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  • Regulatory NewsRegulatory News

    FDA: New Postmarketing Study, Black Box Warning for Essure

    This article has been updated with more information presented by FDA in a press call Monday and the release of the draft guidance referenced in FDA's announcement. After months of deliberation, the US Food and Drug Administration (FDA) announced on Monday that it will require a new postmarketing study and a black box warning label for Bayer's permanent birth control device Essure. Essure is marketed as a non-surgical alternative to tubal ligation and consists of a pai...
  • Regulatory NewsRegulatory News

    Bayer Refutes Congressman's Claims on Essure Safety

    Editor's Note: On Wednesday, Focus reported allegations raised by Rep. Mike Fitzpatrick (R-PA) during a press call that Bayer's permanent birth control device Essure is associated with far more reports of fetal death than previously reported by the US Food and Drug Administration (FDA). After publication we received a statement from Bayer Healthcare refuting those allegations. In this article we discuss Bayer's response and clarify certain aspects of the claims made...
  • Regulatory NewsRegulatory News

    Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement

    Editor's note: After publishing this article, Focus received comments from Bayer refuting the allegations made by Rep. Fitzpatrick. See our coverage of Bayer's comments in a follow up article published Thursday. Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the U...
  • Regulatory NewsRegulatory News

    EMA Investigating Validity of Clinical Trial Led by FDA Commissioner Nominee

    The European Medicines Agency (EMA) has told Focus that it’s currently investigating whether a medical device defect may have had an impact on a major clinical trial that was designed and overseen by FDA commissioner nominee Robert Califf and ultimately led to the drug’s FDA and EMA approvals. The trial , which compared the anti-clotting drug Xarelto (rivaroxaban) for patients with irregular heartbeat with warfarin, used an INR (International Normalized Ratio) device ...
  • Regulatory NewsRegulatory News

    New Bill Directs FDA to Pull Bayer Birth Control Device

    In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure. The safety of the implantable device, which is used for permanent birth control, has been called into question recently, with FDA holding an advisory panel meeting on the device's safety in September. Rep. Rosa DeLauro (D-CT) also requested FDA pull the produc...
  • Regulatory NewsRegulatory News

    Bayer, Boehringer Latest to be Hit by Indian Patent Office Decisions

    In two recent decisions, India’s patent office struck major blows to German drug makers Bayer and Boehringer Ingleheim, saying their respective patents for Nexavar and Spiriva fail to meet the inventiveness requirements under the country’s controversial Patents Act . Background India’s patent system has been a source of frustration for western drug makers, who have argued for intellectual property (IP) reform in the country. India is also listed on the US Trade Repre...
  • Bayer's Eylea Gets NICE Recommendation for AMD Indication

    The UK's National Institute for Health and Care Excellence (NICE) issued final guidance on 24 July 2013 recommending reimbursement for Bayer's Eylea (aflibercept solution for injection) as an option for treating wet age-related macular degeneration (AMD) only if it is used in accordance with the recommendations for ranibizumab.   Clinical commissioning groups in England, the National Health Service (NHS) England and local authorities must comply with the NICE...
  • Consumer Advocacy Group Fires Back at FDA Over Transparency of Advisory Committees

    The consumer advocacy group Project on Government Oversight (POGO) is re-engaging the US Food and Drug Administration (FDA) on whether a panel of experts convened by the agency to review the safety of a class of oral contraceptives was sufficiently independent of conflicts of interest. The entire incident is the result of a January 2012 investigation by the Wall Street Journal into an FDA advisory committee charged with reviewing birth control products containing dro...
  • Landmark Ruling Clears Way for Use of Compulsory License in India

    In a decision upholding a landmark ruling, India's Intellectual Property Appellate Board (IPAB) has upheld a compulsory license granted by the controller of patents earlier in 2012, clearing the way for generics manufacturers to introduce low-cost versions of German pharmaceutical manufacturer Bayer's cancer drug Nexavar (sorafenib). At issue for Bayer was the country's use of the compulsory license-a concept first established under the Trade-Related Aspects of Intelle...
  • UK: Bayer's Blood Clot Drug Gets Draft OK From NICE

    The UK's health technology assessment (HTA) body, the National Institute for Health and Clinical Excellent (NICE), has voted to recommended Bayer's drug Xarelto (rivaroxaban). Xarelto is used to treat deep vein thrombosis, prevent recurrent deep vein thrombosis (VTE) and prevent pulmonary embolism in adults diagnosed with acute deep vein thrombosis (DVT). The decision to recommend the drug is based on additional information that rivaroxaban was more clinically and c...
  • Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto

    The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer's co-developed oral anticoagulant drug Xarelto (rivaroxaban), which the companies were looking to market as a therapy for Acute Coronary Syndrome (ACS). Xarelto is already FDA-approved for reducing the risk of blood clots in limited populations. The advisory committee had expressed some doubts regarding the drug on 22 May, saying m...
  • Reviewers Express Doubts in Advance of Xarelto Review

    An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson's (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary syndrome (ACS), mixed reviews after taking issue with the quality of data used to support the drug. CNBC reports the panel of advisors was particularly troubled by missing data , including 12% of patients in the study and several deaths which were not counted in ...