NOVARTIS

The Heart Failure POC & LOC Devices Market was valued at USD 95.94 million in 2023 and is expected to reach USD 401.91 million by 2032, growing at a CAGR of 17.26% over the forecast period 2024-2032. Key growth drivers include rising demand for early detection, AI integration, and decentralized care. Proteomic testing and microfluidics technology dominate the market segments.

Novartis' Fabhalta (iptacopan) demonstrated improved Hb levels in PNH patients switched from anti-C5 therapies in the APPULSE-PNH phase IIIB study. Fabhalta's safety profile was consistent with previous data, reinforcing its potential as an oral monotherapy for PNH treatment.

Clinical trials of ALN-HTT02, an siRNA-based drug targeting Huntington's disease, have begun at UCLH, offering hope for disease modification. The trial involves 54 participants and aims to analyze the drug's safety and efficacy, with potential to transform current treatment paradigms. Collaboration between pharmaceutical companies and research institutions is crucial for advancing such therapies.

Novartis announced positive results from the phase 3B APPULSE-PNH study, showing iptacopan's efficacy as a twice-daily oral monotherapy for PNH patients transitioning from anti-C5 therapies, with significant Hb level improvements over 24 weeks. The study enrolled 52 participants stabilized on anti-C5 therapies for at least 6 months, with baseline Hb levels of at least 10 g/dL. Iptacopan demonstrated an average increase in Hb levels, addressing anemia in PNH management. The safety profile remained consistent with previous trials, and detailed data will be presented at a 2025 medical meeting. Additionally, the Max Foundation expanded its collaboration with Novartis to provide iptacopan access for PNH treatment in low-resource countries.

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APPULSE-PNH Phase IIIB study shows oral Fabhalta® (iptacopan) improves hemoglobin levels in adults with PNH switched from anti-C5 therapies, with consistent safety profile. Fabhalta is approved in the US, EU, Japan, and China for PNH treatment.

U.S. generic drug market faces challenges due to high costs, low margins, and reliance on China for active pharmaceutical ingredients (APIs). Trump's proposed 60% tariffs on Chinese goods could raise generic drug costs. Despite efforts to boost domestic API production, U.S. capacity remains underutilized. Government investments and advanced manufacturing technologies like continuous manufacturing are seen as key to reshoring drug production.

The GCC pharmaceutical market, led by Saudi Arabia, is rapidly expanding due to factors like population growth and lifestyle diseases. The market is expected to exceed US$ 12 Billion by 2030, with branded and imported drugs dominating. Clinical trials in the region involve over 250 drugs, and healthcare transformation programs are driving growth. Local manufacturing is increasing, especially in generics and biosimilars, while digital health innovations are enhancing market efficiency.

Roche's Evrysdi leads SMA market with 16,000+ patients, growing 21% to $1.45B. Biogen's Spinraza faces 13% revenue decline to $1.15B, but sees growth potential. Novartis' Zolgensma grows 3% to $952M. Biogen explores higher-dose Spinraza, Roche considers combining Evrysdi with an anti-latent myostatin antibody.