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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...
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    FDA Drafts Guidance on Tentatively Approved ANDAs

    In a first for the US Food and Drug Administration (FDA) during the shutdown, the agency has posted new draft guidance to assist generic drug applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. “We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document,” the agency said. “This posting is to provid...
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    Updated: UK Parliament Rejects Brexit Agreement as EFPIA Warns of Threats to Patient Safety

    EU biopharmaceutical industry group EFPIA on Tuesday said that the UK parliament’s decision to reject the Brexit withdrawal agreement, by a vote of 432 to 202, and political declaration increases the prospect of the UK leaving the EU in a disorderly manner on 30 March 2019. The UK's Brexit committee said Wednesday that the government must come up with a decision by Monday, 21 January at the latest on what it proposes to do next. The committee said that there are four op...
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    FDA Restarts Some Drug, Biologic and Device Inspections

    Following Sunday’s announcement that more FDA staffers would come back to work without pay, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday revealed on Twitter the approximate numbers of those returning. “About 400 total staff are being engaged in this mobilization. The vast majority are inspectors and others are professionals who work in support inspectors,” Gottlieb tweeted. Of those 400, about 100 will deal with high-risk medical devic...
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    Pfizer Halts Development of Five Preclinical Biosimilar Assets

    Pfizer on Tuesday told Focus that it’s halting the development of five preclinical biosimilar assets, though the company will continue to market three biosimilars and develop five other biosimilars in mid- to late-stage development. Joining a handful of other companies – from Boehringer Ingelheim to Momenta to Sandoz and more -- in exiting the US biosimilar space in some shape or form, Pfizer’s exit reiterates the need to raise questions about the viability of the US ...