Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a development-stage, insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, today announced the premarket submission of its MODD1 next-generation insulin pump to the FDA for 510(k) clearance.
Friday, January 19, 2024
Kyverna Fast Tracked for Treatment of Refractory Progressive MS
The announcement follows the recent IND clearance for KYV-101 to be used in Kyverna's KYSA-7 Phase 2 open-label, multicenter study
KYV-101 is a fully human CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases
Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced it received fast track designation by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of multiple sclerosis (MS).
Proposed IRA Expansion Would Cripple Biopharma, Lead to Fewer Drugs: Report
The proposed expansion to the Inflation Reduction Act would substantially harm U.S. biopharma, triggering hundreds of thousands of job cuts across the industry and leading to fewer innovative treatments in critical therapeutic areas, according to a new report released Thursday by healthcare consultancy Vital Transformation.
The 34-page report makes the case that the proposed Inflation Reduction Act (IRA) expansion would eliminate around 136,000 to 216,000 jobs in the biopharma industry and lead to an additional 678,000 to 1,076,000 indirect layoffs across the U.S. economy.
The expansion would also result in around 134 fewer FDA approvals over a 10-year period, which would most heavily affect “many areas of unmet need,” such as oncology, neurology, rare diseases and infectious diseases in the elderly population, the report contends.
Vital Transformation expects that these consequences would ripple throughout the entire commercial market but warns that the effects would most strongly impact the industry’s hubs of scientific innovation in California, Massachusetts and New York.
Besides its effects on jobs and innovation, the proposed IRA expansion would also severely cut funding for biopharma, triggering a 70% drop in venture capital as well as a 50% decrease in initial public offerings (IPOs) across the industry, according to the report. The sector is going through a winter in IPO offerings, which have dropped dramatically since a 2021 peak.
“The study projects another $55 billion in lost partnership investments for the most impacted firms on top of the current drops in investments since the introduction of the IRA,” according to the press release.
Thursday’s report is in response to a proposal by Democratic lawmakers in the House of Representatives to expand the IRA by vastly extending the contentious Medicare Drug Price Negotiation Program to cover all people with private insurance. Overall, this would encompass more than 164 million workers and their families with health coverage through their employment, as well as over 16 million people with Marketplace coverage.
The proposed legislative bill—the Lowering Drug Costs for American Families Act (H.R. 4895)—also seeks to block pharmaceutical companies from hiking drug prices faster than the rate of inflation. It would also bump the yearly number of prescription drugs that would be subjected to price negotiations to 50, up from 25.
Dan Leonard, executive director for industry group We Work For Health, in a statement said the proposed expansion to the IRA would effectively double down on a “bad idea” whose effects and unintended consequences are only beginning to be realized.
“While the stated goal of reducing costs for patients is one we can all agree on, this research demonstrates that policies like these will only hurt the very people—seniors—they are purportedly trying to help,” Leonard said, adding that such price-setting efforts by the government are “harrowing” for patients and workers who rely on the biopharma industry for treatments and jobs.
We Work For Health collaborated with Vital Transformation on the report.
However, House Democrats argue that H.R. 4895 will stop drug companies from raising prices faster than inflation by ensuring that the rebates enacted under the IRA also apply to individuals covered by private health plans.
“Extending the inflation rebates to privately-covered American workers can save as much as $40 billion over the next decade alone,” while strengthening the Drug Price Negotiation Program “to deliver more savings,” according to a fact sheet on the proposed legislation.
https://www.biospace.com/article/proposed-ira-expansion-would-cripple-biopharma-lead-to-fewer-drugs-report/
New York Stock Exchange Abandons Plan To Control America's Natural Resources
by Kevin Stocklin via The Epoch Times,
The New York Stock Exchange (NYSE) on Jan. 17 withdrew its proposal to establish and list Natural Asset Companies (NAC), which would pool investors’ money from around the world to buy controlling rights to public and private land throughout the United States.
The NACs would, according to filing documents, manage the lands solely for the purpose of “sustainability.” Critics of the plan charged that wealthy investors and foreign entities would be able to use these vehicles to make decisions to allow or block the public from accessing the publicly owned land that is designated for uses such as hunting, fishing, drilling, mining, hiking, and logging.
While some conservation groups and global warming activists had supported the initiative as a way to protect natural resources, many land-rights activists applauded its demise and questioned whether wealthy investors would be better stewards of America’s land.
“Today’s withdrawal is a major victory for Americans,” Margaret Byfield, executive director of American Stewards of Liberty, a land-rights organization, told The Epoch Times.
“Very few people understand how close we were to losing control of our property and natural resources through this diabolical NAC scam.”
The creation of NACs was the initiative of an organization called the Intrinsic Exchange Group (IEG), which was created with funding from the Rockefeller Foundation and other unnamed investors. IEG entered into a partnership with the NYSE, where the NYSE bought a stake in IEG.
The two organizations collaborated to set up NACs, which would have been financed and traded on the exchange, while licensing IEG’s proprietary software for valuation and reporting according to guidelines based in the U.N. environmental accounting standards. Because this was a nonstandard type of company, which wouldn’t earn profits for investors in the way that other companies do, nor would it use GAAP accounting to value its assets, the NYSE applied to the Securities and Exchange Commission (SEC) to grant an exception to its existing rules of operation.
“Ending the overconsumption of and underinvestment in nature requires bringing natural assets into the financial mainstream,” the NYSE stated in its SEC filing.
“The financing gap for biodiversity is estimated between US$598 and US$824 billion per year, and for climate change is estimated at over US$5 trillion per year, and likely an order of magnitude larger for the transition to a more sustainable, resilient, and equitable economy.”
The initial SEC approval process for NACs was relatively short, critics said, allowing for only a 21-day comment period that ran through the Christmas holiday. Amid protests from 25 state attorneys general, 32 members of Congress, and 22 state financial officers, the SEC extended the comment period until Jan. 18.
Creating a Buyer and Seller
The NAC plan coincided with other Biden administration initiatives, including the “30x30 plan,” according to which 30 percent of America’s land and waters would be set aside for preservation by 2030. In addition, the Bureau of Land Management (BLM) has proposed the creation of “conservation leases” on public lands, which would grant third parties the right to control them and preclude further development of those lands.
“Now you have a seller—BLM created that,” Utah Attorney General Sean Reyes told The Epoch Times in a Jan. 9 interview.
“And now [with NACs], you have a buyer, or a vehicle to use private money to buy what the BLM couldn’t do through proper legislation and couldn’t do at the ballot box.”
State AGs challenged the legality of establishing these nonstandard types of companies, as well as the NACs’ ability to acquire rights to public lands and the Biden administration’s authority to sell such rights.
“The proposed [NAC] rule plainly is intended to serve as the funding mechanism for the Bureau of Land Management’s recent proposed rule, ‘Conservation and Landscape Health,’ which would authorize BLM to grant ‘conservation leases’ for public lands,” the AG’s stated in a letter to the SEC.
“The BLM rule provides that ‘once the BLM has issued a conservation lease, the BLM shall not authorize any other uses of the leased lands that are inconsistent with the authorized conservation use.’”
The AGs applauded the decision to cancel the NAC proposal.
“This is a resounding win for our states and our constituents, as we protect access to multiple legal, productive, and responsible uses of our lands and other natural resources,” Mr. Reyes told The Epoch Times via email.
Kansas Attorney General Kris Kobach, who together with Mr. Reyes co-authored the AGs’ letter, issued a statement that he was “pleased the SEC has withdrawn its proposed rule change. Doing so avoided an unnecessary legal battle.”
Many of the comments posted on the SEC’s website opposed the NYSE’s proposal, with critics arguing that NACs would give private companies control over farmland, grazing areas, national and state parks, and other mineral-rich lands.
“This news illustrates the impact of public engagement on important issues,” Utah State Treasurer Marlo Oaks said in a statement, calling the creation of NACs “one of the greatest threats to rural communities in the history of our nation.”
Rep. Harriet Hageman (R-Wyo.), who had opposed the creation of NACs, called their withdrawal “a clear win for farmers, ranchers, loggers, miners, energy producers, energy users, and all who enjoy the use of public lands.”
“It is also a clear sign that when the insidious policies being considered by this administration are exposed, they can be defeated,” she said in an emailed statement.
https://www.zerohedge.com/political/new-york-stock-exchange-abandons-plan-control-americas-natural-resources
Ex-IRS Consultant Took Job With Intention Of Stealing Trump’s Tax Returns: DOJ
by Caden Pearson via The Epoch Times (emphasis ours),
The Department of Justice told a sentencing judge on Wednesday that a former Internal Revenue Service (IRS) contractor took the job specifically to steal and leak President Donald Trump’s tax returns.
Washington resident Charles Littlejohn pleaded guilty in October last year to one count of unauthorized disclosure of tax returns and return information after he was accused of stealing and leaking data associated with President Trump and other wealthy individuals.
In a 15-page filing, prosecutors pushed for the maximum statutory sentence of five years in prison, arguing that Mr. Littlejohn’s betrayal of the public trust “merits significant punishment.”
Mr. Littlejohn had access to “vast amounts of unmasked taxpayer data” when he worked for Booz Allen, a consulting firm working with public and private clients mostly on IRS contracts, between 2008 and 2013.
After President Trump took office in 2017, Mr. Littlejohn sought to return to work for Booz Allen “with the intention of accessing and disclosing” the tax returns of the president, whom he viewed as “dangerous and a threat to democracy,” according to prosecutors.
Mr. Littlejohn “weaponized his access to unmasked taxpayer data to further his own personal, political agenda, believing that he was above the law,” prosecutors said.
This went on for more than two years, with multiple news organizations receiving unlawfully leaked private tax returns and other private financial information.
Prosecutors did not name the news organizations that received the stolen tax returns in court records, but ProPublica and The New York Times published multiple articles reporting on the leaked documents.
“A free press and public engagement with the media are critical to any healthy democracy, but stealing and leaking private, personal tax information strips individuals of the legal protection of their most sensitive data,” prosecutors said in the filing.
“Everyone is entitled to equal protection under the law,” they continued.
Prosecutors, pushing for the maximum sentence, argued that Mr. Littlejohn leaked the tax returns of over a thousand individuals, resulting in significant harm, including invasion of privacy and psychological distress. They charge that Mr. Littlejohn’s crime “has undermined public faith and confidence in the IRS, an institution that is critical to the effective functioning of our government.”
Sophisticated Scheme
Mr. Littlejohn received access to unmasked taxpayer data in February 2018, and by the end of the year, he had developed “a sophisticated, detailed plan” to secretly download President Trump’s tax returns from a particular internal IRS database without detection, according to the filing.
To avoid triggering scrutiny, Mr. Littlejohn searched for the president’s private data “using more generalized parameters” that would nevertheless collect the tax return and return information.
To extract the data without detection, Mr. Littlejohn exploited a loophole in IRS protocols by uploading the stolen files to a private website he controlled. He then used a personal computer to download the files and made copies, which he stored on an Apple iPod that he had configured as a personal hard drive.
Mr. Littlejohn shopped the tax returns around to a news outlet in May 2019, with one of the publications publishing more than 50 articles using the stolen data.
In September 2020, The New York Times reported that it had obtained the 2016 and 2017 tax records of President Trump, who was in office at the time.
In June 2021, ProPublica published the private tax return information of billionaires such as Elon Musk, Jeff Bezos, Michael Bloomberg, Warren Buffett, Peter Thiel, and others.
Mr. Littlejohn allegedly also obstructed the investigation into his conduct by deleting and destroying evidence of his disclosures.
It is not clear how officials were able to detect Mr. Littlejohn’s behavior.
Booz Allen’s spokesperson told Fox News that the firm fully supports the investigation into Mr. Littlejohn’s actions.
“We condemn in the strongest possible terms the actions of this individual, who was active with the company years ago. We have zero tolerance for violations of the law and operate under the highest ethical and professional guidelines. We fully supported the U.S. government in its investigation into this matter,” the spokesperson said.
Process Pharma Expands NGC-Cap Program into Advanced or Metastatic Breast Cancer
FDA and Processa agree to expand NGC-Cap development into breast cancer providing a more efficient path to approval
FDA agrees that existing data and studies can be used to support the Phase 2 breast cancer trial design
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces it plans to expand the development of Next Generation Capecitabine (“NGC-Cap”) into the treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial. Following the Processa meeting with the FDA, Processa has decided the next NGC-Cap trial would be a Phase 2 trial in breast cancer. This decision was supported through discussions with the FDA where Processa agreed with the FDA that pursuing breast cancer will lead to a more efficient development program while providing a greater likelihood of FDA approval. The FDA stated that the previously generated data in past and existing studies could be used to directly support the Phase 2 trial in breast cancer.
“We believe the pursuit of an advanced or metastatic breast cancer indication for NGC-Cap is a logical progression for Processa as it represents a larger market than colorectal cancer with the potential to differentiate NGC-Cap from the presently approved capecitabine as well as other treatments for breast cancer. The FDA and Processa discussed the advantages and disadvantages of developing NGC-Cap in breast cancer and concluded that the development would be a more efficient and straightforward path to approval with an easier enrolment process for the Phase 2 and 3 trials,” said David Young, PharmD, Ph.D., President of Research and Development at Processa. “Capecitabine is already approved as both monotherapy and combination therapy in breast cancer, which contributes to the logic and efficiency of our current direction. In addition, the FDA’s agreement that our present data would support a Phase 2 trial in breast cancer makes the expansion seamless. We believe our Phase 2 trial will provide the safety-efficacy data to preliminarily demonstrate the benefit of NGC-Cap over capecitabine and other treatment options.”
“Based on this expansion to breast cancer we have identified breast cancer key opinion leaders to join our scientific advisory board, have already determined the Phase 2 study design which we expect to share with the FDA soon, and plan to initiate our Phase 2 study in the third quarter of 2024,” concluded Young.
Breast cancer is the most diagnosed cancer, representing approximately 15% of all new cancer patients in 2023. It has a prevalence of more than 3.8 million patients, with nearly 300,000 new diagnoses last year. Over 150,000 women are currently living with advanced or metastatic breast cancer. The NGC-Cap potential market for breast, colorectal and other cancers is greater than 250,000 patients per year.
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