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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog: Biosimilars

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact

FDA Law Blog: Biosimilars

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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BMS Receives the US FDA’s Approval of Camzyos (mavacamten) sNDA for Label Update to Treat Symptomatic Obstructive HCM

PharmaShots

Shots: The US FDA approved an updated label for mavacamten (2.5/5/10/15mg Shots: The US FDA approved an updated label for mavacamten (2.5/5/10/15mg

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Attention Deficit Hyperactivity Disorder (ADHD)

RX Note

Antidepressants ( off-label ) Bupropion, TCA antidepressants (e.g. Alpha-adrenergic receptor agonists (e.g. Clonidine extended release and Guanfacine extended release) May be used as monotherapy or adjunct to stimulants. Improves comorbid tic disorder.

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GSK’s Benlysta claims first FDA okay for lupus kidney damage

pharmaphorum

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

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FDA to quickly review Incyte’s Jakafi in chronic GVHD

pharmaphorum

Jakafi has been approved by the FDA in acute GVHD since 2019 and has been on the US market since 2011 for myelofibrosis and also picked up an indication in polycythemia vera in 2014. GVHD is a life-threatening complication following stem cell transplant to treat multiple myeloma and certain types of leukaemia and lymphoma.

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Catabasis craters after giving up on muscular dystrophy lead

pharmaphorum

The PolarisDMD study failed across the board, leaving Catabasis with no choice but to abandon the drug, including an ongoing open-label extension study from an earlier failed trial in the muscle-wasting disease.