Pharmaceutical News
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FDA Grants Priority Review for Sanofi’s Venglustat in Gaucher Rare Disease
Sanofi’s venglustat has received priority review from the FDA for treating Gaucher disease type 3, a rare disorder causing neurological complications. If approved by the target date of November 25, 2026, it could be the first therapy aimed at neurological symptoms linked to GD3, addressing significant unmet medical needs. Read more
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Regeneron Lynozyfic rapid myeloma responses strengthen bispecific antibody treatment potential in heavily-treated patients
Regeneron Pharmaceuticals reported that Lynozyfic (linvoseltamab) produced deep and rapid responses in patients with relapsed/refractory multiple myeloma, according to LINKER-MM1 trial results. The bispecific antibody targets BCMA and CD3, enhancing immune activity against cancer cells. This therapy offers hope for patients failing standard treatments and strengthens Regeneron’s oncology portfolio. Read more
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Regeneron otarmenitmgene EMA filing advances gene therapy for hearing loss treatment in children
Regeneron Pharmaceuticals announced that the European Medicines Agency has accepted the Marketing Authorisation Application for otarmenitmgene lunsotogene parvovec, a gene therapy for children with OTOF gene mutation-related hearing loss. The therapy shows promise in restoring hearing function by delivering a functional OTOF gene via an AAV vector. Read more
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EMA backs first oral GLP-1 Wegovy treatment for obesity and weight management globally
The European Medicines Agency has recommended approval for Wegovy (semaglutide) tablets, the first oral GLP-1 receptor agonist for weight management. This treatment targets adults with obesity or overweight and enhances accessibility by offering a non-injectable option, supported by the OASIS clinical trial results. Read more
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Roche launches AI-powered Liver Disease Panel targeting billions with chronic liver conditions
Roche has launched the Liver Disease Panel, a comprehensive suite of certified algorithms for managing chronic liver disease (CLD). It integrates biomarker diagnostics and digital tools like the CE-marked LiverPRO algorithm, facilitating early, non-invasive liver fibrosis assessment. This innovation enhances disease detection and patient care, potentially improving outcomes for over 1.5 billion affected worldwide. Read more
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FDA extends AstraZeneca camizestrant breast cancer review delaying anticipated approval decision
AstraZeneca announced that the FDA has extended the review period for camizestrant, a potential oral treatment for ER-positive, HER2-negative advanced breast cancer, allowing more time for evaluation. Supported by the SERENA-2 Phase II trial and ongoing studies, camizestrant aims to address endocrine resistance and improve patient outcomes. Read more
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Takeda updates Amitiza antitrust jury verdict and revises fiscal 2025 financial results
Takeda Pharmaceutical Company updated stakeholders on a U.S. jury verdict affecting its Amitiza antitrust case, leading to material adjustments in its FY2025 financial results. The company plans legal steps and financial reporting revisions while ensuring continuity of patient support. This issue will not impact its broader R&D and commercial strategies. Read more
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Merck’s Precem-TcT begins Phase 3 for metastatic colorectal cancer, 1,020 patients planned
Merck has initiated the Phase 3 PROCEADE‑CRC‑03 study of Precemtabart tocentecan (Precem‑TcT), an investigational antibody-drug conjugate for metastatic colorectal cancer, enrolling around 1,020 patients globally. Targeting the CEACAM5 antigen, it aims to provide a new treatment option for patients intolerant to standard therapies, addressing high unmet needs in mCRC. Read more
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Novartis Reveals Innovative Kidney Disease Data at ERA 2026
Novartis presented significant advancements in kidney disease research at the ERA Congress 2026, emphasizing findings on Fabhalta and Vanrafia for chronic kidney disease and IgA nephropathy. These data support the company’s expansion into complement-targeted therapies and precision nephrology, potentially improving management of progressive kidney diseases and addressing healthcare demands. Read more
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Lilly VERVE-102 base editor reduced LDL cholesterol 62% after single infusion treatment
Eli Lilly’s investigational therapy VERVE‑102 showed significant results in a Phase 1b study, reducing PCSK9 levels by up to 88% and LDL-C by up to 62% after a single intravenous infusion. The treatment, aimed at patients with familial hypercholesterolemia, demonstrated manageable safety and potential for lasting effects, prompting plans for further studies. Read more
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Merck’s Precem-TcT begins Phase 3 for metastatic colorectal cancer, 1,020 patients planned
Merck has initiated the Phase 3 PROCEADE‑CRC‑03 study of Precemtabart tocentecan (Precem‑TcT), an investigational antibody-drug conjugate for metastatic colorectal cancer, enrolling around 1,020 patients globally. Targeting the CEACAM5 antigen, it aims to provide a new treatment option for patients intolerant to standard therapies, addressing high unmet needs in mCRC. Read more
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Takeda updates Amitiza antitrust jury verdict and revises fiscal 2025 financial results
Takeda Pharmaceutical Company updated stakeholders on a U.S. jury verdict affecting its Amitiza antitrust case, leading to material adjustments in its FY2025 financial results. The company plans legal steps and financial reporting revisions while ensuring continuity of patient support. This issue will not impact its broader R&D and commercial strategies. Read more