Good Day BIO: Biotech unites on CMS coverage decision

Ending the week with what biotech's saying about the CMS decision regarding Aduhelm, how biotech can make fashion more sustainable, and more on California’s new legislation to reinstate key tax benefits. Plus, we celebrate International Day of Women and Girls in Science. (535 words, 2 minutes, 40 seconds)

Biotech sector unites in opposition to CMS coverage decision

Biotech companies and industry groups are voicing opposition to the Centers for Medicare and Medicaid Services’ (CMS) proposed coverage decision for current and future Alzheimer's drugs that attack amyloid, citing concerns for patients now and in the future.

ICYMI: The FDA granted accelerated approval for Biogen’s Aduhelm—the first disease-modifying treatment for Alzheimer’s. But CMS proposed to restrict coverage to patients participating in clinical trials, setting a dangerous precedent.

This will have far-reaching impact beyond Alzheimer’s, explained Tom Mathers, Founder, President, and CEO of Allievex Corporation, speaking during the February 9 Alliance for Aging Research event. Allievex works on Sanfilippo syndrome, a rare disease also known as pediatric Alzheimer’s. 

The decision could also destabilize biotech investment, Mathers continued. And if you destabilize the regulatory process, investors will put their money elsewhere, slowing innovation.

The industry is loud and clear on this issue—with 45 members of the Council of State Bioscience Associations (CSBA) urging CMS to reconsider the decision.

“CMS should be encouraging development of new and innovative treatments for conditions like AD—not adopting restrictions on coverage that threaten to chill the development of an entire class of therapies for a degenerative condition that has no viable treatment option,” the comments say.

“We fear the consequences of this unprecedented overreach could delay patient access to novel therapeutics for years and create real disincentives to continue investments in certain therapeutic areas,” said more than two-dozen small biotechs and investors in a letter yesterday to Health and Human Services Secretary Xavier Becerra.

More Health Care News: 

BIO YouTube: California reinstates key tax provisions for biotech companies
“California Gov. Gavin Newsom signed legislation on February 9, 2022 that would reinstate two important tax provisions for biotech companies large and small—a win for biotech innovation and future cures.”

The science of sustainable fashion

It’s Fashion Week and—thanks to science!—the front row is back. Expect “sustainability” to be the buzzword of the season—and luckily, science can help designers make it work. 

The context: Ahead of New York Fashion Week, the New York State Assembly and Senate introduced legislation to become “the first state in the nation to require global fashion brands to disclose their climate and social impacts and take action to reduce greenhouse gas emissions under a bill introduced in the state legislature,” reported Bloomberg. 

Hey, we’ve got biotech for that—like Genomatica’s plant-based nylon for lululemon and LanzaTech’s use of carbon recycling technology to make everything from Zara dresses to perfume.

Regenerative agriculture “is fundamental to the long-term health of the fashion and textile industry, playing a key role in helping farmers develop more resilient systems,” says a new report from Textile Exchange, a global nonprofit driving climate action in the fashion industry. 

This includes soil carbon sequestration, says the report, which technology like gene editing can advance—as well as ensuring programs are “rooted in justice, equity, and livelihoods.” 

Listen: Fashion experts joined the I am BIO Podcast to discuss how biotech is revolutionizing the industry—from using greenhouse gases to make new materials, to creating entirely biodegradable clothing. Listen at www.bio.org/podcast or Apple, Google, or Spotify.

President Biden’s Friday: Daily brief, then heading to Camp David. ICYMI, yesterday he renewed his call for drug price controls as a way to address inflation, per the AP.  

What’s Happening on Capitol Hill: The Senate could vote on the nomination of Dr. Robert Califf for FDA Commissioner as early as Tuesday, reports POLITICO.