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  1. May’s top news stories
  2. US biosimilar setbacks highlight difficulty of cost-effective development
  3. POINT trial may increase clopidogrel use in secondary ischemic stroke prevention
  4. Changing trends in real-world evidence
  5. AAAAI/WAO 2018: Stallergenes Greer presents US paediatric safety data for Oralair

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May’s top news stories

Abivax unveiled new data that may suggest its clinical candidate ABX464 could be a safe, functional cure for human immunodeficiency virus (HIV), as well as a method to treat inflammatory diseases; and Cancer Research UK and Experimental Cancer Medicine Centres (ECMC) Network joint venture (JV) Combinations Alliance started the SeluDex trial, a Phase I clinical study to evaluate selumetinib in combination with dexamethasone for treating leukaemia.

US biosimilar setbacks highlight difficulty of cost-effective development

Complete response letters (CRLs) were issued by the FDA recently for two biosimilar versions of Roche’s Rituxan—first to Celltrion and Teva on April 9 for Truxima and then to the Sandoz division of Novartis on May 3 for Rixathon, over two months ahead of its Prescription Drug User Fee Act (PDUFA) date, effectively stalling rituximab biosimilar development in the US.

FDA approves first non-opioid treatment for opioid withdrawal

The US Food and Drug Administration (FDA) has announced its approval of Lucemyra (lofexidine hydrochloride), the first non-opioid medication intended for the reduction of withdrawal symptoms associated with opioid use disorder (OUD) in adults, enabling patients’ discontinuation of opioid treatments.

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