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Saturday, December 14, 2024

US working directly with rebels that overthrew Assad in search for US hostage Austin Tice

 The US is working with the Islamist rebel group that overthrew the Syrian government last week, with the goal of finding an American journalist held hostage, according to reports.

The collapse of President Bashar al-Assad’s regime, which sent him fleeing to Russia, and the takeover by the jihadist rebel group Hayat Tahrir al-Sham, has sparked fears of instability in an already tense region.

Opposition fighters in Aleppo, Syria, the first major city to fall in the toppling of Assad’s regime.Getty Images

HTS, which was once was affiliated with al-Qaeda but broke from the group, remains on the State Department’s terrorism list.

Secretary of State Antony Blinken has been holding meetings across the Middle East, including in Turkey and Iraq, to facilitate the transition, signaling a US desire to ensure stability in Syria.

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“Syria has changed more in less than a week than in any week this last half-century,” Blinken told reporters.

“Our message to the Syrian people is this: We want them to succeed and we’re prepared to help them do so.”

A focus of his meeting meeting with Turkish Foreign Minister Hakan Fidan Friday was countering the resurgence of the Islamic State in Syria.

An Israeli army soldier holds a portrait of ousted Syrian president Bashar al-Assad on Dec. 14.AFP via Getty Images
Iraqi Foreign Minister Fuad Hussein, Turkish Foreign Minister Hakan Fidan and Jordan’s Foreign Minister Ayman Safadi held a press conference to discuss in Syria on Dec. 14.REUTERS

Diplomats from the US, the Arab League and Turkey met in Jordan Saturday to discuss Syria’s transition, the Wall Street Journal reported, but no representatives from Syria itself attended those talks.

After the meetings, Middle Eastern leaders said in a statement that they agree to “support a peaceful transition process” in Syria “in which all political and social forces are represented.”

Blinken also said he “impressed upon everyone” the importance of finding missing American journalist Austin Tice.

US officials have been in contact with the terrorist-designated rebel group that led the overthrow of Syrian President Bashar al-Assad, US Secretary of State Antony Blinken said Saturday.via REUTERS
Blinken was the first US official to confirm contact between the Biden administration and Hayat Tahrir al-Sham, the Associated Press reported.Bloomberg via Getty Images

The freelancer and Marine veteran disappeared in 2012 while covering the Syrian civil war.

Tice, 43, hasn’t been heard from since, though his family announced last week that they had intel that he is alive and they have renewed hopes for his return given the changes in Syria.

New reporting revealed that Tice was seen twice following his arrest: once in 2013 after briefly escaping captivity and again in 2016 when he was transported to a hospital in Damascus.

New clues about the case of Austin Tice, an American freelancer and Marine veteran held hostage in Syria, emerged on Friday.AP

Tice’s escape from prison is the strongest evidence the US government has indicating that forces loyal to Assad held Tice, the Reuters report said. 

Meanwhile, Israeli is also taking advantage of Assad’s downfall to find the Syrian burial place of famous spy Eli Cohen, the Times of Israel reported, citing a Lebanese media report.

Cohen, who was born in Egypt, infiltrated the highest ranks of the Syrian military in the 1960s and passed secrets to the Israeli government in what is remembered as one of the most successful intelligence operations in Israeli history.

Cohen was caught in 1965 and hanged in Damascus.

Separately, Israel launched a series of airstrikes targeting military sites in Damascus on Saturday, its latest effort to destroy Syrian military capabilities in an attempt to keep weapons from falling into the hands of hostile forces.

https://nypost.com/2024/12/14/world-news/us-working-directly-with-syria-rebels-that-overthrew-assad/

Unitedhealth CEO killing suspect Mangione and Diddy lawyers are married

 It looks like Luigi Mangione and Sean “Diddy” Combs have more in common than orange jumpsuits and ankle shackles.

Karen Friedman-Agnifilo, the high-powered lawyer hired by UnitedHealthcare murder suspect Luigi Mangione, is married to none other than Marc Agnifilio, who has been representing the rapper as he battles sex trafficking charges.

Friedman-Agnifilo is a former prosecutor who ditched her longtime position as the head of the sex crimes unit in the Manhattan District Attorney’s Office in 2021 to join her husband’s private firm, Agnifilo Intrater LLP .

Karen Friedman-Agnifilo was hired this week to represent Luigi Mangione.MSNBC

Before joining her husband in the private sector, Friedman-Agnifilo clocked in seven years as second in command to District Attorney Cyrus Vance.

Her marital relationship even caused career strife at times — Friedman-Agnifilo was forced to recuse herself from several cases in which her husband was representing accused suspects, including Harvey Weisnetin’s rape prosecution.

The disgraced movie mogul retained a member of the Agnifilo Intrater LLP team in 2017 after “Boardwalk Empire” actress Paz de la Huerta made “credible and detailed” claims that Weinstein raped her several years earlier, meaning Friedman-Agnifilo had no choice but to step down from the case.

Friedman-Agnifilo also clocked in time as the lead investigator on allegations that Seton Hall’s former board chairman sexually harassed the school’s former president’s wife, a claim later found to be unsubstantiated.

Marc Agnifilo and his firm are representing Sean “Diddy” Combs.J.C. Rice

Other attorneys said it was no surprise she was plucked to represent the blockbuster Mangione case.

“She’s got as much experience as any human being, especially in the state court,” a New York prosecutor told CNN.

“She knows every corridor, every judge, every clerk in the courthouse.”

Combs is currently being held at the Metropolitan Detention Center in Brooklyn, New York.Getty Images
Mangione is currently being held in Pennsylvania and has pleaded not guilty to the slew of charges levied against him.Luigi Mangione/Facebook

Mangione — a 26-year-old University of Pennsylvania graduate — is accused of fatally shooting Thompson as the 50-year-old CEO walked to the Hilton hotel on Sixth Avenue, where UnitedHealthcare’s parent company was holding its annual investor conference on Dec. 4.

The alleged assassin led police on a five-day manhunt that ended when he was taken into custody at a Pennsylvania McDonald’s on Monday after an employee recognized him and called the police. 

He is being held in Pennsylvania.

Mangione has pleaded not guilty to the slew of charges levied against him, including murder and gun possession.

https://nypost.com/2024/12/14/us-news/luigi-mangione-and-sean-diddy-combs-lawyers-are-married/

Turns Out That Biosimilars Do Impact Biologic Drug Cost

 Introduction of biosimilars for the rheumatology drug adalimumab, whose original branded version Humira has long been a blockbuster, appears to have led to a dramatic drop in net spending for these products -- even though biosimilars barely dented Humira prescription rates.

Analysis of prescriptions and sales figures for 2023 -- the first year in which Humira faced biosimilar competition -- showed the total number of adalimumab prescriptions remained nearly flat in the year's fourth quarter (Q4) relative to the same quarter in 2022, but net spending on all adalimumab products fell 45% over this period, according to Benjamin Rome, MD, MPH, of Brigham and Women's Hospital in Boston, and colleagues.

Net costs per prescription also declined precipitously, by 43%, the group reported in a JAMA Health Forum research letteropens in a new tab or window. But Humira also retained its stranglehold on the market for adalimumab: biosimilar prescriptions in Q4 2023 were just 1.35% of the total.

The researchers pulled prescription data from the IQVIA National Prescription Audit, and sales figures from manufacturers' published financial reports. (Because some biosimilar makers aren't public companies, not all were included in the analysis; also, patients' out-of-pocket costs were not available.)

While the net spending drop is clearly a good thing, Rome and colleagues warned that it may not be sustainable if biosimilar manufacturers can't do better at selling their products.

"Lower health care spending is a goal of biosimilar introduction, but low uptake raises concerns that manufacturers may withdraw from the market or avoid developing future biosimilars," they explained. "Compared with biosimilars, uptake of new generic drugs is often rapid, averaging 66% of the market shareopens in a new tab or window during the first year after brand-name market exclusivity ends."

Adalimumab ought to be the most lucrative market there is for biosimilars: as Rome and colleagues noted, it's "the best-selling drug in history, with more than $200 billion in global sales since its 2002 approval." It now boasts approvals for nine indications including rheumatoid arthritis and related conditions, both major forms of inflammatory bowel disease, and plaque psoriasis. Biosimilars began to win FDA approval in 2016; but thanks to the patent thicket AbbVie had erected around adalimumab, actual biosimilar sales in the U.S. didn't begin until 2023.

Prospects for cost savings didn't look great initially: AbbVie started 2023 by actually raising Humira's list price by 8%, Rome and colleagues indicated. The onset of biosimilar competition, however, apparently prompted the company also to hike its discounts and rebates paid to insurers and pharmacy benefit managers. That is how AbbVie was able to keep selling Humira at nearly the same rate as before, and also how its net sales plummeted despite the increased list price.

Thus, it turns out that both sides in an earlier debate about biosimilars' impactopens in a new tab or window on the biologic drug market were correct.

In 2017, at the American College of Rheumatology's annual meeting, Roy Fleischmann, MD, of the University of Texas Southwestern Medical Center in Dallas, squared off against Jonathan Kay, MD, of the University of Massachusetts Medical School in Worcester, on the question of whether rheumatologists should switch their patients from original branded products to biosimilar equivalents. Kay took the "yes" position, arguing that prices would surely come down once competition began.

Fleischmann countered that costs hadn't budged and probably wouldn't, because of the many tricks that branded-drug makers have up their sleeves. "For my patients in the United States, there are no savings from biosimilars," he said. (At the time, a biosimilar for infliximab had been on the market for a year.) "The savings, if there are any, go exclusively to pharmacy benefit managers and vertically integrated healthcare systems. There is no benefit in cost to patients and no improvement in access to biologic therapy to patients." The latter, he added, was the key factor -- if patients' costs aren't any lower, then there is no reason to move them from a branded biologic to a biosimilar.

So Kay seems to have been correct that biosimilars would bring total costs down, even as Fleischmann rightly predicted that branded manufacturers could dissuade most prescribers from switching.

Another example (and perhaps driver) of that latter success came in June, with a reportopens in a new tab or window showing that only about half of Medicare Part D plans pay for adalimumab biosimilars, whereas nearly all cover Humira.

On the other hand, hints are emerging that biosimilars could chip away at the Humira monolith. Rome and colleagues observed that the lone adalimumab biosimilar with "interchangeability" designation -- meaning the FDA has approved back-and-forth switching with the originator product -- had begun winning prescriptions.

Perhaps more important was a move earlier this year by one of the nation's biggest insurers, CVS Health. In January, it said it would replace Humira with biosimilarsopens in a new tab or window as the preferred adalimumab versions in its commercial formularies.

Disclosures

Arnold Ventures supported the study.

Rome and one co-author reported receiving grants from the National Academy for State Health Policy and from Elevance Health Public Policy Institute.

One co-author disclosed he was an expert witness for the Federal Trade Commission in a case involving pharmacy benefit managers.

Primary Source

JAMA Health Forum

Source Reference: opens in a new tab or windowRome BN, et al "Use, spending, and prices of adalimumab following biosimilar competition" JAMA Health Forum 2024; DOI: 10.1001/jamahealthforum.2024.3964.


https://www.medpagetoday.com/rheumatology/arthritis/113391

FDA Revokes Emergency Use Authorizations of 4 COVID-19 Monoclonal Antibodies

 The FDA on Friday revoked the emergency use authorizations (EUAs)

opens in a new tab or window of four monoclonal antibodies for COVID-19.

The four drugs -- bebtelovimabopens in a new tab or window, sotrovimab, casirivimab/imdevimab (REGN-COV2), and tixagevimab/cilgavimab (Evusheld)opens in a new tab or window -- had been authorized for COVID-19 as treatments or as pre- or post-exposure prophylaxis for individuals at high risk of severe outcomes.

Casirivimab/imdevimab had famously been used in 2020 to treat Donald Trumpopens in a new tab or window during his bout with COVID-19, while bebtelovimab's claim to fame may have been the degree of difficulty in pronouncing itopens in a new tab or window.

"The four mAb [monoclonal antibody] products have not been authorized for administration to patients for more than a year due to the high frequency of circulating SARS-CoV-2 variants that are not susceptible to each particular mAb product," the agency said.

At various pointsopens in a new tab or window, the FDA had limited each product's useopens in a new tab or window since their initial authorizations, allowing healthcare facilities to hold on to the drugs in case circumstances changed and they became active against later COVID strains.

"However, the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to these particular mAb products has persisted. In addition, the shelf life for nearly all lots of these products has expired," the FDA said.

Antivirals such as nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio) remain approved or authorized for outpatients at high-risk for severe outcomes of COVID-19.

Currently, pemivibart (Pemgarda)opens in a new tab or window is the only monoclonal antibody authorized for COVID-19, after gaining an EUA earlier this year as pre-exposure prophylaxis in immunocompromised individuals who are unlikely to mount a sufficient immune response following vaccination.

A long-acting monoclonal antibody, pemivibart is specifically authorized for people ages 12 years and older (and weighing 40 kg or more) with moderate-to-severe immune compromise either because of a medical condition or due to immunosuppressant medications. Pemivibart is not for use as post-exposure prophylaxis or in people currently infected with SARS-CoV-2.

The FDA recently expressed concernopens in a new tab or window that newer COVID variants may no longer be susceptible to pemivibart, but quickly reversed courseopens in a new tab or window.

According to CDC's Nowcast trackeropens in a new tab or window, XEC is currently the most common circulating variant of SARS-CoV-2, accounting for an estimated 44% of cases, most closely followed by KP.3.1.1 (39%).

The EUAs for bebtelovimab, sotrovimab, casirivimab/imdevimab, and tixagevimab/cilgavimab were revoked at the request of their respective sponsors, the FDA noted.

https://www.medpagetoday.com/infectiousdisease/covid19/113392