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    Biopharma CEOs Explain Problems With Biosimilars to Congress

    Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds of pages of written responses to more specific questions. The lackluster biosimilar market in the US is addressed in nearly all their comments, with some executives explaining in detail as to why their biosimilars have yet to gain market share, while undertones of biosimilar fear-mongering linger in others’ comments. Merck CEO Kenneth Frazier expla...
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    EMA Begins Safety Review of MS Drug Lemtrada

    The European Medicines Agency (EMA) on Friday initiated a review of Sanofi’s multiple sclerosis (MS) drug Lemtrada (alemtuzumab) following new reports of immune-mediated conditions and problems with the heart and blood vessels of those taking the medicine, including deaths. “As a temporary measure while the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two di...
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    FDA Softens Stance on Drinking Alcohol With Female Libido Drug

    Following the completion of postmarketing studies for Sprout Pharmaceuticals’ Addyi (flibanserin), which is used to treat decreased sexual desire in women, the US Food and Drug Administration (FDA) has changed the labeling for the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely. Specifically, the agency told women to discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip ...
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    EMA Officials Debate Going Beyond Safe and Effective Determinations for New Drugs

    In the US and Europe, drug regulators approve new drugs based on whether the benefits of the new product outweigh the risks. But neither of the regulators consider if such new drugs are superior to drugs currently marketed. Now, three senior officials at the European Medicines Agency (EMA) explain how an added therapeutic benefit criterion or head-to-head comparisons could help to drive more innovative therapies. “The aim of these proposals is to contain the rising c...
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    European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit

    Just before the European Council decided, in agreement with the UK, to postpone Brexit until 31 October, the European Commission offered an optimistic report on Wednesday on the preparedness of the drug and medical device sectors. “Based on available information, the majority of medical products concerned by the UK withdrawal should be compliant with EU legislation on the withdrawal date,” the commission said. Still, the commission noted that some medicines and medic...
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    FDA Reclassifies Certain Device Accessories to Class I

    The US Food and Drug Administration (FDA) on Thursday published a final classification action that would reclassify eight types of medical device accessories to class I. The decision to reclassify the accessories — the final list is the same as the proposed list — is part of what’s required by the FDA Reauthorization Act of 2017 , which also reauthorized the user fee programs. The final classification action will be effective on 13 May, and the complete list of ac...
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    Concussion Assessments: FDA Warns Against Using Unapproved Devices

    The US Food and Drug Administration (FDA) on Wednesday warned against using a smartphone- or tablet-based app to assess whether an injured or possibly concussed person is suffering from a change in physical or mental status including vision, concentration, memory, balance and speech. After identifying several manufacturers marketing devices for concussion diagnosis, treatment or management without FDA’s approval or clearance, the agency said it issued a safety communica...
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    Blame Game Continues at House E&C Hearing on Insulin Prices

    As American diabetics continue to die because they cannot access affordable insulin, representatives from pharmacy benefit managers (PBMs) and insulin manufacturers on Wednesday pointed their fingers at each other at a House Energy & Commerce Committee hearing. The particularly dire situation for many comes as executives from Eli Lilly, Sanofi and Novo Nordisk have tried to offer a fig leaf to patients in recent weeks. Sanofi, for instance, said it will offer $99 per 10...
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    FDA Expands RWE Demonstration Project

    The US Food & Drug Administration (FDA) and Brigham and Women’s Hospital on Wednesday announced they are expanding a demonstration project using real-world evidence (RWE) to predict the results of seven ongoing Phase IV trials. The expanded program means researchers for the first time will estimate the results of randomized controlled trials (RCTs) that have not yet concluded. Funded by FDA’s Center for Drug Evaluation and Research and led by FDA’s Office of Medical Pol...
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    CDER Develops New Method to Evaluate an Opioid’s Safety Risk

    As fentanyl analogs present a major risk to public health, and as these analogs can evade prosecution, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has developed a new computational approach to understand these often-unidentified chemicals better and to assist with drug scheduling. The new approach, called Public Health Assessment via Structural Evaluation (PHASE), can evaluate the similarity of a newly identified drug of ab...
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    FDA Warns Chinese OTC Drugmaker

    The US Food and Drug Administration (FDA) last month sent a warning letter to Linyi, China-based Dong Yuan Technology Co., following a five-day inspection in September 2018 that uncovered significant violations of current good manufacturing practice regulations for finished pharmaceuticals. Specifically, FDA cited the firm for having inadequate lab controls and failing to follow its lab procedures. FDA said the company’s lab assay methods for its over-the-counter (OTC) ...
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    MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates

    As Friday’s no-deal Brexit deadline approaches, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday published additional guidance covering the process for applying for a Certificate of Pharmaceutical Product (CPP) in case the UK leaves the EU without a deal. The guidance is part of a series of 41 MHRA guidances and publications on a possible no-deal scenario that have been in the works since January. Grandfathered Products As part of MH...