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

 
  • Regulatory NewsRegulatory News

    US Intervenes in False Claims Suit Against Alere, Arriva Medical

    The US Department of Justice (DOJ) announced Tuesday that federal prosecutors intervened in a lawsuit under the False Claims Act whistleblower provisions against a former supplier of blood glucose monitoring supplies. The case alleges that Arriva Medical and its parent company Alere “submitted or caused false claims to the Medicare program for medically unnecessary glucometers and paid kickbacks to Medicare beneficiaries in the form of free glucometers and copayment w...
  • Regulatory NewsRegulatory News

    Vanda Pharmaceuticals Sues FDA Over Partial Clinical Hold

    In a complaint filed against the US Food and Drug Administration (FDA), Vanda Pharmaceuticals called on a federal district court to lift a partial clinical hold on its experimental drug tradipitant. The complaint—filed with US District Court for the District of Columbia on Tuesday—alleged that FDA acted in violation of the Administrative Procedure Act of 1946 (APA) in imposing the partial clinical hold last December. The hold was imposed on a protocol for a new clinic...
  • Regulatory NewsRegulatory News

    Stage Set for Merck’s SCOTUS Case Over Warnings in Labels

    With the acting solicitor general set to participate in oral arguments before the Supreme Court on 7 January, the high court will be deciding a contentious case centered on who has the final say in warning labels on pharmaceuticals. The case, known as Merck v. Albrecht , presents the question of whether Merck should be held liable for failing to warn about the side effects of an osteoporosis drug, despite attempting to change the warning label and having FDA reject its...
  • Regulatory NewsRegulatory News

    AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process

    Does a medical device cleared under the US Food and Drug Administration's 510(k) application mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer. In an amicus curiae brief filed with the nation's top court last week, AdvaMed takes issue with a decision from the US Court of Appeals for the Fourth Circuit, which upheld a $3.27 million j...
  • Regulatory NewsRegulatory News

    US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval

    The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars. The case, pitting biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz, attempted to clarify what’s known as the biosimilars "patent dance," which is the process by which companies must exchange and figure out the pa...
  • Regulatory NewsRegulatory News

    Supreme Court Weighs Biosimilar Patent Dance

    All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent dance," and whether a notice of licensure 180 days prior to marketing is necessary. Neither side seemed to come away with a decisive win. Sandoz began the arguments on why the additional six months would further delay biosimilars from launching, also explaining why the ...
  • Regulatory NewsRegulatory News

    EU Court of Justice Denies EMA Appeal to Release Documents on Two Medicines

    The Court of Justice of the EU earlier this month delivered a blow to transparency efforts at the European Medicines Agency (EMA), dismissing two appeals by the regulator. The decision means the court has upheld the suspension of the release of clinical study report documents requested by a pharmaceutical company related to PTC Therapeutics’ Duchenne muscular dystrophy treatment Translarna (ataluren) and three toxicity studies for Intervet’s Bravecto (fluralaner), a vete...
  • Regulatory NewsRegulatory News

    EU Court of Justice Clarifies Product Liability for Notified Bodies

    The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives. But the court's decision was more about clarifying the role of notified bodies in a product liability case concerning faulty breast implants made by the now-defunct French manufacturer Poly Implant Prothese (PIP) and German notified body TÜV Rheinland than about deciding if the notified body was liable....
  • Regulatory NewsRegulatory News

    US Solicitor General Calls on Supreme Court to Review Six-Month Delays to Biosimilar Launches

    With the timing of all future US launches of biosimilars at stake, the US Solicitor General has called on the Supreme Court to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. “The proper interpretation of those provisions has a significant impact on the operation of the BPCIA [ Biologics Price Competition and Innovation Act of 2009 ] and the ability of aBLA...
  • Regulatory NewsRegulatory News

    EMA Contests Two Judicial Decisions Over Clinical Trial Transparency Efforts

    The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation. The first order blocked the release of a study report for PTC Therapeutics’ Translarna (ataluren), a Duchenne’s muscular dystrophy treatment, until a final ruling is provided. EMA says it was planning to provid...
  • Regulatory NewsRegulatory News

    India's Supreme Court Denies Petitions Challenging CDSCO

    • 11 March 2016
    Dinesh Thakur, the now-famous Ranbaxy whistleblower who won more than $48 million for calling out the company’s drug safety issues to the US Department of Justice, failed on Friday to get the Supreme Court of India to hear two petitions seeking to challenge the law under which India’s drug regulator Central Drugs Standard Control Organization (CDSCO) operates. Thakur told Focus that the petitions “challenge how CDSCO works and the commitments it makes” to keeping subst...
  • Regulatory NewsRegulatory News

    Sandoz Petitions Supreme Court to Rule on Biosimilars

    Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...