Amgen, Inc.

Novo Nordisk's CagriSema showed superior weight loss in REDEFINE 1 trial, but fell short of expectations, causing stock decline. Competitors like Eli Lilly saw gains.

Amgen is reducing reliance on horseshoe crab-derived materials in endotoxin testing, using Sparing Technology to cut LAL use by 95%. By 2024, Amgen aims to replace LAL with recombinant factor C (rFC) technology, conducting feasibility and bridging studies by Q4 2024. Anticipating USP guidelines by Q2 2025, Amgen plans global rFC validation in 2025, followed by site implementation for new product approvals.

Holly Springs Town Council approved a life sciences-focused charter high school to be built in Holly Springs Business Park. Pine Springs Preparatory Academy, currently serving K-8, aims to bridge education and local biotech industry, preparing students for careers in southern Wake County. Construction is planned for summer 2025, pending state approval.

Verastem Oncology reports no dose-limiting toxicities in RAMP 203 Phase 1/2 study of avutometinib, sotorasib, and defactinib for KRAS G12C mutant NSCLC. Two of three patients showed initial tumor reductions of at least 20%. Enrollment continues, with an interim update planned for 2025.

The US biosimilar market surged in 2024, driven by FDA approvals and looming patent cliffs, with 63 biosimilars approved and 42 launched. Innovator companies like Novartis, Biogen, Pfizer, and Amgen are entering biosimilar development to mitigate sales erosion. Challenges include market access, reimbursement barriers, and HCP/patient perception. Education and transparency are crucial for biosimilar adoption, with AI tools potentially aiding HCPs.

2025 will see new obesity treatments, including Eli Lilly's orforglipron and retatrutide, and Amgen's maritide. Researchers will explore GLP-1 agonists for other illnesses. US regulators may approve a non-opioid painkiller, suzetrigine. Trump's potential return as US president could impact science policies, including AI and climate agreements. The WHO aims to finalize a global pandemic treaty by May 2025.

Viridian's veligrotug meets efficacy and safety endpoints in active and chronic TED patients, offering less burdensome dosing compared to Amgen’s Tepezza.

Digital transformation in pharma is crucial, with 75% of organizations implementing Pharma 4.0. Key drivers include patient demands, regulatory changes, and competition. Top technologies include AI, IoT, blockchain, and digital twins. Strategic insights focus on R&D, supply chain, marketing, and patient engagement.

The global Acute Myeloid Leukemia Therapeutics Market is projected to grow at a CAGR of 13.4% during 2024-2032, driven by advances in targeted therapies and immunotherapies.

Prevention is crucial in cancer research, with vaccines and therapies like tamoxifen showing efficacy. Recent advancements focus on vaccines, dose optimization, and RANKL pathways for breast cancer prevention in BRCA1/2 carriers. Ongoing trials explore vaccine efficacy for colon and breast cancers, while RANKL inhibition aims to reduce risk in high-risk populations.