Pharmaceutical News
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NATCO Ones Again: This Time Wins India’s CDSCO Approval for Generic Semaglutide
NATCO Pharma Limited has gained approval from the CDSCO to manufacture and market a generic Semaglutide Injection in India, set to launch in March 2026. This approval may enhance competition in the GLP-1 diabetes therapy segment, potentially impacting pricing and market shares against established branded products. Read more
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EMA Endorses UCB’s Kygevvi: Hope for Rare Thymidine Kinase Deficiency
The EMA’s CHMP has recommended marketing authorization for Kygevvi®, the first potential treatment for thymidine kinase 2 deficiency (TK2d), an ultra-rare mitochondrial disease. Supported by the PRIME scheme, the therapy demonstrated improvements in motor function and patient support needs. The final decision now rests with the European Commission. Read more
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Beyfortus Reduces RSV Hospitalizations: Sanofi’s New Study Findings Unveiled
Sanofi’s study published in The Lancet Infectious Diseases shows that infants immunized with Beyfortus experienced a significant decrease in RSV-related hospitalizations, with an 85.9% reduction in the first season and 55.3% in the second. High immunization coverage of 94.4% suggests potential for large-scale implementation, impacting public health positively. Read more
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Roche’s Gazyva Shows Promise for Primary Membranous Nephropathy
Roche’s Phase III MAJESTY study demonstrated that Gazyva/Gazyvaro (obinutuzumab) significantly outperformed tacrolimus in achieving complete remission for adults with primary membranous nephropathy at 104 weeks. The results indicate Gazyva may delay complications like kidney failure. The findings will be presented to health authorities for potential regulatory approval. Read more
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Eli Lilly Acquires Orna Therapeutics for $2.4 Billion Deal: Expanding Push Into In Vivo CAR-T Therapies
Eli Lilly and Company has agreed to acquire Orna Therapeutics for up to $2.4 billion to enhance its in vivo cell therapy and genetic medicine capabilities. The acquisition focuses on Orna’s circular RNA technology and its lead CAR-T therapy, aiming to simplify treatment manufacturing and expand patient access while accelerating innovation in various therapeutic areas. Read more
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BridgeBio’s Infigratinib Trial Shows Promise for Achondroplasia
BridgeBio Pharma reported positive results from its Phase 3 PROPEL 3 study of oral infigratinib in children with achondroplasia. The treatment showed significant improvements in growth velocity and body proportionality, marking a first in a randomized trial. Safe and well-tolerated, infigratinib is expected to pursue regulatory submissions in 2026. Read more
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Small but Mighty: Alnylam’s Bold 2030 Growth Targets Eclipse Big Pharma Giant AstraZeneca’s Forecasts
Alnylam Pharmaceuticals reported strong financial results for Q4 and the entire year of 2025, achieving revenues of $995 million and $2,987 million, reflecting significant growth. The company introduced its ambitious “Alnylam 2030” strategy, focusing on TTR-related disease leadership, profitability, and a robust pipeline, with continued revenue expansion projected for 2026. Read more
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Legal Battle: Novo Nordisk vs. Hims & Hers on Compounded Medications
Novo Nordisk has filed a lawsuit against Hims & Hers, accusing the telehealth company of illegally marketing unsafe compounded versions of its semaglutide drugs, Wegovy® and Ozempic®. The complaint cites serious safety risks due to impurities and seeks to halt the sales of these unapproved products, emphasizing patient protection and compliance with FDA standards. Read more
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CSL Showcases Stable Leadership as Pharma Industry Sees CEO Shake-Ups, Including Sanofi’s Executive Overhaul
CSL Limited, a major Australian biotech firm, faces leadership upheaval following the abrupt retirement of CEO Paul McKenzie amid disappointing financial results. Gordon Naylor, a seasoned executive, has been appointed interim CEO as CSL emphasizes its governance strength and strategic vision. This transition reflects broader trends in the pharmaceutical industry. Read more
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Moderna in Trouble Again? FDA Rejects mRNA-1010 Flu Shot Submission
Moderna’s request for a regulatory review of its mRNA-1010 seasonal influenza vaccine has been halted by the FDA’s refusal-to-file letter, due to concerns over the trial’s comparator vaccine. Despite achieving efficacy goals in Phase 3 trials, Moderna plans to engage with the FDA for clarification while pursuing international reviews. Read more
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Novartis Vanrafia® Eases Kidney Decline in IgA Nephropathy
Novartis announced final data from the Phase III ALIGN study, demonstrating that its oral therapy Vanrafia® (atrasentan) may slow kidney function decline in adults with IgA nephropathy. The study showed significant eGFR improvements compared to placebo. Novartis plans to use these results for traditional regulatory approval in 2026. Read more
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FDA Approves Optune Pax: A Breakthrough for Pancreatic Cancer
The FDA has approved Optune Pax, a groundbreaking portable device for treating locally advanced pancreatic cancer, developed by Novocure. It delivers tumor-treating fields to disrupt cancer cell division. Clinical trials showed improved survival rates with its use alongside chemotherapy. This approval represents a significant advancement in cancer treatment options. Read more