Amgen, Inc.

The CBCF ALC panel 'The Road to Health Equity' discussed mistrust in clinical trials among Black communities, citing historical abuses like Tuskegee and Henrietta Lacks. Inclusivity in trials is crucial for medical equity, yet Black Americans are underrepresented. Initiatives like EQBMED aim to increase diversity and trust in clinical research.

Power's AI platform simplifies patient access to clinical trials, reducing recruitment delays and enhancing patient understanding, as highlighted at DPHARM Idol Disrupt 2024.

Bispecific antibodies, with two binding domains, offer targeted therapeutics and address co-administration challenges, gaining traction in biopharma. Initially approved for cancer, they now target various diseases, with 12 approved in the U.S. and more in development. Their dual action reduces patient burden and enhances treatment effects, potentially transforming therapeutic paradigms beyond oncology. The market is projected to grow significantly due to rising chronic disease incidence and technological advancements.

The global erythropoietin drugs market is projected to grow at a CAGR of 3.8% from 2024 to 2034, reaching $14.3 billion by 2034. Advances in precision medicine, regulatory reforms for biosimilars, and telemedicine integration are driving market growth. Key players include Amgen, Roche, and Johnson & Johnson. Epoetin Alfa and biosimilars lead the market segments.

The FDA approved Pavblu (aflibercept-ayyh), the fifth Eylea biosimilar, for treating retinal conditions. Pavblu, developed by Amgen, showed no clinically meaningful differences in a phase 3 study compared to Eylea. Amgen and Regeneron are in a lawsuit over Pavblu's approval.

The Global Gene Therapy Market is valued at USD 2.4 billion in 2024, growing at a CAGR of 19.25% during 2024-2035. Gene therapies aim to treat genetic disorders by introducing healthy genes or inactivating faulty ones. The market has seen significant advancements, with 345 companies involved in developing therapies, and 1,100 active clinical trials in April 2024. By 2034, gene therapies are expected to treat over 65.6 million patients.

Biosimilars are FDA-approved biologic medications highly similar to reference products, offering competitive pricing and expanding patient access. Between 2015-2023, biosimilars provided nearly 700 million therapy days without unique clinical challenges. The US biosimilar approval process is expedited, focusing on similarity to reference products. Interchangeability designation allows biosimilars to be substituted without prescriber intervention. President Biden's FY 2025 budget proposes unifying biosimilar and interchangeable standards. As of July 2024, the FDA has approved 56 biosimilars, including 10 adalimumab biosimilars. Biosimilars contribute to cost savings and market competition, with projected market growth to $129 billion by 2027. Policy changes, like CMS's temporary payment increase for biosimilars, aim to enhance accessibility. Health care systems like Providence St. Joseph Health have successfully integrated biosimilars, achieving significant cost reductions.

The Renal Cell Carcinoma Clinical Trial Pipeline Market is projected to grow significantly from 2024 to 2031, driven by technological innovations, rising demand, and regulatory changes. The market is segmented by type and application, with key players including Amgen, AstraZeneca, and Pfizer. Clinical trials focus on novel therapies, drug combinations, and targeted treatments, aiming to improve outcomes for renal cell carcinoma patients.

Preoperative chemoradiotherapy did not improve survival over perioperative chemotherapy alone in resectable gastric and gastroesophageal junction adenocarcinoma, according to TOPGEAR data. Median overall survival was 46.4 months vs 49.4 months, with no significant differences in progression-free survival. However, preoperative chemoradiotherapy significantly improved pathological outcomes, including complete response rates and tumor downstaging.

R.A.S., M.S.T., C.Y., R.N., H.S.R., M.D., A.J.C., E.S.-R., J.C.B., C.O., K.K., A.D.E., C.V., N.W., K.S.A., A.S.C., C.F., C.I., A.T., J.T., K.Y., L.H., K.G., F.M.H., T.S., A.L.A., P.B., P.N., G.L.H., W.F.S., J.P., P.P., A.D.M., D.Y., L.J.v.V., N.M.H., L.J.E. report various institutional research funding, advisory roles, consultancy, honoraria, patents, and stock ownership.