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A new tack for Illumina, an approval for Roche, & Califf's limbo

 

The Readout Damian Garde & Meghana Keshavan

Hiya, Meghana here. Today we talk next-next-gen sequencing, a new bispecific antibody, and Robert Califf's mounting woes. Happy Monday!

Illumina’s (not-so-)new sequencing technology

Illumina has announced that its new gene-sequencing platform, Infinity, will read larger chunks of DNA than its earlier platform — part of a bid to better diagnose rare diseases and unravel more of the genome. The technology the platform is based on, called long-read sequencing, is not exactly new, STAT’s Jonathon Wosen writes, but it is new for Illumina, whose bread and butter has come from short-read machines.

The future of sequencing is leaning in the long-read direction, a number of industry experts told STAT. But it’s already a fairly crowded space. 

“There’s going to be a lot of competition for that long-read space,” said Dawn Barry, co-founder of sequencing startup Luna DNA, who was once Illumina’s vice president of applied genomics. “The race is on.”

Read more.

Roche’s new bispecific antibody for vision loss

A new Roche drug for two common types of vision loss just got FDA approval — and will present serious competition for Regeneron, which has dominated the space. The drug, called Vabysmo, is the first-ever bispecific antibody drug for wet age-related macular degeneration and diabetic macular edema — which together affect nearly 1.9 million people in the U.S. and 40 million worldwide.

Studies show that the drug works just about as well as Regeneron’s, but needs to be given less frequently. That means it could ultimately be cheaper for patients, and for payers. However, analysts from Cowen don’t think Regeneron needs to worry much: “…the bar set by Eylea in terms of physician and patient experience is about as high as it could possibly be, and the early experience of [Vabysmo] must be absolutely pristine for it to experience significant uptake.”

Read more.

Califf’s facing difficulty to secure a nomination

Robert Califf still doesn’t have the Senate votes to be re-appointed FDA chief. Confirmation proceedings are stymied by Democrats who are dubious of the cardiologist’s industry ties and regulatory track record, Politico reports. A new GOP effort is underway to end his bid for commissioner.

“If the vote were held today, he would not have the votes,” one person with knowledge of the matter said.

Despite the pandemic, the FDA has lacked a leader for a year now, and Janet Woodcock continues to serve as its acting commissioner. Biden nominated Califf in November, but he’s faced more bipartisan blowback than was anticipated.

Drug costs raised by 6.6% on average this year

Drug companies raised their list prices by 6.6% on average so far this year, the Wall Street Journal writes, citing an analysis from Rx Savings Solutions. It's a modest uptick, given the industry’s track record of double-digit increases. And the main reason is clear: scrutiny from both lawmakers and the general public.

Legislation is still pending on Capitol Hill to further bring down drug prices.

“We know people are more stressed financially today than they were a year ago, and the need for information and support needs to grow,” Michael Rea, chief executive of Rx Savings Solutions, told the Journal.

 

More reads

  • ConvaTec breaks into wound biologics market with $450 million bid for Triad Life Sciences. (FierceBiotech)
  • Unable to 'align' with FDA, Regeneron, Sanofi pull application for Libtayo in cervical cancer days before decision date. (FiercePharma)

Thanks for reading! Until tomorrow,

@megkesh
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Monday, January 31, 2022

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