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Wednesday, December 7, 2022

Alvotech and STADA Broaden Access to Hukyndra® adalimumab biosimilar in Europe

 

  • Hukyndra® (adalimumab) launches in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia, increasing availability of high-concentration, citrate-free adalimumab in Europe

  • Follows initial introduction of Hukyndra in nine countries: Austria, Estonia, Finland, France, Germany, Lithuania, Slovakia, Sweden, and Switzerland

  • Adalimumab is first product launched through an exclusive strategic partnership announced by Alvotech and STADA in November 2019 covering biosimilar candidates across immunology, oncology, and ophthalmology indications

Tuesday, December 6, 2022

Loudoun County Situation Is Probably Worse Than You Thought – Certainly Worse Than You Were Told

 Over the past year and a half I wrote a few posts on Loudoun County and how the “narrative” about it was often at odds with the facts on the ground. From an October 2021 post:

A common response to those posts was the idea this Loudoun controversy was all partisan, it was transphobic, it was much ado about nothing. In fact, the local newspaper, The Washington Post, could barely be bothered to report on it in any depth until today. It was freelance journalist Matt Taibbi – far from a local – who did the most definitive deep dive.

This is the key takeaway from a grand jury report released today about Loudoun’s handling of two sexual assaults:

There really aren’t words for such a failure of institutional responsibility to young people. It reminds me a lot of Parkland although thankfully no one was killed.

The report also includes chapter and verse of the school division’s effort to thwart this investigation. Too much to pull quote here, but if you think this entire parents rights and transparency issue is BS that Glenn Youngkin cooked up, well just read it.

Education media, that assiduously managed to avoid this story, might ask themselves why? The role of journalists is to ferret out facts, not parrot political narratives. That it was the Daily Wire or Taibbi looking into this rather than, or at least in addition to, our sector’s ed media (and hometown paper The Post) is a blemish on the sector. Stuff like this is inexplicable, a kid was raped. A preventable assault happened.

The tell should have been that every time, multiple times, the courts had an opportunity to shut down this investigation they didn’t. The most sensational narratives – from the idea on the right that trans students were marauding in bathrooms to the idea on the left that this was all BS – should have been suspect. But it was clear something was going on and local officials were not being transparent.

Education advocates and leaders might ask why they, too, as with Parkland, lost their voice in the face of a politically complicated set of circumstances where, again, we are talking about fundamental issues of student safety.

Seems like that applies more broadly than just LCPS?

http://www.eduwonk.com/2022/12/loudoun-county-situation-is-probably-worse-than-you-thought-certainly-worse-than-you-were-told.html

Same-sex marriage bill pits Biden against Catholic bishops again

 President Biden is butting heads with Catholic bishops again, this time over same-sex marriage protections expected to reach his desk this week.

The U.S. Conference of Catholic Bishops (USCCB) opposes the Respect for Marriage Act, arguing it doesn’t include enough leeway for religious organizations.

“I disagree,” Biden, only the second Catholic president in U.S. history, told reporters on Tuesday about the bishops’ objections.

The fight between Biden and the bishops is all too familiar after the they spent much of his first year in the White House trying to deny him communion over his stance on abortion rights.

Conservative Catholic bishops had called for the church not to offer communion to Biden or other pro-abortion rights politicians, but, in November of last year, the USCCB signaled an end to the debate by issuing a document on communion without mentioning the president or other politicians.

Before the document was finalized, Biden received support from Pope Francis, who the president said told him he should keep receiving communion.

Throughout his time as president, Biden has consistently called for protections for abortion access, and he has often been found attending Catholic mass either in Wilmington, Del., or in Washington.

Biden also regularly calls for defending the rights of LGBTQ Americans.

He has urged Congress to send him the Senate-passed bill that would repeal of the 1996 Defense of Marriage Act, which recognized marriage as “only a legal union between one man and one woman as husband and wife.”

The White House describes the Respect for Marriage Act as “personal” to the president, presenting another balancing act for Biden between his faith and his support for a social issue that is in opposition to the church’s teaching.

The House is posed to pass the bill this week after the Senate cleared the measure last week in a 61-38 vote. Twelve Republicans joined on to the bill once it included an amendment outlining some protections for religious beliefs.

That amendment was also crucial for gaining support from religious institutions because it shields them from having to provide services supporting same-sex marriage. Faiths and groups including the Church of Jesus Christ of Latter-day Saints, the Seventh-day Adventist Church, the Union of Orthodox Jewish Congregations of America and the Council for Christian Colleges and Universities all support the religious freedom protections in the bill.

But the changes haven’t been enough for the Catholic bishops.

“This bill fails to include clear, comprehensive, and affirmative conscience protections for religious organizations and individuals who uphold the sanctity of traditional marriage that are needed,” said Bishop Robert E. Barron, chairman of the USCCB’s committee on laity, marriage, family life and youth.

Barron added that “decades of social and legal developments” have led to society losing sight of the “purpose of marriage.”

Same-sex marriage has been legal nationwide since the Supreme Court’s 2015 ruling in Obergefell v. Hodges, while the Catholic Church is one of several that only recognizes marriage as a union between a man and a woman.

The debate over same-sex marriage was resurrected this summer when the Supreme Court ended the decades-long right to abortion access by overturning Roe v. Wade. In Justice Clarence Thomas’s concurring opinion for that ruling, he called on the court to also reconsider the precedent for Obergefell v. Hodges.

Since then, Biden and other Democrats have sought to move quickly to protect marriage equality, and the White House celebrated the Senate passing the bill as a historic step.

https://thehill.com/homenews/administration/3764086-same-sex-marriage-bill-pits-biden-against-catholic-bishops-again/

China may announce 10 new COVID easing steps on Wednesday

 China may announce 10 new COVID-19 easing measures as early as Wednesday, two sources with knowledge of the matter told Reuters, supplementing 20 unveiled in November that set off a wave of COVID easing steps nationwide.

Three years of zero-tolerance measures, from shuttered borders to frequent lockdowns, have battered China's economy, fuelling last month the mainland's biggest show of public discontent since President Xi Jinping took power in 2012.

Management of the disease may be downgraded as soon as January, to the less strict Category B from the current top-level Category A of infectious disease, the sources said on Monday, speaking on condition of anonymity.

The National Health Commission did not immediately respond to a Reuters fax message seeking comment.

Last week, Vice Premier Sun Chunlan said China was facing "a new situation" as pathogenicity of the Omicron virus weakened, becoming the first high-ranking official to publicly acknowledge that the new variant's disease-causing ability had diminished.

Many major cities have since started to lift wide lockdowns, reduce regular PCR testing and end checks for negative tests in public spaces, such as subway stations and parks.

The national health authority had earlier announced a score of new measures on Nov. 11, in the effort to improve COVID management and strike a better balance between epidemic control and shoring up the economy.

China will allow home quarantine for some of those testing positive, among the supplementary measures set to be announced, two sources told Reuters last week.

That would be a key change in strategy from earlier this year, when entire communities were locked down, sometimes for weeks, after just one positive case.

Last month, new, easier quarantine rules required just the lockdown of affected buildings.

Since January 2020, China has classified COVID-19 as a Category B infectious disease but managed it under Category A protocols, giving local authorities the power to quarantine patients and their close contacts and lock down regions.

https://www.yahoo.com/news/exclusive-china-may-announce-10-082324657.html

Unsubstantiated price hikes drove U.S. drug spending up $805 million in 2021

 Price increases spread among seven of the 10 drugs in 2021 behind an $805 million increase in U.S. spending from the prior year were not supported by clinical evidence, an influential U.S. pricing research firm said on Tuesday.

The Institute for Clinical and Economic Review (ICER) said the spending increase in 2021 was still less than the $1.67 billion rise in the previous year. This is the third year the group has looked at the top 250 drugs by spending and assessed if those driving U.S. spending increases were justified.

"Last year, a huge part of the (increase in) spending was all one drug...in this year, we saw the increase was more spread out across different drugs," ICER's Chief Medical Officer David Rind told Reuters.

In 2020, Abbvie's rheumatoid arthritis therapy Humira led to an almost $1.4 billion increase in U.S. drug spending, accounting for over 80% of the total increase.

Rind said Humira dropped off the ten costliest prescription drug list as its net price hike was lower in 2021. Since there was no single drug which drove the increase in spending this year, the rise is also relatively smaller compared to 2020, he added.

Bausch Health's Xifaxan, an antibiotic drug for traveler's diarrhea, led to an increase of nearly $175 million in spending, among the highest this year.

Johnson & Johnson's schizophrenia therapy Invega Sustenna and Amgen's osteoporosis drug Prolia followed closely with spending increases of $170 million and $124 million, respectively.

All three drugmakers did not immediately respond to Reuters' requests for comment.

President Joe Biden's signature Inflation Reduction Act will allow the government to choose 10 drugs to negotiate from among the 50 costliest drugs for Medicare, the government healthcare program for people aged 65 and older or disabled, starting in 2026.

https://www.yahoo.com/news/price-hikes-medicare-therapies-unsupported-130903848.html

French drug agency says under investigation over thyroid drug

 France's ANSM national drug agency said it is under formal investigation on suspicion of issuing misleading information regarding German drugmaker Merck's thyroid drug Levothyrox, adding it contested the provisional charges.

"The ANSM has never denied the difficulties encountered by some patients during the changeover to the new Levothyrox formula and works each and every day for the safety and health of patients," ANSM said in a statement late on Monday.

The French Association of Thyroid Patients on Tuesday welcomed the development, but expressed disappointment that the provisional charges had not been more far-reaching.

In an earlier civil litigation, France's highest court in March upheld a ruling that ordered Merck to pay 1,000 euros ($982) each to more than 3,300 people with thyroid problems in France after it changed the formula of Levothyrox in 2017.

The plaintiffs said Merck's decision to remove lactose from the drug to make it easier to handle had resulted in side effects such as memory loss, weight gain and palpitations.

A court in the French city of Marseille had in October already placed Merck under formal investigation, meaning it is treated as a formal suspect but the case may yet be dropped.

Merck said in October the investigation against it did not concern in any way the new formula for Levothyrox, but the way it provided information when changing from the old one.

https://finance.yahoo.com/news/french-drug-agency-says-under-154246656.html

Top Marine Genera: COVID-19 Vaccine Mandate Led To Decline In Military Recruitment

 by Katabella Roberts via The Epoch Times,

A top general in the Marine Corps has acknowledged that the COVID-19 vaccine mandate is hampering its recruitment goals, but he credited the requirement with keeping military personnel healthy.

Marine Corps Commandant Gen. David Berger made the comments during a panel discussion at the Reagan National Defense Forum in Simi Valley, California, on Dec. 3.

“Where it is having an impact for sure is on recruiting, where in parts of the country there’s still myths and misbeliefs about the backstory behind it,” Berger said, Military.com reported.

The general noted that the requirement for military personnel to be fully vaccinated has created recruitment issues in the south of the country in particular.

“There was not accurate information out early on and it was very politicized and people make decisions and they still have those same beliefs. That’s hard to work your way past, really hard to work,” he said.

However, Berger also credited the vaccines for preventing deaths among the Marines, stating that they were needed in order to “maintain a healthy unit that can deploy, on ship, ashore.”

Berger’s comments come as House Minority Leader Kevin McCarthy (R-Calif.) has pledged not to pass the annual National Defense Authorization Act (NDAA) if the military COVID-19 vaccine mandate remains in place.

Military Not Meeting Recruitment Goals Right Now

Speaking on the “Ingraham Angle” on Monday, McCarthy, who looks set to be the next speaker of the House, said he has spoken with President Joe Biden regarding the bill and made it “very clear from the very beginning,” that the NDAA will not pass unless the vaccine mandate for military men and women is lifted, citing a decline in recruitment.

The vaccine mandate was announced by the Marine Corps in September 2021 and has faced multiple legal challenges.

“Why? They are not meeting the recruitment goals right now because of this. People are leaving,” McCarthy said. 

“I told the president if we don’t have the lifting of the vaccine, I’ll do it in January.”

As of August, 3,299 Marines had been separated from the Corps for refusing to get vaccinated, Marine Corps Times reported. Separate data from the Defense Department peg that number at 3,717.

Meanwhile, roughly 96 percent of the Marines’ active-duty force is fully vaccinated, according to the latest monthly COVID-19 update from the Marines (pdf), while 99 percent are at least partially vaccinated.

A total of 96 percent of reserves are fully vaccinated and another 96 percent are partially vaccinated too, according to the update.

The White House has said Biden is considering dropping the mandate but that he ultimately supports Defense Secretary Lloyd Austin’s recommendation to keep it in place.

“Discussions about the NDAA are ongoing,” White House spokeswoman Olivia Dalton said on Monday.

https://www.zerohedge.com/military/top-marine-corps-general-admits-covid-19-vaccine-mandate-has-led-decline-military