400 biotech leaders oppose Texas ruling

More than 400 biotech execs and companies oppose the Texas ruling on mifepristone, and the administration announces the $5B follow-up to Operation Warp Speed. Plus, today’s new episode of the I am BIO Podcast looks at what’s next for CRISPR. (587 words, 2 minutes, 56 seconds)

BIO members, chair among 400 biotech leaders opposing Texas ruling

More than 400 biotech leaders, including many BIO members, condemn Friday’s ruling in a Texas federal court to block FDA approval of mifepristone. 

What happened: “A federal judge with no scientific training fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration [FDA] to approve and regulate safe, effective medicines for every American,” the statement says.

Why it matters: “Judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the statement says.

Broad biotech backing: Signatories include Paul Hastings, Nkarta Therapeutics CEO and BIO Board Chair, among “more than 400 leaders of some of the drug and biotech industry’s most prominent investment firms and companies,” The New York Times says. 

What’s next: The Texas decision was suspended by a ruling in Washington State and is being appealed by the Justice Department. Senior White House officials announced an online briefing at 5 pm today.

I am BIO Podcast: CRISPR revolution just starting

Discovered only about a decade ago, CRISPR Cas-9 enables rapid development of exciting new treatments—and more breakthroughs are on the way, today’s new episode of the I am BIO Podcast explains.

What’s CRISPR Cas-9? The technology modifies DNA using an RNA guide to find a single gene, paired with a Cas-9 nuclease that cuts the gene, says Regeneron Executive Director Leah Sabin.

What Regeneron’s doing: The company uses CRISPR to potentially alter the liver’s DNA to address transthyretin amyloidosis, a genetic condition causing dangerous protein buildup around the heart, and to insert genes (rather than cut them) to address hemophilia.

Rapid development: CRISPR Therapeutics’ Julie Bruno says her company has already conducted clinical trials on eight therapies, including a promising sickle cell treatment.

New delivery methods for CRISPR, developed by Scribe Therapeutics, reach the liver or central nervous system effectively, says Benjamin Oakes, who co-founded the firm with CRISPR pioneer Jennifer Doudna.

“There’s still a lot we don’t know about CRISPR’s potential as a tool for transformative therapeutics,” says podcast host and BIO CEO Rachel King. “But one thing is for sure, we should be excited about where CRISPR’s going and the possibilities that lie ahead.” 

Click here to listen to the episode.

Administration announces $5B follow up to Operation Warp Speed

The Biden administration announced yesterday it will spend $5 billion to accelerate development of COVID-19 vaccines and treatments through Project NextGen.

The anticipated follow-up to Operation Warp Speed “would take a similar approach to partnering with private-sector companies to expedite development of vaccines and therapies,” according to The Washington Post. It was announced the same day President Biden ended the COVID national emergency.

Project NextGen has three goals:

1. Creating long-lasting monoclonal antibodies to address the evolving virus.
2. Developing vaccines with mucosal immunity to reduce infection risks.
3. Developing pan-coronavirus vaccines against COVID variants and new threats.

Already seeking private partners: The project will be coordinated by Health and Human Services, says Reuters. Dawn O’Connell, assistant secretary for preparedness at HHS, said her team is seeking “exciting technologies” and informed companies working on monoclonal antibodies that new government investment is possible.

President Biden’s Tuesday: Flying to Northern Ireland to celebrate the 25th anniversary of the Good Friday peace agreement before heading to the Republic of Ireland, a trip mixing some political challenges with a visit to the Biden family ancestral home, The New York Times reports.

What’s Happening on Capitol Hill: Recess.