the public understand the impact from years of prescription pill shipments on their communities, the article reported.
 
A new study suggests that the risk of heart failure associated with diabetes is more common in women than men, MD Magazine reported. According to the article, the researchers conducted a systematic review of population-based studies published between January 1966 and November 2018, including approximately 12 million individuals who experienced 249,560 events. Overall, the pooled risk ratios for heart failure were 5.15 for type 1 diabetes and 1.95 for type 2 diabetes in women compared with 3.47 for type 1 diabetes and 1.74 for type 2 diabetes in men, the article reported.



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