-
1 day ago | 
pharmaphorum.com | Phil Taylor
News Roche has picked up a CE Mark approval in the EU for an artificial intelligence algorithm that can help doctors decide whether patients presenting with acute chest pain are having a heart attack. The Chest Pain Triage algorithm, developed in collaboration with Universitätsklinikum Heidelberg in Germany, is part of Roche's navify library of medical algorithms designed to make clinical decision-making faster and more tailored to patients. Chest pain is the second most common reason for...
-
1 day ago | 
pharmaphorum.com | Phil Taylor
Pharming's Joenja has become the first disease-modifying drug that can be used by the NHS to treat activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), an ultra-rare immunodeficiency disorder. The recommendation to back Joenja (leniolisib) throws a lifeline to people with APDS, who suffer severe, recurrent sinopulmonary infections, autoimmune conditions, and inflammatory damage to the small intestine.
-
1 day ago | 
pharmaphorum.com | Phil Taylor
Zurich-based startup Veraxa Biotech has reached a deal to merge with special purpose acquisition company (SPAC) Voyager, gaining a listing on the Nasdaq that will give it a valuation of around $1.64 billion. The transaction will also add around $263 billion to Veraxa's cash position, which will be used to develop its portfolio of antibody, antibody-drug conjugate (ADC), and bispecific T cell engager (TCE) candidates for cancer.
-
2 days ago | 
pharmaphorum.com | Phil Taylor
Sky-high sales prospects for Bristol Myers Squibb's new schizophrenia treatment Cobenfy may have to be scaled down after a trial designed to expand the label of the recently approved drug failed. Cobenfy (xanomeline tartrate and trospium chloride) was approved last year as a monotherapy for people with schizophrenia, in itself a large potential market, but the new study was hoping to support use as an add-on to standard atypical antipsychotic medications.
-
2 days ago | 
pharmaphorum.com | Phil Taylor
Two senior officials at the FDA's drug promotion regulatory office have resigned, leading to speculation that a clampdown on some direct-to-consumer (DTC) advertising of medicines could be on the way. Catherine Gray and Mark Askine, respectively the director and deputy director of the Office of Prescription Drug Promotion (OPDP), have both stepped down effective immediately, according to a report from Politico's AgencyIQ news service.
-
3 days ago | 
pharmaphorum.com | Phil Taylor
Johnson & Johnson's confidence in its bladder cancer therapy TAR-200 – dented by a negative phase 3 readout last year – seems to be justified. New data from the SunRISe-1 study of TAR-200 in patients with high-risk, non-muscle-invasive bladder cancer (HR-NMIBC) that has not responded to standard BCG treatment build the case for the drug as it heads towards an FDA decision on a marketing application in NMIBC later this year.
-
3 days ago | 
pharmaphorum.com | Phil Taylor
News A smart ring developed by South Korean healthtech Sky Labs has outperformed the Apple Watch in a head-to-head comparison of their ability to detect atrial fibrillation (AFib). The study, published in the journal Heart Rhythm O2 and carried out at three clinical centres in the UK, looked at the sensitivity and specificity of the two devices' automatic AFib detection algorithms using single-lead electrocardiograms (SL-ECG) data, which was subsequently interpreted by physicians. Sky Labs'...
-
3 days ago | 
pharmaphorum.com | Phil Taylor
News Roche has said it will spend $50 billion on manufacturing and R&D facilities in the US, with a pledge to export more medicines from the US than it imports once the investment programme is completed. The announcement – which comes as the pharma industry is bracing for possible tariffs on the sector from the Trump administration – follows similar announcements from fellow Swiss drugmaker Novartis earlier this month as well as US-headquartered companies Eli Lilly and Johnson & Johnson....
-
3 days ago | 
pharmaphorum.com | Phil Taylor
News AstraZeneca and Daiichi Sankyo are preparing regulatory filings that could make their HER2-directed antibody-drug conjugate (ADC) Enhertu an option for previously untreated breast cancer for the first time. The results of the phase 3 DESTINY-Breast09 study will form the backbone of that effort, after showing that the combination of Enhertu (trastuzumab deruxtecan) with Roche's anti-HER2 antibody Perjeta (pertuzumab) was better at extending the time to cancer progression or death in...
-
3 days ago | 
pharmaphorum.com | Phil Taylor
Gilead Sciences has cemented the role of its TROP2 drug Trodelvy in triple-negative breast cancer (TNBC) with a win in a phase 3 combination trial with MSD's PD-1 inhibitor Keytruda. ASCENT-04/KEYNOTE-D19 is the first phase 3 trial to pair a TROP2-directed antibody-drug conjugate (ADC) with a cancer immunotherapy, and the positive result could be the key to Gilead maintaining sales momentum for Trodelvy (sacituzumab govitecan) after earlier efforts to expand its label fell flat.
