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Monday, March 6, 2023

Walgreens to dispense abortion pills in states where legal

  Walgreens Boots Alliance Inc said on Monday that it plans to dispense abortion pill Mifepristone in any jurisdiction where it is legally permissible to do so.

"Once we are certified by FDA, we will dispense this medication consistent with federal and state laws," the company said in a statement

https://finance.yahoo.com/news/walgreens-dispense-abortion-pills-states-000140604.html

White House may restart detention of migrant families - sources

 The White House is considering restarting the detention of migrant families caught crossing the U.S.-Mexico border, four current and former U.S. officials told Reuters, which would reverse a move to end the practice.

The Biden administration also is weighing reviving immigration arrests of migrant families within the United States who have been ordered deported, two of the officials said.

"It's all on the table," said one of the officials, all of whom requested anonymity to discuss internal deliberations.

The Biden administration is exploring options as it prepares for a possible rise in border crossings with COVID-19 restrictions blocking migrants expected to lift on May 11.

President Joe Biden, a Democrat who took office in 2021, pledged to reverse the more restrictive immigration policies of Republican former President Donald Trump but has embraced some of his measures as border arrests soared to record levels.

A U.S. Department of Homeland Security spokesperson said that no final decisions had been made and that "the administration will continue to prioritize safe, orderly, and humane processing of migrants."

The New York Times first reported the possible restart of family detention.

The Biden administration has discussed using two Texas detention centers that previously housed families, three of the U.S. officials said.

A separate Biden official, when asked about reviving family detention in those two centers, said that idea was no longer under consideration.

The Biden administration said in a February 2022 memo that it was repurposing family detention centers to hold only adults, a major shift away from Trump's push to expand such detention.

Neha Desai, who represents migrant children in a decades-long lawsuit that governs conditions for their detention, criticized the possible detention restart.

"Even in conditions that actually meet minimum standards of health and safety, there is absolutely no humane way to detain families," she said.

https://www.yahoo.com/news/white-house-may-restart-detention-041840761.html

Mexico finds 343 migrants in abandoned truck trailer

 Mexican authorities have found 343 migrants, including 103 unaccompanied minors, in an abandoned freight truck container on the side of a highway, the authorities said Monday.

The National Immigration Institute said the trailer was found Sunday night in the steamy Gulf coast state of Veracruz.

It was on a route often used by smugglers to bring people from southeastern Mexico to the U.S. border.

The migrants were well, and it was unclear why the driver fled, authorities said.

Migrants have been found dead inside abandoned freight containers in the past. But the migrants found Sunday were unharmed, and the conditions in the container illustrate the increasing sophistication of migrant smugglers.

The trailer had fans and ventilation ports cut in the roof, and the migrants wore color-coded bracelets, apparently to identify them as smugglers’ clients.

Most of the unaccompanied minors were from Guatemala. Migrants who make it to the United States frequently pay smugglers to bring their children afterward.

The institute said the adult migrants were mainly from Guatemala, Honduras, El Salvador and Ecuador.

https://www.yahoo.com/lifestyle/mexico-finds-343-migrants-abandoned-180452732.html

China warns US against suppressing it or risk 'conflict'

 The U.S. should change its recent mistaken policies towards China or "conflict and confrontation" will follow, China's foreign minister said on Tuesday, while reiterating Beijing's call for dialogue to end the conflict in Ukraine.

The U.S. has been engaging in suppression and containment of China rather than fair or rule-based competition, Foreign Minister Qin Gang told a news conference in Beijing on the sidelines of an annual parliament meeting.

"The United States' perception and views of China are seriously distorted," Qin said."It regards China as its primary rival and the most consequential geopolitical challenge. This is like the first button in the shirt being put wrong."

Relations between the two superpowers have been tense for years over a number of issues including Taiwan, trade and war in Ukraine but they worsened after controversy involving a balloon which the U.S. said was a Chinese spying device and shot down last month.

The U.S. says it is establishing guardrails for relations with China and is not seeking conflict, but what this means in practice is that China is not supposed to respond with words or actions when slandered or attacked, Qin said.

"That is just impossible," he said. "If the United States does not hit the brake, and continues to speed down the wrong path, no amount of guardrails can prevent derailment, which will become conflict and confrontation and who will bear the catastrophic consequences?"

INVISIBLE HAND?

Elsewhere during Tuesday's news conference Qin said an "invisible hand" was pushing for the escalation of the war in Ukraine, without specifying who he was referring to.

The "invisible hand" is "using the Ukraine crisis to serve certain geopolitical agendas", Qin said, whilst also reiterating China's call for dialogue.

China has fiercely defended its stance on Ukraine, amidst Western criticism of its decision not to call Russia the aggressor in the conflict.


Regeneron: Dupixent for Chronic Spontaneous Urticaria Accepted for FDA Review

  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care, H1 antihistamine treatment. The target action date for the FDA decision is October 22, 2023.

CSU is an inflammatory skin condition driven in part by type 2 inflammation, which causes sudden and debilitating hives and swelling on the skin. Swelling, called angioedema, may occur most commonly on the face, hands and feet, but can also affect the throat and upper airways. CSU is typically treated with H1 antihistamines, medicines that target histamine-1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled in up to 50% of patients, who are left with limited alternative treatment options. These individuals continue to experience symptoms, including persistent itch or burning sensations that can be debilitating and significantly impact quality of life.

https://www.biospace.com/article/releases/dupixent-dupilumab-application-for-treatment-of-chronic-spontaneous-urticaria-csu-in-adults-and-adolescents-aged-12-years-and-older-accepted-for-fda-review/

BioMarin: FDA Extends Review for Gene Therapy for Adults with Severe Hemophilia A

 FDA Extends PDUFA Target Action Date to June 30, 2023

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that it received notice this afternoon from the U.S. Food and Drug Administration (FDA) that the agency has extended review of the company's Biologics License Application (BLA) for ROCTAVIAN™ (valoctocogene roxaparvovec) gene therapy for adults with severe hemophilia A.

The FDA determined that the submission of the three-year data analysis from the ongoing Phase 3 GENEr8-1 study constituted a Major Amendment due to the substantial amount of additional data and set a new PDUFA Target Action Date of June 30, 2023. The company had previously communicated that this data submission could be qualified as a Major Amendment. 

The Phase 3 study, which included 134 participants, is the longest and largest to date for a gene therapy in hemophilia.

https://www.biospace.com/article/releases/biomarin-provides-update-on-fda-review-of-roctavian-valoctocogene-roxaparvovec-gene-therapy-for-adults-with-severe-hemophilia-a/

Lots of Dems Want to Sunset Medicare – No Joke!

 Perhaps President Biden misread the teleprompter at his State of the Union address when he claimed that Republicans want to “sunset” Medicare. The truth: Many Democrats are on record calling for the end of Medicare.

Last year, more than half of all House Democrats joined Rep. Pramila Jayapal (D-Wash.) in cosponsoring H.R. 1976 , the “Medicare for All Act,” which would have “sunset” Medicare. In the Senate, 14 Democrats cosponsored companion legislation by Sen. Bernie Sanders (I-Vt).  

Of course, these politicians do not advertise the fact that their legislation would abolish Medicare. Instead, they played word games by entitling it “Medicare for All.” That way, people would think the bills aimed expanding Medicare as we know it.

In fact, Title IX, Section 901(a)(1) of the House bill reads: “with respect to an individual eligible to enroll under this Act… no benefits shall be available under title XVIII of the Social Security Act,” two years after this bill is enacted. 

Title XVIII is, of course, the federal law establishing Medicare.

So, “Medicare for All Act” is in fact “Medicare for None.” The House and Senate “Medicare for All” bills would create an entirely new government-run national health insurance system.

No longer devoted to meeting the unique needs of seniors, the program would try to serve everyone. The Secretary of Health and Human Services would oversee this massive bureaucratic expansion, drafting, implementing and enforcing detailed rules and regulations governing every aspect of health care. Funding for the giant system would be subject, of course, to the annual circus known as the congressional budget process.

To create this new government-run program, “Medicare for All” would not only “sunset” Medicare; it would eliminate virtually all existing private and employer-sponsored health insurance as well as major public health programs such as Medicaid, the State Children’s Health Insurance Program, the Obamacare health plans, and even the Federal Employees Health Benefits Program. Only the troubled Veterans Administration health program and Indian Health Service would remain.

Disregard any congressional promises of big budget savings, or a reduction in the health costs of most Americans. Unprecedented levels of high taxation are guaranteed.

In addition to outlawing virtually all other health coverage options, “Medicare for All” would also impose restrictions (meticulously outlined in Section 303 of the House bill) on patients’ ability to secure independent medical care from physicians.  

Such legislation gives seniors a lot to lose—especially those who have enrolled in Medicare Advantage, the system of competing private health plans offered as an alternative to traditional Medicare. Today, more than 46 percent of seniors are enrolled in these plans, and rapidly accelerating enrollment will soon make Medicare Advantage the dominant form of Medicare coverage for seniors.

Medicare Advantage enrollment is strong across the country, but it is heaviest in some of the nation’s most liberal (‘blue’) states. According to data from the Center for Medicare and Medicaid Services: 52.3% of all Medicare beneficiaries in Connecticut are enrolled in Medicare Advantage; 51.9% in Hawaii; 55.7% in Minnesota; 48.8% New York; 48.7% in California, and 55.3 percent in Rhode Island.

Even in Washington State, home of Rep. Jayapal, the chief House sponsor of the “Medicare for All Act,” 42.8% have chosen Medicare Advantage. Yet, “Medicare for All” supporters want to eliminate these options for citizens in their own states.

The growing popularity of Medicare Advantage is not hard to explain. These plans can deliver traditional Medicare benefits at less cost than traditional Medicare itself, therefore they can provide seniors with richer benefits or lower premiums. Based on data from the Medicare Payment Advisory Commission, 43 percent of Medicare Advantage  enrollees have signed up for health plans that offer traditional Medicare benefits at 80%-90% percent of traditional Medicare spending in their area.

Seniors find Medicare Advantage plans convenient as well as cost-effective. Most pay a single premium that covers a comprehensive set of health benefits outside of what traditional Medicare offers, including prescription drugs and caps on out-of-pocket costs—a crucial protection from the financial devastation of catastrophic illness. And, they do not have to pay extra premiums to purchase supplemental coverage. Moreover, studies show that the quality of care provided through Medicare Advantage plans is generally better than traditional Medicare.

Democrats may believe a cynical “Medi-scare” campaign that frightens vulnerable seniors is “good” politics. But before President Biden spends anymore airtime on national television scaring America’s seniors, he should have a heart-to-heart talk with his liberal Democratic colleagues. It is their legislation that should scare seniors the most.

Robert E. Moffit is a senior research fellow in The Heritage Foundation’s Center for Health and Welfare Policy.

https://www.realclearhealth.com/articles/2023/03/06/memo_to_president_biden_lots_of_dems_want_to_sunset_medicare__no_joke_111471.html