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    Asia Regulatory Roundup: China Approves Gilead HIV Drug Within 18 Months of EMA and FDA

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Analysis of Paclitaxel-Coated Device Data Finds no Safety Signal   The Therapeutic Goods Administration (TGA) has analyzed Australian adverse event data on patients with paclitaxel-coated devices in light of a meta-analysis published last year. The meta-analysis found a link between the devices and increased risk of death, but no safety signal was seen in the TGA...
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    Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence

    Just over two months ago, the US Food and Drug Administration (FDA) released draft guidance explaining to drugmakers what constitutes real-world data (RWD) and real-world evidence (RWE) and how to submit such data to the agency. The draft guidance spells out what the agency considers to be an RWD source (i.e. electronic health record data, medical claims or billing data, etc.) and what relevant submissions may include RWE (i.e. single arm trials that use RWE as an ext...
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    FDA Explains Why it Waived a Shared REMS for Letairis Generics

    The US Food and Drug Administration (FDA) has released a memorandum explaining why it waived the requirement of a single, shared system (SSS) risk evaluation and mitigation strategy (REMS) for generic versions of Gilead’s Letairis (ambrisentan), which treats pulmonary arterial hypertension. This is just the fourth time in FDA’s history that it has waived an SSS REMS for generic competitors. Because the process of creating an SSS can be time-consuming and complex, such a...
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    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH). The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...
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    Malaysia Issues Compulsory License for Gilead Hepatitis C Drug

    Late last month, Malaysia's government issued a compulsory license in an effort to offer a less-expensive version of Gilead's hepatitis C drug and increase access. Reports of the government move in Malaysia coincided with Gilead's decision on 24 August to extend its voluntary licenses on its hepatitis C medicines to include Malaysia, Ukraine and Belarus. Previously, the company signed agreements with 11 India-based manufacturers to make generics of its hepati...
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    FDA Approves First Generic Version of Gilead's HIV Drug Truvada

    The US Food and Drug Administration (FDA) on Friday announced it has approved Teva Pharmaceuticals' generic version of Gilead's HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate). However, Teva has not said how much its version of the drug will cost or when it will be available to patients. A Teva representative declined to comment other than to say the company had received approval. Truvada and HIV PrEP Truvada was initially approved by FDA in 2004 to ...
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    Sarepta Sells Priority Review Voucher for $125M to Gilead

    Sarpeta Therapeutics on Tuesday sold its priority review voucher (PRV) to Gilead for $125 million, speeding up the US Food and Drug Administration (FDA) approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months. The voucher was awarded to Sarepta under the rare pediatric PRV program after winning FDA approval for its Duchenne Muscular Dystrophy (DMD) drug Exondys 51 (eteplirsen) in September 2016. This is the third PRV Gilead ...
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    WHO Prequalifies First Hepatitis C Diagnostic

    The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment. The prequalification of South Korea-based Standard Diagnostics’ point-of-care diagnostic, called SD BIOLINE HCV, comes as an increasing number of people in low- and middle-income countries are now gaining access to hepatitis C cure...
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    Why Don’t People Like Pharma Companies? Pfizer and Regeneron CEOs Discuss

    At the end of Thursday's Forbes healthcare summit in New York, some of the pharmaceutical and biotech industries’ top executives – from Pfizer, Regeneron, Eli Lilly, Gilead and Astellas – sat down and were presented with a simple question: Why don’t people like you? At first the conversation dovetailed away from the question, with John Milligan, CEO of Gilead, discussing his company’s hepatitis C cure Sovaldi (sofosbuvir) and the rapid increases in demand. “What happen...
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    Four Pharma Companies Lead in Regulatory, Legal Compliance

    Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...
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    EMA Recommends Nine Drugs for Approval

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics. As for the new medicines, CHMP recommended granting a marketing authorization to CSL Behring’s Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with hemophilia A, Novo Nodisk’s Fiasp (...
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    FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk

    The US Food and Drug Administration (FDA) on Tuesday warned of serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV). FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between 22 November 2013 and 18 July 2016. Of the cases reported, two pati...