The radiopharma field has garnered increasing attention in recent years due to big-ticket deals like Bayer AG's $2.9 billion acquisition of Algeta ASA and Novartis AG's nearly $6 billion spent on buying Advanced Accelerator Applications SA and Endocyte Inc. As a result, competition is ratcheting up and pipelines are exploding with new combinations of different drugs. The global radiopharmaceuticals market was estimated to be valued at $6.7 billion in 2020, a number expected to reach $11.5 billion by 2027, according to a 2022 William Blair report.

Radioactive revolution: Keeping up with the technology a growing task for regulators

The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.

Proxygen partners with Merck in $2.6B molecular glue deal

Merck & Co. Inc. has seen promise in Proxygen GmbH’s molecular glue degrader technology, agreeing to pay the drug discovery company up to $2.55 billion if specified research, development and commercial milestones are met. Merck will also offer an up-front fee of an undisclosed amount to the biotech firm, as well as royalties on net sales of any drug therapies arising from the joint development and multiyear license agreement. Molecular glue degraders are small, drug-like compounds that induce and mediate interactions between the E3 ubiquitin ligase enzyme and a target protein, resulting in subsequent degradation of the target. They thereby have potential in eliminating disease-causing proteins and, in particular, show promise against targets which are difficult to drug or completely undruggable.

Inflarx’s COVID-19 treatment, once on the ropes, gets an EUA

Despite an early stumble, the U.S. FDA granted emergency use authorization (EUA) to the C5a inhibitor Gohibic (vilobelimab) from Inflarx NV for treating COVID-19 in hospitalized adults. The therapy must be started within 48 hours of a patient receiving invasive mechanical ventilation or extracorporeal membrane oxygenation. A year ago, an initial phase III analysis had failed to show a statistically significant effect on the primary endpoint of 28-day all-cause mortality. But Inflarx rallied, reverted to a non-site stratified analysis of the data and found positive numbers. The company’s stock (NASDAQ:IFRX) was 56% higher at midday, with shares going for about $5.90 each.

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.

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