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  • Regulatory NewsRegulatory News

    Novartis Sues Janssen Over False Advertisements for Psoriasis Drug

    Novartis filed a lawsuit on Friday in DC federal court claiming that Janssen has presented data on its severe plaque psoriasis drug in a false and misleading way in at least two presentations at conferences over the past several months. Novartis, which sold $2.8 billion worth of its plaque psoriasis treatment Cosentyx (secukinumab) in 2018, directly competes with Janssen, which sold $544 million worth of Tremfya (guselkumab) in 2018. In Janssen’s presentations, Novar...
  • Regulatory NewsRegulatory News

    Industry Groups Call on FDA to Dispel Biosimilar Misinformation

    The Association for Accessible Medicines (AAM) and its Biosimilars Council, as well as the pharmacy benefit manager association, the Pharmaceutical Care Management Association (PCMA), are backing a Pfizer petition that calls on the US Food and Drug Administration (FDA) to do more to counteract untruthful or misleading information on biosimilars. The AAM comment, related to Pfizer’s petition , specifically targets the term “non-medical switching” and the concept of inte...
  • Regulatory NewsRegulatory News

    FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label

    Based on new data from two large clinical trials, the US Food and Drug Administration (FDA) on Tuesday concluded that Janssen’s type 2 diabetes medicine canagliflozin (brand names include Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. As a result of the findings, FDA’s "Boxed Warning" will be added to the canagliflozin drug labels to describe this risk. The warning comes as last May, the European Medicines Agency (EMA), t...
  • Regulatory NewsRegulatory News

    Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls

    Congress and President Barack Obama have one week to reauthorize the rare pediatric priority review voucher (PRV) program or else it will end on 30 September 2016, after seven pediatric PRVs have been awarded, one of which sold for $350 million last year. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments, affecting fewer than 200,000 patients under the age of 18. The vouchers can be used to speed FDA’s review ...
  • Regulatory NewsRegulatory News

    EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug

    A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals. “The risk in the canagliflozin groups was 6 per 1000 patient years, compared with 3 per 1000 patient years with placebo,” the regulators and Janssen UK and Ireland’s medical director ...
  • Regulatory NewsRegulatory News

    FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug

    The US Food and Drug Administration (FDA) for the first time in its history allowed a manufacturer to switch from the more antiquated batch manufacturing process to a continuous manufacturing process – a move that FDA is seeking to encourage among more pharmaceutical manufacturers. The manufacturing change, announced last Friday, is for Janssen’s HIV-1 treatment Prezista (darunavir). And although Janssen isn’t the first manufacturer to use continuous manufacturing (Verte...
  • J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • NICE Asks Janssen for More Data for Multiple Myeloma Drug

    The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), has issued draft guidance asking Janssen to provide more data on the effectiveness of bortezomib (Velcade) for treating patients with newly diagnosed multiple myeloma. NICE is evaluating the use of bortezomib in combination with dexamethasone and thalidomide, and has also requested further evidence on the clinical and cost effectiveness of the bortezomib/dexamethasone combi...
  • J&J to Pay $2.2 Billion for Off-Label Marketing of Risperdal in Third-Largest Settlement Ever

    The US Department of Justice (DOJ) has announced that Johnson & Johnson will pay at least $2.2 billion to resolve claims that it improperly marketed three drugs for indications not approved by the US Food and Drug Administration (FDA). The amount, which includes fines, forfeitures and settlement fees, amounts to one of the largest healthcare-related civil settlements in US history. Background The settlement between J&J and DOJ has long been in the works. In Jun...
  • 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...
  • Cancer Drug Returns, and with it FDA's Willingness to Go After its Manufacturer

    Earlier this week, the US Food and Drug Administration (FDA) made a quiet but important announcement: Supplies of the drug Doxirubicin Liposomal Injection, a widely used cancer drug that has been experiencing massive shortages since 2011, have been resolved. But with the resolution of that shortage has come something else that has been in short supply in recent months as well: regulatory scrutiny for the drug. Background In late 2011, regulators became aware of mounting...
  • Exclusive: FDA to Continue Regulatory Exception for Doxil Substitute

    The US Food and Drug Administration (FDA) plans to continue to allow a substitute for the anti-cancer drug Doxil, manufactured by Johnson & Johnson subsidiary Ben Venue Laboratories, into the country in the near future despite Ben Venue's 17 October announcement that it has resumed production at its Bedford, Ohio facility. Ben Venue suspended the majority of manufacturing activities at its Bedford plant in November 2011 after inspectors from FDA identified a series o...