Pharma & Biotech - Page 33

Novo Nordisk and biosimilar developer Alvotech are both contending with renewed regulatory pressure over manufacturing practices at facilities with troubled inspection histories. The U.S. Food and Drug Administration this week disclosed concerns

Novartis has secured traditional FDA approval for Fabhalta, also known as iptacopan, to slow kidney function decline in adults with primary immunoglobulin A nephropathy. The approval targets adults with IgAN who are

Germany’s sweeping health insurance overhaul is colliding with a US Section 301 trade investigation, creating mounting pressure across global pharmaceutical supply chains. A fixed 15.5% manufacturer rebate on patented branded drugs has

Foundation Medicine has announced a new initiative designed to raise awareness about the critical role of quality and accuracy in cancer biomarker testing. The Quality First initiative centres on patient advocate stories

Pharmaceutical companies are losing commercial momentum at a critical moment in the patient journey, according to a new analysis by Flora Health’s chief growth officer. Karina Castagna argues that most practical barriers

Vanda Pharmaceuticals (Nasdaq: VNDA) has announced a sponsorship deal placing its NEREUS brand on Mick Schumacher’s No. 47 car in the NTT IndyCar Series. The pharmaceutical firm will serve as primary sponsor

CVS Health’s pharmacy benefit manager Caremark has reached a settlement with the Federal Trade Commission over its use of rebates and the handling of TrumpRx purchases. Under the agreement, Caremark will count

Zhejiang Huahai Pharmaceutical has poached a senior quality executive from rival Jiangsu Hengrui Pharmaceuticals amid regulatory pressure on both Chinese drugmakers from the US Food and Drug Administration. The move signals an

Novo Nordisk has received European Commission marketing authorization for its Wegovy pill, giving the Danish drugmaker another significant head start over rival Eli Lilly. The approval covers adults with obesity or who

Advanced therapy supply chains are undergoing a fundamental transformation as regulatory expectations and patient-centric risk considerations continue to intensify across the industry. Adam Fox, Chief Quality and Regulatory Affairs Officer of Cryoport