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Friday, January 12, 2024

Merck's Keytruda Combined with Chemoradiotherapy Gets FDA Approval to Treat Cervical Cancer

 Merck received approval from the Food and Drug Administration for cancer drug Keytruda in combination with chemoradiotherapy as a treatment for patients with FIGO 2014 Stage III-IVA cervical cancer.

The healthcare company said the approval marks the third indication for keytruda in cervical cancer and the 39th indication for keytruda in the United States.

https://www.marketscreener.com/quote/stock/MERCK-CO-INC-13611/news/Merck-s-Keytruda-Combined-with-Chemoradiotherapy-Gets-FDA-Approval-to-Treat-Cervical-Cancer-45734920/

Regeneron Pharmaceuticals : RBC Capital upgrades to outperform

  price target raised from USD 884 to USD 1076.

https://www.marketscreener.com/quote/stock/REGENERON-PHARMACEUTICALS-10649/

Ray Epps' 'Sentence' Is "A Thunderous F**k You" To Half Of America

 by James Howard Kunstler via Kunstler.com,

Poison Spiders At The Center Of The Web

“The same people accusing Trump voters of subverting democracy are the ones who cheated in every election since the 1960s, lied to get us into half a dozen stupid wars, created Covid in a lab, and then covered that up. You are free to tell them to STFU”

- Peachy Keenan

You know why the judge let provocateur Ray Epps off the hook for his antics before and during the so-called J-6 “insurrection,” don’t you? Well, yes, it was partly because he was acting at the direction of blob officials, most likely the FBI, but possibly the CIA, Defense Intelligence, or some black-box fed outfit no one ever of (but somehow gets half a billion in funding every year). Ol’ Ray, pleaded to one year’s probation (no jail time), 100 hours of community service (checking books out at his local library?), and a $500 fine. Say, what. . . ? A speeding ticket on the Rockville Pike would probably cost you more.

You remember those videos of Ray on the DC street the day before the riot, importuning the crowd, a commanding presence with his military bearing and red hat, six inches taller than most of the other men around him, yelling, “Tomorrow we need to go into the Capitol, into the Capitol!”  At which moment the crowd groaned “no-o-o-o. . . !” and then commenced chanting, “fed. . . fed. . . fed. . . !” They had his number. His use of the word need was especially beguiling, as in, who actually “needed” that to happen?

I’ll tell you one reason Ray didn’t get, like, twenty years, nor two years of pre-trial detention in the reeking, roach-infested DC lockup, or massive fines, like other J-6 defendants: Because he told his handlers in no uncertain terms that he would blow their cover and vivisect them publicly on the whole fed J-6 operation if they so much as made him show up in person for any proceeding - and, of course, he “attended” his sentencing by phone, in a Zoom meeting from a remote location.

Okay, I’ll tell you the actual reason that Ray Epps got the VIP powder puff treatment: It was to give half of America a poke in the eye with a sharp stick. . . the old double-barreled middle finger. . . a thunderous fuck you, with the subtext: we can do anything we want to you and you can’t do anything about it. . . and we can rub your faces in it, too, ho ho. . . and then empty a bed pan over your head in case you’re not feeling sufficiently impotent and humiliated. And the purpose of all that is their hope to foment some act of genuine violent resistance against the blob to justify further lawless persecution of the blob’s enemies. They’re really hoping to set off a civil war to justify martial law in order to ensure a free and fair election.

The judge in the Ray Epps case is. . . wait for it. . . the fabulous judicial utility infielder, James Boasberg, now Chief Judge of the DC Federal District Court, a big cheese. Yes, the same rascal who sat on the FISA Court during the FBI’s “Crossfire Hurricane” shenanigans, when they fed all manner of fake documents to that court to enable the FBI to conduct warrantless surveillance on Donald Trump’s campaign, and then afterwards on his presidency.

It was Judge Boasberg who let FBI lawyer Kevin Clinesmith off the hook with probation when he was charged with doctoring an email to conceal the fact that FBI target Carter Page had been an active CIA informer in Russia over the years, not just some schlub swanning around the fringe of the Trump Campaign. Getting a FISA warrant on Carter Page was tremendously advantageous to the FBI, because it enabled them to use the “three-hop rule,” meaning they could also surveil anyone else in the Trump retinue who Mr. Page had communicated with by phone or email.

The disposition of Ray Epps’s case also means there will be no further official inquiries into his behavior that fateful day 1/6/21.

The principle of double jeopardy means he can’t be tried for the same thing twice. There will be no further inquiries into what he did that day and on J-6 itself when he appeared at the barricades on the Capitol grounds, apparently goading protesters to bust through them. It’s a dead letter. Chalk up a “W” for the blob

But now, chalk up an “L” for the blob: Fani Willis, the Fulton County (GA) District Attorney, has been caught funneling more than half a million dollars to her love bunny, attorney Nathan Wade, after appointing him “special counsel” in the gigantic RICO case against Donald Trump and eighteen other defendants. Poor optics, as they say, and maybe a good deal more than that — such as prosecutorial misconduct. The fact that the lovestruck pair took Caribbean cruises together with that money may only be a minor part of the story. More will come out when Fani Willis answers the summons she has been served to give a deposition at the request of Joycelyn Wade’s lawyers in the Wades’ ongoing divorce proceeding.

More to the point, both Fani Willis and Nathan Wade (in her service) spent time consulting with lawyers at the White House before they filed charges against Mr. Trump. Mr. Wade was there on May 23 and November 19, 2022 talking to Joe Biden’s White House counsel for sixteen hours. Ms. Willis is shown by White House visitor logs to have been present for five hours a few months later, on February 18, 2023, a week after recommending charges to a Fulton County grand jury. The log states that she spent those five hours with veep Kamala Harris.

I doubt that is who she came to visit.

My guess is that Ms. Willis spent those hours being coached by Deputy US Attorney General Lisa Monaco, possibly joined by Mary McCord, a former head of the DOJ’s National Security division during the “Crossfire Hurricane” years, then “outside counsel” to the first House impeachment committee, then counsel to the House J-6 committee. It was Ms. McCord, in Trump Impeachment # 1, who arranged for then DOJ Inspector General Michael Atkinson to change the whistleblower rules, allowing for hearsay evidence, which gave a green light to NSA mole Eric Ciaramella to report on the infamous Ukraine phone call that he had not personally witnessed (but was fed a story on by Col. Alexander Vindman.) Nice work there. In other words, these two gals, Lisa Monaco and Mary McCord, are the poison spiders in the DOJ web of veteran seditionists.

This week there is also chatter as to whether Special Counsel Jack Smith might ever actually bring an official federal “insurrection” charge against Mr. Trump to facilitate his “branding” so as to get him kicked off the ballot around the country. I doubt that’ll work out for Mr. Smith, too.

If such a matter ever went to trial Mr. Trump would enjoy the right to “discovery” of all sorts of evidence that the DOJ and the FBI would never allow to see the light of day.

So, Jack’s stuck with his lame cases now on the docket which, believe me, will be going nowhere.

https://www.zerohedge.com/political/ray-epps-sentence-thunderous-fk-you-half-america

Applied UV Inc. Announces Launch of Patented Fighter Flex LED Solution

 Applied UV Inc. (NASDAQ: AUVI), a leader in smart building technology solutions, is excited to announce the launch of its groundbreaking Fighter Flex LED solution at the upcoming AHR Expo on January 22nd. This disruptive technology is set to redefine energy efficiency in heating, ventilation, and air conditioning (HVAC) systems across the industry. Applied UV Inc. is finalizing distribution agreements with several major international smart building technology brands. The Fighter Flex LED technology was selected by the GSA and DOE for the GSA Green Proving Ground Program.

Max Munn, CEO of Applied UV, stated, 'We are delighted about the immense potential with this opportunity.”  Munn remarked, “Given the disruptive technology in our patented Fighter Flex LED products, we are confident in our ability to capture a significant share of this market. We believe this market holds an annual sales opportunity in the hundreds of millions of dollars."

Efficiency Gains from UV and Next Gen LED

In the United States, office spaces typically require between 50,000 to 75,000 BTUs per year per square foot for heating, influenced by factors such as building age, insulation quality, and local climate. For a standard office building in a moderate climate, air conditioning costs alone can reach approximately $2-$3 per square foot annually.

Utilizing our patented UVC LED system to maintain the efficiency of HVAC coils has proven to reduce energy consumption by 5-15%. For an owner of a 100,000 square foot office space, the integration of UVC technology could equate to approximately $45,000 in energy savings in the first year alone.

The LED Revolution in HVAC Systems

Applied UV Inc.'s patented UVC LED fixtures offer a refined alternative to traditional mercury vapor UVC bulbs. Our state-of-the-art fixtures deliver targeted UVC illumination, avoiding wastage on non-essential surfaces, and provide precise dosing control. The switch to UVC LED fixtures from mercury vapor tubes (a 100-year-old technology) can result in an additional 100% increase in energy savings within the UV system, leading to on average an additional $10,000 in annual savings for a 100,000 square foot property.

Sustainability Meets Innovation

The Fighter Flex LED solution boasts durable, low-maintenance, and mercury-free emitters, marking a significant advancement in UVC LED technology. Applied UV Inc.’s commitment to innovation has been recognized with a major federal agency initiating a full trial of their patent-pending UVC LED design, signifying a transformative step in UV application for coil cleaning within building HVAC systems.

https://www.morningstar.com/news/globe-newswire/9016857/applied-uv-inc-announces-launch-of-patented-fighter-flex-led-solution-opening-significant-revenue-opportunity

Jill Biden: Trump Supporters "Insurrectionists, Dangerous Extremists", Joe "Works Hard Every Single Day"

 by Paul Joseph Watson via Modernity.news,

During an interview with MSNBC’s Mika Brzezinski Thursday, Jill Biden labelled all supporters of Donald Trump as “insurrectionists” and “dangerous extremists,” saying she can’t believe what they have done to the country.

Brzezinski asked Biden’s wife how she feels about being labelled part of ‘the Biden crime family,’ noting “I have one congresswoman: The Biden crime family sold out America, Marjorie Taylor Greene. He’s a liar. He’s mentally incompetent.”

“And let’s not even talk about what ‘Let’s go, Brandon’ means, but you have U.S. senators holding signs that say that,” the host added.

Dr Jill responded, “It’s hard to realise it’s our country, isn’t it? I mean, to look at it, what we used to have, and what the other side, the extremists have turned this country into.”

“I mean, we would never see things like that, say, 10 years ago,” she added.

She continued, “it is a little scary… not just for me and for Joe, but just to see what happened. I mean, look at the insurrection that took place. I mean, it’s just so hard to believe that the United States of America witnessed an insurrection. I think Americans were just stunned by that.”

Brzezinski then noted that Trump is calling those arrested for entering the Capitol (or just walking around it) ‘hostages’.

“Or patriots, you know, as he - he doesn’t call them what they were, insurrectionists, dangerous extremists,” Dr Jill responded.

She then said she ‘doesn’t know’ what will happen to Democracy and can’t think about it if Biden doesn’t beat Trump in November.

Watch:

Additionally, Jill Biden was ridiculed after claiming Joe Biden “works hard every day,” despite the fact he has been on vacation for over 40% of his presidency.

“I think what people don’t see is how hard Joe works every single day!” said the First Lady during the interview with MSNBC.

“That he gets up thinking what he can do for the American people,” she added.

Big doubt.

According to an analysis of press-pool reports, Biden has spent more time on holiday than any of his recent predecessors.

“Biden has spent all or part of 382 of his presidency’s 957 days – or 40% — on personal overnight trips away from the White House, putting him on pace to become America’s most idle commander-in-chief,” reported the New York Post.

Respondents on X ridiculed Jill’s patently false claim.

During a press conference yesterday, Fox News reporter Peter Doocy asked the White House Press Secretary Karine Jean-Pierre Thursday why Joe Biden is being hidden and who is doing it.

As we previously highlighted, as of last week, Biden had not done anything for over two weeks, and his Press Secretary couldn’t provide any details of any upcoming schedule.

A typical Biden fortnight looks like this;

  • DEC. 22: Spent 9 minutes at Children’s National Hospital
  • DEC. 23: Left for vacation at Camp David
  • DEC. 24: Vacation at Camp David
  • DEC. 25: Vacation at Camp David
  • DEC. 26: Returned from vacation at Camp David
  • DEC. 27: Left for vacation in the U.S. Virgin Islands
  • DEC. 28: Vacation in the U.S. Virgin Islands
  • DEC. 29: Vacation in the U.S. Virgin Islands
  • DEC. 30: Vacation in the U.S. Virgin Islands
  • DEC. 31: Vacation in the U.S. Virgin Islands
  • JAN. 1: Vacation in the U.S. Virgin Islands
  • JAN. 2: Late-night return from vacation in the U.S. Virgin Islands
  • JAN. 3: Nothing
  • JAN. 4: Nothing

During the 2020 presidential campaign, Biden infamously spent copious amounts of time in his basement, yet still managed to somehow get more votes than Barack Obama.

Most observers expect Biden to eventually drop out of the 2024 race due to poor health, with a top JP Morgan analyst predicting that he will exit the campaign “sometime between Super Tuesday and the November election.”

 

Biden’s wife was doing the interview presumably because Biden himself is nowhere to be seen. He’s being hidden somewhere without explanation.

https://www.zerohedge.com/political/jill-biden-trump-supporters-are-insurrectionists-dangerous-extremists-joe-works-hard

Amid Declining Sales, Biogen Hands MS Drug Fampyra Back to Acorda

 After nearly 15 years of partnership, Biogen is turning its back on its multiple sclerosis agreement with Acorda Therapeutics, returning the ex-U.S. licensing rights to Fampyra (fampiridine) to the New York–based biotech. The termination of the agreement will be effective on Jan. 1, 2025.

Under the original agreement, which was signed in June 2009, Biogen has had the exclusive license to commercialize Fampyra in international markets outside the U.S. The pharma was also responsible for all regulatory activities and clinical development of Fampyra in these markets, with Acorda being eligible for milestones and tiered, double-digit royalties.

Once the contract’s termination is complete, Acorda will no longer be entitled to royalties from Biogen, but will instead directly reap the revenues of Fampyra. Until then, the biotech will continue to receive royalties as per the 2009 agreement, which will last “until the transfer of regulatory authorizations have been completed on a country-by-country basis,” according to an SEC filing.

In a statement, Acorda president and CEO Ron Cohen said the company is “grateful to Biogen for their partnership over the last 14 years,” adding that Acorda is “excited” to bring Fampyra in-house and continue providing access to multiple sclerosis patients.

Acorda and Biogen are working on a smooth transition of Fampyra ownership, ensuring continued commercialization and supply of the therapy, according to Thursday’s press release.

Designed as a sustained-release tablet formulation, Fampyra is a broad-spectrum potassium channel blocker whose mechanism of action is still incompletely known. The drug is thought to act on demyelinated nerves, reducing the leakage of current and in turn restoring conduction along the neurons.

The drug was approved by the FDA in January 2010 and is sold in the U.S. as Ampyra. Fampyra is its brand name in all markets outside the U.S., including the European Union, New Zealand and various Asian countries.

Fampyra’s revenues have been declining in recent years. In its third-quarter earnings report, Biogen revealed that for the nine months ending in Sept. 30, 2023, Fampyra made only $67.5 million, down from $73.7 million during the same time period in 2022.

For Acorda, Ampyra has also been an asset in decline. During the first nine months of 2023, the biotech reported that Ampyra’s revenue had declined 17% from the same period the year prior. Acorda made $15.7 million in Ampyra sales in the third quarter of 2023.

https://www.biospace.com/article/amid-declining-sales-biogen-hands-ms-drug-fampyra-back-to-acorda-/

Amgen Emerges as Potential Cytokinetics Suitor as Novartis Pulls Away: Reports

 Novartis is reportedly backing off of its rumored potential acquisition of California–based cardiovascular disease specialist Cytokinetics, according to a Thursday report from The Wall Street Journal, citing a source familiar with the matter.

On Monday, the WSJ reported that the Swiss drugmaker was in “advanced talks” to buy Cytokinetics. According to the Journal’s sources, the agreement could have been inked “as soon as this week” amid the 42nd annual J.P. Morgan Healthcare Conference, which is widely recognized in the biopharma industry as a hub of dealmaking activity.

At the time, however, there was no potential purchase price.

Reuters article earlier this week also identified AstraZeneca and Johnson & Johnson as potential suitors of Cytokinetics, however noting that they were likely to be outdone by Novartis.

On Thursday, Amgen emerged as another potential suitor, according to Seeking Alpha. Cytokinetics is reportedly holding out for $130 to $145 a share, per Betaville, which cited sources familiar with the matter. Amgen has history with Cytokinetics. The larger biopharma terminated a development and collaboration agreement for small molecule cardiac myosin activator omecamtiv mecarbil in 2020.

In response to reports Novartis backing away from the potential deal, Cytokinetics’ shares crashed by as much as 28% on Thursday, as per Seeking Alpha.

Cytokinetics is advancing a pipeline of therapies that “may improve the healthspan of people living with cardiovascular and neuromuscular diseases of impaired muscle function,” according to its website. Its main target indications are heart failure, hypertrophic cardiomyopathy (HCM) and amyotrophic lateral sclerosis.

One of its most mature programs is aficamten, an investigational small molecule inhibitor of cardiac myosin that is currently being evaluated for HCM. In December 2023, Cytokinetics reported positive data for aficamten in the pivotal Phase III SEQUIOA-HCM study, which demonstrated that the candidate significantly improved exercise capacity, leading to better peak oxygen uptake versus placebo.

Cytokinetics is running two other Phase III studies to assess aficamten: ACACIA-HCM, which kicked off in September 2023, and MAPLE-HCM, which launched in June 2023.

Cytokinetics had proposed omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction, but in March 2023, the FDA rejected the application, citing a lack of evidence supporting the drug's clinical benefit.

Novartis’ alleged decision to forego the Cytokinetics acquisition is in contrast to its otherwise busy dealmaking spree in recent days. On Monday, the pharma paid $250 million upfront to acquire Dutch biotech Calypso and signed two RNAi-focused research contracts with Chinese company Shanghai Argo Biopharmaceutical.

A day earlier, Novartis inked an AI partnership with Alphabet’s Isomorphic Labs, paying $37.5 million upfront to collaborate on three undisclosed targets.

https://www.biospace.com/article/novartis-pulls-away-from-rumored-cytokinetics-deal-while-amgen-emerges-as-a-contender-reports/