Biden signs executive order for women’s health research and innovation

President Joe Biden [Image courtesy of the White House]President Joe Biden this week signed an executive order that will direct funds and actions toward expanding and improving research on women’s health.

The initiative builds on First Lady Jill Biden’s announcement last month in which the Advanced Research Projects Agency for Health (ARPA-H) earmarked $100 million in funds to “fundamentally change” how the U.S. approaches and funds women’s health research.

This week’s executive order follows President Biden’s March 7 State of the Union address, in which he called on Congress to invest $12 billion in new funding for women’s health research.

Biden’s executive order will create directives that will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, according to the White House. It will also motivate new research on a wide range of topics in womenR…

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Biden’s supply chain plans include made-in-America medicines

President Joe Biden [Image courtesy of the White House]

The Biden administration recently announced efforts to strengthen the pharmaceutical supply chain, mitigate shortages of essential medicines, and expand domestic manufacturing.

The new efforts are part of an overall package of initiatives to boost U.S. supply chains that the White Houe announced on Nov. 27. Securing the country’s supply of medicines and lowering prices have been an important priority for Biden since he took office nearly three years go. The goal is to increase access to essential medicines and medical products.

The latest round of actions include:

Invoking the Defense Production Act to broaden the Department of Health and Human Services’ (HHS) authorities to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that the president deems essential to the national def…
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Biden reportedly plans to block AI chipmaking exports to China

President Joe Biden’s administration may soon restrict AI chipmaking exports to China. [Image courtesy of Biden for President]

President Joe Biden’s administration plans to restrict U.S. exports of artificial intelligence semiconductors and manufacturing equipment to China, Reuters reported over the weekend.

Citing confidential sources, Reuters said the Commerce Department plans to publish new regulations next month, requiring licenses for certain exports of AI chipmaking equipment and AI computing chips.

Semiconductors and artificial intelligence are increasingly valuable tools for medical device developers and manufacturers as smaller sensors, connectivity tech and algorithms to collect and crunch more data than ever before.

RELATED: 5 steps to help medical device makers deal with semiconductor shortages

The Commerce Department said it is “taking a comprehensive approach…

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HHS to support more healthcare products manufacturing

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

Today’s announcement out of the White House also included news that the Treasury Department will deploy $10 billion of American Rescue Act funds under a new and improved State Small Business Credit Initiative (SSBCI). The move will leverage the funds into more than $70 billion in additional lending and investment for small businesses, including small manufacturers.

Get th…

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HHS to support more manufacturing of APIs, other healthcare products

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

The White House briefing statement said: “The United States remains critically dependent on imports for a range of key pharmaceutical products and active pharmaceutical ingredients—the primary ingredients of generic drugs.”

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

“This program will ensure timely availability of essential domestic industrial resources; establish the necessary authorities and mechanis…

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President Biden reboots Cancer Moonshot project

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In 2016, then-Vice President Joe Biden announced a Cancer Moonshot initiative to speed the development of new therapies to treat cancer.

Biden is now launching a new initiative committed to improving the cancer survival rate by at least 50% by 2047. The plan also aims to improve the quality of life for patients with cancer.

“We can end cancer as we know it,” Biden said in an announcement introducing the initiative.

Get the full story from our sister site, Drug Discovery & Development.

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Addressing vulnerabilities in the medical product supply chain

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While the medical product supply chain has always been subject to vulnerabilities, those weaknesses were laid bare early in the COVID-19 pandemic. Drug and medical device supply chains have historically been susceptible to factors such as a lack of supplier redundancy, components, active pharmaceutical ingredient (API) or finished product manufacturers. But pandemic-driven sourcing and workplace disruptions magnified these pain points, resulting in the ongoing problems that have persisted for the past two years.

Although the root causes are complex and the possible solutions numerous, important developments at the U.S. Food and Drug Administration (FDA) have led to increased transparency about drug and medical device shortages. Although this transparency is a promising starting point for formulating short- and long-term supply chain solutions, strong policy development, planning and …

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President Biden reboots Cancer Moonshot project 

Image courtesy of Wikipedia

In 2016, then-Vice President Joe Biden announced a Cancer Moonshot initiative to speed the development of new therapies to treat cancer.

Biden is now launching a new initiative committed to improving the cancer survival rate by at least 50% by 2047. The plan also aims to improve the quality of life for patients with cancer.

“We can end cancer as we know it,” Biden said in an announcement introducing the initiative.

Biden named Dr. Danielle Carnival as the White House Cancer Moonshot coordinator. Carnival is currently the senior advisor to the director of the White House Office of Science and Technology Policy.

One of the short-term goals of the initiative will be to bolster cancer screening rates, which have plummeted during the pandemic.

Biden seeks to form a Cancer Cabinet with officials from a range of government offices.

Biden als…

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US buys 10 million additional courses of Pfizer’s COVID-19 pill Paxlovid 

As COVID-19 infections in the U.S. hit new highs, President Joe Biden announced that the country would buy at least 20 million courses of Pfizer’s (NYSE:PFE) COVID-19 pill Paxlovid. 

The government had planned on purchasing half as much of the drug, which won regulatory authorization in late December for certain patients with a high risk of developing severe COVID-19. 

Biden also vowed that it had offered Pfizer additional resources to accelerate the manufacture of the drug. 

The federal government is ready to use the Defense Production Act to spur quicker production of the drug.  

Pfizer plans on providing roughly 10 million treatment courses to the government by the end of June. It plans on providing the additional 10 million courses by September 30. 

Pfizer has previously announced that Paxlovid had an efficacy rate of 89% in a study focused on its potential to reduce hospitalization or death from COVID-19. The Phase 3 study involv…

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Biden announces plans to buy, distribute 500M at-home, rapid COVID-19 tests

[Photo by Martin Sanchez on Unsplash]The White House today announced a COVID-19 response plan that includes a large effort to increase at-home rapid testing.

President Joe Biden’s plan includes the opening of new federal testing sites to increase capacity and the distribution of 500 million at-home, rapid tests to Americans.

The Biden administration plans to purchase a half-billion rapid tests this winter with intentions to distribute them for free to those who want them. The initial delivery is slated to begin in January 2022, with the administration planning to put up a website for Americans to request their at-home tests.

Additionally, according to a news release, new federal testing sites will be set up around the U.S., with the first set to go up in New York City this week.

Biden also said the plan includes utilizing the Defense Production Act to accelerate production, making sure the U.S. is “producing as many tests as quickly as po…

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OSHA suspends enforcement of COVID-19 vaccine mandate

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The Biden administration will not proceed with enforcing its vaccine mandate for businesses with at least 100 employees given a recent decision by the U.S. Court of Appeals for the Fifth Circuit.

The administration had planned on putting the Occupational Safety and Health Administration (OSHA) in charge of administering the COVID-19 vaccine mandate. While a statement on the OSHA website proclaims that it “remains confident in its authority to protect workers in emergencies,” the agency agreed it would suspend enforcement of the emergency temporary standard (ETS) that would have required many U.S. employees to be fully vaccinated or face regular testing. However, OSHA could change course in the event of a further court order.

The U.S. Court of Appeals for the Sixth Circuit will hear the challenge to the OSHA-specific vaccine mandate.

For the time being, however, OSHA h…

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States sue to block COVID-19 vaccine mandate

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The attorneys general in 26 U.S. states are opposing the Biden administration’s plan to force many employers to require their workers to obtain vaccination against COVID-19.

While the majority of states were Republican-led, Kansas, Louisiana and Kentucky were three Democratic-leaning states that joined the litigation.

White House spokeswoman Karine Jean-Pierre said in a media briefing that the vaccine mandates have a firm legal footing.

The vaccination mandate threatens penalties of almost $14,000 per infraction.

The federal government intends to begin enforcing the rules on January 4.

The rules are more stringent for healthcare facilities receiving funding from Medicare and Medicaid. In such facilities, eligible staff must receive at least one vaccine dose before providing healthcare, treatment or other services by December 5.

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