Amgen, Inc.

Peptide Therapeutics Market to grow from USD 43.11 billion in 2023 to USD 68.4 billion by 2031, driven by increasing prevalence of cancer and metabolic disorders, and advancements in drug delivery systems.

Avutometinib and defactinib combo shows 31% overall response rate in recurrent low-grade serous ovarian cancer patients, with 44% in KRAS mutant and 17% in KRAS wild-type. Median progression-free survival is 12.9 months, 22 months in KRAS mutant. Verastem Oncology plans NDA submission in October 2024.

Tulisokibart maintained clinical and endoscopic improvements in IBD patients through week 50 in phase II trial extensions, with 48% of ulcerative colitis patients and 56% of Crohn's disease patients achieving clinical remission. The drug was well-tolerated with no identified safety signals.

Bio-pharma advances in endocrinology, dermatology, cardiovascular, oncology, rare diseases, pulmonology, gastroenterology, and neurology highlight promising therapies like Eli Lilly’s orforglipron, Amgen’s MariTide, Novo Nordisk’s oral semaglutide, Johnson & Johnson’s JNJ-2113, Sanofi’s amlitelimab, Ionis’s olezarsen, BridgeBio’s acoramidis, NewAmsterdam Pharma’s obicetrapib, Jazz Pharmaceuticals’ zanidatamab, Syndax’s revumenib, Merus’ zenocutuzumab, Johnson & Johnson’s nipocalimab, Novo Nordisk’s Mim8, Solid Biosciences’ SGT-003, Merck’s sotatercept, Johnson & Johnson’s Tremfya, and Crossject’s Zepizure, with analyses including clinical data, revenue forecasts, and expected launch dates.

AstraZeneca's Farxiga, initially approved for type 2 diabetes, has exceeded $6 billion in sales and is projected to reach $7.4 billion next year. Success factors include addressing unmet needs, clear value propositions, and strategic market access. Farxiga expanded its indications to chronic kidney disease and heart failure, driving sales. Keytruda exemplifies a blockbuster drug with multiple indications. Market access strategies and pricing considerations are crucial for drug commercialization. The definition of a blockbuster is evolving, focusing on high-value drugs that justify R&D investments.

The WSG-TP-II trial (NCT03272477) explored de-escalation of neoadjuvant endocrine therapy plus trastuzumab and pertuzumab in HR-positive, HER2-positive early breast cancer. Conducted in Germany, it compared 12 weeks of endocrine therapy or paclitaxel with trastuzumab and pertuzumab, followed by 1 year of adjuvant therapy. The trial found this regimen safe for chemotherapy de-escalation.

Regeneron loses bid to block Amgen's Eylea biosimilar, plans appeal; Prime Therapeutics adds low-cost Humira biosimilars; FDA and EMA accept Alvotech's denosumab biosimilar for review.

Amgen announces positive Phase 3 MINT trial results for UPLIZNA in treating gMG, showing statistically significant efficacy in AChR+ and MuSK+ patients, with a reduction in corticosteroid use and no new safety signals.

Pfizer, Merck, and Eli Lilly & Co. contribute to one-third of pharma campaign donations. Kamala Harris received $1.12 million in donations, while Trump received $204,748. Both candidates aim to lower prescription drug prices, though the issue was only briefly discussed in a debate. Trump's efforts to lower prices faced industry and legislative resistance, while Harris' administration passed the Inflation Reduction Act, capping drug spending and negotiating lower prices for Medicare recipients. Harris' platform includes expanding drug cost caps to all insured Americans and protecting the Affordable Care Act, contrasting with Trump's opposition to the ACA and his vague healthcare plans. The pharmaceutical industry, aware of the risks, is hedging its bets by donating more to Democrats.

The global peptide therapeutics market is projected to grow from $42.1B in 2023 to $56.2B by 2030, driven by technological advancements, increasing demand for targeted treatments, and the rising incidence of chronic diseases. Peptide therapeutics offer high specificity and low toxicity, making them attractive for treating conditions like cancer and diabetes. Innovations in peptide engineering and delivery systems are enhancing their efficacy and stability, expanding their therapeutic potential across various diseases.