SIGA Technologies Archives - Medical Design Sourcing

U.S. to boost supplies of Tpoxx to fight monkeypox outbreak

[Monkeypox images from CDC]

The Administration for Strategic Preparedness and Response (ASPR) will make 50,000 courses of the small-molecule drug Tpoxx (tecovirimat) from SIGA Technologies (Nasdaq: SIGA) available to help fight the monkeypox outbreak.

There have been 13,517 confirmed monkeypox/orthopoxvirus cases in the U.S. to date, according to the CDC.

In 2018, Tpoxx became the first drug to win an FDA indication for smallpox.

The agency approved the drug under its Animal Rule for treating smallpox using animal efficacy data and human safety data.

The FDA has authorized the use of Tpoxx to treat monkeypox patients through expanded access protocols.

The U.S. maintains a substantial inventory of the drug as part of the Strategic National Stockpile (SNS).

An announcement from the White House noted that it would allocate courses of Tpoxx with a formula based 75% on the number of…

FDA greenlights 786,000 additional monkeypox vaccine doses

[Photo by Artem Podrez from Pexels]

FDA has signed off on a supplement to the biologics license for Bavarian Nordic’s (OTCMKTS:BVNRY) Jynneos vaccine, which is indicated for both monkeypox and smallpox. The move will make an additional 786,000 doses of vaccine available for use in the U.S.

The extra doses are available following an FDA expedited inspection and approval of Bavarian Nordic’s fill-and-finish capabilities.

HHS is moving to ship the doses to states and jurisdictions as soon as it can, according to the U.S. Department of Health and Human Services Secretary Xavier Becerra.

Becerra indicated that the federal government would continue to ramp up the distribution of further monkeypox vaccine doses in the near future.

The U.S. has been working to procure 5.5 million monkeypox vaccine doses for 2023.

The country had distributed more than 300,000 vaccine doses in July.

“We …

The most innovative pharmaceutical agents of 2020

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release.

This year, the foundation nominated 26 pharmaceutical agents that have been FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October this year.

“While scientific discovery and medical in…

The 26 most innovative pharmaceutical agents of 2020

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release.

This year, the foundation nominated 26 pharmaceutical agents that have been FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October this year.

“While scientific discovery and medical in…