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HRA Pharma bids to bring first OTC contraceptive pill to US

Perrigo’s HRA Pharma subsidiary has become the first drugmaker in the US to seek approval for an over-the-counter
The post HRA Pharma bids to bring first…



Perrigo’s HRA Pharma subsidiary has become the first drugmaker in the US to seek approval for an over-the-counter contraceptive pill.

The move comes as access to birth control becomes a pivotal issue following the landmark ruling by the Supreme Court last month to strip US women of their constitutional protection for the right to abortion, although the company says that the timing is a coincidence.

HR Pharma has filed for a prescription to OTC switch for Opill, a decades-old daily progestin-only pill, just a few weeks after its $2 billion takeover by Ireland headquartered Perrigo completed.

The company’s chief strategic operations and innovation officer – Frédérique Welgryn – said that the application “marks a ground-breaking moment in contraceptive access and reproductive equity in the US”, where there are around 3 million unintended pregnancies every year.

“More than 60 years ago, prescription birth control pills in the US empowered women to plan if and when they want to get pregnant,” she added.

“Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

Access to birth control is more important than ever after Roe v Wade was struck down, amid reports that anti-abortion campaigners in the US is now turning its attention elsewhere.

The two-drug mifepristone/misoprostol regimen, which has become the most common way to end pregnancies in the US since the start of the pandemic, is now firmly in their sights.

HRA Pharma is anticipating that the FDA will hold an advisory committee meeting to discuss the Opill switch, and thinks it may be able to get approval in the first half of next year if all goes to plan.

The application has been in the works for several year, Welgryn told the New York Times, so the timing is “a bit coincidental.”

It also comes as President Joe Biden has moved to expand access to birth control in the wake of Roe v Wade, signing an executive order that asks the Department of Health and Human Services (HHS) to expand access to reproductive health services including intrauterine devices, birth control pills, and emergency contraception.

HRA Pharma says that nearly a third of adult women in the US who have tried to obtain a prescription for birth control or a refill have reported difficulties doing so.

“For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach,” commented obstetrician-gynaecologist, Melissa Kottke.

“Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health.”

The post HRA Pharma bids to bring first OTC contraceptive pill to US appeared first on .

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Democrat Sen. Bob Menendez, Wife Indicted Over Gold Bar And Other Bribery Schemes

Democrat Sen. Bob Menendez, Wife Indicted Over Gold Bar And Other Bribery Schemes

Sen. Bob Menendez (D-NJ) and his wife Nadine have been indicted…



Democrat Sen. Bob Menendez, Wife Indicted Over Gold Bar And Other Bribery Schemes

Sen. Bob Menendez (D-NJ) and his wife Nadine have been indicted in New York for allegedly accepting bribes in relation to an allegedly corrupt relationship they had with three businessmen from their home state. The indictment also charges three businessmen, Wael Hana, Jose Uribe and Fred Daibes.

"Those bribes included cash, gold, payments toward a home mortgage, compensation for a low-or-no-show job, a luxury vehicle, and other things of value," reads the indictment.

Daibes, a developer and former bank chairman, allegedly gave Menendez gold bars valued at approximately $400,000, in exchange for assistance in a case in which he faced federal bank charges.

Instead of facing over 10 years in prison, Daibes, a felon, only ended up serving probation after striking an agreement with the US Attorney's Office in New Jersey.

"For purposes of the Federal Extortion Act, it makes no difference if the senator took an official act so long as he accepted the money and there was knowledge the money was in exchange for that official influence, even if he never carried out what he had promised he would do," according to NBC Legal Analyst Danny Cevallos.

Menendez disclosed that his family had accepted gold bars in 2020. Daibes encountered bank fraud charges that could have netted him up to a decade in prison for lying about a nearly $2 million loan from Mariner's Bank, where Daibes served as chairman.

Last year, however, New Jersey's U.S. Attorney's Office agreed to let Daibes plead guilty to one count and serve probation. They said Daibes had repaid the loan. -Fox News

According to the report, Menendez, 69, is 'close' with US Attorney Philip Sellinger - having supported him for the position, while Sellinger had previously raised funds for Menendez's campaign.

Bob Menendez and wife Nadine

Officials are also looking at whether Menendez, the former Chairman of the powerful Senate Foreign Relations Committee, or his wife, had improperly received gifts from a New Jersey food processor who obtained an exclusive contract with the Egyptian government to certify halal food experts around the world.

Egyptian officials and the New Jersey businessman who received the contract were hosted by Menendez in his office in 2018, according to the Wall Street Journal. A year later, the businessman became the "sole certifier of halal meat exported from the U.S. to Egypt," the outlet noted.

NBC News 4 said the gifts included the usage of a Mercedes and a luxury Washington, D.C., apartment. Investigators are attempting to resolve if Menendez, chair of the Senate Foreign Relations Committee, used his standing to help the man secure the contract. -Fox News

According to the indictment, Menendez provided 'sensitive US Government information to Egypt.'

Menendez and his wife are charged with three counts: conspiracy to commit bribery, conspiracy to commit honest services fraud, and conspiracy to commit extortion under color of official right.

In June of last year, federal agents searched Menendez's New Jersey home, where they found "fruits" of the pair's "corrupt bribery agreement" with the three businessman - including over $480,000 in cash, some of which was stuffed in envelopes, and $70,000 in Nadine Menendez's safe deposit box.

They also found gold bars worth over $100,000, "provided by either Hana or Daibes."

In the months before his office admitted he was under federal investigation, Menendez's wife sold up to $400,000 in gold bars between April 7, 2022 and June 16, 2022.

This is hardly the first time Menendez has been under federal criminal investigation.

Tyler Durden Fri, 09/22/2023 - 09:30

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Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

By all accounts, Zelensky came away from his Washington visit with…



Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

By all accounts, Zelensky came away from his Washington visit with nothing new. Biden did announce a fresh $325 million aid package for Ukraine from already committed funds, but the hoped-for long range missile approval never came (however, more cluster bombs are being sent). And as we detailed Thursday, House Republican leadership once again failed to move forward on a mere procedural vote for the Pentagon funding bill, due in large part to GOP members rejecting Biden's proposed $24 billion more in Ukraine aid.

Thursday's package announced by Biden, as Zelensky visited the White House and Capitol Hill, was run-of-the-mill and entirely to be expected. "Today I approved the next tranche of U.S. security assistance to Ukraine including more artillery, more ammunition, more anti-tank weapons and next week, the first U.S. Abrams tanks will be delivered to Ukraine," Biden said.

As for the earlier in the day (Thurs.) meeting with Congressional leaders, House Speaker Kevin McCarthy explained when asked why the Ukrainian leader's request to address Congress was denied, "Zelensky asked for a joint session, we just didn't have time. He's already given a joint session."


Instead in a closed-door meeting, Zelensky later acknowledged he discussed with lawmakers "the battlefield situation and priority defense needs."

But if there is any level of consolation for Kiev, it's seen in the Pentagon announcement which came late in the day Thursday. Facing potential US government shutdown on Oct.1st, given at this point Congress is not expected to pass the 12 appropriations bills needed to fund government operations before next fiscal year, the Pentagon has said it will exempt its operations supporting Ukraine from a shutdown. 

The military typically suspends any activities not deemed vital to national security during government shutdowns, thus the DoD is in effect saying Ukraine aid remains "vital to national security". 

"Operation Atlantic Resolve is an excepted activity under a government lapse in appropriations," Pentagon spokesman Chris Sherwood told Politico, in reference to the operational name still used for actions supporting Kiev.

But Politico points out a potential shutdown would still negatively impact US support to Ukraine:

Sherwood noted that while DOD’s activities related to Ukraine will continue, furloughs and other activities halted under the shutdown could still have a negative impact.

"Training would happen, but depending on whether or not there were certain personnel that were not able to report for duty, for example, that could have an impact," said Pentagon spokesperson Brig. Gen. Patrick Ryder on Thursday.

This Pentagon exemption to keep Ukraine-related support active during a government shutdown seems to be the only significant thing Zelensky came away with. 

It appears to have been the main object of discussion when Zelensky met with Secretary of Defense Lloyd Austin in Washington during the trip. The Pentagon said this was "to reaffirm the steadfast US support for Ukraine."

Meanwhile, Bloomberg takes note of Zelensky "showing the strain" amid increasing divisions among allies:

The Ukrainian president allowed a dispute with one of his biggest allies to spin out of control at the United Nations General Assembly this week, and that’s just a hint of the tensions building behind the scenes.

Zelenskiy has been leading his country through Russia’s brutal assault for 19 months, all the time fighting on another front to wring the weapons and finance he needs from his US and European supporters. Now he suspects that President Joe Biden’s commitment is wavering and other leaders may be taking their cue from the US, according to a person who met with him recently.

He grew very emotional at times during that discussion, the person said, and was scathing in his criticism of nations that he said weren’t delivering weapons quickly enough.

Washington's lackluster greeting of Zelensky this week (compared to how he was received in December 2022) came simultaneous to Poland declaring it will no longer arm Ukraine, amid a fierce diplomatic spat over blockage of Ukraine grain imports by Warsaw, to protect Polish farmers.

The Economist is also taking note of the significant mood shift among Western allies...

A "long war" indeed... given a G7 leader from a European country has told reporters this week that the West is prepared for a years-long war, something likely to last some six or seven years, according to the quote.

"A senior official from one European G-7 country said the war may last as much as six or seven more years and that allies need to plan financially to continue support for Kyiv for such a long conflict," Bloomberg wrote.

Tyler Durden Fri, 09/22/2023 - 10:15

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Michael Bloomberg puts up $500M to shut down this controversial industry

The businessman and former New York City mayor is investing big money for a high-powered campaign.



Years ago, a rich person or company would indicate wealth by donating libraries and orphanages or traverse the world in bespoke yachts or aircraft.

You may commission a boat to extract an enemy submarine off the depths of the ocean floor. Perhaps you'd get an ivy league school of public policy and government named in your honor. If you were really industrious, you might even gather a bunch of your high-powered banker friends in a locked room on a distant island off the coast of Georgia to establish what we now call the Federal Reserve. 

DON'T MISS: China is no longer the leading exporter to U.S. (here's who is)

Nowadays, however, it's quite in vogue to gather large stockpiles of your cash and put it to work not for your people or your country. Billionaires think much bigger than that. If you're really rich, you put your money to work for the good of planet Earth. 

Take, for example, Microsoft  (MSFT) - Get Free Report and Amazon  (AMZN) - Get Free Report, who both recently pledged hundreds of millions of dollars between the two to capture carbon out of the atmosphere and dispose of it where it may no longer be accessed. 

Businessman and former New York City Mayor Michael Bloomberg is the latest billionaire to take a stab at the seemingly unsolvable climate crisis – and he's putting a vast sum of his money up to the challenge. 

Aerial view of Jon Amos Power plant shows smoke stacks and cooling, Coal, Poca, West Virginia. (Photo by: Visions of America/Joseph Sohm/Universal Images Group via Getty Images)

Joe Sohm/Visions of America/Getty Images

Michael Bloomberg pledges millions to fight coal

Bloomberg's charitable organization, Bloomberg Philanthropies, announced on Wednesday that it would front $500 million to shut down all existing coal plants in the U.S. and prevent future natural gas plants from being constructed. 

The pledge may sound anti-industrialist, but Bloomberg's "Beyond Carbon" initiative claims it will "turbocharge," environmental progress. 

The initiative includes the following bullet points: 

  • Finish the job on coal. With 372 of 530 coal plants announced to retire or closed to date – more than 70 percent of the country’s coal fleet – this next phase will shut down every last U.S. coal plant.
  • Slash gas plant capacity in half, and block all new gas plants.
  • Increase U.S. clean energy four-fold. Accelerate the clean energy transition to reach the goal of 80 percent of total electricity generation.

"Bloomberg Philanthropies has helped retire more than 70 percent of all U.S. coal plants, which accounts for more than 80 percent of all emissions reductions in the United States since 2010," Bloomberg, who's a special envoy on climate ambition and solutions to the U.N. proudly announced on Wednesday. 

Beyond Carbon will also fund the following organizations as a part of its mission toward progress: 

  • Earthjustice
  • Hip Hop Caucus
  • Sierra Club
  • RMI
  • League of Conservation Voters
  • Advanced Energy United
  • Coalfield Development

No stranger to controversy, Bloomberg has supported a number of divisive policies during his tenure in the public eye, including calls for banning polystyrene foam that is commercially known as Styrofoam, smoking, trans fats, and restricting sugary drinks in some public businesses. 

Now, it seems the billionaire is more concerned about climate change as a threat to public health than fat or soda. 

"This work has helped achieve more than 80 percent of all U.S. emissions reductions since 2010 and plant closures from the campaigns are estimated to have saved 49,900 lives, prevented nearly 77,500 heart attacks, and saved billions in healthcare costs," Bloomberg Philanthropies writes.

"But the U.S. is now at a pivotal moment — without rapid progress on clean energy, we will fail to meet our U.S. climate targets, and public health risks will skyrocket. Beyond Carbon’s next phase will ensure the U.S. delivers on our global climate commitments by retiring the last remaining coal plants, stopping the expansion of natural gas, and quadrupling clean energy capacity while continuing to prioritize environmental justice and workforce transition."

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