Servier

Clariness supports SERVIER Forschung-und-Pharma-Entwicklung in digital recruitment for a Phase II trial of a new biological therapy for primary Sjögren’s syndrome via the ClinLife portal in Germany, starting Q1 2022.

Drug Hunter offers molecule case studies, patent highlights, and structure search for research ideas. Additional resources include explanations of INDs and clinical holds, Pd-couplings cheat sheets, KT-474 molecule one-pagers, solid form strategies for oral bioavailability, and methods for getting drugs into the brain.

The In Vitro Diagnostics Market Report 2024-2034 highlights growth driven by technological advancements, with a focus on precision, portability, and affordability. The reagents segment leads, fueled by R&D and precision medicine. The market is set to surpass US$100 billion in 2024, with strong growth to 2034, offering lucrative opportunities for investment and expansion.

FDA approves Voranigo (vorasidenib), an IDH1 and IDH2 inhibitor, for treating Grade 2 IDH-mutant glioma in patients 12+ years old post-surgery. Voranigo offers a once-daily pill for disease management, with Phase 3 INDIGO trial results showing significant progression-free survival extension and safety.

Agios Pharmaceuticals shifted focus to rare genetic diseases, leading to FDA approval of Pyrukynd, the first treatment for pyruvate kinase deficiency anemia. Pyrukynd, a twice-daily tablet, showed efficacy in Phase 3 trials, offering a new option for patients previously reliant on blood transfusions. Agios plans further trials in children and other anemia types, maintaining Pyrukynd's price for five years.

The CheckMate 8HW trial showed nivolumab plus ipilimumab significantly reduced disease progression or death risk by 79% in MSI-H/dMMR metastatic colorectal cancer patients, compared to chemotherapy. With a 24-month progression-free survival rate of 72% vs 14%, and fewer severe adverse events, this immunotherapy combination may offer a new first-line treatment option.

Germany's role in clinical trials is declining due to bureaucratic hurdles and data protection challenges, despite EU Regulation 536/2014's efforts to streamline processes. The new CTIS system faces criticism for inefficiency. Federal Health Minister Karl Lauterbach plans legislative changes to enhance Germany's research appeal. Standardized study contracts, like the BZKF's oncology model, aim to expedite trial processes.

FDA approved ivosidenib with azacitidine for untreated IDH1-mutated AML, based on AGILE trial showing improved EFS and OS. The combo has a known safety profile, marking a significant advancement for patients unsuitable for intensive chemotherapy.

FDA approved ivosidenib tablets (Tibsovo) with azacitidine for untreated IDH1-mutated AML in patients ≥75 or with comorbidities, based on AGILE study showing improved survival and response rates. Common AEs included nausea, vomiting, and diarrhea. This marks a significant advancement for patients ineligible for intensive chemotherapy.

FDA approved Agios Pharmaceuticals' mitapivat (Pyrukynd) for pyruvate kinase deficiency, a rare anemia, marking a shift to focus on blood diseases. Priced at $335,000 annually, it aims to treat more rare blood disorders. Agios plans expansion, despite high costs and slow market rollout expectations.