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The US Food and Drug Administration on Thursday announced the approval of?the first generic version of EpiPen.The auto-injector pen delivers the drug epinephrine to patients experiencing a severe allergic reaction that, if untreated, could develop into the life-threatening condition of anaphylaxis. The medication is delivered into a muscle as a single dose, like a shot, through an injector pen with a spring.Allergies from food, bug bites, medications and latex can cause life-threatening reactions.The newly approved generic is made by Teva Pharmaceuticals and offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen made by Mylan. It is approved in a smaller dose for children, as well.There are two other brand products on the market for a severe allergic reaction: Adrenaclick and Auvi-Q.The newly approved option made by Teva is the only approved non-brand option and can be substituted only for Mylan's EpiPen."Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," FDA Commissioner Dr. Scott Gottlieb said in a statement announcing the approval.In recent years, Mylan came under fire for a price increase that put the product out of reach for many who needed to keep the drug on hand. 1488
The road to the White House clearly goes through the state of Michigan as both Joe Biden and Donald Trump have been actively campaigning in the state.Michigan has been a state hard-hit economically in recent years as the once thriving auto industry Nationally, the number of auto jobs has declined amid the pandemic. The auto industry has lost nearly 100,000 jobs this year.At the start of the century, there were more than 1.3 million US auto jobs. When Barack Obama took office, that number had dropped by 50%. During his tenure, the auto industry regained a portion of those jobs lost.But any gains from a revamped trade agreement had yet to be realized in the auto industry based on Bureau of Labor Statistics figures. On Thursday, Joe Biden said in an interview with CNN’s Jake Tapper the new USMCA agreement that replaced NAFTA is an upgrade, but failed to give President Donald Trump for securing the agreement."But look what the overall trade policy has done even with NAFTA. We now have this gigantic deficit in trade with Mexico. Not because NAFTA wasn't made better, because overall trade policy and how he deals with it made everything worse," Biden said.Biden was asked whether Trump should be given credit for the USMCA. Biden said the Obama White House was unable to renegotiate NAFTA because of Congress. For the first two years of the Obama administration, both the House and Senate were held by Democrats.“Because we had a Republican Congress that wouldn't go along with us renegotiating,” Biden told Tapper.In 2008, both Biden and Obama campaigned on changing the US trade agreement between Mexico and Canada. The USMCA, which became effective this year, was amended by Congress, but ultimately won bipartisan support from leaders of both party.The interview with Tapper was taped in Michigan and aired hours before Trump held a campaign rally in the state.On Monday, Trump said, “Biden supported NAFTA. He supported China’s entry into the World Trade Organization. Two disasters. The most disastrous trade deals in history, both of them. I can’t tell you which was worse; they were both terrible.” 2125
The way doctors treat asthma in both children and adults just got a major update.Speaking to the Journal of the American Medical Association, respiratory experts said the changes in guidelines focus on six key areas, including improving asthma diagnosis, management, and treatment.It’s the first published update in 13 years.“So, one of the goals of our update was to address the issue of who can use intermittent inhaled corticosteroids and when used, are they as effective as daily use,” said Michelle M. Cloutier, MD with UConn Health.One of the biggest changes is that many patients may not need to use an inhaler every day anymore.“Especially those families of young children who don’t necessarily buy into using daily medication when their children are having intermittent symptoms,” said Stephanie Lovinsky-Desir, MD, MS with Columbia University Irving Medical Center.The new recommendations for inhaler use vary by age and severity of asthma, so it’s important to talk to your doctor about the new guidelines.Asthma affects nearly 5% of adults and 10% of children.During the pandemic, because of the higher death rate of asthma patients from COVID-19, more people have been seeking treatment for the condition.The average annual cost of asthma per person is more than ,200. But research has also shown among other things, regular use of medication and flu vaccines can reduce the chances of someone with asthma being hospitalized, driving up those costs. 1472
The US government announced additional sanctions and travel restrictions on Cuba Wednesday, following up on an announcement by President Donald Trump earlier this year.Among the specific changes outlined by the Treasury Department are restrictions on travel to Cuba for educational or cultural exchange groups, which will now be permitted only for sponsored groups in the United States, and with the participation of representatives from those groups.Individuals traveling for so called "people-to-people" outreach will no longer be able to visit the country, except where travel arrangements have already been made, or in cases where these individuals are accompanied by permitted, US-based sponsors, a senior administration official explained to reporters on a conference call. 787
The Transportation Security Administration is considering eliminating passenger screening at more than 150 small and medium-sized airports across the US, according to senior agency officials and internal documents obtained by CNN.The proposal, if implemented, would mark a major change for air travel in the US, following nearly two decades of TSA presence since the terrorist attacks of September 11, 2001, and comes as the Trump administration has stepped up screening measures for items such as laptops and tablets.Internal documents from a TSA working group say the proposal to cut screening at small and some medium-sized airports serving aircraft with 60 seats or fewer could bring a "small (non-zero) undesirable increase in risk related to additional adversary opportunity."The internal documents from June and July suggest the move could save 5 million annually, money that could be used to bolster security at larger airports.According to the proposal, passengers and luggage arriving from these smaller airports would be screened when they arrive at major airports for connecting flights instead of the current practice of joining the already screened population at the larger airport. The high-volume airports have greater capacities and more advanced security measures than smaller locations, the documents say.CNN terrorism analyst Paul Cruickshank said it was "stunning that this is even seriously being considered.""Al Qaeda and ISIS still regard aviation as a priority target -- that includes aircraft where you have fewer than 60 people on board," he said. "They would see that as a way to hit the headlines. They would see that as a way to inflict severe economic damage on the United States. If you have an aircraft of 50 or so people being blown out of the sky there is going to be a great amount of panic and there will indeed be significant economic reverberations, and of course significant loss of life.""This is so dangerous," a TSA field leader at a large airport said. The individual is not authorized to discuss the matter publicly.Two senior TSA officials, who asked not to be identified, expressed serious national security concerns over the proposal. They said the idea was explored as far back as 2011 and has been resurrected. The documents referred to some 150 small airports in addition to some midsize ones. TSA currently screens passengers at 440 airports, according to its website.The working group determined that the policy change would affect about 10,000 passengers who are screened by 1,299 TSA employees daily, which amounts to about 0.5% of the people who fly out of US airports on any given day. The report does not list specific airports that could be affected by the policy change.TSA spokesman Michael Bilello said the study reflects a recurring debate within the agency about its legal requirements."This is not a new issue," he said via email. "The regulations which established TSA does not require screening below a certain level, so every year is 'the year' that TSA will reconsider screening." Bilello did not respond to a request for the text of the regulations.The two TSA senior officials said the level of activity around the proposal this year -- the formation of a working group to conduct a risk and cost analysis -- mean this is more than an annual exercise.The documents said a TSA working group of 20 people, including a representative of the agency's administrator's office, met on June 21 to examine the potential risks of the policy change. An internal TSA memo dated July 17 from TSA Director of Enterprise Performance and Risk Strategy Jerry Booker to the TSA administrator's chief of staff, Ha Nguyen McNeill, outlines the group's findings. It contains no formal recommendation. 3761