Fierce Pharma

With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, Novartis is on its way to cornering the market for the indication. On Friday its first drug to hit the market for IgAN, Fabhalta, gained a full blessing from the FDA, with the U.S. regulator converting the drug's accelerated approval into a traditional nod. Fabhalta is now endorsed to slow kidney function decline in adult IgAN patients who are at risk for disease progression.

From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with troubled regulatory histories. In the U.S., Novo Nordisk has been dinged for record-keeping shortfalls, lackluster control procedures over production processes and more at the Bloomington, Indiana, facility it acquired by way of Catalent when its parent, Novo Holdings, acquired the CDMO in 2024.

Antibody-drug conjugates from Kelun-Biotech and Hansoh Pharma, respectively partnered with Merck & Co. and GSK, delivered positive phase 3 readouts in China. AstraZeneca reached out to its spinout Dizal Pharma for an EGFR lung cancer med. Biotechs are growing protective of their intellectual property and business intelligence. And more. 1.

Foundation Medicine has started the “Quality First” initiative to create awareness of how “not all cancer biomarker tests are created equal.” The Roche subsidiary pioneered comprehensive genomic profiling. But with other diagnostic companies entering the market, the cancer testing specialist faces a fight to differentiate its products from its rivals’ tests.

Move over, Sundance. CG Life and its dedicated rare disease storytelling platform 24/364 are rolling out the red carpet for a film festival of its own that will specifically highlight rare diseases next year. The inaugural 24/364 Rare Disease Film Festival (RDFF), scheduled to take place in San Diego on March 12 and 13 of next year, will champion the stories of those in the rare disease community through the power of film and storytelling.

Zhejiang Huahai Pharmaceutical has hired a former FDA staffer as its new chief quality officer, as the company struggles to resolve compliance issues with the FDA at a key manufacturing facility. Xuejian Xu, who most recently served as chief quality officer at Hengrui Pharma, joined Huahai under the same title in June, the Zhejiang Province, China-headquartered generics giant said in a July 15 securities disclosure (Chinese, PDF).

Medical affairs is emerging as a central strategic business driver for life sciences organizations, shaping how evidence, insight and scientific engagement inform decisions across the enterprise. As science accelerates and healthcare professionals gain faster access to information, the function is being asked to connect clinical evidence, field insight and commercial strategy with greater speed and clarity. The barrier is not the amount of data available.

Marketing Vanda Pharmaceuticals sports Motion Sickness Vanda Pharmaceuticals is sponsoring an IndyCar to fuel awareness of its motion sickness pill Nereus. The biotech backed the No. 47 car to represent its ending of the multi-decade wait for a prescription therapy. Nereus won FDA approval late last year, 47 years after the last new motion sickness drug was introduced in the U.S. Vanda is selling the product directly to patients via a website.

A bipartisan bill reintroduced by three senators aims to increase transparency around foreign influence on the United States’ drug supplies as a potential first step to imposing restrictions. The draft legislation (PDF), titled the “Pharmaceutical Investment Oversight and Accountability Act,” would require the U.S. federal government to map out not only the makeup of foreign manufacturing in the U.S. supply chain of pharmaceuticals, but also how foreign investment affects domestic production.

Making a creative pharma campaign that earns recognition at the prestigious Cannes Lions Festival of Creativity is a beast. Gilead Sciences conquered the task with the help of some AI-generated animals, a touch of humor and a staunch understanding of the community it has long served.