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FDA Approves First-Ever Injectable to Prevent HIV

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The Food & Drug Administration (FDA) approved a new drug Monday that will allow patients to ditch the daily pill and receive treatment every two months. The drug, named Apretude, is being considered the first long-acting injectable medication for use as pre-exposure prevention, or PrEP, against HIV.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, said in a statement. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”

According to the U.S. Centers for Disease Control and Prevention (CDC), notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25 percent of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3 percent in 2015. However, there remains significant room for improvement.

PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.

The FDA tested the safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.

Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.

Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.

Apretude has been granted a Priority Review and Breakthrough Therapy designation. The FDA granted the approval of Apretude to ViiV Healthcare, which is majority owned by GlaxoSmithKline.

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Florida GOP Lawmaker Who Wrote ‘Don’t Say Gay’ Bill Facing Up to 35 Years After Pleading Guilty in COVID Fraud Case

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Joe Harding, the now-former Florida Republican lawmaker who authored the extremist “Don’t Say Gay” bill could face up to 35 years in prison after pleading guilty Tuesday afternoon to federal felony fraud charges in a scheme to obtain $150,000 in COVID-19 relief funds, according to Florida Politics‘ publisher Peter Scorsch.

Harding, 35, was a construction project manager who started his own lawn care company. He quickly became a right-wing darling after his anti-LGBTQ legislation, officially the Parental Rights in Education Act, was embraced by Florida GOP Governor Ron DeSantis, who signed it into law.

Harding was charged in a December federal indictment with six counts of wire fraud, money laundering, and making false statements in his plot to obtain $150,000 in COVID funds.He resigned from the legislature the following day. He originally pled not guilty.

READ MORE: ‘Chilling’: Law Enforcement ‘Seriously’ Investigating Threats Ahead of Possible Trump Indictment Says Top WaPo Reporter

After Harding was charged and resigned, Nadine Smith, the executive director of Equality Florida, responded via social media, saying: “So much harm to students, parents and teachers because of his raw political ambitions. He slandered entire communities and trafficked in lie after lie that has emboldened violent bigotry. He will have his day in court but his legacy is already a despicable one.”

Harding is not the only family member accused of criminal acts.

“Harding’s indictment follows a September guilty plea from his brother-in-law, Patrick Walsh,” Florida Politics reported in December. “As reported by Fresh Take Florida, Walsh pleaded guilty to wire fraud and money laundering charges connected to his receipt of nearly $8 million in disaster relief loans.”

Unrepentant to the harm many feel he has done to children and the LGBTQ community, in a statement Tuesday Harding said: “During the past legislative session I have felt the support of millions of Americans while fighting for our shared concerns and for the rights of parents. I will never forget the support I received from every corner of this great country.”

READ MORE: 18 Attorneys General Blast Florida’s “Don’t Say Gay” Law as Unconstitutional

Harding will be sentenced in July.

Florida’s Voice also reported Harding’s guilty plea Tuesday.

 

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Trump Calls for Congress to Investigate NY AG After Judge Refuses to Delay $250 Million Fraud Trial Against Ex-President

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Minutes before Manhattan Supreme Court Justice Arthur Engoron was to gavel in late Tuesday morning, a bomb threat was called in to 911, delaying a pre-trial hearing in New York Attorney General Letitia James’ $250 million civil fraud lawsuit against Donald Trump and his adult children, but only for about 30 minutes.

Over the weekend Trump urged his supporters to “protest,” and “take our country back.” He also claimed he would be indicted on Tuesday. It’s not known who called in the bomb threat, but it wasn’t the delay Trump’s attorneys were hoping for.

Once the hearing began, Trump’s attorneys asked the judge for a six-month delay, Law & Crime reports.

They were denied.

They then asked for a delay of a few weeks.

They were denied again.

READ MORE: ‘Like Al Capone Complaining About Organized Crime’: Jim Jordan Slammed for Demanding Manhattan DA Testify

“I don’t want to move this trial, not only because I said I don’t want to move it,” Justice Engoron said.

“That’s written in stone,” he added.

“This case is complex, but it’s not complicated,” Engoron explained. “It all boils down to whether the statements of financial condition are true, and the rest as Rabbi Hillel famously said, is all commentary.”

After the hearing ended Trump called for Congress to investigate Attorney General James.

“While Congress is at it, they should look at the Corrupt Attorney General of New York State, Letitia James, who got elected solely on a ‘I WILL GET TRUMP’ platform, without knowing anything about me,” Trump alleged on his Truth Social platform.

“She then brought a completely bogus lawsuit, which is presided over by an A.G. picked, Trump hating Judge, a political hack whose Court this case should not be in – It shoud [sic] be in the Commercial Division, but he wouldn’t let go, is pushing it hard, and knows exactly what he wants to do….”

As Law & Crime notes, Attorney General James “alleges that Trump, his children and his businesses have a pattern of wildly inflating or deflating their assets to reap tax benefits. She claims that Trump estimates the size of his Trump Towers triplex at three times its actual square footage. Trump Organization also valued rent-stabilized units more than 66 times higher than an outside appraiser, she says. These discrepancies and others, she says, warrant her massive proposed civil penalty.”

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‘Like Al Capone Complaining About Organized Crime’: Jim Jordan Slammed for Demanding Manhattan DA Testify

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House Republican Judiciary Chairman Jim Jordan is under fire after sending notice to Alvin Bragg on Monday demanding the Manhattan District Attorney currently investigating Donald Trump’s possibly unlawful payoff to Stormy Daniels testify before Congress to explain the ongoing case.

Legal experts have said Jordan’s letter, which was also signed by the powerful House Oversight Chair Jim Comer, could be considered obstruction of justice.

Late Tuesday morning Jordan took to Twitter to defend his actions, which many see as an attempt to intimidate the Manhattan DA and interfere with the potential prosecution of the ex-president.

“Democrats think it’s ok for them to examine and defund local police,” Jordan said. “But not ok for Republicans to examine a local prosecutor in Manhattan abusing his power to take down a political opponent.”

READ MORE: Trump’s Lawyer in Stormy Daniels Case Back in 2018 Called Hush Money Payoff ‘Illegal’: Report

The Judiciary Chair, who has a law degree from Capital University in Ohio, appeared to not understand that he does not have oversight authority over a duly-elected county district attorney.

Attorney Ron Filipkowski, a Republican turned Democrat, slammed Jordan’s remarks.

“This makes literally no sense whatsoever. Local police are funded locally. Democrats aren’t seeking to haul local prosecutors in front of Congress for anything. This is a naked abuse of federal power over something Congress has no jurisdiction over.”

Former federal prosecutor Glenn Kirschner, now an NBC News and MSNBC Legal Analyst, called Jordan’s and Speaker Kevin McCarthy’s actions “a dramatic and transparent abuse of power.”

READ MORE: Republicans Are ‘Obstructing Justice’ and ‘Becoming Accessories’ to Trump’s ‘Crimes’: Former Prosecutor

Aaron Fritschner, Deputy Chief of Staff for U.S. Rep. Don Beyer (D-VA) called Jordan’s letter, “stupid and embarrassing” three times, and, called Jordan’s attempt at oversight of a county DA “is invalid, unconstitutional, inappropriate, stupidly pretextual and political.”

District Attorney Bragg, Fritscher continued, “will be on rock solid legal ground if he should decide to use their letter to kill insects or remove avian waste, but in the meantime we who have seen and written legitimate oversight letters in the past imo should mock Jordan, Comer et al for their hilarious incompetence.”

Others on Capitol Hill also mocked Jordan.

“A kangaroo investigation has been opened by Jim Jordan and the House GOP into the Manhattan DA, Alvin Bragg,” U.S. Rep. Ritchie Torres (D-NY) tweeted. “Republicans complaining about the weaponization of government is like Al Capone complaining about organized crime.”

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