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.

KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib

Life science companies will be pleased to hear that the European Parliament is pressing for close cooperation between the UK and the EU in the area of medicines regulation.

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.

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.

Only two of seven recent applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster made the grade.

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Reimbursement issues continued to dominate the policy sphere in Japan during the last decade, while new forms of therapy benefited from positive regulatory reforms. Meanwhile, consolidation and specialization were major threads running through the corporate sector.

Political worries aside, industry is confidently executing on focused strategies as it welcomes a new decade, even if a lack of deal news at the J.P. Morgan Healthcare Conference didn't excite investors.

Additional highlights from the J.P. Morgan Healthcare Conference, including Takeda’s partnering outlook, Sage’s guidance on Zulresso sales, Frequency’s next steps for its hearing loss drug and Revance’s preparations to take on the aesthetics market. 

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.

Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.

The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.