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Drug Approvals

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Latest From Approvals

FDA's NDA And BLA Approvals: Juluca

Original new drugs and biologics recently approved by US FDA.
Approvals Regulation

EMA Relocation: EU Approval Delays Cannot Be Ruled Out

Now that the European Medicines Agency knows where it is going after Brexit, the business of preparing for the move can begin. Being able to ensure business continuity during and after the relocation will be highly dependent on the EMA’s ability to retain as many of its current staff as possible. Job losses are expected but it could be some time before it’s clear which business operations will be affected.

Europe Approvals

AstraZeneca On Bridging The Gap Between Accelerated Approval And HTA Requirements

Health technology assessment agencies are struggling to evaluate drugs on the basis of evidence generated for early approvals, says AstraZeneca.

BioPharmaceutical Approvals

FDA's NDA And BLA Approvals: Abilify Mycite, Mepsevii, Hemlibra

Original new drugs and biologics recently approved by US FDA.
Approvals Metabolic Disorders

Merck KGaA Says Outcomes-Based Pact With NHS England 'Precedent-Setting'

Merck KGaA Healthcare CEO Belén Garijo tells the Pink Sheet that outcomes-based reimbursement deals like the one it has done with NHS England “are the way of the future”.

Approvals Commercial

FDA Warns Lupin To Stop Blaming Lab And Fix Manufacturing Processes

Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.

Approvals FDA
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