Democrats Choose Fake Women Over Real Women... Again

by Matt Margolis via PJMedia.com,

The Democratic Party has once again shown us exactly where their priorities lie - and it's not with protecting women and girls. 

On Monday, Senate Democrats banded together to block a common-sense bill to keep biological males from invading women's sports.

The Republican-led Protection of Women and Girls in Sports Act fell short of the 60 votes needed to overcome the Democrats' filibuster. Every single Democrat who voted opposed the bill. Sens. Elissa Slotkin (D-Mich.) and Peter Welch (D-Vt.) didn't even bother to show up. Apparently, protecting girls and women from having to compete against biological males with inherent physical advantages isn't important enough for Democrats to support.

The bill, introduced by Senator Tommy Tuberville (R-Alabama) and backed by over 40 cosponsors, would have simply codified President Trump's recent executive order into law, affirming what most Americans already know to be true—that biological sex is "recognized based solely on a person's reproductive biology and genetics at birth." 

"Female athletes who work extremely hard should not have their future in athletics hindered because they are forced to compete against biological males. Instead of standing up for women and girls, Democrats voted to cosign Joe Biden’s attempted assault on Title IX," Bill Cassidy, (R-La.), the chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), said in a statement. 

"I will continue working with President Trump and my Republican colleagues to preserve Title IX, ensuring every woman and girl has the chance to succeed."

President Trump ran on this issue and won in a landslide. Why? Because approximately 70% of Americans agree with him that men don't belong in women's sports or locker rooms. 

"Through an amendment to Title IX of the Education Amendments of 1972, this bill would expressly recognize what is already federal law—that it is an illegal act of discrimination for a man to participate in a federally funded athletic program or activity designated for women or girls," Tuberville's office said in a statement.

But instead of listening to the American people, Democrats chose to side with radical gender ideology. They'd rather force our daughters to compete against biological males who have larger hearts, lungs, muscle mass, and bone density than stand up for women's rights.

Democrats countered with the absurd argument that this issue should be left to local communities. 

Senator Tammy Baldwin (D-Wisc.) claimed, "I, for one, trust our states, our leagues, our localities to make these decisions without interference from Congress." 

We know that’s not true. Democrats don’t believe states have the right to ban men from women’s sports—they simply want the fight to play out in the courts, where they know it’ll be easier to dismantle state and local protections than to overturn federal law.

The hypocrisy is staggering. 

The so-called party of women’s rights is actively destroying them.

They preach about equality while watching girls lose scholarships, championships, and hard-earned opportunities to biological males. 

They turn a blind eye as young women see their privacy and dignity (and fairness) stripped away—all in the name of a radical agenda the vast majority of Americans reject.

The American people see through this charade. Women's sports deserve protection, and Democrats have shown yet again they're too beholden to radical activists to provide it. 

https://www.zerohedge.com/political/democrats-choose-fake-women-over-real-women-again 

Trump's NATO nominee pledges to strengthen alliance despite Russian pivot

 Donald Trump's nominee to be U.S. ambassador to NATO, Matthew Whitaker, pledged on Tuesday to strengthen NATO and said the Republican president remains committed to the alliance.

"If confirmed, I will work tirelessly to strengthen the alliance, ensure the security of the American people and uphold our nation's role as the beacon of freedom and liberty," Whitaker said at his confirmation hearing before the Senate Foreign Relations Committee.

"President Trump has been clear. The United States remains committed to NATO and to peace through strength," he said.

Whitaker, 55, a lawyer with little foreign policy experience, worked in the Justice Department during Trump's first term, including three months from late 2018 to early 2019 as acting attorney general.

He is expected to be confirmed, as Trump's fellow Republicans control a majority in the Senate.

Whitaker's comments came amid tensions over Trump's apparent lurch toward Russia since beginning his second term in the White House in January, shocking traditional NATO allies in Europe and leaving Ukraine increasingly vulnerable as it fights a Russian invasion.

Trump also has demanded that Europe's NATO members ramp up their defense expenditures, given that European nations on average spend below NATO's 2% of GDP guidelines, while the U.S. finances nearly two-thirds of NATO's military budget.

Trump has called for NATO members to spend 5% of GDP on defense, which is far more than Washington spends.

Trump has said he was not sure the U.S. should be spending anything on NATO, leading to speculation that he might withdraw the United States from the alliance, despite a U.S. law forbidding any president from doing so unilaterally.

Whitaker said that, if confirmed, he would visit every NATO member within his first 30 days, to discuss Trump's demand that every member should spend 5% of GDP on defense.

"I believe that a robust NATO can continue to serve as a bedrock of peace and prosperity, but its vitality rests on every ally doing their fair share by growing our economies and investing in our common defense," he said.

On Friday, Ukrainian President Volodymyr Zelenskiy's meeting with Trump devolved into an extraordinarily heated exchange before the world's media.

Trump halted U.S. military aid to Ukraine on Monday, and Zelenskiy said on Tuesday he regretted the clash and wanted to "make things right."

Zelenskiy said he was ready to sign a deal giving the United States access to Ukrainian minerals, which he had left on the table when he abandoned a visit to Washington after the argument with Trump.

https://ca.news.yahoo.com/trumps-nato-nominee-pledges-strengthen-201016228.html

AstraZeneca and Daiichi Sankyo’s Enhertu Enhances Stomach Cancer Case With Phase III Win

 

The partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers.

AstraZeneca and Daiichi Sankyo continue to rack up wins for their lead antibody-drug conjugate Enhertu, with a Phase III readout on Monday pointing to the drug’s strong potential in gastric cancer, with an eye toward adding yet another indication to the drug’s roster.

Results from the late-stage Destiny-Gastric04 study showed that Enhertu resulted in a “statistically significant and clinically meaningful improvement” in overall survival in patients with HER2-positive unresectable and/or metastatic gastric or gastroesophageal junction cancer. The study deployed the antibody-drug conjugate (ADC) as a second-line therapy and compared it against ramucirumab and paclitaxel.

Given these signals of “superior efficacy,” an independent data monitoring committee has recommended that the trial be unblinded ahead of schedule, as per the companies’ announcement.

The partners did not provide specific data on Monday, instead promising to do so at an upcoming medical congress. The two companies will also share these findings with regulatory health authorities, with an eye toward “approval in regions where Enhertu is not currently indicated as a second-line option” in gastric and gastroesophageal junction cancer, Ken Takeshita, global head of Oncology R&D at Daiichi Sankyo, said in a statement.

“Enhertu is the first HER2 directed medicine to demonstrate an improvement in overall survival in a randomized phase 3 trial in the second-line metastatic setting of patients with HER2 positive gastric cancer,” Takeshita added.

Enhertu is an ADC that targets the HER2 protein, commonly found on cancer cells, and carries a topoisomerase I inhibitor payload. Since it was first approved in 2019, the therapy has secured several indications for various types of breast, lung and gastric cancer. Most recently, Enhertu in January secured a label expansion, allowing its use in breast cancer patients with low or ultralow expression levels of HER2.

In gastric cancer, Enhertu bagged its first approval in January 2021 under the FDA’s accelerated pathway, backed by Phase II data showing significant survival and response rate improvements in patients with gastric or gastroesophageal junction cancers. In the press announcement on Monday, Takeshita said the partners will also use Destiny-Gastric04’s findings to “secure full approval in regions where Enhertu is conditionally approved.”

AstraZeneca and Daiichi Sankyo also recently won the FDA’s approval for another ADC they are working on together. Datroway, which also carries a topoisomerase I inhibitor but instead targets the TROP2 protein, was cleared in January for the treatment of HR-positive and HER2-negative breast cancers.

https://www.biospace.com/drug-development/astrazeneca-and-daiichi-sankyos-enhertu-enhances-stomach-cancer-case-with-phase-iii-win

Biohaven Disappoints Again, This Time in Phase II/III Bipolar Mania Trial

 

Biohaven in recent months has reported a clinical stumble in spinal muscular atrophy, alongside a Phase I readout for its protein degrader candidate that investors found underwhelming.

Biohaven on Monday delivered another underwhelming readout, announcing that its potassium channel activator BHV-7000 failed to elicit significant benefit in a Phase II/III bipolar mania study. The announcement came during the company’s fourth-quarter and full-year business report

Without providing specific data, Biohaven revealed that BHV-7000 “did not statistically differentiate from the comparator arm” on the study’s primary endpoint of 21-day improvement in the Young Mania Rating Scale, a validated tool used to measure manic symptoms over time. The study enrolled more than 250 patients with bipolar I disorder who were experiencing manic episodes. BHV-7000 was compared against placebo.

Biohaven is performing additional analyses of the data and promised to present complete data at an upcoming scientific meeting.

BHV-7000 is an investigational oral drug that works by selectively activating the Kv7.2/7.3 potassium channels. This mode of action allows the candidate to modulate pathological hyperexcitability that can play a role in various neuropsychiatric conditions, including mania. Unlike other potassium channel agonists, BHV-7000 elicits only minimal GABAA activation, which is a source of safety concerns for other drugs that treat bipolar mania.

Indeed, in the Phase II/III bipolar mania study, Biohaven touted a “highly favorable and differentiated” safety profile versus other anti-seizure medications. Even at its highest dose of 75 mg once daily, BHV-7000 did not have adverse effects on patients’ vital signs, electrocardiograms and blood laboratory findings, as per the biotech’s news release on Monday.

Despite the underwhelming mania data but buoyed by its encouraging safety and tolerability profile, Biohaven will push through with its ongoing Phase II/III studies of BHV-7000 in major depressive disorder, focal epilepsy and generalized epilepsy. A readout in depression is expected later this year, while data for focal epilepsy are scheduled for the first half of 2026.

As far as clinical performance goes, the last few months have been tough for Biohaven. In November 2024, the company reported a Phase III flop for its myostatin and activin receptor blocker taldefgrobep alfa, which was unable to significantly boost motor function in spinal muscular atrophy. Nevertheless, Biohaven reiterated its confidence in the asset, announcing at the time that it would push through with its Phase II trial in obesity.

A few months earlier, in May 2024, Biohaven also unveiled disappointing Phase I data for its lead protein degrader BHV-1300 for treating antibody-related conditions like rheumatoid arthritis, myasthenia gravis and systemic lupus erythematosus. While results showed a strong and rapid drop in autoantibody IgG concentrations, investors appeared to be underwhelmed, sending the company’s stocks crashing 12.6% in the readout’s aftermath.

https://www.biospace.com/drug-development/biohaven-disappoints-again-this-time-in-phase-ii-iii-bipolar-mania-trial

Roche Continues Regulatory Run With Acute Stroke Expansion for Heart Attack Drug

 

TNKase is the first stroke drug to win FDA approval in nearly three decades.

The FDA signed off Monday on the use of Roche’s thrombolytic drug TNKase to treat acute ischemic stroke in adult patients.

According to Roche subsidiary Genentech, which announced the label expansion on Monday, TNKase is the first new drug for stroke in almost 30 years. Roche and Genentech also own Activase, the only other acute ischemic stroke (AIS) drug approved by the FDA.

Delivered intravenously, TNKase is a tissue plasminogen activator that works by kicking off a cascade that culminates in dissolving blood clots. In AIS, this mechanism helps prevent the formation of blockages that can constrict the flow of blood to various regions of the brain. TNKase was first approved in 2000 to lower the risk of death in patients with acute heart attack.

Monday’s label expansion was backed by data from a large multicenter trial that established the non-inferiority of TNKase to Activase. Data published in July 2022 in The Lancet showed that 36.9% of patients treated with TNKase had no to nonsignificant disability as measured by the modified Rankin Scale, a validated tool that doctors use to assess global disability in stroke patients.

In comparison, 34.8% of comparators in the Activase arm reached the same outcome. The risk difference estimate was 2.1%, which satisfied the threshold of non-inferiority.

In a statement on Monday, Genentech Chief Medical Officer Levi Garraway called TNKase’s label expansion a “significant step forward” for the company and for patients, for whom the drug can provide “a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”

Monday’s label expansion also continues Roche’s regulatory run in recent months.

Last month, for instance, the company’s SMN2 splicing modifier Evrysdi became the first FDA-approved tablet for spinal muscular atrophy, a rare motor disorder. The pill “combines established efficacy with convenience,” Garraway said at the time, and is expected to make the drug easier to take for patients.

Months earlier, in September 2024, Roche—alongside partner Sanofi—won the FDA’s approval for the industry’s first biologic treatment for chronic obstructive pulmonary disease. Dupixent, a blockbuster anti-IL4-alpha antagonist, was cleared for the lung condition after Phase III trials demonstrated a 30% to 34% drop in the rate of exacerbations versus placebo.

In April 2024, Roche’s Genentech also snagged approval for Alecensa as the first and only ALK inhibitor for the adjuvant treatment of ALK-positive non-small cell lung cancer patients with early-stage disease who had undergone surgical resection.

https://www.biospace.com/fda/roche-continues-regulatory-run-with-acute-stroke-expansion-for-heart-attack-drug

Esperion Therapeutics stock surges on strong Q4

 On Tuesday, Esperion Therapeutics (NASDAQ:ESPR), the biopharmaceutical company, reported better-than-expected fourth quarter results and provided an upbeat outlook for 2025.

The company saw its shares jump 9.49% after the release in premarket trading.

The company posted Q4 revenue of $69.1 million, up 114% YoY and surpassing analyst estimates of $63.45 million. U.S. net product revenue grew 52% YoY to $31.6 million, driven by a 45% increase in retail prescription equivalents.

Adjusted loss per share came in at $0.11, narrower than the $0.14 loss analysts were expecting.

For the full year 2024, total revenue soared 186% to $332.3 million, with U.S. net product revenue up 48% to $115.7 million.

"The significant progress we and our partners achieved throughout 2024 has formed a strong foundation that empowers us to enter the new year with a bold vision centered around three strategic pillars for building a blockbuster company: continued revenue growth, operating profitability, and portfolio expansion and pipeline advancement," said Sheldon Koenig, President and CEO of Esperion.

Looking ahead, Esperion expects full year 2025 operating expenses to be in the range of $215 million to $235 million.

The company ended Q4 with $144.8 million in cash and cash equivalents, up from $82.2 million at the end of 2023.

Esperion also announced it has initiated development of two triple combination products in the U.S. with bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin.

https://www.investing.com/news/earnings/esperion-therapeutics-stock-surges-over-9-on-strong-q4-results-93CH-3905177

BeiGene wins FDA nod for Tevimbra in first-line esophageal cancer

 BeiGene (NASDAQ:ONC) announced Tuesday that the U.S. Food and Drug Administration (FDA) approved its anti-tumor agent Tevimbra as a first-line therapy for certain patients with esophageal cancer as part of a combination regimen.

Specifically, the anti-PD-1 therapy will therefore be indicated in the U.S. together with platinum-containing chemotherapy as a first-line treatment for adults with esophageal squamous cell carcinoma whose cancers express PD-L1 proteins. According to the FDA, patients with unresectable or metastatic forms of ESCC will be eligible for the therapy.

Previously, Tevimbra was indicated in the U.S. as a single agent for late-line treatment of adults with unresectable or metastatic ESCC.

It was also licensed by the FDA as part of a combination regimen with chemotherapy for the first-line treatment of adults with gastric and gastroesophageal junction cancers.

Tevimbra’s latest approval is backed by data from BeiGene’s (NASDAQ:ONC) RATIONALE-306, which reached the main goal, indicating a statistically significant improvement in overall survival in adults with ESCC.

https://www.msn.com/en-us/health/other/beigene-wins-fda-nod-for-tevimbra-in-first-line-esophageal-cancer/ar-AA1AdBjB