CHMP Backs Opdivo + Yervoy for Advanced Liver Cancer
Key TakeawaysThe European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Opdivo (nivolumab) combined with Yervoy (ipilimumab)...
Breyanzi Gains CHMP Support for Follicular Lymphoma
Key TakeawaysThe European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol Myers Squibb's CAR T...
BioDuro Enhances Peptide Manufacturing with New Facility
Key Takeaways
•BioDuro has inaugurated a state-of-the-art solid-phase peptide synthesis scale-up facility in Shanghai, enhancing its capacity to meet the growing global demand for efficient...
Efruxifermin Reverses Cirrhosis in MASH Patients
Key Takeaways
•Akero Therapeutics’ efruxifermin (EFX) demonstrated significant reversal of compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH) in a Phase 2b study.•After 96...
Lyndra Partners with Thermo Fisher for Long-Acting Oral Therapies
Key Takeaways
•Lyndra Therapeutics has partnered with Thermo Fisher Scientific to advance the development and manufacturing of long-acting oral therapies.•Thermo Fisher will provide clinical research...
Efruxifermin Shows Promise in Treating Pre-Cirrhotic MASH
Key Takeaways
•Akero Therapeutics’ efruxifermin (EFX) demonstrated significant histological improvements in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in the Phase 2b HARMONY study.•After 96...
Quality Mindset Enhances CDMO Operations
Key Takeaways
•A quality-centric approach is essential for Contract Development and Manufacturing Organizations (CDMOs) to deliver innovative and timely solutions to clients.•Integrating a quality mindset...
Akero Completes Enrollment in MASH Treatment Study
Key Takeaways
•Akero Therapeutics has completed enrollment of 601 patients in the double-blind portion of its Phase 3 SYNCHRONY Real-World study, evaluating efruxifermin (EFX) in...
Atalanta Advances RNAi Therapies for Neurological Diseases
Key TakeawaysAtalanta Therapeutics is advancing RNA interference (RNAi) therapies targeting neurological diseases, with plans to initiate clinical trials for treatments addressing KCNT1-related epilepsy...
Dual Immunotherapy Enhances Outcomes in Metastatic Colorectal Cancer
Key TakeawaysThe combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly reduces disease progression risk in metastatic colorectal cancer patients with specific genetic profiles.
...
Genmab Reports 2024 DARZALEX® Net Sales Reaching Billion
Key TakeawaysGlobal net sales of DARZALEX® (daratumumab) in 2024 totaled $11.67 billion.
Genmab earns royalties on sales through its exclusive worldwide licensing agreement...
Mainz Biomed Launches U.S. Study to Advance Next-Gen Colorectal Cancer Test
Key TakeawaysMainz Biomed begins the eAArly DETECT 2 feasibility study to evaluate its advanced colorectal cancer (CRC) diagnostic test.
The study will involve...
Glox Therapeutics Secures £500K Grant to Combat AMR in Cystic Fibrosis
Key TakeawaysGlox Therapeutics receives £500,000 from the CF AMR Syndicate’s Collaborative Discovery Programme (CDP) to develop precision antibiotics.
Funding targets solutions for antimicrobial-resistant...
ICER Report Highlights Improvements and Challenges in US Drug Coverage
Key TakeawaysICER’s fourth annual report shows improved alignment of payer policies with fair access criteria.
Transparency in coverage policy information remains a key...
MedMira Advances Self-Test and Non-Professional Use for Multiplo® TP/HIV
Key TakeawaysMedMira receives Health Canada authorization to trial self-administered and non-professional Multiplo® TP/HIV tests.
The tests aim to improve accessibility for syphilis and...
