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    FDA Warns 14 Companies for Selling Fake Cancer Treatments

    The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to 14 US-based companies for selling dozens of unapproved cancer treatments online and through social media. The companies, FDA says, have 15 days to respond with plans to address the violations or face possible criminal prosecution, including up to a year in federal prison and fine of $100,000 or twice the companies' gains on the fraudulent products. The agency is also advising patients ...
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    FDA Officials Question Lack of New Cancer Drugs Developed in Combination With Radiation

    Although almost half of patients with cancer who are cured will have received radiation therapy as a component of their care, there is still a dearth of new therapies being developed in combination with radiation, officials from the US Food and Drug Administration (FDA) wrote in an article published this week. The authors, including Richard Pazdur, director of FDA's Oncology Center of Excellence, and FDA medical officer Amanda Walker, say that since 2006 there have been ...
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    Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes

    A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations. Background Pediatric study requirements are included in both the Pediatric Research Equity Act (PREA), which requires biopharma companies to ...
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    FDA’s Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue

    More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature . Those expectations follow 2016 oncology approvals for FDA that included five new molecular entities and 17 ef...
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    UK’s MHRA Allows Early Access to Roche Bladder Cancer Treatment

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will allow Roche’s atezolizumab to be used as part of an early access program for locally advanced or metastatic urothelial carcinoma. In terms of why the new treatment won a positive Early Access to Medicine Scientific (EAMS) opinion, MHRA said: “Atezolizumab has been shown to slow the progression of cancer and increase patient survival in a condition where other treatments currently h...
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    NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs

    The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies. The effort, referred to as the NCI Formulary, is intended to streamline the negotiation process between investigators at NCI-designated cancer centers and participating pharmaceutical companies. "As genomic sequencing data become mainstream in cancer therapy...
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    House to Pass Revamped 21st Century Cures Bill

    The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding. The 996-page bill, known as the 21st Century Cures bill  and released last Friday, has already earned praise from the White House and is likely to pass the Senate, which will take it up early next week. In addition to speeding up the approvals of new drugs, devices...
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    Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval

    Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). Benjamin Davies, MD, an associate professor of urology at the University of Pittsburgh School Of Medicine, writing in Forbes on Thursday, called on the government t...
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    European Regulatory Roundup: Proposal for a European Drug Pricing Initiative (6 October 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Committee Pressures Commission to Create Europe-Wide Drug Pricing Initiatives The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) has called for continent-wide initiatives to improve access to medicines. In a draft report, ENVI takes the biopharma industry to task for prioritizing profits, not patients, when making research d...
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    ICER on PD-1 Immunotherapies to Treat Lung Cancer: Lower the Prices

    In a new report on non-small cell lung cancer (NSCLC) treatments, the Institute for Clinical and Economic Review (ICER) found that for PD-1 immunotherapies, which are also often used to treat melanoma, the cost may be too high in terms of lengthening progression-free and overall survival. PD-1 immunotherapies target the checkpoint signaling pathway involving the programmed death 1 (PD-1) receptor, which can help protect tumor cells from being destroyed by the immune syst...
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    Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals

    With the restoration of diplomatic relations betweeen the US and Cuba in late 2014, the island is prepping for a wave of new and generic US pharmaceuticals and biologics, the head of the Havana-based regulatory agency, known as the Center for State Control of Drugs, Medical Devices (CECMED), told  Focus  in an exclusive interview. Rafael Pérez Cristiá, director general of CECMED, who oversees 300 staffers, said that as relations between the two countries continue to no...
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    EC Seeks to Update Scientific Opinions on Non-Human Primate Research, Safety of Breast Implants

    The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on Friday announced that it’s seeking more information to update its scientific opinions on the need for non-human primate research, production and testing of drugs and devices, and whether to update its opinion on the safety of PIP breast implants and the possible link between breast implants and a rare cancer. The review of using primates for biomedical research comes as...