Search This Blog

Thursday, September 12, 2024

'Biden administration rolls out grants to combat gender-based violence'

 U.S. President Joe Biden was set to announce a suite of grants and initiatives to help combat domestic abuse and support survivors of gender-based violence on Thursday, marking the 30th anniversary of the Violence Against Women Act.

Among the Biden-Harris administration's initiatives will be a resource center run by the Department of Justice to help law enforcement, attorneys and victims service organizations respond to cyber crimes like revenge porn and online stalking, White House Gender Policy Council head Jennifer Klein told reporters.

The Department of Justice will also expand technical assistance for local law enforcement to remove firearms from domestic abusers, and it will announce more than $690 million in fiscal year 2024 grant funding for programs to help communities address gender-based violence, she said.

Klein said the administration would also establish an office of gender-based violence through the Department of Housing and Urban Development to help meet domestic violence survivors' housing and economic needs.

Biden was scheduled to speak to survivors and advocates at the White House on Thursday evening ahead of the Violence Against Women Act's 30th anniversary.

He helped craft the 1994 legislation, which criminalized physical abuse against women at the federal level and provided government funding for victim services, advocate training, shelters and prevention education.

The law expired under President Donald Trump in 2019. Biden signed a spending bill that renewed the legislation in 2022.

https://www.aol.com/biden-administration-rolls-grants-combat-090501836.html

Election officials raise 'serious questions' about US Postal Service ballot delivery plans

 A group of about three dozen state and local election officials on Wednesday raised serious concerns about the U.S. Postal Service's ability to deliver millions of ballots for the 2024 presidential election.

The letter, from the National Association of State Election Directors and other state and local election officials, said election officials "have raised serious questions about processing facility operations, lost or delayed election mail, and front-line training deficiencies impacting USPS’s ability to deliver election mail in a timely and accurate manner."

The officials said that, despite repeated meetings with USPS election staff, "we have not seen improvement or concerted efforts to remediate our concerns."

The letter added that over the past two years in nearly every state local election officials are receiving postmarked ballots "well outside the three to five business days USPS claims as the First-Class delivery standard."'

USPS said it is "committed to the timely and secure delivery of the nation’s Election Mail" and local and state election officials "have brought any issues to our attention, we have promptly addressed those concerns, and we will continue to do so."

USPS said on average it is currently delivering mail in 2.7 days but continues "to recommend as a common-sense measure that voters should mail their completed ballot before Election Day, and at least one week prior to their state’s deadline."

The USPS inspector general's office has said 46% of votes were cast by mail in the November 2020 presidential election, compared with 21% in the 2016 election.

USPS implements "extraordinary measures" to speed delivery of ballots two weeks before the day of the general election, including steps like additional pickups, extra deliveries, and special sort plans on processing equipment.

USPS said in the 2020 general election, it delivered 99.89% of ballots from voters to election officials within seven days. Voting by mail is set to begin in mid-September.

An inspector general's office report in July found some USPS operational changes "pose a risk of individual ballots not being counted" and made recommendations to improve readiness for timely processing and delivery of ballots.

In December 2021, USPS and the NAACP reached a settlement to resolve a 2020 lawsuit over election mail that the Justice Department said would ensure prioritizing delivering ballots in future elections.

https://www.aol.com/news/election-officials-raise-serious-questions-184548797.html

ECB cuts interest rates as growth dwindles

 The European Central Bank cut interest rates again on Thursday (September 12).

It lowered its deposit rate by 25 basis points to 3.50% in a widely predicted move.

It made the cut as inflation slowed and economic growth faltered.

ECB President Christine Lagarde:

"Based on our updated assessment of the inflation outlook, the dynamics of underlying inflation and the strength of monetary policy transmission, it is now appropriate to take another step in moderating the degree of monetary policy restriction."

It follows up on a similar cut in June as inflation is now close to its 2% target and the domestic economy is skirting a recession.

Investor attention has already shifted to what comes next.

But the ECB gave no clues to its next step, even as market watchers bet on steady policy easing in the months ahead.

"Our interest rate decisions will be based on our assessment of inflation outlook in light of the incoming economic and financial data, the dynamics of underlying inflation, and the strength of monetary policy transmission. We are not pre-committing to a particular rate path."

More dovish ECB policymakers have argued recession risks are rising and high ECB rates are now restricting growth far more than needed.

But inflation-wary hawks are still in a majority, and they believe the labor market remains too hot for the ECB to sit back.

They also argue underlying price pressures raise the risk inflation could surge again.

Inflation is still only seen back at target in the second half of next year.

That means few policymakers will likely argue against further easing, but the key divide is how quickly the ECB should move.

Investors are also divided.

Another cut by December is fully priced into financial markets but some also see a chance of an interim move in October.

https://finance.yahoo.com/video/european-central-bank-cuts-interest-142912676.html

207 Chinese Ships Spotted In West Philippine Sea In New Record-High

 By Michael Delizo of ABS-CBN news

The Philippine Navy on Tuesday said it recorded at least 207 Chinese ships in the West Philippine Sea – a new record high this year after a strong storm passed through the area.

In a regular media briefing at Camp Aguinaldo, Philippine Navy spokesperson for the West Philippine Sea Rear Admiral Roy Vincent Trinidad said a few Chinese vessels withdrew during the passage of  tropical storm Enteng, but they were soon replaced by other vessels.

“No number is acceptable inasmuch as one ship within our EEZ is not acceptable,” Trinidad told reporters.

“The numbers are within the range of the force projection capability of the South Sea Fleet, the Chinese Coast Guard, and the maritime militia. So long as these are the forces within theater and they don’t bring in other forces from the East Sea Fleet and the North Sea Fleet, then this is still within the normal range of their capability,” he added.

Recent data showed that there were 182 maritime militia vessels, 18 China Coast Guard (CCG) vessels, 6 People’s Liberation Army Navy (PLAN) vessels, and 1 research and survey vessel in the area from September 3 to 9.

This was slightly higher than the 203 ships recorded from August 27 to September 2.

Most of the vessels were concentrated in Escoda Shoal – the center of the recent Chinese hostilities – swarming around the lone Philippine Coast Guard (PCG) vessel BRP Teresa Magbanua.

Trinidad said the Philippine Navy was also assessing the situation in Rozul Reef (Iroquois Reef), where there was an increased deployment of Chinese vessels – 58 maritime militia ships and 1 from PLAN.


“We are still trying to assess why there is an increase in number in Iroquois or Rozul Reef. However, we could state that for Sabina or Escoda, it's because of the extra attention that we have given to that particular shoal. For Iroquois or Rozul, we are still trying to assess,” Trinidad said.

Meanwhile, Trinidad said the BRP Teresa Magbanua remained seaworthy despite the damage it incurred during the Aug. 31 ramming by a CCG vessel.

He added the Philippine Navy and the Armed Forces of the Philippines were ready to support the PCG to maintain its presence in Escoda Shoal.

“The ship is still seaworthy. Whatever damage has been incurred will not compromise the overall integrity, water integrity of the ship. Hence, it is still there performing its mission,” Trinidad said.

https://www.zerohedge.com/geopolitical/207-chinese-ships-spotted-west-philippine-sea-new-record-high

Kamaflage: The Harris Policy Dump

 by Richard Porter via RealClearPolitics,

The Harris-Walz campaign has been vibe-a-licious and content-free; its positions on domestic and foreign policy have (with apologies to Hollywood) essentially consisted of open defiance of any presidential campaign norms: “Policy? We ain’t got no policy. We don’t need no policy. We don’t have to show you any stinkin’ policy.”

In a word, Harris’ policy dump should be seen for what it is: Kamaflage. She uses words that score well with Republicans and moderates, but inverts the meaning of those words, creating an unintelligible stinkin’ mess.

“Kamala Harris will create an Opportunity Economy where everyone has a chance to compete and a chance to succeed – whether they live in a rural area, small town, or big city.” Really? How is she going to do that?

The campaign also promises that Harris would “make it a top priority to bring down costs and increase economic security for all Americans.” It added, “As President, she will fight to cut taxes for more than 100 million working and middle class Americans while lowering the costs of every day needs like health care, housing and groceries.”

How would Harris cut taxes? Not by actually reducing anyone’s taxes, but by increasing spending: “restoring” (i.e. increasing) the amount paid out under two tax credits that provide cash payments to lower income families, most of whom already do not pay federal income taxes. But, as we learned from the ironically named Inflation Reduction Act, pumping more money into the system without increasing the supply of goods and services just devalues the dollar and creates inflation for everyone.

Harris’ campaign calls for both “making our tax system fairer and prioritizing investment and innovation,” while also calling for higher taxes on corporate earnings, quadrupling the tax on corporate distributions through stock buybacks, and increasing the capital gains rate by 40%. With a flourish that would make George Orwell blush, she blithely asserts that tax increases bolster the economy too: “When the government encourages investment, it leads to broad-based economic growth and creates jobs, which makes our economy stronger.” In what alternate reality does raising taxes on investments encourage investments?

A lifelong government employee who never worked in the private sector, Harris apparently envisions herself a preternaturally talented real estate developer. Her campaign’s policy paper claims she has a “comprehensive plan” to build three million more rental units and affordable homes “to end the national housing supply crisis in her first term.” What’s the big plan? She’ll “cut red tape” to build housing faster, while also penalizing companies that “hoard available homes to drive up prices,” and “outlaw new forms of price fixing by corporate landlords.”

Did you follow that? She will cut red tape and build more housing by imposing new red tape in the form of federal rent regulations so that landlords make less money. This is merely contradictory nonsense with poll-tested verbiage. 

She would also give $25,000 to first-time home buyers, “with even more generous support for first-generation homeowners.” Obviously, giving people more money to buy houses means houses will cost more, not less. Note, too, that not all first-time home buyers would be treated equally. Some, such as immigrants (whether here legally or illegally), would get even more than young Americans who are descended from (gasp!) previous homeowners.

Harris also wants you to know that “neighborhood shops, high-tech startups, small manufacturers, and more – are the engines of our economy.”

“Kamala Harris will always support small businesses and invest in entrepreneurs as president,” the campaign vows in employing good Republican words! How will she do this? By expanding set-asides for minority-owned small businesses. She has set a goal of 25 million new business applications (apparently you’ll have to apply to start a small business under Kamala Harris) and would expand the start-up expense deduction, while driving venture capital to the talent that exists all across our country, including in rural areas. Does this portend new geographic investment regulations for venture capital? Note too, that she asserts she will drive this investment at the same time as increasing the tax on investments.

She also calls for the first-ever price regulations for grocery and food businesses, claiming that price gouging is rampant in an industry where the profit margins are usually around 1.5%. She also calls for extending price regulations with respect to health care and prescription drugs. Of course, it’s axiomatic that price regulations reduce supply – so what would happen in the real world is that there would be less food, drugs, and healthcare services, and what’s still produced will cost more too.

The Orwellian theme of using Republican words to Kamaflage socialist policies while asserting that down is up continues throughout the entire package of policies: Secure the borders by hiring more agents to process more immigrants! Reduce crime by making lawful gun ownership harder! Stand up for Israel’s right to defend itself, except with respect to Palestinian terrorists! Protect voting by blocking states from taking steps to secure the vote, like imposing ID requirements!

You get the gist. Her policy dump is an incoherent mess put out under the thin guise of poll-tested verbiage in the hope of Kamaflaging the reality that a Harris administration would double down on the dumbest ideas of Sen. Bernie Sanders and the socialist “squad” in the House. The only thing clear from her policy proposals is that Kamala Harris has not changed. She’s only hiding her hard-left values behind verbiage she’s expropriating from her opponents.

Richard Porter is a lawyer in Chicago and a former policy advisor to President George H.W. Bush and Vice President Dan Quayle.

https://www.zerohedge.com/political/kamaflage-harris-policy-dump

Sanofi's $80M bet on Fulcrum's dystrophy drug ends in phase 3 failure after 4 months

 Just four months after Sanofi bet $80 million in upfront cash on Fulcrum Therapeutics’ losmapimod, the program has ended in a phase 3 failure.

The licensing deal with the Big Pharma was agreed upon while counting down to the release of late-stage data in the progressive muscle wasting disorder facioscapulohumeral muscular dystrophy (FSHD) which, if successful, could have opened the door to the p38 inhibitor becoming the first approved therapy for the disease.

But the results are just in, and it looks like a wipeout. Not only did the 260-patient study miss its primary endpoint of showing an improvement in an individual’s arm reach when taking a 15-mg losmapimod tablet twice a day compared to placebo, but the study’s secondary endpoints like muscle fat infiltration and patient-reported improvements “did not achieve nominal statistical significance,” Fulcrum explained in a Sept. 12 premarket release.

Specifically, the primary endpoint of reachable workspace (RWS)—an analysis of how far an individual can reach—saw a 0.013 improvement among patients receiving losmapimod at Week 48 compared to a 0.010 improvement among those who received placebo.

Fulcrum’s chief medical officer Pat Horn, M.D., Ph.D., blamed the results on the lack of deterioration among the placebo cohort.

“These results in patients receiving losmapimod when compared to baseline were similar to those observed in our phase 2 study,” Horn said. “However, in contrast to what was seen in the ReDUX4 study as well as what has been reported in other FSHD studies, the patients receiving placebo in REACH did not show a decline in functional status as measured by RWS and shoulder dynamometry over the 48 weeks of the study.”

The safety and tolerability of losmapimod was consistent with previously reported studies, according to Fulcrum, which said it will fully evaluate the data before sharing the results at an upcoming medical meeting.

“We are deeply disappointed that the REACH trial did not replicate the clinical results observed in the phase 2 ReDUX4 trial,” Fulcrum’s CEO Alex Sapir said in the release. “In light of these results, we plan to suspend the losmapimod program in FSHD.”

The biotech’s stock plummeted 70% in premarket trading Thursday morning to $2.60 from a Wednesday closing price of $8.85.

Massachusetts-based Fulcrum said it would use its $273.8 million in cash and equivalents to swiftly pivot to its remaining pipeline. This is headed up by pociredir, a phase 1-stage small molecule designed to treat sickle cell disease by increasing expression of fetal hemoglobin.

Today’s results mark a fork in the road for Fulcrum, which could have been on track to get the first-ever FSHD drug to market if the phase 3 data had shown promise. Losmapimod had a two- to three-year head start on Roche’s myostatin inhibitor that is being targeted at FSHD, while Avidity Biosciences and Arrowhead Pharmaceuticals both have antibody-oligonucleotide complexes in clinical development for the condition.

It also means Fulcrum can wave goodbye to potentially $975 million in milestone payments that were tied to the Sanofi licensing deal. When the French Pharma secured the ex-U.S. rights to losmapimod in May, the drugmaker’s global head of rare disease Burcu Eryilmaz pointed to “meaningful clinical benefits” shown in phase 2 studies that “underscore the disease-modifying potential and opportunity to address the high unmet need for a safe and effective drug that slows disease progression.”

But losmapimod already had a number of clinical misses on its scorecard. Fulcrum rescued the molecule in 2019 from the vault of GSK, where losmapimod had failed a phase 3 trial in patients with acute coronary syndrome and a midstage study in chronic obstructive pulmonary disease. 

Under its new owner, it had also failed a phase 2 trial in FSHD in 2021, although Fulcrum was heartened by phase 2b data showing losmapimod could still slow disease progression and improve function in FSHD patients.

https://www.fiercebiotech.com/biotech/sanofis-80m-bet-fulcrums-dystrophy-drug-ends-phase-3-failure-4-months-later

Summit Therapeutics Raises $235 Million

 Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the Company accepted offers from multiple leading biotech institutional and individual investors to purchase an aggregate of approximately 10.35 million shares of the Company’s common stock at $22.70 per share, the closing price on Wednesday, September 11, 2024, for aggregate gross proceeds to the Company of approximately $235 million. The capital raise was completed without bankers’ fees.

All of Summit’s Section 16 officers participated in the capital raise. A total of $79 million was raised by insiders, including Robert W. Duggan, Dr. Maky Zanganeh, Manmeet S. Soni, and Bhaskar Anand, as well as Jeff Huber, a member of the Board of Directors, who invested via a controlled entity. The remaining $156 million was raised with multiple leading biopharma institutional investors.

Summit intends to use the net proceeds to advance, in part, the clinical development of ivonescimab, including in non-small cell lung cancer and in settings outside of lung cancer by leveraging the data that will be presented at ESMO, which may include, but is not limited to, colorectal cancer, and triple-negative breast cancer, in addition to working capital needs and general corporate purposes.

https://www.businesswire.com/news/home/20240912965249/en