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STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted

STAT News

The generic drug industry’s lobbying group, the Association for Accessible Medicines, fired its president Dan Leonard, two sources familiar with the decision said Friday evening. It was not immediately clear why Leonard was fired, and AAM didn’t immediately respond to a request for comment.

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STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

STAT News

Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. For instance, a generic drug could be marketed to treat one type of heart problem, but not another.

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Novartis begins plans to spin off generic drug business

Bio Pharma Dive

After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.

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FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

FDA Law Blog

As predicted in an earlier blogpost , FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these circumstances.

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Finding and Evaluating Generic Drug Market Entry Opportunities

Drug Patent Watch

Here is a copy of the talk I gave at the recent Marcusevans 13th Portfolio Management and Pipeline Optimization for Generics. I cover: How to find and evaluate generic entry…. The post Finding and Evaluating Generic Drug Market Entry Opportunities appeared first on DrugPatentWatch - Make Better Decisions.

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Novartis forecasts improving generic drug business as it weighs unit's future

Bio Pharma Dive

The pharmaceutical company is considering selling or splitting off its struggling Sandoz division and expects to give an update by the end of the year.

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Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

Drug Patent Watch

International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions.