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    Asia Regulatory Roundup: TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls   Australia’s Therapeutic Goods Administration (TGA) has advised physicians about how to manage the shortages created by recalls of ranitidine medicines. The notice follows decisions by eight companies to recall batches of ranitidine medicines in response to contamination concerns.   TGA firs...
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    FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

    The US Food and Drug Administration (FDA) on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada. The collaboration, dubbed Project Orbis , was launched with FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai's Lenvima (lenvatinib) in combination with Merck's Keytruda (pembrolizumab) for the tre...
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    FDA Alerts on Risks From Merck’s Keytruda in Multiple Myeloma Following Halted Trials

    The US Food and Drug Administration (FDA) on Thursday released an alert and summary of findings from two halted Merck clinical trials evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. The immunotherapy Keytruda is approved by FDA for the treatment of melanoma, lung cancer and other cancers but it is not approved to treat multiple myeloma. On 3 July, FDA required that all patients in these two trials b...
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    FDA Considers Label Changes for Keytruda, Opdivo and Yervoy

    The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors. Currently, the labels of Bristol-Myers Squibb’s Yervoy (ipilimumab), Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) have uveitis listed as a potential immune-mediated adverse reaction (AR), and four of the five FDA-approved anti-PD1 therapies’ labels...
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    A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker

    The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker. FDA noted in a statement : "This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated." Keytruda, an anti-PD-1 therapy that has been approved to treat a variety of cancers dating back to 2014 ...
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    Cancer Drugs First to Take Advantage of UK Early Access Scheme

    The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly. The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma. Background In March 2014, MHRA ann...
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    UK Regulator Issues First Positive Opinion in Early Access Program

    Merck’s new skin cancer treatment has become the first product approved under a new accelerated review process by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The product, Keytruda, has been shown to be effective in slowing the progression of advanced melanoma, a deadly form of skin cancer with few treatment options. Accelerated Approval Keytruda is the first product to be approved under MHRA’s early access to medicines scheme (EAMS), whic...