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Opioid Spotlight: Trump Announces Plans For More Spending As Congress Introduces Two Dozen Bills

Administration also plans to roll out slate of proposals to decrease drug prices and bring discounts to patients.

Legislation Neurology

Swayed By Industry Opposition To 'Intended Use' Rule, FDA Definitively Delays Implementation

US FDA is considering calls to drop 'totality of circumstances' test and to clarify that mere knowledge of unapproved use does not constitute evidence the use was intended.

Advertising, Marketing & Sales Legal Issues

Biosimilar Labeling Carve-Out Turned Erelzi's Psoriatic Arthritis, Plaque Psoriasis Uses Into 'Another Indication'

US FDA review documents for first-ever carve-out labeling supplement of a biosimilar reveal how references to Erelzi's deleted uses were replaced with 'another indication(s)' when data could not be separated or was needed to convey safety information.

Biosimilars Biologics

Sofosbuvir Compulsory License Nears In Chile

Generic competition is nearing for hepatitis C medicines formulated with Gilead’s sofosbuvir in Chile, following moves by the health ministry to allow compulsory licensing.

South America Chile

US Launch Of Sensipar Generics May Await Patent Case Even After FDA Approval

Aurobindo remains embroiled in litigation with Amgen on a Sensipar formulation patent, while Cipla settled ahead of  bench trial. Generic firms won approval of cinacalcet generics after two federal courts denied Amgen's emergency request for an injunction in dispute with FDA over pediatric exclusivity.

Generic Drugs Pediatrics

Use Of Compulsory Licensing ‘More Frequent Than Commonly Assumed’

A report in the WHO Bulletin says that the use of the TRIPS flexibilities has been much greater than is commonly assumed, dispelling the belief that such use has been sporadic and limited.

Emerging Markets Market Access
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