STAT+: Pharmalittle: Illumina will divest Grail after court finds deal was anti-competitive; FDA found problems at Moderna facility
Illumina plans to divest Grail, which it bought over the objection of regulators in the U.S. and Europe in August 2021.
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that familiar routine of online meetings and deadlines has predictably returned. But you knew this would happen, yes? To cope, we are firing up the coffee kettle and brewing another cup of stimulation. Our choice today is caramel brûlée. As always, you are invited to join us. Meanwhile, we have collected another assortment of tidbits for you to peruse as you attempt to navigate another challenging day. Best of luck and do keep in touch …
Illumina, the leading maker of DNA sequencing machines, plans to divest Grail, the developer of a multi-cancer screening test, which it bought over the objection of regulators in the U.S. and Europe in August 2021, STAT writes. The decision followed a ruling of the U.S. Fifth Circuit Court of Appeals, which held that the merger was anti-competitive. Illumina will either sell Grail to another company or list it on capital markets, consistent with an order from the European Commission, and aims to finalize the terms of the deal by the end of the second quarter of 2024. The decision opens what should be the final chapter in one of the most disastrous attempted mergers in biotech history.
The Food and Drug Administration found quality control lapses at Moderna’s main factory, including with equipment used to manufacture drug substance for its Covid-19 vaccine, Reuters reports. The September 2023 inspection took place at Moderna’s facility in Norwood, Mass., which is used to manufacture the company’s Covid shot and an experimental mRNA cancer vaccine being developed with Merck. The FDA report noted five separate observations, including that Moderna had released eight batches of “drug substance” — the active ingredient used to make mRNA vaccines — that was produced with equipment that had failed company cleaning verification tests.
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