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Regulation

Set Alert for Regulation

FDA Re-Evaluates Orange Book Patents

With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.

Intellectual Property Regulation

CJEU Opinion Backs Lundbeck Fine Over Citalopram ‘Pay For Delay’ Deals

A CJEU advocate general has backed a European Commission fine of almost €94m imposed on Lundbeck over “pay for delay” deals struck with four generics firms over citalopram.

Legal Issues Regulation

Mylan And Pfizer Announce Key Date For Viatris Merger

Mylan and Pfizer’s Upjohn have revealed a key date for their merger to create Viatris, after the deal set for midway through the year was pushed back recently due to the coronavirus pandemic.

Deals Strategy

FDA Asks For Input On Therapeutic Equivalence

The FDA wants to know if the second letter in its product equivalence ratings system is helpful and whether changes could make the information more user-friendly.

Regulation United States

Mylan Pulls Generic Gilenya Application Over Study Concerns

Separate concerns raised by the EMA over bioequivalence studies have led Mylan and Accord to withdraw generic applications, including the former’s generic version of Gilenya for the treatment of multiple sclerosis.

Generic Drugs Regulation

Anti-Generic Tactics Attacked In Austria

Austria’s competition authority is seeking a ruling that an originator abused its dominant position through “dumping prices” to remove the incentive to switch to an oncology generic.

Regulation Austria
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