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Wednesday, December 4, 2024

Court Rules in Favor of Heron in Patent Lawsuit Against Fresenius Kabi USA, LLC

 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced that the U.S. District Court for the District of Delaware ruled in Heron's favor in the Company's patent litigation against Fresenius Kabi USA, LLC with respect to CINVANTI® (aprepitant) injectable emulsion. The district court found that Heron's U.S. Patent Nos. 9,561,229 and 9,974,794, which expire in 2035, are valid and would be infringed by Fresenius' proposed generic product.

The district court decision concludes the litigation initiated in July 2022 in response to Fresenius' submission of an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval of a generic version of CINVANTI®. As a result of the decision, Heron will seek an order from the Court prohibiting Fresenius from launching its generic CINVANTI® until after the expiration of the patents in 2035. This decision is subject to appeal.

https://www.prnewswire.com/news-releases/us-district-court-upholds-validity-of-cinvanti-patents-302321651.html

Cross Country Healthcare Agrees To Be Acquired By Aya Healthcare at 67% Premium

 Cross Country Healthcare, Inc. (NASDAQ:CCRN) shares are rocketing premarket on Wednesday after the company inked a deal to be acquired by Aya Healthcare for $18.61 per share in an all-cash transaction valued at around $615 million.

This price represents a 67% premium over Cross Country’s closing price on December 3, 2024, and a 68% premium over its 30-day volume-weighted average trading price ending on the same date.


The merger will expand Aya’s services by adding Cross Country’s clinical offerings in non-clinical settings such as schools and homes, alongside Aya’s expertise in travel nursing, allied health, and staffing for per diem, permanent roles, interim leadership, locum tenens, and non-clinical professionals nationwide.

Together, the companies aim to reduce care costs, improve clinical outcomes, and provide better staffing solutions, while also offering employees growth opportunities through shared best practices.

The transaction is expected to close in the first half of 2025, pending approval from Cross Country’s stockholders and other customary conditions.

The Cross Country Board of Directors has unanimously approved the agreement and will recommend stockholders vote in favor at a Special Meeting of Stockholders, which will be scheduled shortly.

Once the transaction is complete, Cross Country will become a private company, and its common stock will be delisted from NASDAQ.


https://finance.yahoo.com/news/cross-country-healthcare-agrees-acquired-134052995.html

Scared to stay in Mexico, afraid of Trump's policies, some migrants look to return home

 Every day, Nidia Montenegro spends hours checking her cellphone, hoping to receive a long-awaited appointment with U.S. border officials to seek asylum in the United States.

The 52-year-old Venezuelan migrant in Mexico says she fears her appointment will not come before President-elect Donald Trump takes office on Jan. 20, when he has vowed to scrap a slew of programs that have allowed migrants to enter the U.S. legally - including the government app that Montenegro is using to try and get her appointment

That could leave thousands of migrants like Montenegro in limbo and facing the choice of trying to cross into the U.S. illegally, staying in Mexico, or returning home.

Given those options, Montenegro says she would return home, more fearful of the violence she has encountered while traveling through Mexico than the hardship she left behind in Venezuela.

"I am traumatized. If I don't get the appointment, I will go back," she said, disheartened.

"There is always the threat of cartels that kidnap us," added the woman, who says despite thinking about returning home she does not have the money to do so.

A dozen migrants interviewed in Mexico by Reuters said they would prefer to return to their countries despite the ongoing issues that drove them to migrate, such as poverty, lack of employment, insecurity, and political crises.

That is too small a sample size to draw clear conclusions of how migrants will react after Trump takes office, and much will depend on exactly what policies he implements and how.

But it does highlight the hard choices likely to face many after Jan. 20.

The violence in Mexico weighs heavily on any decision.

Montenegro told Reuters she was kidnapped along with two nephews and dozens of others, including children, on the day she arrived in southern Mexico from Guatemala two months ago. Two days later, the group managed to escape.

Now she lives confined in a shelter in the southern state of Chiapas, fearing criminals in the area will kidnap her again.

Organized crime has established extensive human trafficking networks across Mexico, making the journey north through the country treacherous. Mexico is plagued by violence, with around 30,000 people murdered a year and over 100,000 people officially registered as missing.

Many migrants are extorted, beaten, raped, forced to commit crimes, and even killed. Mexican government attempts to slow the arrival of migrants at the U.S. border, by busing and flying non-Mexican migrants to the country's south, add to the risk.

Mexico's presidency and National Migration Institute did not immediately respond to requests for comment.

The International Organization for Migration told Reuters that in the last seven years, it has assisted several thousand migrants — especially Central Americans — return voluntarily from Mexico to their home countries, including victims of violence. However, it declined to provide specific figures.

"I cry every day and ask God to take me back, I don't want to be here anymore... this is horrible," said Yuleidi Moreno, a Venezuelan migrant who fears staying in Mexico. Through tears she said she had been the victim of violence, but declined to give any further details.

A Venezuelan official familiar with migration issues said that currently, between 50 and 100 compatriots request what is called "voluntary return" each week from Mexico, either covering costs themselves or with state assistance. "There are serious calamity cases like kidnappings, sexual exploitation, a myriad of issues, and some want to return immediately."

Despite the risks, others will persist, whether joining caravans, paying a human trafficker, or clinging to the hopes of a U.S. government border appointment.

"I trust I will arrive before Mr. Trump takes office," said Johana, a young Venezuelan migrant planning to cross from Guatemala to Mexico this week. "If it's not by appointment, there's always a way," she added.

https://www.yahoo.com/news/scared-stay-mexico-afraid-trumps-130352086.html

World Food Program’s troubles in Sudan hurt hunger relief, alienated donors - internal report

 Serious problems in the United Nations World Food Program’s response to the Sudan crisis are hampering the organization’s ability to alleviate hunger in the war-torn country and damaging its reputation with donors, according to a recent internal report seen by Reuters.

The U.N.’s main food-aid distributor, the WFP is struggling to feed millions of people in the African country, which is suffering one of the world’s worst hunger crises. The report identifies a range of problems in the WFP’s Sudan response, including an inability to scale up its operations, missed funding opportunities and what it describes as “anti-fraud challenges.”

The report is the result of an assessment in July and August by the WFP’s Regional Emergency Coordination (REC) team, which was tasked with helping to expand the U.N. body’s operations in Sudan and neighboring countries. The team’s findings are detailed in a five-page “REC Diagnostic Report,” marked confidential and dated August 30. The report calls Sudan the WFP’s largest emergency.

News of the report comes as the WFP is struggling to secure billions of dollars for hunger hot spots around the world and is battling a crisis of confidence among the United States and other top donors. In Sudan, roughly half the population of 50 million is estimated to be suffering from severe hunger amid the civil war that has ravaged the country since April 2023. Hundreds are believed to be dying from starvation and hunger-related disease each day.

“WFP’s reputation for rapid emergency response has been damaged,” the report says of its Sudan operation. “Key stakeholders, including key donors, are now demanding concrete progress before committing additional funding.”

Asked about the report, WFP Deputy Executive Director Carl Skau didn’t address its specifics but told Reuters that the WFP and other humanitarian agencies weren’t prepared for the sudden crisis in Sudan. “It took us too long to actually get back on our feet and deliver in an effective and efficient and principled way,” Skau said in an interview in Cairo on Monday. “I'm confident the WFP is there now and that we are doing everything possible.”

Skau said that over the past few months, the WFP has put in place the strongest leadership available for its Sudan response, bolstered teams in area offices and reviewed its strategy to reach people in need. The WFP has some 700 trucks on the roads in Sudan, he added. The WFP also said it had reached over 2 million people in the country with cash-based assistance this year.

“We always want our colleagues to provide honest assessments,” Skau said. “And the spirit is always that we then address that.”

A WFP spokesperson didn’t respond to detailed questions about the report’s findings.

The WFP’s internal report also criticizes overly optimistic targets for distributing aid. The Sudan office’s initial target of reaching 8.4 million people in need was “deemed unrealistic and posed a reputational risk to the organization,” the report says. “Current projections suggest that WFP may only be able to fulfill around 50 percent of its current implementation plan by October 2024,” the report concludes.

The report says that an analysis of agreements between the WFP and its food-distribution partners found “excessively high operational costs irrespective of the quantities distributed.” High costs and “unrealistic planning” resulted in payments to non-government organizations that “achieved less than 5 per cent” of their distribution targets, the report says.

https://www.investing.com/news/world-news/exclusiveworld-food-programs-troubles-in-sudan-hurt-hunger-relief-alienated-donors--internal-report-3753070

'Big hedge funds call on doctors, scientists for an edge on pharma'

 Some of the world's largest hedge funds are hiring doctors, scientists and analysts to give them expert insight into the prospects for pharmaceutical stocks after big share swings in the sector, eight sources told Reuters.

This year has seen sharp stock moves as companies report financial results and update investors on early and mid-stage drug studies.

Abbvie shares opened 11% lower on Nov. 11 after the company announced its mid-stage schizophrenia drug trials had failed. The same day, rival Bristol Myers Squibb shares rose almost 13% in pre-market trade.

Shares of Novo Nordisk, one of Europe's biggest listed companies, surged more than 7% in one day following November third-quarter guidance including better-than-expected sales of its popular Wegovy weight-loss drug.

Hedge funds, known for splashing out to gain a technological or research-based edge on market trends, are paying attention. Some of the biggest multi-strategy hedge funds are now looking to hire doctors and medical scientists globally and in Europe, said two people with knowledge of the firms' mandate for recruitment that has kicked off in the past six months.

These include Balyasny, D.E. Shaw, Point72, Schonfeld, Qube and Squarepoint, together overseeing more than $200 billion in assets, the sources said. All the funds declined to comment. Hedge funds employ such experts in research departments to provide insights on company growth prospects, including any early-stage drug trials ultimately gaining regulatory approval, said another recruiter and two investors

All spoke on condition of anonymity because the details are private.

Multi-strategy hedge funds, which are among the largest in the industry, pursue diverse investment approaches under the same roof.

Some use independent teams called "pods", within which researchers work as part of a team led by a portfolio manager. Other multi-strategy funds have more collaborative structures, employing analysts with scientific and medical backgrounds as resident experts.

MEDICAL ASSISTANCE

In the past, hedge funds have hired scientists with specialist knowledge such as geology or engineering to inform commodities trading, said two sources with knowledge of how the funds work.

Weather engineers and meteorologists are regularly hired by the biggest to monitor fluctuations in the weather to inform trading in the power market.

Research and development in the pharmaceutical industry is expected to expand as borrowing costs in the wider economy begin to drop.


https://finance.yahoo.com/news/exclusive-big-hedge-funds-call-060601785.html

French lawmakers set to vote on ousting Prime Minister Barnier

 French lawmakers will vote on Wednesday on no-confidence motions which are all but certain to oust the government, throwing the euro zone's second-biggest economy deeper into a lingering political crisis.

Barring a last-minute surprise, the French government of Prime Minister Michel Barnier will be the first to be forced out by a no-confidence vote in more than 60 years, at a time when the country is struggling to tame a massive budget deficit.

In a TV interview on Tuesday, Barnier said he still believed his government could survive the vote, scheduled for the evening after a debate that starts at 4:00 p.m. (1500 GMT).

But the far-right National Rally (RN) made clear on Wednesday morning that it would vote to topple Barnier alongside leftwing parties. The left and the far right combined have enough votes to oust the government.

Asked if the RN would back the no-confidence vote, lawmaker Laure Lavalette told TF1 TV: "Without a doubt."

Asked about potentially catastrophic consequences warned by Barnier and his ministers, Lavalette said: "There is no reason this leads to major chaos. Don't play with fears ... it's not all going to crumble."

Interior Minister Bruno Retailleau told CNews: "Nothing's over until the vote but we can see we're headed towards a censorship (of the government)."

The impending collapse of the government will leave a hole at the heart of the European Union at a time when Germany is also weakened and in election mode, just weeks ahead of U.S. President-elect Donald Trump re-entering the White House.

President Emmanuel Macron could well ask Barnier to stay on in a caretaker role as he seeks a new prime minister, which could happen only next year.

Bond investors are likely to spare France the dire financial "storm" Barnier has warned of, but the fallout from the political crisis will hurt businesses, consumers and taxpayers, economists and experts have told Reuters

"This is a slow-burning crisis which will lead to an ongoing widening of spreads and an ongoing deterioration of sovereign creditworthiness," said Union Investment's head of fixed income and FX Christian Kopf.

"But for the time being, I do not see the ingredients for this to totally get out of hand and morph into an outright sovereign debt crisis," said Kopf, who is underweight French debt.

https://www.usnews.com/news/world/articles/2024-12-04/french-lawmakers-set-to-vote-on-ousting-prime-minister-barnier

US Won't 'Cry' About The Pressure Syria Is Facing From Al-Qaeda-Linked Fighters: Sullivan

 by Dave DeCamp via AntiWar.com, 

National Security Advisor Jake Sullivan said on Sunday that the US will not "cry" over the pressure the Syrian government and its allies are facing from an offensive on Aleppo led by Hayat Tahrir al-Sham (HTS), an offshoot of al-Qaeda.

Sullivan acknowledged that HTS was "a terrorist organization designated by the United States" and said the US has "real concerns about the designs and objectives of that organization."

Commander of designated terror organization Hayat Tahrir al-Sham (HTS) Abu Mohammad al-Jolani. Source: Enab Baladi

But he added, "At the same time, of course, we don’t cry over the fact that the Assad government, backed by Russia, Iran and Hezbollah, are facing certain kinds of pressure."

HTS captured Aleppo following a surprise offensive that was launched last Wednesday, which came after Israel stepped up airstrikes on Syria.

US officials have not been shy in the past about their preference for HTS and its leader, Abu Mohammad al-Julani, over other factions in Syria. James Jeffrey, an American diplomat who served as a special envoy to Syria under the Trump administration from 2018-2020, said in a 2021 interview that HTS was "an asset" to the US’s strategy in Idlib, a northwestern Syrian province that’s been under HTS control since 2017.

"They are the least bad option of the various options on Idlib, and Idlib is one of the most important places in Syria, which is one of the most important places right now in the Middle East," Jeffrey said.

Julani was formerly the leader of al-Nusra Front, which was the al-Qaeda affiliate in Syria. In 2016, Julani publicly announced he was splitting with al-Qaeda and changed his group’s name to Jabhat Fatah al-Sham, which merged with other Islamist groups to form HTS in 2017.

Julani’s rebranding campaign was part of an effort to gain more support from the West. Jeffrey said he was in regular contact with Julani and HTS while he was working as the US envoy to Syria. Jeffrey said a typical message from al-Julani was like this, "This is what we’re doing. These are our goals. We’re not a threat to you."

Jeffrey said he responded to Julani by saying, "I couldn’t agree more. … Keep me informed as often as possible."

Al-Qaeda and other extremist groups always made up a significant portion of the opposition to Assad after the war broke out in 2011. In 2012, Jake Sullivan, who worked as an aide to then-Secretary of State Hilary Clinton at the time, told his boss in an email released by WikiLeaks that "AQ (al-Qaeda) is on our side in Syria."

https://www.zerohedge.com/geopolitical/sullivan-says-us-wont-cry-about-pressure-syria-facing-al-qaeda-linked-fighters