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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...
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    Another Biosimilar Approval From FDA, Another Unknown Launch Date

    The US Food and Drug Administration (FDA) on Friday approved Pfizer’s Zirabev (bevacizumab-bvzr), the 21 st biosimilar in the US and the second for Roche’s cancer treatment Avastin (bevacizumab). But the launch date in the US for Zirabev, a treatment for five types of cancer, remains unknown, as does the launch date for its predecessor, Amgen’s Mvasi (bevacizumab-awwb), approved in September 2017. Similarly, two Enbrel (etanercept) biosimilars have been approved, the f...
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    FDA Approves 20th Biosimilar, 5th for Roche’s Herceptin

    The US Food and Drug Administration (FDA) on Thursday approved Amgen’s Kanjinti (trastuzumab-anns), which is the fifth biosimilar to be approved for Roche’s Herceptin (trastuzumab) and 20 th biosimilar overall. Although none of the five Herceptin biosimilars have launched in the US yet, the first launches are expected soon. Roche has settled three court cases with Pfizer, Mylan and Biocon, and Celltrion and Teva. Roche also said publicly that it expects competition s...
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    FDA Approves First NDA Under Real-Time Oncology Review Pilot

    As the US grapples with whether Novartis’ new gene therapy for spinal muscular atrophy should cost $2.1 million, the US Food and Drug Administration (FDA) on Friday also quietly signaled that another Novartis drug would effectively kick off a new way for cancer drugs to be approved more quickly. The approval for the breast cancer treatment Piqray (alpelisib) in combination with fulvestrant and alongside a companion diagnostic — came more than three months ahead of its P...
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    FDA Approves 18th Biosimilar, 4th for Herceptin

    The US Food and Drug Administration (FDA) late Monday approved the 18 th biosimilar, Pfizer’s Trazimera (trastuzumab-qyyp), which is the fourth approved in the US for Roche’s Herceptin (trastuzumab). Pfizer told Focus it’s working to make Trazimera available to patients as soon as possible but could not provide a specific launch date. The biosimilar is approved for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 ...
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    European Regulatory Roundup: Roche Escapes Penalty for Breaching EU Pharmacovigilance Rules (21 December 2018)

    Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe. Roche Escapes Penalty for Breaching European Pharmacovigilance Rules Roche has escaped punishment over its failure to comply with pharmacovigilance requirements. The European Commission showed leniency after concluding Roche's response to its shortcomings made the imposition of a financial penalty unnecessary. The genesis of the case dates back to 2012, when the Commission...
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    Greek Health Minister Takes Issue With Roche's Withdrawal of Cancer Medicine Due to Mandatory Discount

    Drug prices are not just a US problem. Greece's minister of health on Tuesday expressed dismay over Roche's decision to withdraw a cancer medicine because of a new mandatory discount imposed by the country. Greek health minister Andreas Xanthou called the move by Switzerland-based Roche "unacceptable" and said citizens' access to innovative medicines should not be a business decision, according to a translation of a statement released Tuesday. The cancer treatme...
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    Asia Regulatory Roundup: Roche Cancer Drug First to Win TGA Priority Review Status (29 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Releases Draft Drug Data Management Practices for Consultation The China Food and Drug Administration (CFDA) has detailed the data management standards it expects companies to follow when researching, developing, making, distributing and monitoring the use of medicines. The rules hold senior management responsible for the reliability of data. CFDA set out its exp...
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    NICE, Roche Reach Deal on Breast Cancer Drug

    Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday. Currently, the UK pays for Kadcyla through its Cancer Drugs Fund, which requires patients to apply for funding to get access. The announcement comes just six months after NICE issued its second draft guidance rejecti...
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    Asia Regulatory Roundup: India’s NPPA Withdraws List of Pricing Rule Violators (30 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Withdraws Lists of Alleged Violators of Pricing Rules After Industry Pushback India’s National Pharmaceutical Pricing Authority (NPPA) has withdrawn lists of drugmakers it thinks have violated its rules. NPPA published three such lists in recent months to get drug manufacturers including Abbott, Novartis and Sanofi to provide it with information, causing "discomfo...
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    New Indication for Roche’s Actemra Means First FDA-Approved Drug to Treat Giant Cell Arteritis

    The US Food and Drug Administration (FDA) on Monday expanded the approved use of Roche’s Actemra (tocilizumab) to treat adults with giant cell arteritis, making it the first FDA-approved therapy for this condition. The efficacy and safety of subcutaneous (injected under the skin) Actemra for giant cell arteritis were established in a double-blind, placebo-controlled study with 251 patients with giant cell arteritis. A greater proportion of patients receiving subcuta...
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    BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices

    Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification. The comments follow the release in March of FDA’s draft list , which was released as part of a provision in the 21st Century Cures Act . The devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like ...