Takeda Pharmaceutical Company Ltd

Technological advancements like AI, next-gen sequencing, and CRISPR have revolutionized drug discovery and development, with regulatory shifts streamlining approval processes. Future biopharma will leverage immunological pathways to treat chronic inflammation, emphasizing patient representation in clinical trials. AI and ML may transform treatment algorithms, personalized medicine, and health outcome prediction, requiring careful management of privacy and consent.

HUTCHMED to receive US$10M milestone payment from Takeda following European approval and Spain's first national reimbursement for FRUZAQLA® (fruquintinib), a novel oral targeted therapy for metastatic colorectal cancer.

HUTCHMED to receive $10 million milestone payment from Takeda following Spain's first national reimbursement for FRUZAQLA® (fruquintinib) in Dec 2024, marking the first European reimbursement for previously treated metastatic colorectal cancer. FRUZAQLA® received EU approval in June 2024 as the first novel oral targeted therapy for metastatic CRC regardless of biomarker status in over a decade.

Takeda's late-stage pipeline includes six programs with peak revenue potential of $10B - $20B, with Phase 3 data readouts expected in 2025 for Oveporexton, Zasocitinib, and Rusfertide. Regulatory filings for these drugs are planned for FY2025-2026, with additional filings anticipated through FY2029.

Keros Therapeutics' shares dropped 77% after halting Phase 2 study of high doses of cibotercept due to pericardial effusion. Investors lost faith in the drug, previously seen as a potential improvement over Merck's Winrevair. Keros' market value decreased by over $2 billion.

Keros Therapeutics suspended dosing in the 3-mg/kg and 4.5-mg/kg arms of its Phase II TROPOS trial for cibotercept due to unanticipated pericardial effusion cases. The 1.5-mg/kg group continues treatment. Keros is working to understand these findings and informed the FDA. The company's stock dropped over 70% following the news.

The 1034th NESACS meeting, hosted by Takeda in Cambridge, MA, on December 12, 2024, features presentations on medicinal chemistry advancements. Topics include molecular glue degraders for sickle cell disease, SARS-CoV-2 inhibitors, WRN covalent inhibitors, and RIPK1 inhibitors for neurodegeneration. Registration required by December 5, 2024.

Phathom Pharmaceuticals submitted a Citizen Petition to the FDA requesting correction of Orange Book listings for VOQUEZNA tablets to ensure a 10-year New Chemical Entity exclusivity until May 3, 2032, aligning with VOQUEZNA TRIPLE PAK and DUAL PAK. The exclusivity includes a five-year standard period plus five additional years under the GAIN Act, preventing generic competition. The FDA must respond within 180 days.

Olverembatinib shows promise as a second-line therapy for non-T315I-mutant CP-CML, offering high efficacy and safety. Data from a study presented at ASH 2024 revealed significant response rates and clinical benefits, especially for patients previously treated with second-generation TKIs. Ascentage Pharma aims to expedite global development to meet unmet clinical needs.