News & Analysis as of

Pharmaceutical Distribution

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...more

EMA's reply to the EU Ombudsman inquiry on pre-submission interactions with medicinal product developers

by Hogan Lovells on

The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities....more

Turing, Daraprim, and Refusals to Deal with Generic Manufacturers

Drug company Turing Pharmaceuticals made headlines recently when it reportedly raised the price of Daraprim, used commonly by AIDS patients to fight life-threatening infections, from $13.50 to $750 per tablet. Amidst...more

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

Permanent Injunction Against Medtronic

The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s...more

Changes to the regulation of pharmaceutical business in Kazakhstan: implications for pharmaceutical companies

by Dentons on

A significant number of amendments have been introduced to the Healthcare Code* of the Republic of Kazakhstan on 6 April 2015 by the adoption of the Law On Introduction of Amendments and Additions to Certain Legal Acts of the...more

China Amended Good Supply Practices for Pharmaceuticals

by Ropes & Gray LLP on

The Chinese Ministry of Health (“MOH”) published the long-awaited amendment of Good Supply Practices for Pharmaceuticals (the “Amended GSP”) on January 22, 2013, to be effective as of June 1, 2013. After three rounds of...more

Drug Wholesaling In Florida—The Top Five Myths

by Holland & Knight LLP on

Florida boasts the most stringent pharmaceutical distribution regulations in the United States. When they do business in Florida, some of the most sophisticated drug companies in the world discover the hard way that their...more

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