Coronavirus, Rare Disease Day, and biofuels – who's ready for the weekend?

Coronavirus news has evolved rapidly over the past week. Following President Trump’s announcement that VP Mike Pence will lead the coronavirus task force, a whistleblowerclaimed HHS workers were required to interact with Americans evacuated from Wuhan without proper training or protective gear. Meanwhile, House and Senate Appropriationsare working on a deal on emergency coronavirus funding, a package expected to be “much higher” than the $2.5 billion requested by the Trump administration.

BIO members continue to work around the clock on R&D for coronavirus vaccines and antivirals, with Gileadannouncing they launched two late-stage studies to test the effectiveness of their experimental antiviral remdesivir, which was developed during the recent Ebola outbreak. Sandoz, meanwhile, promised to freeze prices on about 20 antiviral and antibiotic drugs that may help. And the FDA’s Center for Biologics Evaluation and Research told STAT that while a vaccine may be “months away,” effective treatments against the virus could come much sooner.

As you head into the weekend, here’s a final reminder: wash your hands regularly and don’t panic. 

For more news on the coronavirus response, visit www.bio.org/coronavirus.

Tomorrow (February 29) is Rare Disease Day, an international day to raise awareness for rare, “orphan” diseases—and a good time to remember why we must protect the Orphan Drug Act and incentivize R&D for new cures.

There are about 7,000 identified “orphan,” or rare, diseases—which, combined, affect more than 300 million people, or as much as 6% of the world’s population.

And 72% are genetic, with 70% starting in childhood. 

But they’re rarely covered by the media,says BIO CEO Jim Greenwood, because each disease affects just a small number of patients.

The Orphan Drug Act has helped. Passed by Congress in 1983, the legislation has incentivized development of 400+ innovative treatments for rare diseases, giving hope and a new life to millions of patients around the world suffering from diseases like Duchenne muscular dystrophy, Batten disease, spinal muscular atrophy, and more.

But 95% of rare diseases still have no treatment available—which is why we must protect the legislation’s market exclusivity and tax credit provisions to promote continued investment. 

And above all, we can’t enact price controls—because we know they will disincentivize investment in cures across the board, whether for rare diseases or widespread ones, like the coronavirus.

Read more about why the Orphan Drug Act matters:  

• Drug Development & Clinical Trials Process for Rare Diseases
• The Orphan Drug Act: Making the Impossible Happen for Rare Disease Patients
• The Orphan Drug Act: Spurring Innovative Rare Disease Drug Development

More Health Care News: 

BioPharma Dive: Where are all the deals?
In 2020, we’ve only seen one billion-dollar biopharma deal.

STAT: Anti-vaccine activists co-opt a populist slogan to try to repeal a state immunization law
Advertisements across Maine say “Reject Big Pharma.” 

There’s sunshine peeking through the clouds hanging above the American biofuels industry: the Trump administration is taking a closer look at how it issues waivers to the biofuel requirements, and might even give waivers to fewer refineries, according to reports.

A quick catch-up: Trump’s Environmental Protection Agency (EPA) has granted an unprecedented number of Small Refinery Exemptions (SREs) to the Renewable Fuel Standard (RFS), which requires a certain percentage of biofuels to be mixed in transportation fuel in the United States. 

But an appeals court ruled the EPA had gone too far, and “overstepped” its authority on three 2016 exemptions. The court asked EPA to reconsider these exemptions, because the particular refineries “had not received exemptions in the previous year,” Reuters reported in January. 

The administration is considering paring back the number of SREs,sources told Bloomberg. 

And EPA Administrator Andrew Wheeler confirmed there will be news soon, telling a House Energy and Commerce subcommittee yesterday that they’ll announce their decision on how to respond to the appeals court ruling “very shortly,” reports Agri-Pulse. 

Right now, it’s TBD whether or not SREs will be limited going forward—but we’re optimistic, and it’s a good sign the administration is at least considering the change.