The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. NICE Takes Sides in Fight for PCSK9 Market, Recommending Amgen While Rejecting Sanofi The National Institute of Health and Care Excellence (NICE) has recommended using Amgen’s PCSK9 inhibitor Repatha in certain indications, while rejecting the use of Sanofi and Regeneron’s rival drug Praluent. While both manufacturers offered discounts of undisclosed magnitudes, only A...
  • 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 ...
  • NICE Gives Thumbs-Up to Bayer's Xarelto

    The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending rivaroxaban (Xarelto, Bayer Healthcare) as an option for treating pulmonary embolism (PE) and preventing recurrent deep vein thrombosis (DVT) and PE after acute PE in adults. Rivaroxaban is an orally administered anticoagulant. It has a UK marketing authorization for the treatment of DVT and PE, and prevention of recurrent DVT and PE in...
  • J&J's Janssen Gets Second Untitled Letter in as Many Months as FDA Targets Xarelto Advertising Piece

    On Wednesday, the US Food and Drug Administration (FDA) released the text of a new Untitled Letter sent to Johnson & Johnson - the second sent in as many months to the same company - regarding promotional material for its blockbuster anticoagulant Xarelto (rivaroxaban), alleging that the company failed to present the risks of the drug in a fair and balanced manner. Background: Doxil Untitled Letters are less serious than the more widely-known Warning Letters, whic...
  • UK: New Anti-clotting Drug Cleared for NHS Use

    According to final guidance issued 25 July by the National Institute of Health and Clinical Excellence (NICE) -- the UK's health technology assessment entity -- Bayer's Xarelto (rivaroxaban) has been cleared for use by the National Health Service (NHS) for treatment of deep vein thrombosis (DVT).   NICE officials said a key factor in the positive assessment was that the new oral anticoagulant is easier to use than warfarin because it does not require the...
  • 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 ...
  • FDA Drug Approvals Up 42% in 2011, Regulatory Quality Highlighted

    The US Food and Drug Administration (FDA) approved 30 new molecular entities (NMEs) during 2011, marking a 7-year high for the agency, according to an analysis by Bloomberg . Notable success stories include Johnson & Johnson and GlaxoSmithkline, both of which tripled their approvals from the year prior.  The entire industry, however, may stand to benefit from the 42% increase in approvals as patent expiries begin in earnest this year. Twenty-one patented me...