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Product Reviews & Approvals

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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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Drug Reviews

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Latest From Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Bronchiectasis Trials Should Be Longer, Focus On Exacerbation Frequency

Bayer's endpoint for Phase III trials of ciprofloxacin inhaler should have focused on frequency of, rather than delay in, exacerbations, US FDA advisory committee members say; Aradigm's pending NDA in non-cystic fibrosis bronchiectasis could be impacted recommendations on endpoints, trial duration and concerns about long-term development of antibiotic resistance.

Advisory Committees Drug Review

100% User Fees: A 'Bad Idea' That May Be Inevitable

The Trump Administration isn’t likely to drop the idea of having user fees pay the full cost of reviews. The pharmaceutical industry can afford higher fees, but industry officials worry about the perception if reviews are fully funded.

Drug Review FDA

Keeping Track: A Second Straight Burst Of FDA Approvals

The latest drug approval and development news from our US FDA Performance Tracker.

Performance Tracker Drug Review

KemPharm Taking Ritalin Prodrug Into Phase III For ADHD

Months after reaching agreement with FDA to refile the NDA for its abuse-deterrent opioid Apadaz, KemPharm has gotten the okay to take its prodrug of Ritalin into Phase III for ADHD.

Clinical Trials Drug Review

US FDA's Patient Affairs Office Is An Office … In Spirit

Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office.

FDA Drug Review
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