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Impax Defeats FTC Pay-For-Delay Complaint, Helped By Status As Sole Marketer Of Generic Opana ER

 
• By Brenda Sandburg

FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.

Man Controlling Trade statue in front of the Federal Trade Commission Building

In dismissing the Federal Trade Commission's pay-for-delay complaint against Impax Laboratories Inc., the agency's Chief Administrative Law Judge provided clarity as to what patent settlement deals would clear the antitrust bar set by the US Supreme Court's ruling in FTC v. Actavis.

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OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

Sunshine Becomes Latest To Compete On Everolimus In Canada

 
• By Dave Wallace

Sunshine Biopharma is continuing to roll out generic launches in Canada, with its latest product challenging Afinitor and other everolimus rivals in the market.

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Aurobindo Plots Rivaroxaban Roll-Out As FDA Approves 2.5mg Strength ANDA

 
• By Dean Rudge

Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.

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Polpharma Looks To Supercharge Biosimilar Development With Help Of Chime

 
• By Dean Rudge

With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By Dave Wallace

In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.