Law firm Sidley Austin says the net overall effect of the pharmaceutical package on innovation and investment is “uncertain at best.”
The amendments to the proposed reform of the pharmaceutical legislation approved by a European Parliament committee this week have received a mixed reception from industry bodies and life science lawyers.
According to law firm Sidley Austin, the text approved by the environment and public health (ENVI) committee on 19 March...
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The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
Insulin efsitora alfa, Eli Lilly’s once-weekly, subcutaneous treatment for type 2 diabetes, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Cessatech and Proveca’s investigational, sufentanil/ketamine fixed-dose combination analgesic nasal spray is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.
The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.
