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Thursday, January 23, 2025

Catalent backs decentralised manufacture of Galapagos’ CAR-T therapy

Catalent has entered a strategic partnership with Galapagos to facilitate decentralised manufacturing in the US for the trials of the latter’s CAR-T therapy, GLPG5101, aimed at treating relapsed/refractory non-Hodgkin lymphoma (NHL).

This manufacturing approach will support upcoming studies in New York, New Jersey and nearby regions leveraging Catalent's commercial cell therapy manufacturing facility in Princeton.

The financial terms remain undisclosed.

Catalent global cell therapy and plasmid DNA vice-president Delara Motlagh said: “Catalent is passionate about increasing patient access to life-changing cell therapies like those being developed by Galapagos.

“We are delighted by this collaboration to support Galapagos’ decentralised cell therapy approach to bring these pioneering treatments to more patients with certain aggressive forms of NHL in a median vein-to-vein time of seven days.”

Galapagos' decentralised manufacturing platform is tailored to be established close to centres that provide cancer treatment, potentially benefiting NHL patients.

It claims to offer a "fresh" and "stem-like" early memory cell therapy. This approach could eliminate the need for cryopreservation and bridging therapy.

The platform features an end-to-end xCellit workflow management and monitoring software system, a decentralised and automated manufacturing platform powered by Lonza’s Cocoon technology, and a quality control testing and release strategy.

GLPG5101 is an anti-cluster of differentiation 19 (CD19)/4-1BB CAR-T candidates, designed to be administered in a single fixed intravenous dose.

Galapagos is a biotech company with a presence in Europe and the US.

In December 2024, Galapagos shared additional data from the Phase I/II ATALANTA-1 study of GLPG5101, revealing a promising efficacy and safety profile in subjects with relapsed/refractory NHL.

Novo Holdings completed the previously announced acquisition of Catalent in a $16.5bn all-cash transaction in the same month.



https://finance.yahoo.com/news/catalent-backs-decentralised-manufacture-galapagos-094208348.html

'Trump hits NIH with ‘devastating’ freezes on meetings, travel, communications, and hiring'

 President Donald Trump’s return to the White House is already having a big impact at the $47.4 billion U.S. National Institutes of Health (NIH), with the new administration imposing a wide range of restrictions, including the abrupt cancellation of meetings including grant review panels. Officials have also ordered a communications pause, a freeze on hiring, and an indefinite ban on travel.

The moves have generated extensive confusion and uncertainty at the nation’s largest research agency, which has become a target for Trump’s political allies. “The impact of the collective executive orders and directives appears devastating,” one senior NIH employee says.

Today, for example, officials halted midstream a training workshop for junior scientists, called off a workshop on adolescent learning minutes before it was to begin, and canceled meetings of two advisory councils. Panels that were scheduled to review grant proposals also received eleventh-hour word that they wouldn’t be meeting.

“This kind of disruption could have long ripple effects,” says Jane Liebschutz, an opioid addiction researcher at the University of Pittsburgh who posted on Bluesky about the canceled study sections. “Even short delays will put the United States behind in research.” She and colleagues are feeling “a lot of uncertainty, fear, and panic,” Liebschutz says.

The hiring freeze is governmentwide, whereas a pause on communications and travel appears to be limited to the Department of Health and Human Services (HHS), NIH’s parent agency. Such pauses are not unprecedented when a new administration comes in. But some NIH staff suggested these measures, which include pulling job ads and rescinding offers, are more extreme than any previously.

NIH travel chief Glenda Conroy sent an email to senior agency officials early today notifying them of an “immediate and indefinite” suspension of all travel throughout HHS with few exceptions, such as currently traveling employees returning home. Researchers who planned to present their work at meetings must cancel their trips, as must NIH officials promoting agency programs off site or visiting distant branches of the agency. “Future travel requests for any reason are not authorized and should not be approved,” the memo said.

The travel ban has left many researchers, especially younger scientists, bewildered, says a senior NIH scientist who asked to remain anonymous. Today, the scientist encountered one group of early-career researchers who were scheduled to attend and present at a distant conference next week—presentations that are now impossible. “People are just at a loss because they also don’t know what’s coming next. I have never seen this level of confusion and concern in people that are extremely dedicated to their mission,” the scientist says.

Separately, HHS announced a communications ban through 1 February in a memo issued yesterday. (The Washington Post and Associated Press first reported the memo’s existence.) It orders a stop on the publishing of regulations, guidance documents, grant announcements, social media posts, press releases, and other “communications,” and the canceling of speaking engagements. Any exceptions must be applied for and approved through the president’s appointees.

“This is a short pause to allow the new team to set up a process for review and prioritization,” an NIH spokesperson says.

Another consequence of the communications pause is a freeze on meetings of federal advisory committees and study sections. NIH today canceled meetings of advisory councils at its dental and bioengineering institutes.

The council meetings include a closed-door session where grant proposals from extramural researchers that have already been approved by peer-review panels undergo a final review before the awards are made. It is not clear what will happen to those grants if the council meeting to finalize the review is canceled. Many more councils for NIH’s 24 grantmaking institutes and centers are scheduled to meet in the coming weeks.

Even more troubling to many researchers is a pause on study sections that many received word of today. Without such meetings, NIH cannot make research awards.

Previous administrations have imposed communications pauses in their first days. And the administration of former President Barack Obama continued a cap on attendance at scientific meetings first imposed by former President George W. Bush’s administration, which in some cases meant staff canceled trips to meetings.

But an immediate, blanket ban on travel is unusual, says one longtime researcher in NIH’s intramural program. “I don’t think we’ve ever had this and it’s pretty devastating for a postdoc or graduate student” who needs to present their work and network to move ahead in their career, the researcher says.

Another consequence of the communications pause, according to an NIH staffer involved with clinical trials at NIH’s Clinical Center, is that agency staff cannot meet with patient groups or release newsletters or other information to recruit patients into trials. Another unknown is whether NIH researchers will still be allowed to submit papers to peer-reviewed journals.

Hiring is also affected. No staff vacancies can be filled; in fact, before Trump’s first day in office was over, NIH’s Office of Human Resources had rescinded existing job offers to anyone whose start date was slated for 8 February or later. It also pulled down currently posted job vacancies on USA Jobs. “Please note, these tasks had to be completed in under 90 minutes and we were unable to notify you in advance,” the 21 January email noted, asking NIH’s institutes and centers to pull down any job vacancies remaining on their own websites.

The various directives have shaken the vast community of extramural scientists NIH supports. “[We] have not seen anything concrete from NIH yet,” said one scientist at a major academic medical center. “But just like about everyone in science, we are worried and waiting.”

https://www.science.org/content/article/trump-hits-nih-devastating-freezes-meetings-travel-communications-and-hiring

'Study finds big life expectancy deficit in adults with ADHD'

 Adults with attention deficit hyperactivity disorder (ADHD) show large reductions in life expectancy compared to those living without that diagnosis, according to a UK study.

The striking finding – gleaned from GP patient records from around 30,000 people with ADHD matched to 300,000 without – is that men diagnosed with the disorder live on average for 6.8 years less than the general population, while for women the difference is 8.6 years.

The ranges were 4.5 to nine years for men and 6.5 to 11 years for women, according to the researchers, who have published their observational study in the British Journal of Psychiatry and conclude that adults with an ADHD diagnosis "are living shorter lives than they should."

So, what could be behind the finding? Professor Joshua Stott, a senior author of the research from University College London, reckons that it is not a consequence of ADHD itself, but more likely factors like smoking, poor diet, drinking, risk-taking behaviour, and even higher rates of suicide.

From their study and other research, they also suggest that one reason for the difference could be that adults diagnosed with ADHD do not receive adequate treatment for the disorder itself and for mental and physical health conditions, like anxiety, depression, hypertension, and obesity, which can be associated with it.

They point out, however, that while almost 3% of adults in the UK have an ADHD diagnosis many are undiagnosed, so the gap in life expectancy may be overestimated. That raises concerns about under-diagnosis of ADHD, which could lead to patients missing out on treatment and support.

They conclude that the shortfall in life is "likely caused by modifiable factors such as smoking, and unmet mental and physical health support and unmet treatment needs" and expose "an important inequity that demands urgent attention."

A prior study in the US also found that ADHD was linked to shorter life expectancy, but did not look at health records, instead using self-reported education, occupation, health, and lifestyle variables at age 27 to predict life expectancy.

Commenting on the findings, Professor Philip Asherson of the Institute of Psychiatry, Psychology, and Neuroscience at King's College London (KCL), said that "ADHD is increasingly recognised as a serious condition in adults associated with poor health outcomes."

"Services to support adults with ADHD and improve both physical and mental health outcomes lag behind those for other common conditions such as anxiety, depression, hypertension, and obesity," he added.

"Of particular concern are limited access to diagnosis and treatment, including psychosocial support. Until this is addressed the shorter life expectancy demonstrated in this study is likely to continue."

https://pharmaphorum.com/news/study-finds-big-life-expectancy-deficit-adults-adhd

Samsung Biologics Continues Mega-Deal Streak With $1.4B European Contract

 

The deal follows a $1.06 billion U.S. contract in July 2024 and a $1.24 billion agreement with an Asia-based pharma a few months later.

In a public disclosure last week, Samsung Biologics announced that it had entered into a manufacturing contract with an unnamed pharmaceutical company based in the European Union.

The deal, valued at over $1.4 billion, or nearly 2.1 trillion Korean won, is among the largest in the company’s history, and sustains its recent trend of signing hefty contracts. In July 2024, for instance, Samsung Bio closed a $1.06 billion manufacturing agreement with an unnamed U.S.-based pharmaceutical company. At the time, South Korean media outfit Korea JoongAng Daily reported that the deal was the CDMO’s largest since its founding in 2011.

Samsung Bio broke its personal record a few months later, in October 2024, with a $1.24 billion agreement with a similarly unnamed Asia-based pharma. With this deal, Samsung Bio counted more than $3 billion in contract proceeds in 2024, it said at the time.

Buoyed by these high-value deals, Samsung Bio announced Wednesday that it saw a 23% increase in 2024 earnings, jumping from almost $2.6 billion in 2023 to just shy of $3.2 billion last year. Its operating profit likewise spiked, surging 18.5% from around $770 million in 2023 to $920 million in 2024.

As per its earnings report, Samsung Bio counts more than 110 clients worldwide, including 17 of the world’s top biopharma players. Taken together, these partnerships have resulted in an aggregate contract value that exceeded $4.3 billion in 2024.

Looking ahead to the coming year, Samsung Bio is expecting to start operations at its upcoming Plant 5 in South Korea by April 2025, bumping up its total production capacity to nearly 750,000 liters. The CDMO is also planning to open a sixth plant “to proactively respond to the growing demand for biologics” and further increase its capacity to 964,000 liters.

In 2025, Samsung Bio also plans to launch antibody-drug conjugate (ADC) services, according to CEO John Rim, which will help meet the growing demand for ADC-based therapies.

Samsung Bio’s growth comes as the U.S. biopharma industry grapples with the need to look for alternatives to Chinese manufacturers. The BIOSECURE Act—a piece of legislation introduced in January 2024 to prevent biotech firms of national security concern from accessing taxpayer dollars—easily passed the House vote in September 2024.

The bill is currently waiting for its day in the Senate, where it is expected to have strong bipartisan support. According to a March 2024 report from STAT News, the Senate Committee on Homeland Security and Governmental Affairs approved a similar bill that month, with only one negative vote.

https://www.biospace.com/business/samsung-biologics-continues-mega-deal-streak-with-1-4b-european-contract

AbbVie Teams Up With Neomorph for Molecular Glue Collab Worth up to $1.64B

 

Protein degradation–focused Neomorph nabs its third Big Pharma deal of around $1.5 billion in less than a year.

In a licensing deal that could reach up to $1.64 billion, AbbVie is teaming up with Neomorph to develop molecular glue degraders, a modality that has caught Big Pharma’s attention of late, with Biogen, Novartis, Takeda and Novo Nordisk all striking deals last year and potentially throwing over $6 billion into the space. Biogen’s and Novo’s deals were also with Neomorph.

The new partnership will see AbbVie and Neomorph develop multiple targets in oncology and immunology. The specific terms of the deal were not revealed, although Neomorph has received an upfront payment in addition to the milestone potential.

Molecular glue degraders are a type of small molecule drugs that target and trigger degradation of proteins to disrupt cancer growth or immune system dysregulation. The drugs bring together proteins that wouldn’t typically interact and have been touted as having the potential to tackle “undruggable” targets.

Neomorph emerged in 2020 with a $109 million series A to develop targeted protein degraders for a broad range of diseases, including oncology. Its founders, which include Phil Chamberlain, Eric Fischer, Benjamin Ebert and Scott Armstrong, are leaders in the molecular glue field, specifically.

In October 2024, Neomorph signed a molecular glue deal with Biogen worth up to $1.45 billion. Earlier in the year, Neomorph secured a licensing deal worth a potential $1.46 billion with Novo Nordisk. Other Big Pharma players in molecular glues include Novartis, Roche and Takeda.

https://www.biospace.com/business/abbvie-teams-up-with-neomorph-for-molecular-glue-collab-worth-up-to-1-64b

WTI Tumbles On Trump Comments, Shrugs Off 9th Straight Weekly Crude Draw

 Oil prices are lower this morning (extending a multi-day slump) following comments from President Trump to Davos that he will push Saudi Arabia and OPEC to lower oil prices. Prices had recovered some overnight weakness (due to across the board inventory builds reported by API) before Trump's comments.

“I’m also going to ask Saudi Arabia and OPEC to bring down the cost of oil,” Trump said in remarks delivered virtually to world leaders gathered in Davos Thursday. “You’ve got to bring it down.”

The remarks stifled a rebound earlier in the session that had been driven by signs that fresh US sanctions on Russian crude, introduced before Trump took office, were tightening the global market.

API

  • Crude +1mm

  • Cushing +500k

  • Gasoline +3.2mm

  • Distillates +1.9mm

DOE

  • Crude -1.02mm

  • Cushing -148k

  • Gasoline +2.33mm

  • Distillates -3.07mm

While API reported across the board builds, the official data was almost the opposite with only gasoline stocks rising (though only modestly... even if it was the 10th weekly build in a row). Crude inventories are down for the 9th straight week

Source: Bloomberg

Total US crude stocks dropped to their lowest since March 2022 and the seasonally lowest since 2015...

Source: Bloomberg

US crude production remains near record highs...

Source: Bloomberg

WTI was trading around $74.50 ahead of the inventory data and tricked up very slightly on the crude draw...

“Oil markets are now facing the introduction of a new variable this year, that is the ‘Trump call option’ on energy prices,” said Frank Monkam, head of macro trading at Buffalo Bayou Commodities.

https://www.zerohedge.com/energy/wti-tumbles-trump-comments-shrugs-9th-straight-weekly-crude-draw

Milei's Blistering WEF Speech: Slams DEI, Says Woke Ideology "Cancer", Urges Limited Government

 Argentina's President Javier Milei delivered a blockbuster speech at the World Economic Forum in Davos on Thursday, where he said that woke politics are a "cancer" on the world and must be eradicated to usher in a "new golden age" of freedom and prosperity.

"What once seemed like a global hegemony of the ‘woke’ left in politics, educational institutions, in the media, in supranational organizations or even in forums like Davos, has begun to crumble," said Milei, who took office in 2023.

The Argentinian politician says he's been forming alliances with other conservative figures and leaders.

"Over the course of this year, I have found allies in this fight for the cause of freedom in every corner of the world, from the amazing [tech billionaire] Elon Musk to that fierce Italian lady [Prime Minister] Giorgia Meloni, from [President Nayib] Bukele in El Salvador to Viktor Orban in Hungary," he said, adding "Slowly, an international alliance has been forming among all those nations who want to be free and believe in the ideas of liberty."

"Merit has been cast aside in favor of the doctrine of diversity," he continued, adding "Quotas are invented for every minority that politicians can come up with, which undermines the excellence of institutions."

Milei then said called out transgender men who adopt children to abuse. "They are pedophiles," he said.

Milei also said that if the West wants to "reclaim" its progress, "we have to drastically reduce the size of the state," adding "The function of the state must once again be limited to defending the right to life, liberty, & property."

Milei, who said that "the battle is not yet won," spoke days after US President Donald Trump's inauguration - after which Trump signed a slew of executive orders reversing woke policies from the Biden administration.

"Although hope has been rekindled, it is our moral duty and responsibility to dismantle the ideological edifice of sickly wokeism," he continued.

Libertarian Milei has been credited with revamping market confidence in Argentina’s downtrodden economy, implementing cuts to public sector spending and energy subsidies, among his policies. Inflation has also fallen from one of the world’s highest annual inflation rates of 289.4% in April to 117.8% in the year to December 2024, according to data from the country’s central bank. -CNBC

Last year Milei called on global leaders to reject socialism and instead embrace "free enterprise capitalism."

Watch the whole speech below via Rebel News.

 https://www.zerohedge.com/geopolitical/milei-gives-blistering-wef-speech-slams-dei-calls-woke-ideology-cancer-and-calls