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    Researchers Propose Framework to Validate Surrogate Endpoints

    A team of researchers and health officials, including European Medicines Agency (EMA) Executive Director Guido Rasi, are proposing a three-step validation process to enhance the use of surrogate endpoints in regulatory and reimbursement decision-making. The issue, they say, is that poorly validated surrogate endpoints can lead to products being approved or reimbursed that have little or no benefit, and in some cases even harm patients. In recent years, drugmakers have i...
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    Judge Overrules FDA, Allows Trial for Terminally Ill Patient at Questionable Clinic to Resume

    A US District Court Judge late Tuesday overturned a US Food and Drug Administration (FDA) hold on a clinical trial for at least one patient with an incurable brain tumor, though the institute running the trial has been cited by FDA with numerous warning letters and criticized for offering false hopes to desperate patients for more than 30 years. “The full clinical hold imposed by the Defendant [FDA] is lifted as to treatment for Eugene Neil Fachon for DIPG [Diffuse Intr...
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    US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries

    New Jersey-based generic drugmaker Heritage Pharmaceuticals last week announced that counterfeit drugs labeled the same as its 100mg chemotherapy BiCNU (carmustine for injection) have been sold and distributed in India, Ireland and Israel. The injection is primarily used for the treatment of several types of brain cancer, multiple myeloma and lymphoma (Hodgkin's and non-Hodgkin) and according to the company, is also sometimes used for immunosuppression before organ trans...
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    Genomic Data and Drug Development: EMA Offers New Draft Guidance

    As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and understand genomic factors that influence drug responses. The aim of the guidance, according to EMA, is to lay out the requirements related to the choice of appropriate genomic methodologies during the development and lifecycle of a drug. Background Pharmacogenomics research...
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    FDA Offers Specific Guidance on Bioequivalence Trials for Next Generation of 38 Generic Drugs

    The US Food and Drug Administration (FDA) on Thursday unveiled 38 new specific recommendations on the types of bioequivalence trials generic drug companies should run in order to win approval for their abbreviated new drug applications (ANDAs). The list targets what trials should be run by those developing a number of new generic oncology treatments, though many have yet to lose patent protection and some were recently approved, including Pfizer’s breast cancer drug Ibra...
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    European Regulatory Roundup: CHMP Adopts Guidance on VTE Treatments (31 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Cardiovascular Working Party Signs off on Final Reflection Paper, Guidelines The Committee for Medicinal Products for Human Use (CHMP) has adopted a pair of final regulatory documents created by the Cardiovascular Working Party (CWP). Most significantly, the committee has adopted final guidelines on clinical trials of treatments for venous thromboembolism (VTE). Having bee...
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    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...
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    EMA Offers Updated Draft Guidance on Human Clinical Trials for Cancer Drugs

    The European Medicines Agency (EMA) on Tuesday published new draft guidance on the evaluation of anticancer medicines in humans that covers all stages of clinical development. The guidance, which is available for comment through 15 September, delves into the development of treatments for malignancies, including “drug resistance modifiers or normal tissue protective compounds.” A very large number of anti-cancer compounds are being developed, EMA notes, though only a min...
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    Gilead Halts Six Cancer Trials as EMA, FDA Warn of Increased Adverse Events

    Biotech juggernaut Gilead Sciences is halting six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas after an increased rate of serious adverse events, including deaths, mostly due to infections. The US Food and Drug Administration (FDA) late Monday issued an alert to health professionals of the stoppages, noting that they should be aware that the cancer medicine Zydelig (idelalisib) is not approve...
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    European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Major Changes to Pharmacovigilance Risk Management System Guidelines The European Medicines Agency (EMA) has proposed major changes to its good pharmacovigilance practices (GVP) module on risk management systems. EMA wants to implement the modifications to bring the guidelines in line with its current thinking, which has evolved over the past three years as it ...
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    Obama’s FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices

    President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request. The overall request from Obama and FDA includes a net increase of $14.6 million in budget au...
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    Asia Regulatory Roundup: India Taxes Cancer, HIV Drug Imports (9 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Imposes Tax on Imports of Cancer and HIV drugs India has stopped exempting more than 70 drugs from customs duties. The ruling means companies that import any of the products or manufacture them within special economic zones will have to pay more tax, potentially giving local producers an advantage over foreign businesses. Officials at the Central Board of Excise and...