Good Day BIO: FDA approves Biogen's Alzheimer’s drug

This June is shaping up to be a historic Alzheimer’s and Brain Awareness Month with approval yesterday of BIO member Biogen’s new Alzheimer’s drug—which could change treatment for this insidious disease.

Biogen’s Aduhelm is the first treatment to address a likely cause of Alzheimer’s—and the first new treatment for the disease in nearly two decades. 

“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s,”said Patrizia Cavazzoni, M.D., Director of the FDA’s Center for Drug Evaluation and Research. “As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”

The drug eliminates “clumps of a toxic protein believed to destroy neurons and cause dementia,”explains STAT News. 

What they’re saying: “The approval of Aduhelm represents a crucial inflection point in our collective battle against Alzheimer’s disease. By addressing a defining pathology of the disease, this novel therapy has the potential to help fundamentally change the way patients are diagnosed and treated,” said Biogen CEO Michel Vounatsos—read his entire letter. 

The next steps: “Instead of judging Biogen’s treatment solely on its effects on cognition, the FDA granted a conditional approval based on Aduhelm’s ability to clear the toxic proteins,” continues STAT. “In order to continue marketing the drug, Biogen will need to complete a large clinical trial to confirm that removing the plaque has cognitive benefits.” 

Join us: Biogen CEO Michel Vounatsos will speak at BIO Digital on June 17 during a one-on-one conversation about the company’s commitment to corporate responsibility and the future of biotechnology.

More Health Care News: 

Modern Healthcare: With the help of Black women, we can boost vaccine acceptance and uptake
“Black mothers, Black grandmothers, Black aunts, Black teachers—figures of unique moral authority in the community—need to be enlisted,” write BIO’s Dr. Michelle McMurry-Heath and Linda Goler Blount, President and CEO of Black Women’s Health Imperative. 

NPR: The CDC's No. 2 official says the U.S. isn't ready for another pandemic
“The United States was unprepared for the coronavirus, the response ‘wasn't a good performance,’ and there's still ‘a lot of work to do’ to get ready for the next pandemic when it comes,” said Dr. Anne Schuchat, retiring principal deputy director of the CDC. 

Maine’s wild blueberry fields are warming at a faster rate than the rest of the state, which “could imperil the berries and the farmers who tend to them,” reports the AP. Can we save our favorite summer pie?

Analyzing 40 years of data,scientists at the University of Maine “found that the state experienced a 1.1 degrees Celsius (1.98 degrees Fahrenheit) increase in average temperature, but the blueberry fields of Down East Maine experienced an increase of 1.3 degrees Celsius (2.34 degrees Fahrenheit),” explains the AP. 

Rising temperatures will lead to water deficits, making the plants “water stressed,” said Rafa Tasnim, the lead author of the study. This could “result in smaller crop sizes and blueberries that are less likely to survive to be harvested.” 

This is also bad for farmers. Maine is “home to the only commercial producers of wild blueberries in the U.S.,” but farmers have faced hardships recently including drought and “volatile markets.” 

“The study authors found that wild blueberry growers might need to change the way they farm to prepare for future climate change,” concludes the AP. “That could include changes to strategies such as irrigation and fertilizer use.” 

But biotech could save the blueberry pie—by reducing the need for nitrogen fertilizers as well as by using gene editing to produce blueberries that are more resilient in the face of climate change, as two examples.

More Agriculture and Environment News:

The New York Times: Carbon dioxide in atmosphere hits record high despite pandemic dip
“The amount of carbon dioxide piling up in Earth’s atmosphere set a record last month, once again reaching the highest levels in human history despite a temporary dip in the burning of fossil fuels worldwide caused by the coronavirus pandemic, scientists said Monday.”

President Biden’s Tuesday: The White House COVID Response Team will give a briefing at 10:15 AM ET, followed by Deputy Director of the National Economic Council Sameera Fazili and Senior Director for International Economics and Competitiveness Peter Harrell at 1 PM ET. Ahead of Biden’s first international trip, Axios World published a comprehensive look at his foreign policy. 

What’s Happening on Capitol Hill: The Senate is poised to vote as early as today on a bill aimed at making the U.S. more competitive against China, reports The New York Times. Meanwhile, it’s a busy day of hearings. Health & Human Services (HHS) Secretary Xavier Becerra will testify before the House Ways & Means Committee at 10 AM ET, the first of several hearings this week on the agency’s budget. Senate HELP will consider two HHS nominees, Dawn O’Connell for Assistant Secretary for Preparedness and Response and Miriam Delphin-Rittmon for Assistant Secretary for Mental Health and Substance Use. This afternoon, House Oversight & Reform will hold a hearing on opioid legislation.