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  • Regulatory NewsRegulatory News

    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bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).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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    Two Draft FDA Guidelines on NGS Set Foundation for Precision Medicine Initiative

    New next generation sequencing (NGS) technologies that can examine millions of DNA variants at a time and help inform treatment decisions are at the heart of two new draft guidance documents released Wednesday evening by the US Food and Drug Administration (FDA) as part of President Barack Obama’s Precision Medicine Initiative. FDA says the guidance offers a streamlined approach to the oversight of diagnostics that detect medically important differences in a person’s gen...
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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...
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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...