• Regulatory NewsRegulatory News

    Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate

    A recent study in Health Affairs suggests that drugs given an expedited review by the US Food and Drug Administration (FDA) offer greater health gains than drugs that receiving a conventional review. But experts caution that the study might only show incremental benefits. The study, conducted by Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health and three of his colleagues at Tufts Medical Center, compared the change in quality-adjuste...
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    Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Accepting Priority Review Notifications, Implements Revised Orphan Drug Program The Therapeutic Goods Administration (TGA) of Australia has opened its priority review pathway. TGA is now accepting notifications from sponsors who plan to apply for priority review status to accelerate the approval of their medicines in the coming months. Officials at TGA are ...
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    FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition

    The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug. Both moves seek to increase generic drug competition and lower the cost of pharmaceuticals in the US. The generic dr...
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    Priority Generic Drug Reviews: New FDA Draft Guidance

    In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II) , the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs. Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their a...
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    EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25

    The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25. The agency also said it denied seven requests for eligibility, which seeks to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors. While this latest batch of recomme...
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    FDA Approves First Treatment for a Form of Batten Disease

    The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV). FDA approved Brineura (cerliponase alfa) to slow the loss of walking ability in symptomatic pediatric patients three years old and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency. ...
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    FDA Officials: Priority Review Drugs Have Higher Likelihood of Getting Boxed Warning After Approval

    A team of officials from the US Food and Drug Administration (FDA) say that drugs approved following a priority review are three-and-a-half times more likely to receive a boxed warning after entering the market. Unlike standard reviews, which can take up to ten months, drugs that treat serious conditions or offer a significant improvement over existing treatments can qualify for a shorter, six-month review. However, the authors note that because drugs given priority rev...
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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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    Australia’s TGA Looks to Mirror US FDA, EMA With Two New Expedited Drug Approval Pathways

    As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways. TGA’s priority review pathway, like Health Canada’s and FDA's  pathway with the same name , will involve faster reviews of prescription drugs ...
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    China to Begin Priority Reviews of Medical Devices in January 2017

    China Food and Drug Administration (CFDA) announced Thursday that its priority review and approval procedure for medical devices will come into force as of 1 January 2017. The move is part of CFDA’s implementation of reforms to its approval systems for drugs and devices, and to meet the clinical demands of medical devices. According to the law firm Ropes & Gray , the new policy, first drafted in June, will allow applicants with a Class II device (limited to importe...
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    EMA Prioritizes Three New Treatments as Part of its PRIME Scheme

    The European Medicines Agency (EMA) on Wednesday announced that it recently granted eligibility to three new treatments as part of its PRIME scheme, which focuses on medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The newly added medicines, which are considered priority medicines by EMA, include Cymabay Therapeutics’ MBX-8025 , which is intended to treat Primary Biliary Cholangitis, a ch...
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    Global Regulatory Strategy

    This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers. The term "strategy," per Merriam Webster (Edition 11), means "a careful plan or method for achi...