Francis deSouza, Illumina CEO (Kevin Dietsch/Getty Images)
Ahead of expected objections by European regulators Wednesday to its deal to acquire Grail, Illumina defended itself in papers submitted to the agencies Tuesday.
Illumina is anticipating a formal bloc objection to the $8 billion Grail buyout, it said in a briefing document for EU competition authorities, and tried to preempt the move by asserting the deal is not anti-competitive. It’s an argument Illumina has used previously, but it’s unclear whether or not the new brief will prove persuasive.
Bloomberg and Reuters were the first to report the news late Tuesday.
As of press time Wednesday morning, it remained unclear when exactly the objections would come, or what details they might include. Bloomberg reported, however, that Illumina could face up to a $400 million fine.
Though Illumina faced antitrust measures from both the EU and the FTC, the biotech marched on ahead with the buyout regardless. In August, the companies completed the merger in a move that was seen as ‘provocative,’ per a Financial Times report at the time. American regulators initially sought an injunction to block the deal from closing.
But once the antitrust issues cropped up in Europe, the FTC moved to conduct its review in an in-house hearing rather than in the courts. Last month, the EU issued an order that Grail be kept as a separate company and run by independent managers. It was the first in a series of interim measures expected to try to undo the acquisition before the EU review ends next February.
Illumina founded Grail and spun it out in 2016, but announced re-acquisition plans in September 2020. That news came just two weeks after Grail had filed for a potentially massive IPO, aiming to combine Illumina’s genetic sequencing tech with Grail’s screening tests for early cancer detection.
The move resulted in the companies almost immediately being caught up in the FTC’s crosshairs, however, with President Joe Biden and new agency chair Lina Khan having signaled a more aggressive stance toward pharma M&A. Regulators had concerns over Illumina’s hold on the DNA sequencing market affecting potential Grail competition, as all liquid biopsy companies rely on such technology.
It’s not the first time in recent years Illumina has potentially run afoul of antitrust regulators, as they successfully blocked the company’s attempt to acquire Pacific Biosciences in early 2020.
For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Al Sandrock (Biogen via Youtube)
Two years after Al Sandrock jumped from CMO to the top post in R&D — and just months after the hyper-controversial approval of the experimental Alzheimer’s drug aducanumab (Aduhelm) — Sandrock is planning to step out of his long career at Biogen.
Late Monday evening the big biotech put out word that Sandrock, a longtime fixture in the company after a 23-year stint, is hitting the exit.
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A month after conceding a mid-stage failure, Roche is dropping the Covid-19 antiviral pill it was jointly developing with Atea.
The little biotech, which had received $350 million cash upfront from Roche last October and raised another $215 million earlier in the pandemic, said it has both the financial resources and talent to carry on with a planned Phase III trial and eventually steer the drug, AT527, to market. Roche had originally bought in to grab the ex-US rights.
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The US Securities and Exchange Commission has launched a probe into claims that Cassava Sciences, an Austin-based drug developer, manipulated data key to its case for its experimental Alzheimer’s drug simufilam, the Wall Street Journal reported Wednesday.
The report comes just two days after Cassava in an SEC filing revealed that ‘certain government agencies’ had asked the biotech for documentation. It wasn’t clear which agencies were inquiring or what information they sought, and Cassava went out of its way to say the requests weren’t accusations of wrongdoing.
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A cell containing smallpox viruses, as captured by transmission electron microscopy
Smallpox was declared eradicated in 1980 by the World Health Organization, after an effort to vaccinate the globe. But several vials labeled as the disease were found at a Pennsylvania vaccine research facility belonging to Merck, when a laboratory worker was cleaning out a freezer.
There’s no indication that anyone was exposed to the vials, the CDC told CNN in an email. The lab worker was wearing gloves and a face mask, and the FBI is now investigating.
A few weeks after Jennifer Doudna introduced CRISPR/Cas9 genome editing to the world, one of her old students decided to take the central part of the biology-altering invention and kill it.
CRISPR/Cas9, as the name implies, is a two-part system: a string of letters called a guide RNA, that says where to cut the DNA. And an enzyme, Cas9, that does the cutting. Often compared to molecular scissors, it was the first system that allowed researchers to cut DNA with ease and precision, promising potential cures for genetic diseases such as sickle cell and cystic fibrosis.
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Seema Kumar, J&J Global Head, Office of Innovation, Global Health and Scientific Engagement (via J&J)
In the early days of the pandemic, there was a mad scramble for information. What was a coronavirus, how likely was a vaccine and how soon could it be developed?
At Johnson & Johnson, where Janssen scientists were already at work on vaccine candidates even before Covid-19 was officially a pandemic, Seema Kumar, along with her global health communications team, noticed that information void and jumped in with an idea.
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Bristol Myers Squibb is looking to shine a light on the rarely diagnosed heart condition hypertrophic cardiomyopathy (HCM) as it awaits an FDA decision on a proposed drug to treat it.
The unbranded ‘Could It Be HCM?’ campaign that launched Monday doesn’t mention mavacamten, which has an FDA decision deadline in January, but instead focuses on awareness of the condition with Utah Jazz National Basketball Association player Jared Butler who has HCM. Butler found out he had the heart condition while at Baylor University, where he helped lead the team to an NCAA national championship last season, and is now under a doctor’s care.
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Chiquita Brooks-LaSure (Photo by Caroline Brehman/CQ Roll Call via AP Images)
Although sales of Biogen’s expensive new Alzheimer’s drug have been anemic since the approval in June, the prospect of CMS eventually paying for it opens up a billion-dollar can of worms, and already has the agency defending some premium and deductible increases for seniors.
CMS explained late Friday that Medicare Part B will have to increase its standard monthly premium — from $148.50 in 2021 to $170.10 in 2022 — in part because of the massive spending that could occur should the agency sign off on a national coverage decision for the drug, known as Aduhelm, and its $56,000 annual price tag next year.
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