| | | |   | Hiya! Hope you had a lovely Labor Day weekend. It's mostly Meghana today, with some help from Damian previewing upcoming milestones from Amylyx and Alnylam. Beyond that, we have a curveball from Illumina, we see Pfizer still holding its vaccines close to the chest, and more. | | | It’s a big week in biotech This week, a pair of fervently anticipated events for Amylyx Pharmaceuticals and Alnylam Pharmaceuticals are likely to swing billions of dollars in value and determine the future of two potentially meaningful medicines.
On Wednesday, the FDA will convene a panel of expert advisers to weigh in on Amylyx’s investigational treatment for ALS. It’s a do-over after a March meeting in which the same panel voted narrowly against the company’s supporting evidence. To many (including STAT’s Adam Feuerstein) the very existence of a second meeting suggests the FDA is keen to approve Amylyx’s drug and simply wants some expert support before doing so. But the agency’s neurology division has, famously, made surprising decisions in the recent past.
Then, on Thursday, Alnylam will present detailed data from a clinical trial whose top-line success sent the company’s share price up about 50% last month. The study, enrolling patients with a progressive heart disease, met its primary endpoint of beating placebo on a test of how far they could walk over the course of six minutes. That’s likely enough to win FDA approval, but the commercial future of Alnylam’s drug, called patisiran, depends on just how impressive the data turn out to be, which we won’t learn until this week’s presentation. | Illumina may divest Grail thanks to EU decision Illumina is in talks with European Union antitrust regulators to divest Grail before the $7.1 billion acquisition is likely vetoed by the EU next week, Reuters reports. Illumina last year wrapped up its Grail takeover without waiting for sanction from the EU — and now, the European Commission, arguing that the sequencing giant’s efforts to stave off a cancer screening monopoly aren’t robust enough, intends to block. The deal could be blocked as early as today, the Financial Times writes. Illumina’s argument to the EU is that Grail doesn’t really have any competitors — a somewhat dubious claim as there are other players in the cancer liquid biopsy space. Illumina says that blocking the deal could prevent lives from being saved, as the acquisition would allow early detection screening of cancer to be conducted at scale. Just last week, Illumina won a case against the U.S. Federal Trade Commission in its efforts to hang onto Grail. Divesting the company, which spun out of Illumina in 2016, could be a devastating blow in this market. | Modern collaboration, free for emerging biotechs Collaborating with distributed teams and CROs is mission critical for getting treatments to patients faster. Egnyte’s modern collaboration platform is purpose-built for today's life sciences companies – simple to deploy and easy to maintain data integrity, across any partner, anywhere. And now, early-stage biotechs will get a full year’s subscription -- free. Find out if you qualify. | Pfizer’s not sharing its vaccine with other researchers Pfizer's and Moderna’s Covid vaccines, if shared, could help other researchers develop next-generation vaccines to fight the evolving virus. They could also serve as powerful comparator vaccines — should another research outfit attempt to develop an alternative form of Covid vaccine. But right now, Pfizer is not sharing its vaccines for external trials, the company told STAT's Rachel Cohrs — even though millions of these shots have already gone to waste. Moderna did not comment when asked. Some scientists argue that Pfizer’s approach, while legal, slows global progress toward more effective vaccines. Take Yale immunologist Akiko Iwasaki, whose study of nasal vaccines against the disease would have been more effective if it were on subjects that already had a primary vaccine series, to simulate a real-world scenario. When she asked Pfizer if she could use its vaccine in her study of nasal vaccines, she received none. “In order for us to develop a better vaccine, we need a comparator,” she said. “For that reason, everyone who’s doing research in this area is in the same boat, we don’t have access to a comparison.” Read more. | From computer viruses to actual viruses Mathematicians Leland McInnes and John Healy developed a tool in 2017 that could quickly spot the differences between computer viruses — simplifying datasets and visualizing the data points in them. They had no idea it would ever have any application in biology. But their algorithm, called the Uniform Manifold Approximation and Projection, has become one of the most important and ubiquitous tools in modern biology research. It’s not just computer viruses: UMAP can be used to study actual viruses. “Almost every paper is going to have a UMAP in figure one,” one top bioinformatics researcher told STAT's Edward Chen. “I would say it’s almost become standard in the analysis.” Read more. | More reads - California biotech executive is guilty in $77 million blood-testing scheme, New York Times
- China just approved the world’s first inhaled Covid vaccine, Fortune
- Google debuts a new AI tool in the global fight against tuberculosis, STAT
- Open access to research can close gaps for people with disabilities, STAT
| Thanks for reading! Until tomorrow,  | | | |
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