GSK plc is preparing filings for its respiratory syncytial virus (RSV) vaccine in older people following supportive late-stage trial results, a product which could play a vital role as it spins out its consumer business arm. The vaccine could be a potential blockbuster for GSK, worth as much as $7 billion in peak annual sales if approved in all its potential uses – although trials in pregnant women remain on hold because of safety concerns. Read More
After surprising Wall Street by unanimously voting in favor of the gene therapy elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy from Bluebird Bio Inc., the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee met again June 10, this time to examine the risk-benefit profile of the company’s betibeglogene autotemcel (beti-cel) for people with transfusion-dependent beta-thalassemia. Read More
Analysts have already started tagging Cogent Biosciences Inc.’s bezuclastinib as potentially best in class, after the company presented impressive, though early stage, data at the European Hematology Association Congress in Vienna demonstrating promising efficacy and a possibly differentiating safety profile for the selective KIT D816V inhibitor in advanced systemic mastocytosis. Read More
A paper published March 22 in the journal Chest highlighted research that found patients with interstitial lung disease (ILD) who had poor quality of life specifically related to cough were more likely to be hospitalized for respiratory issues, need a lung transplant and die. The findings in 1,447 patients matter because they back previous investigations and provide a way of predicting the advance of ILD, of which idiopathic pulmonary fibrosis (IPF) is a prominent type. A handful of companies are working on drugs to tackle cough in IPF, often an early symptom of the disease. Read More
The EMA has a list and it’ll be checking it frequently to avoid shortages with the help of COVID-19 marketing authorization holders and EU members states. Read More
Singapore’s Agency for Science, Technology and Research (A*STAR) has inked a deal with Boehringer Ingelheim GmbH to develop and commercialize targeted cancer therapies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Alnylam, Aptevo, Brii, Cend, Fusion, Immunome, Lyndra, Olema, Takeda, Tryp, Verona, Zhittya. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4basebio, Anpac Bio-Medical Science, Bavarian Nordic, Chromadex, Critical Path Institute, Cyanvac, Eleusis, Frederick Gardner Cottrell Foundation, Genmab, Gritstone, Halozyme, Janssen, Kinarus, Perfect Holding, Silver Spike. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Anaveon, Astellas, Eledon, Immunicum, Ipsen Novartis, Resvita, Roche, Sinomab, Sinovac. Read More
