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    Immunogenicity Testing: FDA Finalizes Guidance on Assay Development and Validation

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help industry develop and validate immune assays for the assessment of the immunogenicity of therapeutic protein products during clinical trials.  The 33-page guidance features updated information on the development and validation of screening assays, confirmatory assays, titration assays and neutralization assays, as well as an additional discussion of immunogenicity risk assessment. The re...
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    EMA: No New Patients Should Start Treatment With Lilly’s Lartruvo

    The European Medicines Agency (EMA) on Wednesday told doctors that no new patients should begin treatment with Eli Lilly’s Lartruvo (olaratumab) because a recent study found it is not more effective in combination with doxorubicin for patients with soft tissue cancer when compared to doxorubicin alone. The EMA warning comes just five days after Lilly announced that the Phase 3 study had failed. “Specifically, the study did not meet the primary endpoints of overall ...
  • J&J, Attorneys General Settle Hip Implant Allegations for $120m

    Johnson & Johnson (J&J) and subsidiary DePuy reached a $120 million settlement agreement to resolve allegations that the company unlawfully promoted two metal-on-metal hip implant devices. The attorneys general alleged that DePuy engaged in unfair and deceptive practices in its promotion of the ASR XL and Pinnacle Ultamet hip implant devices by making misleading claims as to the longevity, or survivorship, of the implants. According to the attorneys general, DePuy ad...
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    FDA Offers ICH S11 Guidance for Comment as Shutdown Threatens Further Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance, developed by the International Council for Harmonisation (ICH), on the standards for nonclinical safety studies in the development of pediatric medicines. The 38-page guidance should be consulted for study design, and early consultation is recommended for consideration of nonclinical support for pediatric medicine development. The guideline lays out advice on determining the need for additional ...
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    FDA Officials Look to Tackle PRO Bias in Cancer Trials

    Thanks to the 21 st Century Cures Act , the US Food and Drug Administration (FDA) is expecting to see more patient-reported outcome (PRO) assessments, and in light of that anticipated growth, three officials in FDA’s Center for Drug Evaluation and Research are explaining the ways in which open-label bias may arise and how to address some of the challenges. A potential effect of PRO bias noted in FDA’s guidance is overly optimistic reports of outcomes among patients in...
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    More FDA Furloughs Expected, Gottlieb Warns

    As the government shutdown enters its second month, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and fellow leaders at the agency will be tasked with difficult decisions on who to furlough. The agency is expected to halt its review of prescription drug applications around the first week of February, and other medical products reviewed under user fee laws will follow suit in the coming months. “As our biggest user fee program, PDUFA, begins to run...
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    FDA Approves 17th Biosimilar, Third for Herceptin

    The US Food and Drug Administration (FDA) on Friday approved Merck and Samsung Bioepis’ Ontruzant (trastuzumab-dttb) , the third biosimilar approved in the US to Roche’s Herceptin (trastuzumab). In the US, where no Herceptin biosimilar has launched, there are two other competitors: Celltrion’s Herzuma (trastuzumab-pkrb), approved in December 2018, and Mylan and Biocon’s Ogivri (trastuzumab-dkst), approved in December 2017. In Europe, Ontruzant launched in March and ...
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    Research Examines Applications of Model-Informed Drug Development

    A new article published in Clinical Pharmacology & Therapeutics digs through case studies, research papers and regulatory documents to highlight some common features of Model-Informed Drug Development (MIDD) applications and future considerations.   The US Food and Drug Administration (FDA) officials from the Office of Clinical Pharmacology explain in the article how MIDD applications can be classified into four categories: dose optimization, supportive evidence for ...
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    Mail Order Pharmacies Can Lessen Generic Usage, Study Finds

    Although nearly 90% of all drugs dispensed in the US are now generic drugs, a new study published in Therapeutic Innovation & Regulatory Science explores the determinants of generic substitution across therapeutic classes and found that in five of eight studied classes, patients using a mail order pharmacy had significantly less generic substitution than patients filling at retail pharmacies. The research, funded by a grant from the US Food and Drug Administration, sa...
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    FDA Takes Steps to Make Naloxone an OTC Drug

    The US Food and Drug Administration (FDA) on Thursday announced new steps to try to increase the availability of the decades-old opioid overdose antidote naloxone. The announcement comes as more than 72,000 died of opioid overdose deaths in 2017 and as naloxone sales have doubled from about 2.5 million units sold in 2013 to about five million units sold in 2017. And although naloxone is not yet an over-the-counter (OTC) product, CVS told Focus that it has pharmacy ...
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    FDA Revises Draft Guidance on Rare Diseases

    The US Food and Drug Administration (FDA) has updated a 2015 draft guidance on rare diseases, with new information gleaned since the original draft was released. Among the revisions to the 24-page draft guidance, according to FDA, are updates to the natural history studies section, the inclusion of issues for evaluating and validating biomarkers as surrogate endpoints, a discussion of additional flexibility on the non-clinical aspects of the evaluation of novel drug com...
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    FDA Approves First Generic Version of Lundbeck’s Sabril

    The US Food and Drug Administration (FDA) on Wednesday approved Teva Pharmaceuticals’ first generic tablet version of Lundbeck’s seizure medicine Sabril (vigabtrin). Vigabatrin tablets are FDA-approved for the treatment of refractory complex partial seizures (CPS) as an adjunctive therapy in patients 10 years of age and older who have responded inadequately to several alternative treatments. The vigabatrin powder market had US sales of approximately $333 million for the...