Congress Approves Extension Of Warrantless Surveillance Powers

 Update(1300ET): As expected given there were only a handful of senators and House reps opposing, Congress has approved the short-term extension of the US government's warrantless surveillance powers:

Congress has approved a short-term extension of the nation’s warrantless surveillance powers, punting to the new year a decision over how to reform the law.

Included in the defense policy bill headed to the president’s desk after approval by the House on Thursday is a measure that extends Section 702 of the Foreign Intelligence Surveillance Act (FISA) until mid-April.

Here's what Rep. Chip Roy of Texas had to say: "The fact of the matter is what’s being stated is it is impossible to oppose the National Defense Authorization Act because we put a pay raise in it or because we put something in there that is seemingly so important that we have to ignore the critical destruction of our civil liberties by adding FISA extension right on the top of it without doing the forms necessary to protect the American people."

He and some others have argued that the FISA issue should be a standalone bill and not part of the NDAA. Naturally, the US intelligence community praised its passage as "necessary" to national security.

* * *

At a moment Republicans are continuing to hold out on their refusal to support a massive $111 billion supplemental spending package that Biden wants for Ukraine, Israel, and Taiwan - the Senate did manage to get something big done, namely passage of the mammoth $886 billion 2024 National Defense Authorization Act (NDAA).

It passed on Wednesday, authorizing funding for the Department of Defense for this next year, in a vote of 87-13. Those voting against it included six Republicans, six Democrats, and an Independent. It now heads to the House where a vote is expected Thursday.

The no votes included GOP hardliners who "have been criticizing House Republicans... after the text of the compromise with the Democrat-controlled Senate removed a number of conservative policy goals on transgender surgeries and abortion, among others," according to FOX.

Other controversial, arguably more pressing aspects which also attracted a minority of Democrat criticism includes an amendment to extend Section 702 of the Foreign Intelligence Surveillance Act (FISA).

This controversially allows warrantless spying of foreign targets and Americans who have communications with those foreign subjects. The new extension in the NDAA authorizes it further until at least April 19.

Sen. Mike Lee raised the alarm on the FISA issue in particular, writing on X, "The Senate just voted to waive the point of order against the NDAA. 35 of us opposed the motion to waive. We needed only 41 to prevent this outcome, and to remove FISA 702 from the NDAA. This is not good. The House should #StopTheNDAA."

And here's what Sen. Lee is urging Americans to do:

It’s a new day in America. The Fourth Amendment still prohibits warrantless searches of Americans. FBI disregards that under FISA 702. The NDAA would further enable FBI’s lawless abuse of 702. One-third of the House can still stop the NDAA. Ask your representative to vote NO!!!

Rand Paul was another objector. House Rep from the same state of Kentucky Thomas Massie had this to say: "It was close in the Senate, but now it’s up to the House tomorrow to stop the reauthorization of warrantless spying on Americans."

NSA whistleblower Edward Snowden also urged Americans to voice their opposition to the NDAA...

Even CNN has highlighted that Section 702 easily sets up the government to exploit the law and conduct mass wireless spying, a severe violation of the Fourth Amendment.

"The searches are governed by a set of internal rules and procedures designed to protect Americans’ privacy and civil liberties, but critics say that loopholes allow the FBI to search the data it collects for Americans’ information – as opposed to from foreign adversaries – without proper justification," CNN writes.

Also interesting is another fight centered on historic abuse of government power, as The Hill details: 

The rocky relationship between Senate Republican Leader Mitch McConnell (Ky.) and Sen. Josh Hawley (R-Mo.), a rising conservative populist star, is in the spotlight after McConnell played a leading role in killing a Hawley-sponsored amendment to the annual defense bill.  

Further, "Hawley says McConnell was dead set on killing his provision, which would have provided compensation to St. Louis-area residents who were exposed to radiation from improperly stored nuclear waste left over from the Manhattan Project in the 1940s."

https://www.zerohedge.com/political/ed-snowden-sounds-alarm-over-warrantless-spying-loophole-massive-886-billion-ndaa-passes

Maersk says container ship en route to Saudi Arabia was targeted by missile

 Danish shipping company A.P. Moller-Maersk said on Thursday its container ship Maersk Gibraltar was targeted by a missile while en route from Salalah, Oman, to Jeddah, Saudi Arabia and that the crew and vessel were reported safe.

It was not immediately clear if the missile had struck the vessel or not.

"At this time, we are still working to establish the facts of the incident," Maersk said in a statement. 

https://finance.yahoo.com/news/1-maersk-says-container-ship-143440740.html

Michael Cohen's Former Attorney Ordered To Explain Citing Cases The Judge Believes Don't Exist

 by Jana Pruet via The Epoch Times,

A lawyer for Michael Cohen appears to have cited non-existent court rulings in a legal filing seeking to have his client's post-prison supervision terminated early, according to a federal judge in New York who is threatening penalties.

On Tuesday, U.S. District Judge Jesse Furman ordered David M. Schwartz to provide copies of three rulings cited in the motion he filed last month. Mr. Schwartz must respond with copies to the judge by Dec. 19. If he cannot, he must explain in writing why he should not sanctioned.

"As far as the Court can tell, none of these cases exist," Furman wrote.

He added that if copies of the rulings aren't submitted, he wanted "a thorough explanation of how the motion came to cite cases that do not exist and what role, if any, Mr. Cohen played in drafting or reviewing the motion before it was filed."

Mr. Cohen, who served as a personal attorney for former President Donald Trump, gained notoriety as the "fixer" but later fell out of grace to become one of the former president's loudest critics.

Mr. Schwartz did not immediately respond to phone and email messages Wednesday.

E. Danya Perry, a new attorney representing Mr. Cohen, said she could not verify the case law cited in Mr. Schwartz's motion.

In late 2018, Mr. Cohen was sentenced to prison after pleading guilty to tax evasion, campaign finance charges, and lying to Congress. He served about 13 1/2 months in prison, along with 18 months in home confinement, before being placed on three years of supervised release.

Mr. Cohen, 57, has been on supervised release since November 2021.

During discussions of possible sanctions, Judge Furman referred to a separate, unrelated case in a Manhattan federal court earlier this year involving the citing of case law that did not exist.  Two lawyers in that case were fined $5,000 for citing bogus cases invented by ChatGPT, the artificial intelligence-powered chatbot.

There is no mention of the use of artificial intelligence in the motion issued by Judge Schwartz.

Mr. Cohen has served approximately two years of his supervised release from prison. His campaign finance conviction came after he arranged payouts to prevent porn star Stormy Daniels and model Karen McDougal from making public claims of extramarital affairs with former President Trump during his 2016 campaign.

On Nov. 29, Mr. Schwartz filed a motion requesting Mr. Cohen's supervised release ended early, citing his client's testimony in New York Attorney General Letitia James' ongoing civil lawsuit alleging President Trump and his business inflated his wealth in financial documents.

Ms. Perry said she conducted her own research to support the judge's motion, and she could not verify the case law cited by Mr. Schwartz.

"Consistent with my ethical obligation of candor to the Court, I advised Judge Furman of this issue," Ms. Perry said in a statement, adding that she believed the motion still had merit.

In his motion to end Mr. Cohen's supervised release, Mr. Schwartz cited three cases that he claimed were all affirmed by the 2nd U.S. Circuit Court of Appeals in New York.

But Judge Furman said one of those citations actually referred to a 4th U.S. Circuit Court of Appeals ruling that was unrelated to supervised release. A second case mentioned by Mr. Schwartz is a Board of Veterans Appeals decision, the judge said. And the third citation "appears to correspond to nothing at all," Judge Furman wrote.

Earlier this year, Mr. Cohen told Semafor he was considering running for Congress as a Democrat in New York's 12th Congressional District, the Manhattan seat currently held by Rep. Jerry Nadler.

https://www.zerohedge.com/political/michael-cohens-former-attorney-ordered-explain-citing-cases-judge-believes-dont-exist

EU Lists Hundreds of Critical Medicines in Effort to Prevent Shortages

The European Commission, the Heads of Medicines Agencies and the European Medicines Agency released a first list of more than 200 medicines on Tuesday considered critical for healthcare systems across Europe.

Critical medicines are those that are used to treat serious diseases, and for which there are no easy and equivalent replacements in case of a shortage. According to a Q&A document, the European medicines regulatory network will closely monitor these medicines and take steps to minimize the risk of shortages and supply disruptions.

Medicines on the agencies’ list will also come with “additional reporting requirements” for national authorities and holders of marketing authorizations, as defined by the proposed revisions for the European Union’s pharmaceutical legislation. The list will also support European Commission (EC) efforts to analyze the supply chains of these critical medicines to spot potential weaknesses.

The agencies will expand the list in 2024 and will update it annually thereafter, according to Tuesday’s announcement.

“Inclusion in the list does not mean that the medicine is likely to experience a shortage in the near future,” the agencies noted. “It means that the prevention of shortages is particularly important as a shortage could cause significant harm to patients and pose important challenges to health systems.”

Some of the drugs on the agencies’ list include the antithrombotic agents warfarin and heparin, the systemic corticosteroids prednisolone and hydrocortisone and the cancer drugs cisplatin, carboplatin, oxaliplatin and tretinoin. Several anti-infectives are also on the list, including doxycycline, cefixime, emtricitabine and various bacterial and viral vaccines.

Products on the list can still be prescribed and used by healthcare professionals and patients, according to the agencies. The list will also not affect any existing or upcoming national lists of critical medicines, though it may serve as a guide for countries that do not yet have such lists.

Tuesday’s initial list comes shortly after the EC announced in October 2023 additional steps to “prevent and mitigate” drug shortages. The Commission launched the European Voluntary Solidarity Mechanism for medicines, which identifies shortages in one member state and connects it with another member state with available stock.

The EC has likewise allowed regulatory flexibilities which would enable member states to extend shelf lives of medicine products and accelerate the approval of alternatives.

By early 2024, the EC will also institute the Critical Medicines Alliance, which will act as an industrial policy pillar to the European Health Union. The effort is aimed at helping to prevent shortages by coordinating procurement practices across the EU, improving Europe’s capacity to produce and innovate in the field of critical medicines, while fostering strategic partnerships to improve supply chains.

https://www.biospace.com/article/eu-lists-hundreds-of-critical-medicines-in-effort-to-prevent-shortages/

Pharma, Life Sciences Sector to See Healthy M&A Activity in 2024: PwC

 Mergers and acquisitions across the pharmaceuticals and life sciences sector will reach a “healthy” level next year, with deals totaling $225 billion to $275 billion, according to professional services firm PwC’s new US Deals 2024 Outlook report.

The report points to precision medicine opportunities in oncology and immunology, areas that typically see high levels of dealmaking activity. PwC also predicts that the weight loss and cardiovascular diseases spaces will see increased investor interest in 2024 after it “went through a renaissance in 2023.”

This year “was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels,” according to report, adding that the firm expects “similar levels of activity” in 2024.

Nevertheless, the industry will still have to contend with geopolitical tensions and regulatory uncertainties, alongside what PwC calls the “reality of higher interest rates,” all of which might push investors to focus more on “margin accretion” rather than put their money in growth-driven dealmaking.

“As regulators’ perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps,” according to the report.

In terms of initial public offerings (IPOs), PwC anticipates a gradual uptick in activity, with a preference for young companies armed with strong clinical data.

Still, beyond IPOs and M&As, companies in 2024 will look for more creative funding structures that will provide strong support for their R&D activities, while allowing them to retain control over critical compounds, PwC contends. These funding structures could include private equity and private credit, alongside other solutions such as asset swaps, innovative joint ventures, divestitures, collaborations and profit-sharing agreements.

The PwC report also identifies key drivers of dealmaking, which could help pharmaceutical and biotech companies more effectively secure funding.

Investors could be more attracted to companies with clear core areas, rather than those that work to diversify their portfolios. In addition, current and impending patent expirations will likely push big companies to seek out deals in an attempt to address gaps in their pipelines, according to the report.

The biopharma industry faced several difficulties in 2023, including a fraught macroeconomic environment, climbing interest rates and increasingly prudent investors, all of which led to a marked drop in IPO activity this year, especially compared with the previous pandemic-driven high of 2021.

Many companies had trouble staying afloat this year and were forced to launch broad cost-cutting programs or reduce their workforces.

The industry also contended with several regulatory challenges this year, including new merger guidelines from the FTC that would increase antitrust scrutiny on deals, as well as several FDA rejections, many of which have forced companies to abandon programs.

“The competition for high quality assets will remain incredibly fierce and the regulatory landscape remains challenging,” according to PwC. “With the implications of the Inflation Reduction Act (IRA) now better understood, we expect that companies will direct innovation dollars increasingly towards biologics at the expense of small molecules.”

https://www.biospace.com/article/pharma-life-sciences-industry-to-see-healthy-m-and-a-activity-in-2024-pwc/

White House Hits Pharma Again, Requires Rebates Over Drug ‘Price Gouging’

 Pharmaceutical companies have come under fire from the White House for the second time in as many weeks. The Biden administration announced Thursday “dozens” of drugmakers will be required to pay inflation rebates back to the Centers for Medicare and Medicaid Services due to “price gouging.” 

Under the Inflation Reduction Act (IRA), CMS has come up with a list of 48 Medicare Part B drugs that raised their prices faster than inflation and “may be subject to inflation rebates in the first quarter of 2024,” according to the agency’s announcement.  

The White House contends that the IRA will save some seniors who take the 48 Medicare Part B drugs from their yet undisclosed list “as much as $2,786 per average dose.” 

CMS said in its press release that it will issue invoices for the rebates to the drug companies involved starting in 2025, including years 2022, 2023 and 2024. 

The White House’s press release specifically called out Signifor, an endocrine disorder drug developed by Novartis, for raising prices faster than inflation every quarter since the IRA passed into law in August 2022. 

“Some Medicare beneficiaries who take Signifor could save $311 per monthly dose starting January because of the law,” according to the Biden administration. 

Last week, the White House announced its intention to invoke “march-in rights” to take back patents of expensive medications whose research relied on federal funds. While use of march-in rights is not likely to be widespread, Department of Health and Human Services Secretary Xavier Becerra said in a statement that it is a “powerful tool” to help “ensure that the benefits of the American taxpayer’s investment in research and development are reasonably accessible to the public.” 

HHS on Thursday also announced that the Administration for Strategic Preparedness and Response (ASPR) is making fair pricing a standard part of contract negotiations for medical products.  

In September 2023, ASPR finalized a Project NextGen contract—a government initiative to advance new vaccines and therapeutics faster and at lower cost—which was signed by Regeneron, agreeing that if pharma’s COVID-19 treatment is commercialized, its list price in the U.S. will be equal to or less than retail price in comparable global markets.  

Similar language has also been added to agreements with a handful of other vaccine developers like CastleVax, Codagenix and Gritstone Bio, the first three vaccines selected for development under Project NextGen, the Biden administration said. 

Pharma companies have been fighting the IRA’s Drug Price Negotiation Program in court, with lawsuits claiming the Medicare negotiations are unconstitutional. They say it will force companies to sell at lower-than-market value and threaten R&D in the future for new and innovative medicines. 

However, as of October 2023, all 10 of the pharma companies whose products were selected in the first round of Medicare price negotiations begrudgingly agreed to participate in the talks under the IRA.

A recent report found that if the Medicare price negotiation program had been in effect in 2021, out of pocket costs for Part D participants would have dropped 23% for patients on the 10 costliest drugs at the time. 

https://www.biospace.com/article/white-house-hits-pharma-again-requiring-rebates-over-drug-price-gouging-/

Immix: 100% ORR (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in AL Amyloidosis

 

• 100% (10/10) overall response rate (ORR) and 70% (7/10) complete response (CR) rate observed in standard of care (Dara-CyBorD) relapsed/refractory AL Amyloidosis patients with median 6 lines of prior therapy in updated Phase 1/2 data as of December 10, 2023
• Best responder duration of response was 23.7 months with response ongoing as of December 10, 2023
• U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 29,712 patients in 2023

https://www.globenewswire.com/news-release/2023/12/11/2793969/0/en/Immix-Biopharma-Announces-100-Overall-Response-Rate-n-10-23-7-months-Best-Response-Duration-ongoing-for-CAR-T-NXC-201-in-Relapsed-Refractory-AL-Amyloidosis-Patients-at-ASH-2023.html