The European Union has reached an agreement on new emergency rules allowing compulsory licensing of pharmaceutical patents during health crises, enabling production of critical medicines without patent-holder consent.

Science 37 significantly boosted U.S. enrollment in GSK's Phase 3 trial for primary biliary cholangitis (PBC) by leveraging a direct-to-participant model.

Science 37 facilitated nearly half of the U.S. enrollment for GSK's Phase 3 trial on primary biliary cholangitis (PBC) using a direct-to-participant approach.

Recent advancements in medical technology include the launch of the CrossWise RF transseptal access system by Circa Scientific, completion of enrollment in a pivotal trial for Inquis Medical's Aventus thrombectomy system, a distribution agreement between Medtronic and Contego Medical, a $12 million Series A round for Relief Cardiovascular, CE mark approval for Johnson & Johnson MedTech's dual-energy catheter, a temporary pause on Varipulse PFA system cases by Johnson & Johnson MedTech, and the completion of a first-in-human study by AerWave for its lung denervation therapy.

Lumanity and the Parker Institute for Cancer Immunotherapy have announced a strategic alliance to accelerate the development and delivery of next-generation cancer immunotherapies.

BNT327, a bispecific antibody targeting both PD-L1 and VEGF-A, demonstrated an 85.4% confirmed response rate when combined with chemotherapy in extensive-stage small cell lung cancer patients.

The U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling in favor of Moderna, rejecting Alnylam Pharmaceuticals' patent infringement claims over mRNA-based COVID-19 vaccine technology.

AGC Biologics will provide lentiviral vector material using its proprietary ProntoLVV™ platform to support Quell Therapeutics' development of multiple T-regulatory cell therapy candidates targeting severe immune disorders.

• Phase 3 trial data reveals that retifanlimab combined with chemotherapy significantly reduces the risk of disease progression or death in patients with recurrent or metastatic squamous cell carcinoma of the anal canal. • Patients receiving the retifanlimab combination therapy experienced a median progression-free survival of 9.3 months, compared to 7.4 months in those treated with chemotherapy alone. • The combination therapy also showed potential for higher overall survival rates, although further long-term data is needed to confirm this advantage, suggesting a new treatment option for this cancer.

The House of Representatives narrowly passed President Trump's "One Big Beautiful Bill Act" with a 215-214 vote, including modifications to drug price negotiations and restrictions on pharmacy benefit managers.

New data from ASH 2024 demonstrates that IDH1-targeted therapy significantly extends survival in high-risk MDS patients, with median overall survival increasing from 5.1 to 28.6 months.

Researchers at Dana-Farber Cancer Institute have developed CAR-enhancers (CAR-E) to extend the effectiveness of CAR T-cell therapy.

AstraZeneca has agreed to acquire Belgium-based EsoBiotec for up to $1 billion, with an initial payment of $425 million and additional milestone-based payments of up to $575 million.

Regeneron and Eli Lilly have released new trial data supporting the efficacy of their respective COVID-19 antibody cocktails. Regeneron's REGEN-COV showed 100% protection against symptomatic infection in a trial, while Lilly's combination of bamlanivimab and etesevimab reduced hospitalizations and deaths by 70% in high-risk patients.

Recent studies and reports have shed light on liver cancer's metabolic triggers, the impact of Jimmy Carter on cancer immunotherapy, and the link between breast cancer and cardiovascular disease. Additionally, advancements in cancer treatment and the closure of a phase II trial for a novel therapy were announced.

A clinical trial investigates the efficacy of robot-assisted kidney transplantation (RAKT) compared to open kidney transplantation (OKT), focusing on vascular and major surgical complications within 30 days post-surgery. The study aims to determine if RAKT can significantly reduce these complications, with a sample size of 106 participants.

A clinical trial investigated the efficacy and safety of neoadjuvant or concurrent atezolizumab with chemoradiation in patients with locally advanced cervical cancer. The study involved 36 eligible patients, showing promising 2-year disease-free survival rates and exploring the evolution of T-cell receptor repertoire in response to therapy.

Japan's Ministry of Health, Labor and Welfare has become the first regulatory body to approve Amgen and UCB's bone-forming drug Evenity (romosozumab) for osteoporosis treatment. This milestone approval comes ahead of a crucial FDA advisory committee review, following an initial rejection in 2017 due to cardiovascular safety concerns.

China has approved its first stem cell therapy, marking a significant milestone in the field of cell and gene therapies. Meanwhile, global efforts are underway to improve regulatory pathways, access, and manufacturing methods for these innovative treatments, with particular focus on rare diseases and the challenges of regulatory convergence.

GSK plc announced promising results from the B-Clear phase IIb trial of bepirovirsen, showing potential for functional cure in chronic hepatitis B patients. The trial demonstrated sustained clearance of hepatitis B surface antigen and HBV DNA, with a Phase III trial set to begin in H1 2023.