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  • Regulatory NewsRegulatory News

    Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity

    Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity. The deal, which has previously stumbled over the issue of biologics data exclusivity, would either provide eight years of exclusivity to biologic drugs, or provide five years of exclusivity, plus up to three more years under a regulatory framework for the 12 countries in the trade bloc, which includes the ...
  • Regulatory NewsRegulatory News

    Biologics Exclusivity Still Central in Trade Talk Debate

    The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history. While the US Trade Representative (USTR) and the biopharmaceutical industry have publicly called for a 12-year exclusivity period, Politico reports that some industry lobbyists are tempering their expectations. Background Among the 12 parties to TPP, the United States is the on...
  • Regulatory NewsRegulatory News

    FDA Launches New 'Trusted Trader' Import Program With Long List of Incentives

    The US Customs and Border Protection (CBP) and US Food and Drug Administration (FDA) have announced the launch of a new "Trusted Trader" program meant to expedite the import of products made by companies that meet a rigorous selection process. Background FDA and CBP have long sought to make improvements to the process used to import of products, and particularly pharmaceuticals. As explained in numerous Federal Register announcements over the years, the problem ...
  • Report Claims Staffing Problems Continue to Plague FDA

    The reputation of a federal agency often precedes it. For the US Food and Drug Administration (FDA), the public's perception of its reputation is proving to be a significant impediment to its attempts to recruit the best regulatory staff it can get, says a new report from the Partnership for Public Service (PPS). The group acts as a sort of advocacy group for those working in, or hoping to work in, the government. PPS said it had recently been approached by the Pew Cha...
  • Major Pharmaceutical Companies Join Together to Address Regulatory Challenges

    • 19 September 2012
    Ten of the world's largest biopharmaceutical companies have banded together to find ways to solve what the group is calling, "common drug development challenges," including the improvement of the quality of clinical studies. The companies-Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi- announced the formation of a nonprofit entity cal...
  • New Regulatory Data Standards Partnership Formed to Accelerate Research

    A new partnership between two regulatory organizations supported by the US Food and Drug Administration (FDA) has the potential to accelerate clinical research and medical product development, the groups said in a statement. In a 21 June statement, the Clinical Data Interchange Standards Consortium (CDISC) and the Critical path Institute (C-Path), announced the formation of a partnership with FDA to develop new data standards, tools and methods to guide the development o...
  • 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...
  • Patient Group Collaborations Continue as Sanofi, Michael J Fox. Foundation Team Up

    • 20 April 2012
    Following in the footsteps of other successful partnerships between pharmaceutical manufacturers and patient groups, French life sciences company Sanofi is teaming up with the Michael J. Fox Foundation (MJFF) to collaborate on testing a new treatment for Parkinson's disease. The partnership will test a compound known as AVE 8112, a phosphodiesterase type 4 inhibitor, in a phase 1 b clinical trial to assess the drug's safety and tolerability, Sanofi said in a statement. ...
  • NIH, Eli Lilly Creating Public Drug Database

    The US National Institutes of Health (NIH) and Eli Lilly and Company are working together to create a publicly available database of thousands of approved and investigational medicines and molecules. The collaboration will see NIH's new National Center for the Advancement of Translational Sciences (NCATS) working with Eli Lilly's Research Laboratories branch. NCATS already has a library of more than 3,800 medicines, which will be screened using a Phenotypic Drug Discover...