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  • Regulatory NewsRegulatory News

    FDA Offers Accelerated Approval for 3rd Tissue-Agnostic Cancer Treatment

    The US Food and Drug Administration (FDA) on Thursday granted accelerated approval to Roche’s Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for whom there are no effective treatments. This is the third time FDA has approved a cancer treatment based on a common biomarker across different tumor types rather than the location in the body wher...
  • Regulatory NewsRegulatory News

    Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar

    Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents. According to the complaint , Amgen has opted into the information exchange procedures under the Biologics Price Competition and Innovatio...
  • Regulatory NewsRegulatory News

    Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics

    The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA. Background The long-awaited draft guidance, released in July , was in the works for more than a decade and is meant to be a practical guid...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EUnetHTA Nears Start of Third Phase of HTA Cooperation Agenda The European network for Health Technology Assessment (EUnetHTA) is on the cusp of entering the third phase of its agenda. Members of the European Commission and the Dutch National Health Care Institute began a 30-day countdown to the official start of the program by signing a grant agreement.  When the of...
  • Regulatory NewsRegulatory News

    India’s CDSCO Warns Against Using Roche’s Avastin as Eye Treatment

    India’s Central Drugs Standards Control Organization (CDSCO) issued an alert Thursday notifying state and local authorities that Roche’s blockbuster drug Avastin has not been approved to treat any ophthalmology conditions and can lead to vision loss. The notice comes just two days after officials in two Indian states put sales of the cancer drug on hold after injections of the drug damaged the vision of 15 patients in the western state of Gujarat. According to Reuters, ...
  • India Moves to Grant Three More Compulsory Licenses for Cancer Medications Based on Cost

    • 03 May 2013
    • By
    India's Union Health Ministry is pursuing three more compulsory licenses that would allow generic manufacturers in the country to compete with patent-protected medicines, including Roche's Herceptin and Bristol-Myers Squibb's Sprycel and Ixabepilone, reports PharmaBiz .  The announcement comes just months after the country's Supreme Court issued a landmark compulsory license for Bayer's Nexavar (sorafenib). What made that decision so remarkable to both critics...
  • New Breast Cancer Treatment Approved by FDA is Fourth in Last Six Years

    The US Food and Drug Administration (FDA) this morning announced the approval of Kadcyla (ado-trastuzumab emtansine), a new breast cancer therapy for patient with HER2-positive, metastatic breast cancer that did not respond to prior treatment. The 22 February 2013 announcement by FDA follows the product's six-month expedited review by FDA under its priority review program, which has been used to approve other breast cancer therapies such as trastuzumab, lapatinib and per...
  • FDA Untitled Letter Chides Genentech Promo for Inadequate Substantiation of Claims

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Genentech over marketing materials used to promote its drug Tarceva (erlotinib), used to treat metastatic non-small cell lung cancer (NSCLC). OPDP's letter references a visual aid entitled, " Improving Outcomes in First-Line Advanced Pancreatic Cancer ." The advertisement depicts an adult and child in a mostly-horizontal hourglass on a beach, loungi...
  • Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative

    Comments on the US Food and Drug Administration's (FDA) February 2012 draft guidance documents on biosimilar are mostly negative and reflecting discontent with the required studies to prove biosimilarity , reports Genetic Engineering & Biotechnology News (GEN) . In comments submitted to the Federal Register during FDA's comment period, several large biopharmaceutical manufacturers and patient organizations expressed their views on the trio of guidelines, which we...
  • New Batch of Counterfeit Cancer Drug Avastin Found in US

    The US Food and Drug Administration (FDA) warned the public 3 April of newly-found counterfeit bevacizumab (Avastin) containing no active ingredient-the second case to occur within the last two months. FDA previously warned consumers and healthcare professionals about counterfeit batches of Avastin on 14 February 2012 , when it found an unauthorized supplier selling the counterfeit drug. As many as 19 medical practices had purchased the counterfeit drug. FDA's newest s...
  • Agency Releases Rationale Behind Withdrawal of Avastin's Breast Cancer Indication

    The US Food and Drug Administration (FDA) released on 27 February the text of their final decision on their withdrawal of Avastin's (bevacizumab) breast cancer indication . FDA Commissioner Margaret Hamburg's 69-page decision is meant to be an explanation of FDA's application of the law and relevant regulations in its decision to withdraw approval for Avastin's breast cancer indication. Avastin is still marketed for several other indications. The action followed a pu...
  • Counterfeit Avastin Found in US, Warns FDA

    Counterfeit copies of Roche Holding AG's anticancer drug Avastin (bevacizumab) have been found in the US, the US Food and Drug Administration (FDA) warned on 14 February. According to investigators at Genentech, a subsidiary of Roche, the counterfeit copies did not contain the active pharmaceutical ingredient (API) that makes the drug safe and effective for its approved indications. Reporting by The Wall Street Journal indicates that supplies of the counterfeit produ...