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The Readout Damian Garde & Meghana Keshavan

Charting Illumina's path forward

Technology from industry giant Illumina was used to decipher the genetic code that went into developing Covid-19 vaccines. It's also being used to track variants of the SAR-CoV-2 virus. It's no wonder that CEO Francis deSouza believes we're "entering the era of the genome." 

“Genomics has emerged into the public, and it’s emerged as a force for good,” deSouza told STAT’s Matthew Herper.

The question, though, is what role will the company play in it. Illumina is attempting to acquire liquid biopsy spinout Grail — and is eyeing cancer diagnosis, treatment, and management as the next major application for genomics. But the FTC has made clear it might have other thoughts.

Read more. 

Building on an erstwhile Trump executive order

The Trump administration very nearly deployed a sweeping interagency plan to create a national bioeconomy strategy — something the biotech sector has been keen to have.

Now, the Biden administration has the chance to continue where President Trump left off. But according to a draft of an executive order, obtained by STAT, Trump’s approach would have given defense agencies a major role in regulating U.S. biotech, a real concern for many in the sector.

Biotech companies are hoping to see an amended approach, STAT’s Nicholas Florko writes. A Senate bill called the Bioeconomy Research and Development Act is currently in the works, which could reach President Biden’s desk as early as this fall. 

Read more. 

Sanofi, GSK moving forward with Covid vaccine

Sanofi and GSK’s joint Covid-19 vaccine is finally headed to Phase 3 trials. The companies, which made the announcement this morning, are far behind others in the broader effort to vaccinate the world against Covid — but they believe there’s still a role for their shot to play. 

That they're entering late-stage trials is quite a milestone, considering the major setback they faced last year when they found that an inadequate formulation of their vaccine had been given to volunteers in their Phase 1/2 trial. The error delayed efforts to test and deploy their shot. 

“Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and thermostable booster vaccines increases,” Thomas Triomphe, executive vice president and head of vaccines division Sanofi Pasteur, said in a statement.

Read more.

The Vascepa debate smolders on

Vascepa, a fish oil-based drug, is approved to prevent heart attacks and strokes in patients with high triglycerides. But in a new analysis presented at the annual virtual meeting of the American College of Cardiology and published in JAMA Cardiology, researchers argue that experts should take another look at the data.

Vascepa's benefit is supposed to be based on its ability to raise levels of eicosapentaenoic acid, or EPA, in the blood. But in a new analysis of a failed study of an AstraZeneca fish oil drug, EPA levels went up, without being associated with any benefit for patients. "Fish oils increase the risk of atrial fibrillation substantially, and there is no solid evidence that they help the heart in any way," study author Steven Nissen of the Cleveland Clinic told Medscape.

A new approach to clinical trials yields data on aspirin

Another piece of info from the ACC meeting: a new, cheaper way of doing clinical trials, backed by the Patient-Centered Outcomes Research Institute, a federal institute created by the Affordable Care Act. Researchers were able to directly enroll patients directly at routine medical visits and use electronic health records to collect data. The study's lead researcher says this allowed researchers to conduct a study that would cost $100 million for $19 million

But the new approach isn't a slam dunk. The trial appears to show it doesn't matter whether heart patients take low-dose or high-dose aspirin. But many patients switched from the dose they were assigned, making the result more difficult to interpret — and an editorial in the New England Journal of Medicine argues it may be impossible to do so.

More reads

  • Biogen reveals gene therapy trial failure as investors remain laser-focused on aducanumab drama. (FierceBiotech)
  • Biotech companies with the highest median pay for employees. (Business Insider)
  • Nix the bald cancer patient motif. Precision medicine needs precision marketing. (STAT

Thanks for reading! More tomorrow,


Monday, May 17, 2021


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