LEGAL AND REGULATORY


With support of FDA committee, Remicade biosimilar edges closer to market

With support of FDA committee, Remicade biosimilar edges closer to market

The FDA is set to announce its decision on the drug in April.

Five things for pharma marketers to know: Wednesday, February 10, 2016

Five things for pharma marketers to know: Wednesday, February 10, 2016

SEC is investigating Salix Pharmaceuticals; FDA adcomm recommends approval of Remicade biosimilar; Medicare considers payment changes

Five things for pharma marketers to know: Tuesday, February 9, 2016

Five things for pharma marketers to know: Tuesday, February 9, 2016

The FDA to review biosimilar Remicade; lawmaker looks at panelists' ties to painkiller manufacturers; Novartis signs risk-sharing contracts for Entresto

Five things for pharma marketers to know: Friday, February 5, 2016

Five things for pharma marketers to know: Friday, February 5, 2016

Johnson & Johnson collaborates with biotech on diabetes stem-cell treatment; the FDA warms up to Remicade biosimilar; Woodcock warns about biosimilar backlog

House Oversight committee upbraids Turing, Valeant execs

House Oversight committee upbraids Turing, Valeant execs

A House lawmaker called pricing strategies used by Turing and Valeant "repulsive."

Five things for pharma marketers to know: Thursday, February 4, 2016

Five things for pharma marketers to know: Thursday, February 4, 2016

Valeant to push for changes to financial-assistance rules; House to hold hearing on drug-pricing practices; FDA committee says Lundbeck can add information to leaflet

Five things for pharma marketers to know: Wednesday, February 3, 2016

Five things for pharma marketers to know: Wednesday, February 3, 2016

Seven potential blockbusters set to launch in 2016; Amarin case may lead to 'misleading' marketing; Valeant, Turing raised prices to meet preset targets

Speeding up FDA Approvals Calls for Pause

Speeding up FDA Approvals Calls for Pause

The idea that 30 days is enough time for the FDA to evaluate anything is, of course, quite silly. But Sen. Cruz takes it one step further.

Five things for pharma marketers to know: Wednesday, January 27, 2016

Five things for pharma marketers to know: Wednesday, January 27, 2016

The FDA plans to release new guidance on advertising in 2016; Trump supports Medicare price negotiations; Novartis CEO: golden days of drug pricing are over

Five things for pharma marketers to know: Tuesday, January 26, 2016

Five things for pharma marketers to know: Tuesday, January 26, 2016

The FDA accepts bid for new label for Jardiance; Markey puts on a hold on Califf's FDA nomination; GSK is studying the Zika virus