PRIME Dry Spell Continues At EMA
Developers of medicines that benefit from the European Medicines Agency’s priority medicines scheme can expect to be eligible for accelerated assessment when they eventually file for approval. But there have been no new entries to the scheme for two months now.
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EMA Ends Year With Set of Straight Noes For PRIME Applicants
The European Medicines Agency rejected all seven eligibility requests for its priority medicines scheme that it reviewed in December.
Deals Shaping The Medical Industry, December 2017
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance or Financing. This month’s column covers deals announced in November 2017.
EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.