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  • Regulatory NewsRegulatory News

    FTC Settles Complaint Over Deceptive Marketing of Unapproved Cancer Products

    The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products. The settlement comes less than a year after FDA sent CellMark an advisory letter notifying the company that it must remove claims from its website and other materials indicating that CellAssure could treat or prevent cancer. FDA said that the company would need to ...
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    Internal HHS Memo: Some FDA Employees Will be Exempt From Trump Hiring Freeze

    An internal memo from the Department of Health and Human Services (HHS) obtained by Focus on Thursday reveals that a number of positions at the US Food and Drug Administration (FDA), particularly within the Office of New Drugs, will likely be exempt from President Donald Trump’s federal hiring freeze. The memo , sent from Colleen Barros, acting deputy secretary at HHS, to staff division heads and operations division heads on 6 February, notes that HHS has a resp...
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    US Solicitor General Calls on Supreme Court to Review Six-Month Delays to Biosimilar Launches

    With the timing of all future US launches of biosimilars at stake, the US Solicitor General has called on the Supreme Court to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. “The proper interpretation of those provisions has a significant impact on the operation of the BPCIA [ Biologics Price Competition and Innovation Act of 2009 ] and the ability of aBLA...
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    Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents

    Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s known as the “on sale” bar, according to an opinion released Monday from the US Court of Appeals for the Federal Circuit. The opinion hinges on an important concept linked to the patenting of pharmaceuticals, the use of CMOs and the manufacturing processes necessary to produce pharma...
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    Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory

    The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review. The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that th...
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    FTC Asks FDA to Reevaluate Framework for Homeopathic Products

    The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient. Now, the Federal Trade Commission (FTC) is weighing in, calling on FDA to "consider amending or repealing its framework for homeopathic medications." Background In March 2015, FDA announced a public hearing to evaluate its regul...
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    Following Negative Comments by Reviewer, EU Committee OK's Gene Therapy

    Last month, German regulators postponed their review of UniQure's gene therapy Glybera after the European Medicines Agency (EMA) rapporteur assigned to the product claimed new data showed Glybera lacked efficacy and called for it to be reassessed . Now, EMA's Committee for Advanced Therapies (CAT) has completed its assessment, and is maintaining its positive opinion of Glybera, Reuters reports. Background Glybera is the first gene therapy approved for use in the E...
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    German Regulators Decry Lack of Trial Transparency in Look at Stem Cell Transplantation

    The German Institute for Quality and Efficiency in Health Care (IQWiG) has found recent clinical data on the use of stem cell transplantation to treat multiple myeloma—a rare and deadly form of cancer—to be inconclusive . Background and 2012 Conclusion Stem cell transplantation is a therapy used to treat certain cancers, immunodeficiencies and hematologic diseases. It has also been widely used to treat multiple myeloma. Patients undergoing stem cell transplantation a...
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    First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report

    Regulators at the German Federal Joint Commission (G-BA) have postponed their review of the gene therapy Glybera, Reuters reports . The decision was made after the European Medicines Agency (EMA) rapporteur assigned to Glybera found the product lacked efficacy and called for it to be reassessed. Glybera, which treats a rare condition called lipoprotein lipase deficiency (LPLD), made headlines both for being the first gene therapy approved in Europe and for its record-...
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    German Price Watchdog Says ‘No’ to 3 Cancer Drugs

    The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month. IQWiG is one of several bodies in Germany charged with conducting health technology assessments (HTAs) for newly approved drugs in Germany. The goal of these assessments is to weigh the benefit of new therapies against the costs to the country’s healthcare system. According to IQWiG’s assessment, the drugs idelalisib , sipuleucel...
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    FDA Will Soon Need to Publish More Information About the Outside Standards it Uses

    The US government's Office of the Federal Register (OFR) has finalized a rule calling on the federal agencies, including the US Food and Drug Administration (FDA), to offer more information about third-party standards they require companies to comply with. Background If you're in the regulated healthcare products space—and in particular are involved with medical devices —you probably already know a thing or two about standards. There are of course standards FDA creates...
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    It's Not Just You: FDA Regulatory Requirements Really Are Increasing

    The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year. According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus , the number of regulatory requirements...