FDA OKs 1st drug to treat smallpox, in case of terror attack
16 Juillet, 2018, 03:25 | Auteur: Yves Courtet
Manufactured by SIGA Technologies, an OR pharmaceutical company with research in the biodefense arena, TPOXX proved effective in animal studies conducted on viruses that are closely related to smallpox.
Even though smallpox was eradicated in 1980, there have been longstanding concerns that it could be used to hurt others. "This new treatment affords us an additional option should smallpox ever be used as a bioweapon", said FDA Commissioner Scott Gottlieb, M.D.
It's the first anti-bioterror drug to win approval under the government's Material Threat Medical Countermeasure program, Gottlieb said. They reported that more animals that were administered tecovirimat had survived versus those treated with placebo.
Smallpox is caused by the variola virus and is capable of spreading through direct contact between people. Symptoms would usually start 10 to 14 days after the infection, including fever, exhaustion, and headaches.
The approval "reflects the FDA's commitment to ensuring that the USA is prepared for any public health emergency with timely, safe and effective medical products", he added.
Symptoms of smallpox are fever, fatigue, and sores filled with pus.
Complications commonly associated with smallpox included encephalitis, corneal ulcerations, and blindness.
According to the FDA, these studies were performed under the Animal Rule, which allows animal studies to be used to support approval "when it is not feasible or ethical to conduct efficacy trials in humans".
For drugs to treat diseases such as smallpox, which can not ethically be tested in people by infecting them on objective, the FDA has special rules. In the human safety trials, the most frequently reported side effects were headache, nausea and abdominal pain.
SIGA develops vaccines and medicines for biological, chemical, radiological and nuclear attacks. TPOXX (tecovirimat) is now the world's first drug created to treat smallpox and was approved on July 13, according to an announcement by the FDA.
"Today's action reflects the FDA's commitment to ensuring that the U.S.is prepared for any public health emergency with timely, safe and effective medical products".
NASA says these are "spider-like radiating mounds that form when carbon dioxide ice below the surface heats up and releases". The dark spots in the image, meanwhile, are formed by dust deposited around vents where the Carbon dioxide erupts.
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Some in the crowd held cameras up to take video, while others behind them threw rocks and glass bottles, some filled with urine. At least four people were arrested and several officers were injured, Chicago police spokesman Anthony Guglielmi tweeted .
China typically requires foreign automakers to set up joint ventures with Chinese firms when establishing manufacturing plants. That gives it plenty of room to grow in a Chinese market that still is expanding, while USA and European demand is flat.
It prompted Mr Trump to say it made him "feel unwelcome" in the city, on his second day of a four-day United Kingdom visit. On Friday, Trump said he gave Theresa May advice on how to negotiate Brexit, but she found it too "brutal ".
Such was the attacking onslaught, the Irdning goalkeeper eventually just gave up attempting to limit the damage. Not a single f**k is given but keep watching below because this rout also featured a truly iconic own-goal.
En effet, avoir mille et une tâches à accomplir à la fois, ça peut avoir des effets négatifs. En effet, les travailleurs effectuent les tâches beaucoup plus rapidement tout en conservant leur qualité de vie.
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