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Wednesday, July 5, 2023

RFK Jr. Decries Biden Admin's Withholding Of Some JFK Assassination Records

 by Alice Girodano via The Epoch Times,

On the afternoon of Friday before arguably one of the busiest holiday weekends in America, the Biden administration issued a memo announcing that due to national security, it was going to postpone the release of certain classified documents relevant to the assassination of President John F. Kennedy (JFK).

Despite the quiet announcement on the eve of the July 4th weekend, it sparked off outrage led by  Robert F. Kennedy Jr. (RFK Jr.) who has in recent times openly speculated that the Central Intelligence Agency (CIA) was behind his uncle’s assassination and that he could be in danger from the agency.

In a barrage of Twitter posts, Kennedy, who is gaining momentum against Joe Biden for the 2024 Democratic nomination for president, suggested a coverup. 

“The assassination was 60 years ago. What national security secrets could possibly be at risk? What are they hiding?” he asked.

He blasted Biden for choosing the timing to cover the “bad news” he would be “maintaining secrecy indefinitely” on JFK assassination records.

Kennedy charged that the postponement was an “unlawful” violation of the President John F. Kennedy Assassination Records Collection Act of 1992, which mandated the release of all government-held JFK assassination records no later than October 2017. 

The records have been kept with the National Archives and Records Administration (NARA). The deadline to release the JFK assassination documents has been repeatedly extended including under the Trump Administration. 

However, the law does include an exception in instances where the president certifies that a continued delay is “made necessary by an identifiable harm to the military defense, intelligence operations, law enforcement, or conduct of foreign relations” and the harm is “of such gravity that it outweighs the public interest.”

In December, as part of a partial release of new records, Biden issued a signed agreement that the remainder would be released on June 30, the eve of the Independence Day weekend.

On Friday, the White House announced that more than 99 percent of the records have been publicly released. But in the memo signed by Biden, the president said that NARA’s acting archivist recommended he postpone the public release of “certain redacted information” in the records released back in December. 

“[C]ontinued postponement of public disclosure of that information is necessary to protect against identifiable harms to the military defense, intelligence operations, law enforcement, and the conduct of foreign relations that are of such gravity that they outweigh the public interest in disclosure,” the memo states.

Biden also said that future release of the withheld JFK assassination records would  “occur in a manner consistent” with a policy called the Transparency Plan, which was established by the National Declassification Center (NDC).

“The Transparency Plans will ensure that the public will have access to the maximum amount of information while continuing to protect against identifiable harms to the military defense, intelligence operations, law enforcement, and the conduct of foreign relations under the standards of the Act,” wrote Biden in the memo.

Since declaring his candidacy for president, Kennedy has become increasingly vocal about his belief that evidence shows his uncle JFK was murdered by the American government. 

He noted that among the members of the Warren Commission, as it was named, to review the assassination, was ex-CIA Director Allen Dulles, who was fired by President Kennedy.   

Dulles died in 1969, six years after Kennedy’s 1963 assassination and denied any involvement in Kennedy’s murder. 

Dulles International Airport in Washington was named after his brother John Foster Dulles, who served as secretary of state under President Dwight Eisenhower.

RFK Jr. believes Dulles used his position with the Warren Commission to cover up evidence of CIA involvement. He said in a recent interview that his own father’s “first instincts” was that the federal agency carried out the killing.

The CIA has long denied any involvement in the 35th president’s death.

In 1979, a U.S. House review committee appointed to study evidence of the assassination concluded that at least two gunmen and co-conspirators were involved in Kennedy’s murder. 

The only person ever accused of killing Kennedy was former U.S. Marine Lee Harvey Oswald. Oswald, who denied being the assailant, was killed a few days after Kennedy’s death by nightclub owner Jack Ruby. 

Ruby was convicted and sentenced to prison where he died in 1967 while waiting for a new trial after winning an appeal of his conviction.

In mid-June, national conservative podcaster Joe Rogan asked Kennedy if he was concerned about his safety in relation to being targeted by intelligence agencies, like the CIA.

Kennedy said yes, that “he has to be careful” and that he does “take precautions.”

Biora Therapeutics Continues to Monetize Legacy Diagnostics Assets

  Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it has completed an agreement with a large diagnostics company for the sale of legacy assets related to Biora’s former diagnostics business.

“This represents continued progress in monetizing our legacy assets,” said Eric d’Esparbes, Chief Financial Officer of Biora Therapeutics. “This transaction provides incremental non-dilutive funding to advance our therapeutics platforms, while enabling the assets to be leveraged for important diagnostic applications.”

Biora Therapeutics will receive a one-time payment for the sale of assets including rights to certain antibody sequences. Specific terms of the agreement were not disclosed.

https://www.biospace.com/article/releases/biora-therapeutics-continues-to-monetize-legacy-diagnostics-assets/

Amgen, Horizon Hit Back at FTC Lawsuit Seeking to Block Merger

 In response to the Federal Trade Commission’s May lawsuit, Amgen and Horizon Therapeutics have filed their own counter suit, alleging that the FTC’s attempt to prevent their $28 billion merger violates the U.S. Constitution, according to a Law360 report.

In their counter suit, filed in an Illinois federal court, the companies wrote that instead of letting an Article III court decide on the matter “the FTC seeks to have the ultimate merits of its case adjudicated in an administrative proceeding that is riddled with constitutional defects,” Endpoints News reported.

“The FTC’s case is wholly novel and impossibly speculative,” the companies’ filing states.

Amgen and Horizon inked their multibillion merger in December 2022. At an initial value of $26.4 billion, it was easily the industry’s largest deal of last year.

A month later, however, government officials flagged the acquisition for potential anti-trust violations. Sen. Elizabeth Warren (D-MA) wrote to the FTC, bringing focus to the companies’ “records of anti-competitive business practices” which she claimed could potentially lead to higher medicine prices and prevent the entry of competitors offering more affordable alternatives.

The FTC eventually heeded Warren’s warnings and in May 2023 filed a lawsuit seeking to block the merger from pushing through—at least until after it has filed a complaint, which the agency also plans to adjudicate in an administrative proceeding.

“Rampant consolidation in the pharmaceutical industry has given powerful companies a pass to exorbitantly hike prescription drug prices, deny patients access to more affordable generics, and hamstring innovation in life-saving markets,” Holly Vedova, director of the FTC Bureau of Competition, said in a statement released at the time of the lawsuit.  

In particular, the FTC is concerned that Amgen might provide “cross-market bundles or bundled rebates,” which could leverage its blockbuster assets to “secure favorable formulary placement” for Horizon’s rare disease therapies Tepezza (teprotumumab-trbw) and Krystexxa (pegloticase), the agency wrote in its court filing.

Amgen called these concerns “entirely speculative” in a statement released in response to the FTC’s lawsuit. “The medicines offered by Amgen and Horizon generally treat different diseases and patient populations, and there are no overlaps of competitive concern,” the company said.

In a June 2023 interview with BioSpace, Noah Brumfield, antitrust attorney with the firm Allen & Overy, agreed that the FTC might be on shaky ground with this lawsuit and that its challenge is unusual.

“They are saying that there is no competition between the parties and no supply-chain relationship, yet their combination would violate the antitrust laws. That’s a pretty novel approach when you consider the standards the courts apply to merger challenges,” Brumfield said.

Still, the FTC has strong backing from the government. Last month, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—joined the agency’s lawsuit and are seeking a preliminary injunction against the deal and a temporary restraining order against any other related transactions.

https://www.biospace.com/article/amgen-horizon-hit-back-at-ftc-lawsuit-seeking-to-block-merger/

Protagonist Therapeutics-Janssen Partnered Psoriasis Candidate Fall Short Of Rival

 Protagonist Therapeutics Inc 

 announced topline results from the Phase 2b FRONTIER 1 trial of the oral interleukin-23 receptor (IL-23R) antagonist JNJ-2113 (formerly PN-235) in adult patients with moderate-to-severe plaque psoriasis presented at World Congress of Dermatology in Singapore

JNJ-2113 is being developed by Janssen Biotech Inc, a unit of Johnson & Johnson 

.

In March, Protagonist released preliminary results from the trial, saying it had outperformed the placebo on the PASI 75 primary endpoint.

Results from the Phase 2b FRONTIER 1 trial showed that JNJ-2113 hit its primary and secondary endpoints, beating the placebo when measuring 75%, 90%, and 100% improvements in skin lesions at 16 weeks. 

Those results held across dose groups and were statistically significant.

In the FRONTIER 1 trial, 37.2% of patients on the lowest 25 mg dose of JNJ-2113 hit the 75% improvement primary endpoint, and 78.6% of patients also hit that goal on a twice-daily 100 mg dose. That compared with 9.3% of patients on placebo.

On the 90% improvement measurement, 59.5% of patients getting the highest dose twice daily reached that threshold. 

Targeting PASI 100, 41% of patients on the highest twice-daily dose reached that goal.

In comparison, Skyrizi, another psoriasis drug targeting IL-23, commercialized by AbbVie Inc 

, reported 75% values for the PASI 90 score.

Cassava Simufilam for Alzheimer's Slows Cognitive Decline by 38% in Clinical Study

 Cassava Sciences Inc 

 announced topline clinical results from its Cognition Maintenance Study (CMS), a small proof-of-concept study designed to demonstrate the effects of simufilam versus placebo in a randomized withdrawal trial design.

The study enrolled 157 patients with mild-to-moderate Alzheimer's disease.

Simufilam treatment for six months slowed cognitive decline by 38% compared to placebo in mild-to-moderate Alzheimer's disease (MMSE 16-26). 

The placebo arm declined 1.5 points on ADAS-Cog. The simufilam arm declined 0.9 points, a 38% difference in favor of the drug.

Upon randomization into the CMS, mean baseline MMSE scores were 18.6 and 18.1 for the simufilam and placebo arms, with mean baseline ADAS-Cog scores of 19.3 and 21.9, respectively.

Simufilam treatment slowed cognitive decline > 200% compared to placebo in mild Alzheimer's disease. 

CMS patients with mild Alzheimer's (MMSE 21-26) on placebo declined 0.6 points on ADAS-Cog, while patients on simufilam improved 0.6 points, a 205% difference in favor of the drug.

Mild patients randomized to simufilam in the CMS showed no material decline in ADAS-Cog scores over 18 months, indicating stable cognition, whereas the placebo declined by 0.8 points.

Simufilam 100 mg twice daily was safe and well tolerated in this study. There were no drug-related serious adverse events. 

Cassava Sciences is currently evaluating simufilam tablets for Alzheimer's disease dementia in two Phase 3 studies. Patient enrollment is expected to be completed for Phase 3 studies by year-end 2023.

Earlier this year, Cassava Sciences announced topline Phase 2 results for simufilam for Alzheimer's dementia

https://www.benzinga.com/general/biotech/23/07/33115997/promising-alzheimers-treatment-cassava-sciences-simufilam-slows-cognitive-decline-by-38-in-clinic

aTyr Pharma's Cash Runway Secured till 2026, Despite Lack of Material Catalysts: Oppenheimer

 Oppenheimer has downgraded aTyr Pharma Inc 

 to Perform from Outperform, citing a few material catalysts in the next few quarters. The analyst has also removed the price target of $17.

The analyst says that aTyr is in a fallow period until 2024/25 from the perspective of data readouts. 

The lead program in pulmonary sarcoidosis (PS), in the Phase 3 global study, is the company's main focus now; patient recruitment will take time, and inclusion/exclusion criteria are complex (study completion estimated in 2025). 

The analyst says it would look to greater visibility on patient recruitment and trial progress before re-evaluating the view. 

The second program in the Phase 2 study (N=25 SScILD patients) should enroll quicker than the pivotal trial (EFZO-FIT)—initiation is slated for 3Q23, with data readout by Y2024, an ambitious schedule, the analyst says.

Oppenheimer notes a lack of visibility on EFZO-Fit recruitment and the absence of material catalysts in the next 6-18 months.

As of March 31, the company's cash balance was $117.6 million, sufficient to provide a cash runway into 2026.

https://www.benzinga.com/analyst-ratings/analyst-color/23/07/33118380/atyr-pharmas-cash-runway-secured-till-2026-despite-lack-of-material-catalysts-oppen