• AIDS Foundation Petitions Supreme Court to Invalidate Gilead HIV Drug Patents

    The nonprofit AIDS Healthcare Foundation (AHF) recently filed a petition for writ of certiorari with the US Supreme Court seeking a review of its lawsuit against Gilead Sciences, alleging the company's patent for a key HIV/AIDS drug is invalid because Gilead manipulated the patent system. The filing follows the US District Court for the Northern District of California granting of a Motion to Dismiss by Gilead, though AHF says the court’s order suggested that the case wa...
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    Janssen, Lundbeck and Takeda Raise Issues With FDA Draft Guidance on MDD Drugs

    Three drugmakers have raised questions with the US Food and Drug Administration’s (FDA) draft guidance on developing major depressive disorder (MDD) treatments. Lundbeck used its comments to urge FDA to refrain from classifying antidepressants based on the timing of their onset of effect. Instead, Lundbeck said it believes that this attribute is best reflected in prescription drug labeling claims. Similarly, Janssen said it disagrees with the categorical distinction ...
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    Microdose Radiopharmaceutical Diagnostic Drugs: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance to help sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. In terms of changes between the draft from last September and the final guidance, FDA said it now incorporates comments received, includes a few editorial changes and a new sentence clarifying the definition of the term diagnostic rad...
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    Chewables: FDA Finalizes Guidance on Quality Attributes

    The US Food and Drug Administration (FDA) on Monday finalized draft guidance that provides manufacturers of chewable tablets with current thinking on the critical quality attributes that should be assessed during the development of these drugs. The draft guidance,  released in June , comes as FDA has warned that for “numerous approved” chewable tablets, companies have not evaluated critical quality attributes such as hardness, disintegration and dissolution "as may have...
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    Microbiome-Based Products: FDA Delves Into the Unregulated

    As part of a broader push to advance the regulatory science around microbiome-based products, the US Food and Drug Administration and National Institutes of Health will host a workshop on 17 September. Currently, FDA has not approved any microbiome-based probiotics as a live biotherapeutic product (LBP), which is a biologic other than a vaccine that contains living organisms used to prevent or treat a disease or condition in humans. However, there are dietary supplement...
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    FDA and NCI Draft Pediatric Molecular Target List

    Thanks to the law reauthorizing the user fee programs, known as the FDA Reauthorization Act (FDARA), FDA’s Oncology Center of Excellence Pediatric Oncology Program recently drafted a list of molecular targets to provide better guidance to industry in planning for initial pediatric study plan submissions. The efforts from FDA, with input from the National Cancer Institute (NCI), are meant to increase the number of written requests for pediatric studies of new drugs dev...
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    FDA Approves First Generic Versions of EpiPen

    The US Food and Drug Administration on Thursday approved Teva Pharmaceuticals’ first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis) in adults and children weighing more than 33 pounds. The approval comes as the US has grappled with shortages of EpiPens  and following delays. The approval means Teva can market its generic, substitutable epineph...
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    DOJ, DEA Seek 10% Reduction in Opioid Manufacturing

    The Department of Justice (DOJ) and US Drug Enforcement Administration (DEA) on Thursday announced they are seeking a 10% reduction in manufacturing for the six frequently misused opioids for 2019. The proposal would impact the manufacturing of more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl. DEA said the quota was set in consultation with the US Food and Drug Administration and other dat...
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    Export Certificates for Devices: FDA Issues Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday released new draft guidance to explain the process by which persons can be denied a Certificate to Foreign Government (CFG) for a device and what to do if one receives a denial. The 7-page draft describes the information that FDA’s Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) will provide to a person whose request for a CFG for a device is denied, and t...
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    Brexit Impact: EMA Suspends Publication of Clinical Trial Data

    As of 1 August, the European Medicines Agency (EMA) has suspended all new activities related to the publication of clinical data. EMA said it will continue to publish clinical data submitted by the end of July but no new data packages will be processed until further notice. “This is a result of the implementation of the third phase of  EMA's business continuity plan  to prepare for its relocation to the Netherlands,” the agency said. EMA has stopped sending “invit...
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    Health Canada Proposes ‘Pause the Clock’ Mechanism for Premarket Submissions

    Health Canada recently released for consultation a plan to establish a mechanism that allows for the review clock on premarket submissions to be formally paused. “A pause the clock policy will be implemented in parallel with the new user fees for drugs and medical devices, by April 2019,” Health Canada said. The consultation, which is part of the  user fee proposal , seeks to pause the review clock during a review only when pre-specified conditions (triggers) are met...
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    Merck, GSK, BIO and Pew Comment on Draft Guidance on LPAD Approval Pathway

    Merck, GlaxoSmithKline, BIO and Pew Charitable Trusts weighed in on recent draft guidance on the establishment of a limited population pathway for antibacterial and antifungal drugs (LPAD pathway). The draft is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway, which was created under the 21st Century Cures Act . FDA says it will accept greater uncertainty and higher risk for products...