Harvey Weinstein will be retried in New York after rape conviction overturned

 Harvey Weinstein will be retried in New York, the Manhattan District Attorney's Office said in court on Wednesday, a week after the state's highest court threw out his 2020 rape conviction.

Weinstein appeared in court before Judge Curtis Farber in a wheelchair, more than four years after his conviction was hailed as a milestone for the #MeToo movement, in which women accused hundreds of men in entertainment, media, politics and other fields of sexual misconduct.

“There was nothing consensual about this conduct,” prosecutor Nicole Blumberg said. "We believe in this case and will be retrying this case."

Weinstein, 72, had been serving a 23-year sentence in a prison in upstate Rome, New York. He then was transferred to Bellevue Hospital in Manhattan following last week's order, according to his spokesperson, Juda Engelmayer.

Farber remanded Weinstein back into custody and said he expected to hold a new trial after the Labor Day holiday but did not set a firm date. Labor Day falls on Sept. 2.

"There's a tremendous sense of relief that we're back here," Weinstein's lawyer, Arthur Aidala, said after the court hearing.

"We're very confident that if he goes to trial, the only words we'll hear at the end of trial are 'not guilty,'" he added.

In February 2020, jurors in Manhattan convicted Weinstein of sexually assaulting former production assistant Miriam Haley in 2006 and of raping aspiring actress Jessica Mann in 2013. They are among more than 80 women who have accused him of sexual misconduct.

The conviction included charges of first-degree sexual assault and third-degree rape. Weinstein, who has denied having non-consensual sexual encounters with anyone, was acquitted on other charges.

A lawyer for one of Weinstein's accusers, Gloria Allred, was present in the courtroom amid a gallery packed with reporters. She said she planned to address the media after the hearing.

Manhattan District Attorney Alvin Bragg was present in the courtroom but did not address reporters immediately after the hearing.

Last week, the New York Court of Appeals found that Judge James Burke, who presided over the trial, made a critical mistake by allowing three women to testify about alleged sexual assaults by Weinstein that were not part of the criminal charges against him. The court said this "prior bad acts" testimony violated his right to a fair trial.

https://finance.yahoo.com/news/2-harvey-weinstein-retried-york-184024191.html

Israel backers attack pro-Palestinian camp at UCLA

 Supporters of Israel attacked a pro-Palestinian protest camp at the University of California in Los Angeles on Wednesday, hours after New York City police arrested some 300 protestors, as days of mounting tensions on some U.S. college campuses boiled over.

Eyewitness videos from UCLA, verified by Reuters, showed people wielding sticks or poles to hammer on wooden boards being used as makeshift barricades to protect the pro-Palestinian protesters before police were deployed to the campus.

On the other side of the country, New York police arrested pro-Palestinian demonstrators occupying an academic building at Columbia University and removed a two-week-old protest encampment that had inspired similar protests at campuses across the country and abroad.

Arrests at Columbia and nearby City College of New York numbered about 300, Mayor Eric Adams said, with many of them charged with trespassing and criminal mischief.

The clashes at UCLA and in New York are part of the biggest outpouring of U.S. student activism since the anti-racism rallies and marches of 2020. The protests were triggered by the Oct. 7 attack on southern Israel by Hamas militants from the Gaza Strip and the ensuing Israeli offensive on the Palestinian enclave.

Students have rallied or set up tent encampments at dozens of schools across the U.S. in recent days, expressing opposition to Israel's war in Gaza and demanding schools divest from companies that support Israel's government. Many of the schools have called in police to quell the protests.

With the presidential election coming in November, Republican lawmakers have accused some university administrators of ignoring antisemitic rhetoric and harassment, some demanding that Columbia's president resign. Many protesters, some of whom are Jewish, reject allegations of antisemitism.

UCLA PROTESTERS REPORT VIOLENT ATTACKS

UCLA officials declared on Tuesday that the encampment was unlawful, violated university policy and included people unaffiliated with the campus.

Footage from the early hours showed counter-demonstrators, many of them masked and some apparently older than students, throwing objects and trying to smash or pull down the wooden and steel barriers erected to shield the encampment.

Some screamed pro-Jewish comments as pro-Palestinian protesters tried to fight them off.

"They were coming up here and just violently attacking us," said pro-Palestinian protester Kaia Shah, a researcher at UCLA. "I just didn't think they would ever get to this, escalate to this level, where our protest is met by counter-protesters who are violently hurting us, inflicting pain on us, when we are not doing anything to them."

Demonstrators on both sides used pepper spray, and fights broke out; pro-Palestinian demonstrators said the counterprotesters threw fireworks at them and beat them with bats and sticks.

Benjamin Kersten, a UCLA graduate student and member of the group Jewish Voice for Peace, called it "a devastating night of violence."

"The encampment would be a peaceful effort were it not for the continuous presence of counterprotestors and agitators," he wrote in a text message. "While Congress holds more hearings on whether Jewish students feel safe enough on campuses, Jewish students are among those withstanding attacks from Zionist protestors."

Police said UCLA called them to restore order and maintain public safety "due to multiple acts of violence" within the encampment. Broadcast footage later showed police clearing a central quad beside the encampment and erecting a metal crowd barrier in front of it.

The atmosphere was calmer on Wednesday. Hundreds of police officers and squad cars were on campus and lining its perimeter. It was unclear how many arrests were made or the number of people who were injured.

COLUMBIA DEMONSTRATORS ARRESTED

In New York, police had arrested dozens of pro-Palestinian demonstrators holed up in a building at Columbia University and removed a protest encampment that the Ivy League college had sought to dismantle for nearly two weeks.

Columbia President Minouche Shafik asked police to stay on campus until at least May 17, two days after graduation.

"Free, free Palestine!" protesters chanted outside the building. "Let the students go!"

"A lot of people are shaken. I think I'm forever changed by what happened today," said Bo Tang, a history student who has been part of the protesting students research group.

"The university fails to learn its own history and repeats its mistakes with such brutishness," Tang wrote in a text-message from the locked-down campus.

Ben Solomon, a 22-year-old Jewish student at Columbia, said he welcomed the move to clear the protesters from the occupied building and the encampment.

"I'm glad to see universities took decisive action," he said, as more than 100 students and professors gathered in a street adjoining the campus to protest the school's decision to call the police.

Columbia "must prevent this mob from taking back the campus and continuing to disrupt student life," Solomon said.

Shafik said the occupiers had vandalized university property and were trespassing, and her staff shared pictures of piles of furniture turned into barricades inside Hamilton Hall. She said the events filled her "with deep sadness."

"I am sorry we reached this point," she wrote in an email to the university community on Wednesday, saying that property damage was not "political speech" and promising efforts to reunite a frayed campus.

The university earlier warned that students taking part in the occupation faced academic expulsion.

Police were also called in to clear encampments and make arrests overnight at Tulane University in New Orleans, University of Arizona and City College of New York in Harlem.

https://www.yahoo.com/news/police-move-quell-clashes-los-103933459.html

Do Our Flu Antivirals Work on H5N1?

 With avian influenza A (H5N1) infecting more mammals than ever before -- including U.S. dairy cattle

opens in a new tab or window -- infectious disease experts are paying close attention to whether current influenza antivirals would be effective should H5N1 adapt to humans.

All influenza viruses have extremely similar internal mechanisms for reproduction, William Schaffner, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, and a spokesperson for the Infectious Diseases Society of America (IDSA), told MedPage Today. So if an antiviral works against one strain, it will also work on other strains, he said.

"Everything I've heard from the CDC and elsewhere ... is that the antivirals that we have available today will work against H5N1. And that's consistent with the effect of the antivirals against past avian influenza strains," Schaffner said.

This includes neuraminidase inhibitors, such as oseltamivir (Tamiflu), zanamivir (Relenza), and peramivir (Rapivab), as well as the polymerase inhibitor baloxavir (Xofluza). While neuraminidase inhibitors interfere with the enzyme that allows a virus to cleave itself off an infected cell in order to spread, polymerase inhibitors interfere with replication at the level of messenger RNA.

The CDC is working in the lab "to better characterize the virus from the human case in Texas," and the agency "completed susceptibility testing for the most common class of influenza antiviral medications that are used for seasonal influenza," a spokesperson for the CDC's Center for Global Health told MedPage Today.

The testing confirmed that "the H5N1 virus was susceptible to all commercially available FDA-approved and recommended neuraminidase inhibitors," the spokesperson said. Testing to confirm the susceptibility of a different type of antiviral medication is ongoing since it takes longer, he added.

Interim CDC guidanceopens in a new tab or window suggests initiating antiviral treatment with a neuraminidase inhibitor as early as possible for symptomatic outpatients, and using oseltamivir to treat severe, progressive, or complicated H5N1. For people who meet the epidemiologic exposure criteria, oseltamivir also is recommended as prophylaxisopens in a new tab or window.

Still, Schaffner noted that "antivirals are by no means a panacea."

Andrew Pavia, MD, professor and chief of the division of pediatric infectious diseases at the University of Utah in Salt Lake City, said that while evidence indicates oseltamivir would be effective, "effective doesn't mean it's an ideal drug." For instance, oseltamivir, like other antivirals, is most effective if taken in the first 48 hours, which can be a difficult window to catch.

There are many other unknowns about treating H5N1 with antivirals, such as whether antivirals would have clinical benefit or if resistance would develop. "We don't know the answer because we have not seen a lot of human infections with this particular strain of H5N1," Pavia said. Some experts have questioned whether the U.S. has been adequately testing for H5N1opens in a new tab or window.

The U.S. has a large stockpile of oseltamivir but has less of newer drugs like baloxavir, which has a different mechanism and could be vital if oseltamivir resistance became a problem, Pavia said. In terms of using a combination of drugs, he said there have not been studies showing clear benefits, though that's something the research community is pursuing.

In terms of other potential treatments, a trio of vaccines has already been developed and approvedopens in a new tab or window, and last year Via Nova Therapeutics received an FDA Investigational New Drug application for a nucleoprotein inhibitoropens in a new tab or window, VNT-101.

"H5N1 has been behaving in ways that we didn't expect which means that we know we have to watch it very carefully," Pavia said. "That doesn't mean we know what it's going to do, but it means we have to have a lot of humility and invest some real resources in studying it and watching it."

https://www.medpagetoday.com/special-reports/features/109891

FOMC Leaves Rates Unch, Says (Bigger Than Expected) QT Taper To Start In June

 The Fed just told the market that 'yields are too damn high'.

*  *  *

Since the last FOMC meeting, on March 20th, gold has been the biggest outperformer (interesting along with dollar strength), while stocks, bonds, and crude (and crypto) have all been sold (with bonds and oil equally ugly)..

Source: Bloomberg

And since March 20th, US macro data has serially disappointed...

Source: Bloomberg

More problematically, since the last FOMC meeting, inflation data has dramatically surprised to the upside and growth data to the downside - screaming stagflation in the face of the Fed...

Source: Bloomberg

Rate-cut expectations (for 2024 and 2025) have plunged significantly since the last FOMC (that is now just one 25bps rate-cut priced in for 2024)...

Source: Bloomberg

Expectations are fully priced for a nothing-burger today on rates...

Source: Bloomberg

... with a slight hawkish bias in the language-changes in the statement (and the possibility of QT-taper signaling). But it will be Powell's press conference that everyone will be focused on.

So what did The Fed say?

Rates unchanged...

• *FED HOLDS BENCHMARK RATE IN 5.25%-5.5% TARGET RANGE

Key statement changes

Fed adds following sentence:

"In recent months, there has been a lack of further progress toward the Committee's 2 percent inflation objective."

Fed also replaces

"The Committee judges that the risks to achieving its employment and inflation goals are moving into better balance"

with

"The Committee judges that the risks to achieving its employment and inflation goals have moved toward better balance over the past year.

And the QT Taper is here - and its bigger than expected (-$35BN/mth vs -$30BN expected):

Beginning in June, the Committee will slow the pace of decline of its securities holdings by reducing the monthly redemption cap on Treasury securities from $60 billion to $25 billion.

The Committee will maintain the monthly redemption cap on agency debt and agency mortgage‑backed securities at $35 billion and will reinvest any principal payments in excess of this cap into Treasury securities

This means $105BN less gross issuance needed in Q3, with The Fed implicitly saying 'yields are too high'.

Just as we said...

Read the full redline below:

What happens next (on average)?

https://www.zerohedge.com/markets/fomc-15

Prime editing comes of age as FDA clears human trials

 Prime Medicine has been given the go-ahead by the FDA for the first human trial of its prime editing technology, which promises to deliver one-shot therapies for a range of severe genetic diseases.

According to the Cambridge, Massachusetts biotech, the US regulator has cleared an investigational new drug (IND) application for ex vivo use of its Prime Editor platform to correct a mutation associated with chronic granulomatous disease (CGD), which leaves patients vulnerable to recurrent life-threatening infections and severe inflammation.

The planned phase 1/2 trial will see Prime Medicine’s PM359 candidate used to modify haematopoietic stem cells (HSCs) taken from CGD patients outside the body, to edit out a mutation in the gene coding for the NADPH oxidase complex that prevents phagocytic cells of the immune system from destroying microorganisms.

At the moment, patients with CGD – which normally manifests in childhood – often have to take near-constant doses of antibiotics to protect them from infections, as well as high-dose steroids to reduce inflammation, unless they are lucky enough to have a matched donor for a bone marrow transplant.

PM359 will be tested in adults with stable disease in the phase 1 portion of the trial and, if all looks okay with safety and gene expression data, it will then enrol adults and children with active infection and/or severe inflammation.

Prime Medicine’s ‘search-and-replace’ genome editing technology – initially identified by gene-editing pioneers David Liu and Andrew Anzalone at the Broad Institute – has already been shown to work in non-human primates, and moving it into clinical trials is a major step forward for the company.

Prime editing aims to improve on the CRISPR-Cas9 gene-editing approach by allowing changes to be made to DNA without breaking the double helix or using donor DNA. It is more broadly applicable than CRISPR-Cas9, according to the biotech, which says it could be used to target more than 90% of known disease-causing mutations.

“We are thrilled to achieve this important milestone for our first product candidate, PM359, which represents the first-ever IND clearance for a Prime Editor product candidate and a significant advancement in the field of next-generation gene editing,” said Keith Gottesdiener, Prime Medicine’s chief executive.

“Based on data from our preclinical studies, we believe PM359 has the potential to sufficiently correct a prevalent disease-causing mutation of CGD, leading to amelioration of disease for these patients,” he added. Data from the study will start to emerge next year, according to the company.

The approval to start the trial comes shortly after Prime Medicine completed an upscaled $161 million public offering that will help fund the CGD trial and other candidates in its pipeline, including candidates for eye disease retinitis pigmentosa, liver diseases, and Friedreich’s ataxia. It finished 2023 with cash reserves of $135 million, down from $307 million at end-2022.

Before the end of this year, Prime Medicine is hoping to have IND-enabling activities in place for its first liver and ocular disease programmes.

https://pharmaphorum.com/news/prime-editing-comes-age-fda-clears-human-trials

''California to sell state-branded Narcan generic to cut costs'

 California has said it will start selling its own generic version of overdose reversal agent naloxone in another example of the use of government-level purchasing power to reduce drug prices in the US.

The state’s Democratic governor Gavin Newsom has reached a deal with generic drugmaker Amneal Pharma to supply a nasal spray formulation of naloxone – the active ingredient in Emergent BioSolutions’ Narcan – at a 40% discount to the brand.

Twin packs of the product costing $24 will be distributed under the CalRx brand for free to qualifying organisations, like first responders, universities, and community organisations, and will be sold to California businesses and local governments - provided they do not sell them on at a profit.

The discount means that California will be able to acquire 3.2 million twin-packs of naloxone instead of the 2 million twin-packs purchased at the previous price, helping the state manage an opioid crisis that claimed around 7,000 lives in 2022, according to a statement from the governor's office.

The latest deal comes a few months after California unveiled the CalRx project with a $50 million contract with non-profit pharma manufacturer Civica to produce affordable insulin within the state, with plans to extend that to include insulin analogues like insulin glargine, aspart, and lispro. The state also sued the ‘big three’ insulin makers – Novo Nordisk, Eli Lilly, and Sanofi – accusing them of working together to set artificially inflated prices for their products.

“California is disrupting the drug industry with CalRx, securing life-saving drugs at lower and transparent prices,” according to Newsom, who signed an executive order to introduce the programme on his first day in office. “People should not be forced to go into debt to get lifesaving prescriptions.” The naloxone product will be the first to be sold using a CalRx label.

The governor said that the drive plans to leverage California’s power as the world’s fifth-largest economy to find other ways to drive down the cost of medicines in the state. At the federal level, the US government is also drawing on purchasing power with its scheme to negotiate the prices of certain medicines reimbursed by Medicare, which is being challenged by the pharma industry.

The naloxone deal has been announced just a few days after Amneal secured FDA approval for its over-the-counter naloxone nasal spray from the FDA, a generic of Emergent’s OTC product that was launched last year at a list price of $45 per pack.

According to IQVIA, US annual commercial sales for Narcan for the 12 months ended February this year were $266 million.

https://pharmaphorum.com/news/california-sell-state-branded-narcan-generic-cut-costs

Walmart retreats from healthcare, closing clinics across US

 For the last few years, Walmart has been promising to disrupt the US healthcare sector with a national network of clinics providing low-cost care and telehealth services. Now, it is reining back on those plans.

The retail giant has said it will close all 51 of its Walmart Health clinics across the country and shut down its telehealth service, built with its acquisition of MeMD in 2021, saying “there is not a sustainable business model for us to continue.”

The company said the decision was taken on the back of “the challenging reimbursement environment and escalating operating costs” that were making it impossible to run Walmart Health as a profitable business.

The clinics – which provided medical, dental, and behavioural health services – are clustered in five states, namely Arkansas, Georgia, Florida, Illinois, and Texas.

It’s not a complete retreat, as some health services will be provided through its 4,600 pharmacies and 3,000 optician centres, a network which also underpins its recently launched clinical trials business. However, there’s no doubt it is a major reversal and comes just weeks after Walmart said it planned to open up more than 20 new clinics this year.

Other big retailers like CVS Health, Walgreens Boots Alliance, and Amazon have also tried to provide healthcare services, and so far the track record is mixed, reflecting the difficulties of bringing real change to an entrenched sector.

Walgreens has been closing dozens of its VillageMD primary care clinics and took a $5.8 billion charge in connection with the business in its last quarterly results, for example, although CVS Health has said it is committed to growing its network of Oak Street Health clinics. Amazon, meanwhile, has been adding additional sites to its One Medical service, bought for $3.9 billion in 2022, but has been slashing staff to cut costs.

The Walmart decision has raised concerns that some patients may face a gap in access to healthcare, particularly those on lower incomes and no insurance or high deductibles. The company said when it announced its first clinic in 2019 that a key objective was to provide access to people in underserved communities.

In its statement on the decision, Walmart said its “priority will be ensuring the people and communities who are impacted are treated with the utmost respect, compassion, and support throughout the transition,” adding: “In the coming days, we are focused on continuity of care for patients and providing impacted associates with respect and assistance as we begin the closing process.”

https://pharmaphorum.com/news/walmart-retreats-healthcare-closing-clinics-across-us