Radiopharmaceuticals require sophisticated infrastructure, with just-in-time radioactives delivered to patients who must isolate while receiving the therapy. Quality control and numerous layers of regulation makes for a daunting space to enter. Although the demand for medical isotopes is growing, the facilities that can make these products are aging, and one of the major facilities globally has already come offline. Next steps for the industry will be to solve supply and regulatory challenges as clinical trial data start to differentiate therapies in the pipeline. Read More
Supply issues are a “major concern for the whole industry and for the medical community as well, because they see targeted radiotherapy as a very promising field with very interesting results in the clinic, but they are concerned that drugs may not be available for a large number of patients, and it is a legitimate concern,” Orano Med SAS CEO Julien Dodet said. Companies such as Orano, Fusion Pharmaceuticals Inc. and Telix Pharmaceuticals Ltd. are working to meet those supply challenges. Read More
While the larger market has slowed, venture capital (VC) financing continues with two new funds, one from 35-year-old Canaan Partners and one from newbie Cure Ventures. The 13th fund from Canaan contains $850 million in new capital, including an oversubscribed $650 million fund intended for seed and series A funding. Cure Ventures launched its inaugural fund with $350 million in capital commitments. Read More
The long-running Makena saga came to a close April 6 with the U.S. FDA announcing its decision to immediately withdraw approval of the drug and its generics – the only drugs indicated in the U.S. to reduce the risk of preterm birth. Read More
A live-attenuated vaccine targeting SARS-CoV-2 infection, which can be administered through the nose, has shown promise in preclinical animal studies carried out by researchers in Berlin. In an article published April 3, 2023, in Nature Microbiology, the authors reported that the COVID-19 vaccine candidate – sCPD9 – triggered the most robust immune response in a hamster model when compared with Biontech/Pfizer’s mRNA vaccine BNT162b2 and Ad2-Spike. Read More
Noxopharm Pty Ltd.’s stock plummeted nearly 40% on the morning of April 6 after the company announced it was quitting development of its lead program, Veyonda (idronoxil/formerly OX-66), shuttering its DARRT-2 and CEP-2 oncology clinical trials and disbanding its clinical trial team to contain costs. Read More
Beckley Psytech Ltd. is advancing lead BPL-003 psychedelic therapy on two fronts, opening phase IIa trials in alcohol use disorder and in treatment-resistant depression. Read More
It all goes to show how a good idea can’t be kept down. Madam Curie started radiopharmaceuticals in the late 1800s and now it’s a multibillion-dollar industry. BioWorld’s eight-part series on a new era of radiopharmaceuticals reveals their increasing importance as part of cancer treatments because they have fewer side effects and cause far less damage to tissue than previously. The big idea is taking the hallmarks of two cancer therapies – radiology and chemotherapy – and merging them. That’s what makes this evolving technology a disrupter. The series, led by BioWorld Staff Writer Tamra Sami, takes a close look at the different radiopharmaceutical moieties and the science behind them, the supply chain vulnerabilities, the regulatory landscape, the patient journey and therapies in the pipeline. Sami summarizes this special report in the latest edition of the BioWorld Insider Podcast. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Karveer, Merck & Co., Nanoviricides, Respirerx, Seelos, Simcha, Transcode. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, AB Science, Accord, Advantage, Direct, Edesa, Inflarx, Mirum, Perfuse, Soligenix, Verismo. Read More
