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Thursday, December 8, 2022

Dexcom G7 CGM Receives FDA Clearance

 

  • Dexcom G7 is now cleared in the U.S. for people with all Types of diabetes ages two years and older, giving more people than ever access to a powerfully simple diabetes management solution

  • With an overall MARD of 8.2%, Dexcom G7 is the most accurate CGM cleared by the FDA,1 building on the trusted performance of Dexcom CGM, which is clinically proven to lower A1C, reduce hyper- and hypoglycemia and increase time in range2,3

  • Cleared as an integrated continuous glucose monitoring (iCGM) system, Dexcom G7 will be part of the most connected CGM ecosystem in the world,1 with real-time connectivity that can drive integrated insulin delivery systems, connect with wearables like the Apple Watch and integrate with popular digital health apps*

  • As the number one covered CGM on the market,4 most Dexcom users pay less than those using other CGM systems1

AcelRx Publishes on Sublingual Sufentanil Tablets For Post-Operative Pain Management

 Patients reported lower pain scores, required fewer rescue doses and had a shorter hospital stay than patients receiving continuous femoral nerve block

This study of patients following knee replacement surgery adds to a growing database supporting the benefits of using sufentanil sublingual tablets for surgical pain management

https://finance.yahoo.com/news/acelrx-pharmaceuticals-announces-european-peer-133000091.html

Biden Explains Why He Swapped Russian 'Merchant Of Death' For WNBA Star

 Update(8:50ET)During his announcement from the White House, with Griner's family present, Biden spent a lot of time defending his administration from widespread accusations that Griner's release was prioritized because of her fame while at the same time other detained Americans were left behind.

"This was not a choice of which American to bring home," Biden said while vowing to continue working on freeing detained US Marine veteran Paul Whelan. 61-year old teacher Marc Fogel is also languishing in Russian prison. 

An understandably very frustrated and "devastated" Whelan family has issued the following statement upon the White House announcement of Griner's release:

Despite the possibility that there might be an exchange without Paul, our family is still devastated. I can't even fathom how Paul will feel when he learns. Paul has worked so hard to survive nearly 4 years of this injustice. His hopes had soared with the knowledge that the US government was taking concrete steps for once towards his release. He'd been worrying about where he'd live when he got back to the US. And now what? How do you continue to survive, day after day, when you know that your government has failed twice to free you from a foreign prison? I can't imagine he retains any hope that a government will negotiate his freedom at this point. It's clear that the US government has no concessions that the Russian government will take for Paul Whelan. And so Paul will remain a prisoner until that changes.

* * *

In a huge and unexpected development, Russia has released into US custody WNBA star Brittney Griner, after in October her 9-year prison sentence was upheld by a Russian court. She had already spent weeks in a harsh penal colony some 300 miles southeast of Moscow.

She was freed in a prisoner exchange which took place in Abu Dhabi Airport on Thursday. In return the Biden administration agreed to give up notorious international arms dealer Viktor Bout. US officials speaking to CBS say the deal had been reached by last Thursday, with the logistics details having been hammered out since then. Biden is imminently expected to address Griner's release and the prisoner exchange at 8:30eastern. Watch Live: 

"To secure Griner's release, the president ordered Bout to be freed and returned to Russia. Mr. Biden signed the commutation order cutting short Bout's 25-year federal prison sentence," CBS reports.

But the report underscores, "Notably, the Griner-for-Bout exchange leaves retired U.S. Marine Paul Whelan imprisoned in Russia. Whelan has been in Russian custody for nearly four years. He was convicted on espionage charges that the U.S. has called false."

When Russian state media began first signaling that the Kremlin will pursue getting Bout back, and Secretary of State Antony Blinken starting over the summer hinted the administration was actually entertaining the possibility, it unleased a wave of controversy, especially given Griner's own recent public displays which some interepreted as "anti-US"... most notably refusing to stand for the national anthem and even staying in the locker room during its playing. 

One commenter previously had this to say in summary of the controversial exchange for Bout:

"It took nearly 10 years for US to apprehend Viktor Bout, and close to 3 more years to convict him for terrorism and arms trafficking. Allegedly, thousands of civilians in multiple African countries, were injured and killed by weapons supplied by Bout. Fair trade for Griner?"

It's likely that the Department of Justice had been vigorously arguing against releasing Viktor Bout, considering it took a significant extradition process (from Thailand) to even get him into US custody over a decade ago.

Before his just-announced release, he was serving a 25-year sentence in federal prison after being convicted in the Southern District of New York for conspiring to kill Americans and conspiring to provide material support to terrorists.

Getty Images

Already there's brewing anger that Paul Whelan, as well as another American locked up in Russia, 61-year old teacher Marc Fogel, over the widespread perception that they've been left behind.

https://www.zerohedge.com/political/watch-live-biden-explains-why-he-swapped-russian-merchant-death-wnba-star

House GOP Asks (Again) To Discuss Fentanyl Crisis With Biden

House Republicans are requesting a sit-down meeting with President Biden to discuss the ongoing scourge of fentanyl overdoses after he traveled to Arizona earlier this week but declined to visit the southern border, telling reporters that there were “more important things going on.”

Rep. Jim Banks of Indiana, outgoing chairman of the Republican Study Committee, authored the letter obtained by RealClearPolitics. It wasn’t the first, however, that House Republicans have sent.

Banks and seven other House Republicans requested a meeting with Biden in October to discuss fentanyl and also to deliver letters, photos, and obituaries from families who have lost loved ones to the drug. “Our meeting request has been ignored for 48 days,” they now write, and over that period “more than 7,500 Americans have died from fentanyl-related deaths.”

The request is a blunt message that the White House has already received: Republicans do not believe Biden is doing enough. It is also a preview of conservative attitudes as an incoming GOP majority prepares to ratchet up oversight of the Biden administration’s handling of the border crisis – House Republicans will put victims of the drug epidemic front-and-center and blame Biden for inaction.

“Almost every person in America today has been impacted by, or has a loved one who has been impacted by, the deadly fentanyl crisis. Hearing directly from mothers that lost children to fentanyl poisoning was one of the most powerful meetings I have had during my time in Congress,” Banks said.

“We are asking President Biden to stop ignoring our request and allow us to share these families’ stories,” he added.

Overdoses reached a catastrophic high during the first year of the pandemic and then kept rising. According to the Centers for Disease Control and Prevention, there were nearly 94,000 deaths in 2020. The Biden administration launched a “whole-of-government" response, directing hundreds of millions in new funding toward combating the epidemic and adopting new drug control strategies to treat addiction more as an illness and less as a crime.

A senior administration official pointed RCP to that ongoing work and dismissed Republican criticism as shortsighted. “This crisis does not begin or end at the border,” they said, “and that is exactly why this administration is trying to tackle untreated addiction and also stop the flow of illicit drugs, like fentanyl, into communities.”

Improvements have been slow but, according to the administration, significant. According to the latest CDC data, overdose deaths increased, though at half the expected rate, to around 107,000 in 2021.

“We're looking at continuing to make progress because we know there's still a ways to go,” Health and Human Services Sec. Xavier Becerra said at a press conference last week. “We're not going to let stigma drive us anymore. We're going to go where we need to go to help people thrive.”

Biden, along with Rahul Gupta, director of the White House Office of National Drug Control Policy, have repeatedly said that ending the opioid epidemic remains “a top priority.” In October, Gupta noted that “we are losing an American every five minutes” and called on Congress during a Fox News interview to provide increased funding to combat fentanyl trafficking.

“We hosted families at the White House to hear directly from people who have lost loved ones and discuss how we can all work together to save lives,” said Gupta, who was confirmed by the Senate last November and who has traveled to the southern border to observe the situation directly. “I’ve met so many families with similar stories in red states and blue states; this is not a partisan issue.”

A synthetic opioid, fentanyl is often prescribed as a powerful painkiller, but its low cost and ready availability has made the drug an unfortunate accelerant in the opioid epidemic. Mexican cartels synthesize chemicals that come from China to make the drug before sending it across the southern border. Both Republican and Democratic administrations have struggled to stem the flow.

“The economics of fentanyl have just been pushing the other drugs out of the market,” Dr. Joshua Sharfstein, a vice dean of the Bloomberg School of Public Health at Johns Hopkins University, told the New York Times. “It’s just so cheap to buy fentanyl and turn around and put it in whatever.”

The administration has directed new funding to programs meant to treat addiction and worked to make naloxone products, which reverse overdoses in an emergency, more available. Biden also directed the Treasury Department in December of last year to begin targeting the finances of anyone connected to the cartels that smuggle the drug into the U.S.  

But the fundamental disconnect between the two parties remains how to secure the southern border, with Republicans complaining that Biden has neglected his duty to do so. Rep. Kat Cammack of Florida called it “criminal negligence.”

“By turning a blind eye to what is happening at our southern border and in our communities,” argued Rep. Tom Tiffany of Wisconsin, “Biden is leaving countless families who have lost a child behind as collateral damage.”

“I urge President Biden to meet with us and hear the stories of the young victims of the fentanyl crisis,” added Rep. August Pfluger of Texas.

The president’s offhand comment about the border last Tuesday touched a nerve with families who lost loved ones to fentanyl. Theresa Juillerat, who met with House Republicans to share how her son died from a fentanyl overdose, said the remark was “an insult.” The bereaved Indiana mother argued that while fentanyl-related deaths are at a record high, the lives of victims “do not seem to be significant enough to matter to President Biden.”

https://www.realclearpolitics.com/articles/2022/12/08/house_gop_asks_again_to_discuss_fentanyl_crisis_with_biden_148581.html

Biden to announce $36 billion in relief for major pension fund to avoid benefit cuts

 President Biden on Thursday will announce $36 billion in financial relief to stave off pension cuts for thousands of union workers, the White House said.

Biden will be joined by Labor Secretary Marty Walsh and union leaders and workers to detail the funding for the Central States Pension Fund, which provides benefits mostly for Teamsters union employees that include truck drivers, warehouse workers, construction workers and others. The money will come from the American Rescue Plan’s Special Financial Assistance Program, the White House said.

The Central States Pension Fund reported in August that it had $7.4 billion assets and had applied for $35.1 billion in relief. The White House estimated that retirees would have faced a roughly 60 percent reduction in benefits without financial relief.

With the funding to be announced Thursday, it will be able to protect pensions earned by Teamsters employees through at least 2051. The White House estimated that it will protect the benefits of more than 350,000 retirees and current union workers.

“Ensuring that workers and their families enjoy the retirement security they earned through a lifetime of work is a central part of President Biden’s economic plan,” the White House said in a fact sheet.

The announcement comes as a major show of support from Biden for union employees, as he has billed himself as the most pro-union president ever to take office. It also comes on the heels of Congress imposing a labor contract on railroad workers to avert a strike, an action they took with support from Biden, who warned of severe economic consequences if freight rails shut down.

That deal did not include additional sick days that union workers had been advocating for, but Biden stressed that he hoped Congress could return to the issue in the future and pass legislation ensuring sick leave for all workers.

https://thehill.com/homenews/administration/3766146-biden-to-announce-36-billion-in-relief-for-major-pension-fund-to-avoid-benefit-cuts/

Pharvaris Positive Top-line Phase 2 Data for On-Demand Treatment of HAE Attacks

 

  • Primary endpoint met, substantially reducing HAE attack symptoms

  • All secondary endpoints met

  • PHVS416 was well tolerated at all dose levels

  • Pharvaris to host a conference call today at 8:00 a.m. ET

Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced positive top-line data from the RAPIDe-1 Phase 2 clinical study, demonstrating statistically significant results of PHVS416 as an oral on-demand treatment for HAE attacks. Pharvaris plans to present data from the study at future medical meetings.

https://finance.yahoo.com/news/pharvaris-announces-positive-top-line-115000418.html

Akero NASH therapy gets breakthrough tag

 Designation based on Akero’s Phase 2b HARMONY study finding that both the 50mg and 28mg EFX doses achieved statistical significance on primary and secondary histology endpoints after 24 weeks

https://finance.yahoo.com/news/efruxifermin-granted-fda-breakthrough-therapy-120000101.html