Amgen, Inc.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.

The global regenerative medicine market was valued at USD 29.42 billion in 2023 and is projected to reach USD 154.05 billion by 2033, driven by rising prevalence of disorders, aging population, and demand for precision medicines. North America leads with a 48.57% share, while Asia-Pacific is expected to grow at a 23.60% CAGR. Key segments include cell therapy, gene therapy, tissue engineering, and small molecules & biologics, with applications in cardiovascular, oncology, dermatology, and musculoskeletal areas. Challenges include high costs and operational inefficiencies, but opportunities exist in novel technologies and advancements in medical devices.

Luxa Biotechnology appoints Keith Dionne, Ph.D. as CEO to advance RPESC therapy for dry AMD/GA, aiming to restore vision for patients lacking treatment options.

The Family Heart Foundation launched Cholesterol Connect, a free at-home lipid screening and personalized support program to reduce CVD risk, sponsored by Amgen. The program addresses the lack of awareness about high LDL-C and increased Lp(a) levels, aiming to empower individuals with knowledge and resources for heart health.

The KRAS Inhibitors market is poised for significant growth driven by increasing cancer incidence, treatment access, and a robust pipeline. The market size in the 7MM was $500 million in 2023, expected to rise by 2034. KRAZATI (adagrasib) is projected to outperform LUMAKRAS (sotorasib) in revenue. The US leads in KRAS mutation cases in NSCLC, with 46% of 7MM cases. Competition in G12C NSCLC is intensifying, with Chinese biotechs entering the KRAS space. Despite G12D being the most prevalent KRAS variant, G12C is the primary target in colorectal cancer. KRAZATI is the first KRAS inhibitor approved for KRAS G12C-mutant colorectal cancer. Pancreatic cancer, with 60-90% KRAS mutations, presents a significant market opportunity. Pan-KRAS drugs, targeting multiple mutations, offer broad market potential. Key companies include Novartis, Roche, Genentech, and Mirati Therapeutics. Emerging therapies like JDQ443, Divarasib, and Avutometinib are expected to reshape the market. The KRAS inhibitor market is evolving, driven by high unmet needs, competitive drug development, and regulatory approvals.

August 2024 biopharma deals highlight trends in bispecific T-cell engagers, CD-19 targeting in autoimmune diseases, and Chinese biopharma innovation. Merck's $1.3B acquisition of Curon's CD3xCD19 BiTE CN201 reflects confidence in early trial outcomes and market enthusiasm for BiTEs. JPMorgan reports a 50% reduction in upfront payments since 2020, indicating a more back-loaded deal structure.

September saw FDA approvals for two Niemann-Pick Disease Type C drugs, an OTC hearing aid software, and upcoming October decisions include Biofrontera's Ameluz dosage increase, Zealand Pharma's Dasiglucagon for hypoglycemia, Bristol Myers Squibb's Opdivo for lung cancer, Amgen's LUMAKRAS for colorectal cancer, Camurus' Oclaiz for acromegaly, Iterum Therapeutics' Oral Sulopenem for UTIs, PharmaTher's Ketamine for anesthesia, and Lexicon Pharma's Zynquista for diabetes.

Global Injectable Cytotoxic Drugs Market valued at USD 18.3 Billion in 2023, driven by rising cancer prevalence, advanced drug delivery systems, and targeted therapies. North America leads in market value, with alkylating drugs as the largest segment.