Latest News & Analysis
Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.
First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district court to decide if this constitutes antitrust violation.
Patient access schemes have helped the Scottish Medicines Consortium recommend rare disease products, including Regeneron/Sanofi’s Libtayo for skin cancer.
Daniel Kracov and Jackie Mulryne analyze the differences in data requirements for the authorization of orphan medicines in the EU and the US and the challenges they pose for global drug development.
The European Medicines Agency has agreed to review pan-EU marketing applications for a number of new medicines.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.
US Federal Trade Commission has mainly focused in pay-for-delay cases over the past decade, but pricing strategies are an emerging area of attention; industry is paying close attention to potential enforcement in biosimilar market.
Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.
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