| | | |   | Good morning, everyone. Damian here with the latest in the KRAS race, an end in sight for Illumina's $8 billion boondoggle, and a plea from two former FDA commissioners. | | | Mirati’s cancer drug clears a safety hurdle in key study Combining Mirati Therapeutics’ KRAS-blocking cancer treatment with established immunotherapy did not lead to dangerous liver side effects, the company said yesterday, a vital step toward advancing its medicine.
As STAT’s Adam Feuerstein reports, a combination of Mirati’s adagrasib and Merck’s Keytruda led to elevated liver enzymes in fewer than 10% of lung cancer patients in a clinical trial. None of the patients had serious enzyme increases, and none stopped taking adagrasib due to side effects.
The data are particularly important after a similar study, combining immunotherapy and Amgen’s KRAS-targeting Lumakras, ran into serious liver side effects that led patients to abandon treatment and contributed to substantially lower tumor response rates.
Read more. | Illumina’s $8 billion distraction might soon disappear More than a year after Illumina bought the cancer testing firm Grail without waiting on antitrust approval, the genome sequencing giant looks likelier than ever to have no choice but to divest from its $8 billion acquisition — a move that, at least to Wall Street, can’t come soon enough.
Yesterday, European regulators detailed the terms by which Illumina must "swiftly and with sufficient certainty" get rid of Grail, following their October decision to block the companies’ merger. A final divestment order is expected in early 2023, and while Illumina is still appealing, analysts expect the company to stop throwing good money after bad and simply move on from Grail.
The question now is how much — if any — of those $8 billion Illumina can get back. The company has been burning cash to run Grail at arm’s length, and it recently reported a $3.9 billion goodwill charge reflecting the diminished value of a potential IPO for its acquisition.
Analysts are already looking past it, encouraged by an October investor day in which Illumina said its core business would grow at roughly 15% per year, driven by a soon-to-launch machine that promises to bring the cost of reading a whole human genome from about $600 to $200. | The tech-enabled model reshaping healthcare A new breed of tech players is poised to transform the US healthcare model. Providers are getting the technology and financial services they need to move towards a value-based system vs. the existing model of rewarding providers for the number of patients they treat. This move is inevitable, given unsustainable costs and less-than-optimal outcomes incurred in healthcare today, but value-based care is still in its early stages. Get RBC’s perspective on this potentially huge market. | Ex-commissioners: It’s time to let the FDA truly regulate diagnostics For years, the FDA has taken a bifurcated approach to diagnostic tests, strictly regulating the ones made by commercial manufacturers while loosely overseeing the ones made by individual labs. The result is a confusing, inefficient system, according to two former FDA commissioners, and that needs to change.
As Scott Gottlieb and Mark McClellan write in STAT, Congress has the means at its fingertips to modernize how the FDA regulates diagnostics.
The so-called VALID Act is under consideration as a rider to the spending bill that would fund the federal government for next year. And passing it would “would create a consistent standard for all tests, regardless of the kind of facility they were developed in or made in, as well as a modern regulatory framework that’s uniquely designed for the recent and emerging technologies being used to develop tests,” Gottlieb and McClellan write, allowing the FDA to abandon an outdated framework.
Read more. | Can Amgen elbow into the market for weight-loss drugs? Amgen might be years behind its rivals in the blockbuster race to commercialize a new generation of obesity treatments, but early data suggest the company’s late-coming treatment could have a pathway to competition.
In data from a small study presented over the weekend, Amgen’s monthly injection, called AMG133, led to reductions in body weight roughly on par with weekly treatments from Eli Lilly and Novo Nordisk. That might not be enough to crack what will be an established market by the time Amgen’s drug could win approval, but there’s a potential upside. In the Phase 1 trial, AMG133 seemed to have a prolonged effect on weight loss, and Amgen intends to test extended dosing intervals in its Phase 2 study, which could include every-eight-weeks and quarterly administration. That, Evercore ISI analyst Umer Raffat said yesterday, could be enough to differentiate Amgen’s drug.
The debate over AMG133’s future illustrates just how lucrative Wall Street expects the next generation of weight-loss treatments to become. There are more than 100 million people in the U.S. who meet the criteria for obesity, making drugs like AMG133 “the ‘electric vehicles’ of biopharma for this decade,” as SVB Securities analyst David Risinger wrote in a note to clients last month, “because the market opportunity is so significant and current penetration is extremely low.” | More reads - New concerns about a paper co-authored by Stanford president prompt journal to take a ‘closer look,' STAT
- J&J says it won’t make an offer for Horizon Therapeutics, Bloomberg
- FDA takes tougher line on fast-tracked drugs, Wall Street Journal
- Verve reveals letter from FDA that lays out conditions to lift base editing trial hold, Endpoints
| Thanks for reading! Until tomorrow,  | | | |
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