The Pharma Letter

1 in 4 ABC patients treated with Novartis' Kisqali remain progression-free beyond 4 years

Swiss pharma giant Novartis’ has announced results showing that one in four patients with hormone receptor-positive, human ...
The Pharma Letter

FDA clears first gene therapy for Wiskott-Aldrich syndrome

The US regulator has approved Waskyra (etuvetidigene autotemcel), the first gene-correcting therapy for Wiskott-Aldrich ...
The Pharma Letter

Spica Therapeutics

Headquartered in Antwerp, Belgium, with an additional site in Denmark (Aarhus). The company is developing macrophage-targeted ...
The Pharma Letter

BRIEF—FDA final guidance on promotional labeling and advertising for biosimilars

The US Food and Drug Administration (FDA) yesterday issued the final guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Products, and ...
The Pharma Letter

US FDA clears first product under new fast-track voucher scheme

The US Food and Drug Administration has approved a US-manufactured version of Augmentin XR (amoxicillin-clavulanate potassium) through its new Commissioner’s National Priority Voucher pilot, ...
The Pharma Letter

Generic makers in India rethink semaglutide prices, eye $36 to $60 range

Generic drugmakers in India are revising pricing plans after Denmark’s Novo Nordisk (NOV: N) slashed costs for its weight-loss injection Wegovy (semaglutide). Companies that had aimed to launch ...