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    Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Quality Control of Medical Devices China Food and Drug Administration (CFDA) has posted guidance on quality control and finished product release for medical devices. The document details the procurement control procedures, finished product inspection rules and other processes CFDA wants companies to establish to ensure medical devices meet manda...
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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...
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    EMA Adds Four New Drugs to PRIME Scheme

    The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight. Like the US Food and Drug Administration's (FDA) breakthrough therapy program, PRIME aims to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors in order to facilitate an accelerated product assessme...
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    How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives

    The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent. The reversal of the lower court decision could mean a loss of patent protection and the launch of new Safyral and Beyaz generics before the patent expires in April 2020. The story and patent claim on the contraceptives...
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    Asia Regulatory Roundup: China Fast Tracks Hepatitis C, Cancer Drug Approvals (26 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Hepatitis C, Cancer Drugs on Regulatory Approval Fast Track China has granted priority review status to a clutch of drugs being developed by Western companies. The products affected by the actions include the expensive hepatitis C drugs from Gilead Sciences and other manufacturers that have transformed treatment of the disease in the West. Versions of Gilead’s b...
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    Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals?

    Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated. In January, FDA released draft guidance outlining how it plans to track and release early signals on medical device safety. The release of such information is expected to be for concerns that have yet to be fully analyzed, validated or confirmed by the agency and ...
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    FDA Warns Chinese API Manufacturer for Serious Data Manipulation

    The US Food and Drug Administration (FDA) has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US. Specifically, the warning letter released Tuesday for the Chinese active pharmaceutical ingredient (API) manufacturer was for failing to stop unauthorized access or changes to company data, and failing to provide...
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    HHS Pharmaceutical Pricing Forum: Lots of Questions, Few Definitive Answers

    The Department of Health and Human Services’ (HHS) invite-only Pharmaceutical Forum on Friday turned out to be more of a listening session for a range of stakeholders to explain concerns and discuss a number of potential ways to lower drug prices, some of which involve US Food and Drug Administration (FDA) reforms. HHS Secretary Sylvia Burwell kicked off the event by noting the steep cost increases for medicines, particularly for specialty drugs, which made up about $87 ...
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    Indian Court Sides with Merck in Patent Dispute

    A prominent court in India has issued an interim injunction, overturning a previous ruling, in favor of US drug maker Merck in a patent dispute with Glenmark Pharmaceuticals over an active ingredient used in two of Merck's diabetes medicines, Januvia and Janumet. Background India’s patent system has been a source of frustration for western drug makers, which have argued for intellectual property (IP) reform in the country. While there have been several high-profile ...
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    Merck's Insomnia Drug Belsomra Clears Final DEA Hurdle

    The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug. Background Belsomra is an orexin receptor antagonist intended to treat insomnia in patients. While its sponsor, Merck, has already obtained FDA approval to market the drug, it has been awaiting scheduling by DEA as a controlled substance under the Controlled Substances Act (CSA) . In February 2...
  • Will Merck's Suvorexant Avoid DEA's Regulatory 'Black Hole' That Snared Arena's Belviq?

    Merck's insomnia drug Suvorexant may not be approved yet by the US Food and Drug Administration (FDA), but if it ever is, its path to market will probably be even shorter thanks to a decision made by the US Drug Enforcement Administration (DEA) this week. Background Suvorexant is an investigational orexin receptor antagonist intended to treat insomnia in patients. While its sponsor, Merck, has already completed several Phase III trials in support of the drug's mark...
  • FDA Debars Two for Falsifying Clinical Trial Data

    Federal regulators have debarred two researchers formerly employed by Kansas-based Lee Research Institute for falsifying data obtained from a clinical trial conducted on behalf of Schering-Plough, now a subsidiary of Merck & Co. The researchers, Lisa Jean Sharp and Wayne Spencer , were both convicted in march 2012 of felony counts of failing to prepare and maintain records required under the Federal Food, Drug and Cosmetic Act (FD&C Act) with the intent to d...