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    Here Come the Oncology Biosimilars in the US: How Low Will Prices Go?

    A quick look at biopharma’s top-selling drugs (including forecasted sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion. But biosimilar competition for Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) is now ready to launch in the US, and Bernstein biopharma analyst Ronny Gal said in a report issued Friday that prices over...
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    MDIC Kicks Off Framework on Patient Input in Device Trials

    The nonprofit Medical Device Innovation Consortium (MDIC) is seeking comments on the first of three resources to support its Framework for Patient Input in Medical Device Clinical Trials, which is set to be complete next year. Overall, MDIC seeks to use this framework to better integrate patient input and preferences into the design of device trials and seek to reduce the burden on patients participating in such trials. The white paper published Wednesday, which is o...
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    Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

    Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA). This has been the story at FDA from FY 2016 to FY 2017 to FY 2018 and now to FY 2019 , with two months to spare. But questions remain on whether these approvals are actually translating into greater competition and lower costs for patients. A report from Pew earlier this year found that the increase in approved generic drugs fr...
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    EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016. In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case ...
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    FDA Offers Accelerated Approval for 3rd Tissue-Agnostic Cancer Treatment

    The US Food and Drug Administration (FDA) on Thursday granted accelerated approval to Roche’s Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for whom there are no effective treatments. This is the third time FDA has approved a cancer treatment based on a common biomarker across different tumor types rather than the location in the body wher...
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    Drugmakers Seek US, EU Harmonization on NASH Drug Development Guidance

    Novartis, Gilead, Regeneron, Novo Nordisk, Boehringer Ingelheim and others recently told the US Food and Drug Administration (FDA) to better align its draft guidance on drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis with the European Medicines Agency (EMA). They also took issue with the way that the latest NASH draft guidance, released in June , does not seem to allow for the use of the accelerated approval pathway. The draft guidance fol...
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    Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices

    With an eye on post-Brexit drug and medical device shortages, the UK’s Department of Health and Social Care said Thursday that it’s established a £25 million contract to set up a 12-month express freight service to deliver medicines and medical products into the country. The UK is seeking proposals until 21 August and will select providers in September. “The service is intended to deliver small parcels of medicines or medical products on a 24-hour basis, with additio...
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    FDA’s OCE Taps Syapse for Research on RWE

    San Francisco-based data company Syapse said Wednesday that it has signed a multi-year research collaboration agreement with the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) to work on using real-world evidence (RWE) to support regulatory decision making. Syapse and OCE will work with EHRs, labs and registries, among other data sources, to characterize the regulatory suitability of RWE derived from multiple sources. They will also work tog...
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    FDA Adds New Q&As to Lab Controls Section of CGMP Guidance

    The US Food and Drug Administration (FDA) on Wednesday added three new questions and answers to its Laboratory Controls questions and answers (Q&A) on Current Good Manufacturing Practices (CGMP) guidance. The new Q&As discuss instrument calibration standards for chromatographic systems, system suitability and trial injections.   On the issue of trial injections, where a sample of a lot is injected into the chromatographic system with the intention of obtaining an unoff...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 14 August 2019 to include: FDA approved pretomanid in combination with b...
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    EC Designates Third Notified Body Under MDR

    The European Commission announced on Wednesday that Germany-based Dekra Certification GmbH is the third notified body (NB) to be designated under the Medical Devices Regulation (MDR). Dekra joins Germany-based TÜV SÜD  and BSI UK as the only NBs to be designated and listed in the European Commission’s New Approach Notified and Designated Organisations (NANDO) database. A fourth NB is expected to be announced soon, as the MDR/IVDR implementation rolling plan, updated...
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    FDA to Drug Manufacturers: Outdated Listings Will be Inactivated

    While noting that tens of thousands of drug listing records have not been updated in the past year, the US Food and Drug Administration (FDA) on Tuesday announced that it will begin inactivating drug and manufacturing establishment listings that are not current in one month. The announcement is part of FDA’s push to encourage drugmakers to ensure that their listed human drugs and any information in their drug listings, including drug establishments, are accurate. “If...