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  • Regulatory NewsRegulatory News

    Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals

    Earlier this week, an FDA advisory committee recommended that the agency withdraw Amag Pharmaceutical’s preterm birth drug Makena, a treatment that brought in more than $1 billion in sales before failing a confirmatory trial. The agency is now faced with the task of whether to take the committee’s vote and pull Makena from the market or allow it to remain until another confirmatory trial can be completed. Keeping Makena on the market would also present a rare situation,...
  • Regulatory NewsRegulatory News

    CDER Warns Chinese, Indian Manufacturers

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released two warning letters sent recently to India-based active pharmaceutical ingredient (API) manufacturer CTX Lifesciences Private Ltd and China-based drug manufacturer Ningbo Pulisi Daily Chemical Products Co. Following a six-day inspection at CTX Lifesciences, FDA found that the firm did not ensure that the water used for parenteral grade APIs was suitable for its...
  • Regulatory NewsRegulatory News

    Here Come the Oncology Biosimilars in the US: How Low Will Prices Go?

    A quick look at biopharma’s top-selling drugs (including forecasted sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion. But biosimilar competition for Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) is now ready to launch in the US, and Bernstein biopharma analyst Ronny Gal said in a report issued Friday that prices over...
  • Regulatory NewsRegulatory News

    FDA Approves First Biosimilar Cancer Treatment

    The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen’s biosimilar was approved under the brand name Mvasi (bevacizumab-awwb). FDA’s approval of Mvasi follows an advisory committee’s unanimous backing of the treatment and is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and...
  • Regulatory NewsRegulatory News

    FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars

    The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab). In the morning session, ODAC members voted 17-0 in favor of approving Amgen's Avastin biosimilar candidate, ABP 215, for six of Avastin's indications. However, the committee did not consider whether Amgen's data would support a...
  • 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

    Asia Regulatory Roundup: India Reverses Opposition to Off-Label Ophthalmic Use of Avastin (15 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Reverses Opposition to Off-Label Ophthalmic Use of Avastin India has quickly reversed its opposition to the off-label ophthalmic use of Roche’s Avastin (bevacizumab).  Drug Controller General of India Dr. GN Singh warned against using Avastin in ophthalmology conditions in January after reports linking it to loss of vision emerged, only to withdraw the alert th...
  • 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, ...
  • Regulatory NewsRegulatory News

    French Regulator and Roche Trade Blows Over Off-Label Avastin Use

    On Monday, Swiss drugmaker Roche announced its opposition to the use of its cancer drug Avastin to treat wet age-related macular degeneration (AMD) in France. The move is aimed squarely at France's drug regulator, who temporarily recommended the drug for AMD as a cost saving maneuver in April 2015. Background Health authorities around the world have been eyeing Avastin (bevacizumab) as a cheaper alternative to Novartis' Lucentis (ranibizumab injection). After being app...
  • MHRA Launching New Anti-Counterfeiting Strategy

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is unveiling a new Falsified Medical Products Strategy it says will improve its existing anti-counterfeiting strategy by enhancing communication, collaboration and regulatory activities between MHRA and stakeholders. The agency's updated strategy will seek to enhance its original strategy by focusing on preventing counterfeit products, changing how counterfeit products are handled once they are found...
  • Report: 'Track and Trace' Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup

    • 25 April 2012
    • By
    A long-awaited and much-called-for plan to introduce a 'track and trace' plan to cut down on pharmaceutical counterfeiting may be cast by the wayside in the legislative markup process for new legislation, reports Reuters ' AlertNet . Track and trace programs, used by regulatory authorities to keep track of authentic drugs and trace their transmission through the supply chain, have been receiving increased attention in recent years. The US Food and Drug Administrati...
  • After Counterfeit Avastin Infiltrates Supply Chain, FDA Goes After Doctors

    The US Food and Drug Administration (FDA) is going after doctors in an attempt to protect the pharmaceutical supply chain from more instances of counterfeit medicines, reports Medscape News . There have been two instances of fake Avastin being found in the US in 2012-one in early April and another in mid-February . Both cases involved doctors deviating from approved suppliers to purchase Avastin from unauthorized wholesalers. While FDA Commissioner Margaret Hamburg ...