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Biden leaning on Defense Production Act to bolster COVID-19 vaccine supplies

[Joe Biden photo from Wikipedia]

President Joe Biden has unveiled a series of anti-COVID-19 measures in his first full day in office, including signing an executive order instructing federal agencies to use the Defense Production Act (DPA) and other tools to speed the manufacture of COVID-19 vaccines and materials.

In total, the president has signed 10 executive orders intended to curb the spread of the novel coronavirus.

According to the “National Strategy for the COVID-19 Response and Pandemic Preparedness” document, the Biden administration will use the Defense Production Act to “fill any distribution gaps, including with respect to any needed refrigeration, transportation, or storage facilities.”

Biden has also moved to create a centralized federal approach to virus testing while ramping up the U.S. government’s involvement in vaccine distribution.

“President B…

Amazon offers to help Biden administration with vaccine distribution

Amazon (NSDQ:AMZN) issued a letter to recently inaugurated President Joe Biden offering assistance with COVID-19 vaccine distribution.

President Biden, who was sworn into office yesterday, was addressed in the letter from Amazon announcing its availability to help with his intent to distribute 100 million COVID-19 vaccine doses in his first 100 days in office.

Get the full story at our sister site, Pharmaceutical Processing World.

Amazon offers to help Biden administration with vaccine distribution

Amazon (NSDQ:AMZN) issued a letter to recently inaugurated President Joe Biden offering assistance with COVID-19 vaccine distribution.

President Biden, who was sworn into office yesterday, was addressed in the letter from Amazon announcing its availability to help with his intent to distribute 100 million COVID-19 vaccine doses in his first 100 days in office.

The letter congratulated Biden and Vice President Kamala Harris on their inauguration and said that its more than 800,000 U.S. employees — most of whom are classified as “essential workers” amid the pandemic — should receive the approved vaccines from Pfizer/BioNTech and Moderna as soon as possible.

“The essential employees working at Amazon fulfillment centers, AWS data centers and Whole Foods Market stores across the country who cannot work from home should receive the COVID-19 vaccine at the earliest appropriate time,” Amazon CEO, Worldwide Consumer, Dave Clark wrote.

…

Former FDA commissioner Kessler to help lead Biden’s COVID-19 response

Dr. David Kessler, former FDA commissioner and incoming chief scientific officer of the Biden administration’s COVID-19 response [Photo by Justin Hoch, CC BY 2.0]

President-elect Joe Biden today announced that Dr. David Kessler, who led FDA through much of the 1990s, will serve as chief science officer of his administration’s COVID-19 response.

Kessler’s achievements at FDA included speeding the approval of drugs to reduce the AIDS death toll. He’ll now be helping to lead efforts to speed authorization and delivery of vaccines to bring the COVID-19 pandemic under control — as well as an overall, comprehensive, whole-of-government COVID-19 response.

“We are in a race against time, and we need a comprehensive strategy to quickly contain this virus,” Biden said in announcing the appointment of Kessler and other new members of the COVID-19 response team.

Kessler has alr…

Former FDA commissioner Kessler to help lead Biden’s COVID-19 response

Dr. David Kessler, former FDA commissioner and incoming chief scientific officer of the Biden administration’s COVID-19 response [Photo by Justin Hoch, CC BY 2.0]President-elect Joe Biden today announced that Dr. David Kessler, who led FDA through much of the 1990s, will serve as chief science officer of his administration’s COVID-19 response.

Kessler’s achievements at FDA included speeding the approval of drugs to reduce the AIDS death toll. He’ll now be helping to lead efforts to speed authorization and delivery of vaccines to bring the COVID-19 pandemic under control — as well as an overall, comprehensive, whole-of-government COVID-19 response.

Get the full story on our sister site Pharmaceutical Processing World.

Biden vows to ramp up COVID-19 vaccine distribution with $1.9T stimulus package

[Joe Biden photo from Wikipedia]

President-elect Joe Biden has announced a proposal for a $1.9 trillion economic rescue package that includes $415 billion to fight the pandemic, including boosting COVID-19 vaccine deployment. Of that latter total, some $20 billion would be invested in a national vaccination program to establish community vaccination centers across the country, including mobile vaccination units in rural areas. Another $30 billion would cover supplies and personal protective equipment.

The possibility of a Senate trial in Biden’s first 100 days in office could be a roadblock for the plan.

Nevertheless, Biden aims to have 100 million COVID-19 vaccine doses administered in his first 100 days in office.

Biden’s plan also earmarks $50 billion for COVID-19 testing and would strengthen the nation’s use of genomic testing to track SARS-CoV-2 mutations.

To date, there have bee…

Former CDER head Woodcock to lead FDA for now

Dr. Janet Woodcock

FDA veteran Dr. Janet Woodcock has been tapped as interim FDA commissioner by the Biden administration, according to published reports.

An article by BioCentury also said that former FDA commissioner David Kessler, who had been mentioned as a possible replacement for current commissioner Stephen Hahn, will be a consultant to the agency but will not serve as its head. Another former FDA official, Joshua Sharfstein, remains in the running for the commissioner’s slot, according to BioCentury.

Get the full story on our sister site, Medical Design & Outsourcing.

Ambu, Boston Sci execs see domination for single-use scopes

Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost.

In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S and Boston Scientific (NYSE:BSX) said improved technology make single-use scopes as effective as reusable scopes without carrying the price tag or risk of infection traditional scopes require.

Steve Block, president of Ambu US, projected that over the next decade disposable scopes will account for a majority of devices sold, saying they’ll perform better than traditional devices, cost less, and eliminate the risk of infection. “There is just no reason to use a reusable product,” he said. He said Ambu has sold single-use scopes into 96% of the Top 500 hospitals in the US performing bronchoscopies.

Block appeared on the podcast alongside…

The top 5 MassDevice stories of the week — September 11, 2020

From the Theranos case to wearable medical devices, it’s been another busy news week for the medical device industry.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. Bardy Diagnostics names new CEO

Kevin Hykes— who over the years has led companies including Relievant Medical Systems, Metavention and Cameron Health — will take over the corner office at Bardy Diagnostics. Bardy has developed the CAM (Carnation ambulatory monitor) for monitoring cardiac rhythms. Read the full story.

4. Drug companies say they won’t release COVID-19 vaccine until it’s ready

Executives from nine different drug companies announced a pledge to ensure safety with a potential COVID-19 vaccine. “We believe this pledge will help ensure public confidence in the rigorous scienti…

How the presidential election could affect medtech

No matter who ends up in the White House, there will need to be a reckoning over how the government’s relationship with medtech has changed, according to industry insiders.

(Image by Markus Winkler on Unsplash)

It’s been a tumultuous few years for the medical device industry, with highs and lows that no one could have foreseen.

President Donald Trump’s administration streamlined some FDA processes. The medical device excise tax, enacted during the Obama-Biden administration, was permanently repealed.

But any normal state of affairs in the industry was upended by the coronavirus pandemic. COVID-19 disrupted supply chains, brought elective surgeries to a halt and attracted all sorts of businesses to jump into an industry that they knew nothing about. The pandemic also brought about unprecedented cooperation within medtech and betw…

MedTech 100 roundup: Stocks top pre-pandemic high

After weeks of flirting with the heights hit before COVID-19 ravaged the markets, medtech stocks finally topped the pre-pandemic high last week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — spiked up to 93.11 points on Sep. 2, nearly a full point ahead of the pre-pandemic high of 92.32, which the market reached on Feb. 19.

Medtech stocks had hit a previous mid-pandemic high of 91 points last week, hanging around there before the sudden rise to 93.11, which was followed by a quick dip to 90.64 points 24 hours later.

The index dipped from that peak, though, sitting at 89.29 points at the end of last week (Sep. 4). Overall, medtech stocks saw a -1.6% decrease from the 90.78-point total at the same time a week prior (Aug. 28).

The most recent high mark represents a 0.9% rise from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -3.3% decrease from that pre-pande…

Biden is getting the most money from medtech employees

Medtech company employees and their families have donated $289,533 to former Vice President Joe Biden, versus $190,570 for President Donald Trump, according to OpenSecrets.org. Check out our breakdown covering 25 of the largest companies.

[Image courtesy of Biden for President]

Medical device company employees’ preference in the U.S. presidential election appears to be clear: They’re providing more money to the Democratic presidential nominee Joe Biden, according to campaign contribution data compiled by the nonpartisan, nonprofit Center for Responsive Politics’ Opensecrets.org.

The difference is even starker when adding donations to other Democrats who failed to secure the nomination.

As of June 30, employees and their families at 25 major medtech companies had donated nearly $1.1 million. Biden received 26.6%, Bernie Sanders received 21.6%, Trump received 17.5%, Elizabeth Warren received 11%, Pet…