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 starts to differentiate therapies in the pipeline.
Radioactive revolution: How are radiopharma companies managing supply challenges?
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.
VCs keep moving with new funds despite a sluggish market
While the larger market has slowed, venture capital financing continues with two new funds. The 13th fund from Canaan Partners contains $850 million in new capital, including an oversubscribed $650 million fund intended for seed and series A funding. The remaining $200 million is for growing existing portfolio companies in Canaan’s active funds. The markets for the funding include oncology, immunology, neurology, cardiology and respiratory diseases. These new funds bring Canaan’s total assets under management to $6.8 billion. Canaan’s most recent investments include Vivace Therapeutics Inc., Synthekine Inc. and Halda Therapeutics Inc. Cure Ventures also launched this week its inaugural fund with $350 million in capital commitments. Cure focuses on early stage investments in biotechnology and life science.
In rare move, US FDA withdraws approval for Makena
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. “After thoroughly reviewing the record for this matter, we have determined that there is an insufficient demonstration of effectiveness to balance any level of risk,” FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus said in their joint decision. However, outsourcing facilities can continue to compound unapproved versions of hydroxyprogesterone caproate, reverting to what was common practice before Makena was granted accelerated approval in 2011 to reduce the risk of preterm birth. Although it was the only drug approved for the indication, its fate had been in question ever since a confirmatory trial failed to demonstrate clinical benefit.
Live-attenuated nasal vaccine shows early promise against COVID-19
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.
Noxopharm quits development of Veyonda, reduces headcount as stock plummets nearly 40%
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.
Beckley Psytech testing fast-metabolizing psychedelic in alcohol use disorder, depression
Beckley Psytech Ltd. is advancing lead BPL-003 psychedelic therapy on two fronts, opening phase IIa trials in alcohol use disorder (AUD) and in treatment-resistant depression (TRD). Both of these open-label studies, being run at King’s College Hospital London, will recruit 12 participants. At the same time, the company is in the final throes of setting up a 235-patient placebo-controlled trial of BPL-003 in TRD, under a U.S. FDA IND. The hope is that the first patient will be enrolled next month.
The BioWorld Insider Podcast – Radiopharmaceuticals: The next big disrupter?
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.
BioWorld's offices will be closed in observance of Good Friday. No issue will be published April 7.
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