Search This Blog

Friday, January 5, 2024

Ligand ZELSUVMI OKd as a First-in-Class Medication for Molluscum

 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that the U.S. Food and Drug Administration (FDA) has approved ZELSUVMI™ (berdazimer topical gel, 10.3%) for the treatment of molluscum contagiosum (molluscum) in adults and pediatric patients one year of age and older.i The FDA approved ZELSUVMI as the first novel drug for the treatment of molluscum infections.

https://www.businesswire.com/news/home/20240105377376/en/

Immunocore: strategic priorities, pipeline expansion ahead of 42nd Annual J.P. Morgan

 Increasing commercial access to KIMMTRAK (tebentafusp-tebn) globally, and pursuing future growth opportunities with two registrational trials in advanced cutaneous melanoma and adjuvant uveal melanoma

Multiple clinical readouts expected to start in 2Q 2024 for IMC-F106C (PRAME HLA-A02) from Phase 1/2 clinical trial monotherapy and combination arms; IMC-P115C (PRAME HLA-A02 HLE) and IMC-T119C (PRAME HLA-A24) ImmTAC candidates on track for expected CTA/IND submission in 2024

Submitted clinical trial applications (CTA) for IMC-R117C, a first-in-class ImmTAC targeting PIWIL1 for colorectal and other gastrointestinal cancers

Data from IMC-M113V Phase 1 clinical trial in people living with HIV expected in the second half of 2024

Advancing novel TCR bispecific candidates for autoimmune diseases

Company to present at 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024 at 9:00 AM P.T. / 5:00 PM GMT

https://www.globenewswire.com/news-release/2024/01/05/2804565/0/en/Immunocore-announces-strategic-priorities-and-pipeline-expansion-ahead-of-42nd-Annual-J-P-Morgan-Healthcare-Conference-presentation.html

Inovio, Coherus to join effort on oropharyngeal squamous cell carcinoma therapy

 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, today announced a clinical collaboration and supply agreement with Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) to evaluate the combination of INO-3112 and LOQTORZI™ (toripalimab-tpzi) as a potential treatment for patients with locoregionally advanced, high-risk, HPV16/18 positive oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer commonly known as throat cancer.

Under the terms of the supply agreement, Coherus will provide LOQTORZI™ (toripalimab-tpzi), for a Phase 3 clinical trial to be conducted by INOVIO, pending alignment with the U.S. Food and Drug Administration (FDA) on study design. LOQTORZI™ is a PD-1 inhibitor recently approved by the FDA for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma (R/P NPC).

https://www.prnewswire.com/news-releases/inovio-and-coherus-announce-clinical-collaboration-to-advance-development-of-ino-3112-in-combination-with-loqtorzi-toripalimab-tpzi-302025891.html

BioCryst prelims, 2024 outlook

 —ORLADEYO preliminary 2023 full year net revenue of $325 million (+29 percent y-o-y)—

—ORLADEYO net revenue expected to be between $380-$400 million in 2024, on trajectory for
$1 billion in peak sales—

—Operating expenses expected to remain flat ($365-$375 million) in 2024—

—Company expects operating profit in 2024, approaching positive EPS and positive cash flow in 2H 2025—

https://www.globenewswire.com/news-release/2024/01/05/2804867/29446/en/BioCryst-Announces-Preliminary-Full-Year-2023-ORLADEYO-berotralstat-Net-Revenue-of-325-Million-Provides-2024-Guidance-and-Accelerated-Path-to-Profitability.html

'Use Mexican Peso, Chinese Yuan to Bet on US Election, Citi Says'

 

  • Strategists say currencies swing wider on US vote results
  • Peso and yuan slid in aftermath of Trump’s victory in 2016

The Mexican peso and Chinese yuan are shaping up to be the best ways for currency traders to bet on the outcome of this year’s US presidential election, according to Citigroup Inc.

Both currencies are expected to have outsize reactions to the vote thanks to their home nations’ relationships with the world’s top economy. To Citi, that makes them compelling choices to express views on the political result ahead.

https://www.bloomberg.com/news/articles/2024-01-05/use-mexican-peso-chinese-yuan-to-bet-on-us-election-citi-says

Blue States Saw Highest Rates Of Homelessness In 2023

 by Eric Lundrum via American Greatness,

In the year 2023, the highest recorded rates of homelessness on average were found in states that lean Democratic, as well as the District of Columbia.

As the Daily Caller reports, the data from the Department of Housing and Urban Development (HUD) was released in December.

Although not actually a state, Washington D.C. had the highest rate of homelessness in the country, at 73.3 for every 10,000 residents, which amounts to roughly 4,922 total homeless.

New York came in second with 52.4 homeless people for every 10,000, or 103,200 total. Vermont came in third with 50.9 per 10,000, or about 3,295. Rounding out the top five was Oregon, in fourth place, with 50 per 10,000, equating to about 20,000 people; and California, with 46.5 per 10,000, equivalent to 181,399 people.

The city of San Francisco in particular saw a surge in homeless tent encampments in the aftermath of the Chinese Coronavirus pandemic, reaching a record high of over 500. The city of New York has also faced a similar crisis, though the numbers are more due to illegal aliens than homeless residents, with over 70,000 illegals currently being housed in homeless shelters or emergency shelters.

Even though the city of Los Angeles has pledged to spend $1 billion to combat homelessness as part of Mayor Karen Bass’s (D-Calif.) “Inside Safe” program, the number of homeless encampments in the city has increased by 40.

The nationwide rate of homelessness rose by 12% from 2022 to 2023, recording the highest-ever number of homeless Americans since these numbers first started being tracked in 2007; the current total is approximately 653,000.

There was a particularly alarming rise in the number of young people who became homeless, with over 34,7000 people under the age of 25 identifying as homeless at least once; this marks a 15% increase from the previous year.

By contrast, the lowest rates of homelessness in the country were found in states that lean Republican.

The state with the lowest rate is Mississippi, at just 3.3 per 10,000 people, followed by Louisiana’s 6.9 per 10,000, or roughly 3,169 total people, and Alabama’s 3,300 homeless people.

https://www.zerohedge.com/political/blue-states-saw-highest-rates-homelessness-2023

Judge Shuts Down New Attempt To Remove Trump From Ballot

 by Jack Phillips via The Epoch Times,

A federal judge in Wyoming rejected a motion that called for former President Donald Trump to be removed from the state’s ballot - claiming that he is not eligible to become president under an interpretation of the Constitution’s 14th Amendment.

Albany County District Court Judge Misha Westby dismissed the case “without prejudice,” which means the plaintiff, Tim Newcomb, can bring it again, according to court papers that were posted by lawyer and former California GOP chairwoman Harmeet Dhillon on X, formerly Twitter, this week.

“Not again! Yes again ...Wyoming federal judge threw yet another 14th amendment challenge out on its ear today. Bye!” she wrote.

The plaintiff had sought to “preclude the names” of both President Trump and Sen. Cynthia Lummis (R-Wyo.) from appearing on the state’s ballots, attempting to argue that the former president violated his oath of office for his activity around the breach of the U.S. Capitol on Jan. 6, 2021. Mr. Newcomb, in his challenge, claimed that Ms. Lummis also betrayed her oath of office for refusing to certify the 2020 election results in Pennsylvania.

A former attorney, Mr. Newcomb wrote that his complaint “grounds the two facts required by the 14th Amendment to disqualify traitors from ever again holding office,” referring to the former president and the GOP senator. He also asked the state court to ”reserve judgment until the meaningful opportunity to be heard allows [me] to demonstrate relevance and admissibility of adjudicative facts,” which cited more than 250 news articles about the former president.

Some of the articles he referenced appeared to contain claims that President Trump had colluded with the Russian government. A 2019 Department of Justice investigation headed by former special counsel Robert Mueller later found there was no evidence that the former president had colluded with the Kremlin.

According to the Cowboy State Daily, when reached for comment last month, Mr. Newcomb pointed to footnotes in a recent court filing, including a Wikipedia article that links to “stochastic terrorism,” a CNN report about threats allegedly made to the Colorado Supreme Court, and a YouTube video including an interviewer who questioned about reported threats to public officials.

It came as Wyoming Secretary of State Chuck Gray, a Republican, filed a motion to dismiss Mr. Newcomb’s lawsuit, describing it as “repugnant.”

“The attempt to remove Donald Trump and Cynthia Lummis from the ballot is outrageously wrong and repugnant to our electoral process,” Mr. Gray said in a statement.

“Today, we filed a motion to dismiss this blatant, radical attempt to interfere with Wyoming’s elections. The weaponization of the Fourteenth Amendment to remove political opponents from the ballot undermines the sanctity of the Constitution. We are committed to protecting the integrity of our elections and ensuring that the people of Wyoming can choose who to elect for themselves.”

The lawsuit was also criticized by at-large Wyoming House Rep. Harriet Hageman (R-Wyo.), who defeated former Rep. Liz Cheney (R-Wyo.) in her reelection bid during the state’s primary.

“These boneheaded attempts to keep President Trump off the ballot have sadly made their way to my state of Wyoming,” Ms. Hageman said in a statement.

“This is an attempt to use the court system to interfere with an upcoming election and deny voters the chance to support a candidate of their choosing. Nothing could be more tyrannical than that.”

Wyoming, a solidly red state, overwhelmingly went for President Trump in 2020. It means that if he were to be struck from the state’s ballots, it could be damaging to the former president’s 2024 chances.

In recent days, multiple federal judges have dismissed 14th Amendment-related challenges to prevent President Trump from appearing on various state ballots.

A judge in California this week rejected a suit “with prejudice” after a plaintiff argued they suffered “emotional injury” from watching news reports and reading media outlets’ descriptions of the Jan. 6 breach.

The California judge wrote that because the events occurred “more than two years before the plaintiff” filed the lawsuit, the challenge was outside of the two-year statute of limitations, according to Ms. Dhillon, who posted the court papers on X.

Several other federal judges have also dismissed attempts to block the former president from appearing on ballots. In a ruling issued in late December 2023, U.S. District Judge Leonie Brinkema wrote that the plaintiffs—two activists—who filed suit against President Trump in Virginia to keep him on that state’s ballot lacked standing.

But at least two of those 14th Amendment challenges have seen some success in Maine and Colorado. However, there has been widespread speculation that higher courts or even the U.S. Supreme Court will strike those decisions down.

Colorado’s Supreme Court ruled to keep the former president off the primary ballot in the state in mid-December, which was promptly appealed to the Supreme Court. And last week, Maine Secretary of State Shenna Bellows, a Democrat, unilaterally decided to keep President Trump off the ballot. Her order also has been appealed by President Trump.

https://www.zerohedge.com/political/judge-shuts-down-new-attempt-remove-trump-ballot