Moderna Walks Away from Potential $3B Gene Editing Deal with Metagenomi

 Moderna has backed out of its gene editing deal with Metagenomi, handing back full global rights to the primary hyperoxaluria type 1 program and other related technologies, including base editors and RNA-mediated integration systems.

Metagenomi in Wednesday’s announcement said that the partners have “mutually agreed” to terminate the agreement, but that the decision came after a “strategic prioritization” by Moderna. However, the mRNA-focused biopharma company will remain a shareholder of Metagenomi.

Despite losing a powerhouse partner, Metagenomi CEO Brian Thomas said in a statement that the biotech is “pleased to regain full control of the development of base editing technology” and its RNA-mediated integration systems (RIGS), which will allow the company to harness these platforms to develop treatments in “areas of significant need, such as Alpha-1 antitrypsin deficiency and Wilson’s disease.”

Metagenomi is capable of advancing programs on its own, Thomas said, adding that the biotech has over the years built up its footprint and talent base, as well as “leveraged significant private and public funding to greatly expand our gene editing toolbox, and established in-house manufacturing.”

Moderna and Metagenomi inked the gene editing partnership in 2021, combining the former’s mRNA platform with the latter’s gene editing expertise to develop in vivo human therapies.

At the time, the partners did not disclose the specific financial details of the deal, though subsequent SEC filings showed that Metagenomi could have potentially generated more than $3 billion from the agreement, plus an upfront payment and royalties. As of December 31, 2023, the biotech had secured $49.6 million from the partnership.

In February 2024, Metagenomi debuted on the Nasdaq Global Select Market with a nearly $94 million initial public offering (IPO). The biotech’s shares cratered 31% the following day, highlighting the problems faced by earlier-stage companies that go public.

Some of the market’s apprehension over Metagenomi’s IPO could be attributed to the fact that it has no candidates in the clinic. Instead, the biotech has focused on creating what it brands as “the most diverse genome editing toolbox” to target various genetic conditions.

For Moderna, the discontinuation of the Metagenomi partnership comes after it suffered more than $1 billion in losses and write-downs linked to low demand for its vaccine and cancelled orders for Africa. The company has in turn suspended the construction of an mRNA manufacturing facility in Kenya while it assesses the demand for its vaccines.

https://www.biospace.com/article/moderna-walks-away-from-potential-3b-gene-editing-deal-with-metagenomi/

FDA Approval Fuels Boehringer’s Biosimilar Challenge to AbbVie’s Humira

 The FDA on Wednesday approved a high-concentration and citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), its interchangeable biosimilar to AbbVie’s blockbuster antirheumatic treatment Humira (adalimumab).

The high-concentration version of Cyltezo, which carries a 100-mg/mL dose of the biosimilar, comes in a pre-filled syringe or autoinjector and is sold at a 5% discount to the branded reference product. An unbranded version of Cyltezo is also available at an 81% discount to Humira. A low-concentration, 50-mg/mL version of the biosimilar has been on the market since July 2023, according to Boehringer Ingelheim.

Stephen Pagnotta, biosimilar commercial lead at Boehringer Ingelheim, in a statement said that this latest Cyltezo approval will further expand “treatment access for patients living with certain chronic inflammatory diseases.”

Approved in October 2021, Cyltezo is an interchangeable biosimilar to Humira and is indicated for all the same conditions, including moderate-to-severe rheumatoid arthritis, Crohn’s disease and ulcerative colitis. With the FDA’s interchangeability designation, Cyltezo can be used in place of Humira without needing to change the patient’s prescription.

Cyltezo is backed by data from the Phase III VOLTAIRE-X comparative clinical trial, which looked at the effects of switching between Humira and the biosimilar. The study found that Cyltezo was equivalent to Humira, leading to no meaningful clinically differences in safety, efficacy and pharmacokinetic profile.

Wednesday’s FDA approval is supported by findings from the Phase I VOLTAIRE-HCLF study, which compared the bioavailability of the high- and low-concentration formulation of Cyltezo in 200 healthy volunteers.

The approval of Cyltezo’s high-concentration, citrate-free formulation comes as biosimilars claim more market ground against AbbVie’s Humira. Earlier this month, biosimilars saw a 36% surge in prescriptions after leading pharmacy benefit manager CVS Caremark took Humira off of its major national commercial formularies.

Sandoz’s biosimilar Hyrimoz (adalimumab-adaz)—which is being co-developed and commercialized by the CVS Health subsidiary Cordavis—accounted for more than 93% of the biosimilar growth. In the week ending April 5, 2024, there were nearly 8,300 new prescriptions for Hyrimoz, compared to only 640 in the week ending March 29.

In addition to Hyrimoz and Cyltezo, there are several other Humira biosimilars competing in the market, including Amgen’s Amjevita, Celltrion’s Yufly,a Alvotech and Teva’s Simlandi and Organon and Samsung Bioepis’ Hadlima.

https://www.biospace.com/article/fda-approval-fuels-boehringer-ingelheim-s-biosimilar-challenge-to-abbvie-s-humira/

'Biden Says There Are Very Fine People On Both Sides Of The Oct. 7 Debate'

  by David Harsanyi via The Epoch Times (emphasis ours),

“I condemn the anti-Semitic protests ...” President Joe Biden told reporters after days of anti-Jewish demonstrations at Columbia University and other Ivy League schools. “I also condemn those who don’t understand what’s going on with the Palestinians ...”

Any morally clearheaded American already has a very good idea of what’s going on. Biden is bothsidesing the actions of keffiyeh-wearing terror cheerleaders on Columbia’s Gaza Quad—who target American Jews who have absolutely no bearing on Israel’s actions—with those who refuse to accept the blood libel of “genocide” in Gaza. It is the kind of odious moral relativism one expects to hear from a “Squad” member or clout-chasing far-right “influencer,” not the president.

Hamas, the governing authority in an autonomous Gaza—still supported widely by the Palestinian people—flooded over the border on Oct. 7, 2023, raping, murdering, and kidnapping more than a thousand men, women, and children in Israel, including American citizens. Afterward, Hamas retreated and hid among civilians to generate as many Palestinian martyrs as possible. The Israelis retaliated against this nihilistic death cult, keeping the civilian-to-combatant casualty ratio lower than perhaps any other instance of modern urban warfare.

That’s what’s going on. But because a not-insignificant contingent on the contemporary left is now both anti-Semitic and anti-“colonialist,” the president demanded Israel stop before the job was done. And he is willing to sell out a longtime ally and forsake the lives of American hostages to try to entice the votes in Jew-hating enclaves like Dearborn, Michigan, Yale University, and The Washington Post newsroom.

A number of people have pointed out the similarities between Biden’s condemnations and former President Donald Trump’s post-Charlottesville, Virginia, march “very fine people” comment. It’s a good gotcha. After all, Biden has risibly claimed that Trump’s comments impelled him to run for president (for the third time).

There is, however, a key difference. Trump’s garbled line was almost surely not aimed at tiki-torch neo-Nazis. Believe what you like about Trump’s motivations, but he also later unequivocally condemned the white supremacists on more than one occasion. Biden, on the other hand, can’t even get himself to call out brownshirts without throwing them a bone.

Also, incidentally, unlike the nuts in Virginia, these people will be working at our top law firms, in media organizations and in the State Department. Oh, the president also wants you to pay their loans.

Earlier, The Washington Post, like most outlets, claimed that “Biden denounces antisemitism on college campuses amid Yale, Columbia protests.” While technically true, the framing ignores the president’s equivocation. The denouncement was a pro forma White House Passover press release that spent as much space prattling on about a two-state solution as it did the “protests.” For comparison, Biden’s Ramadan press release noted the “terrible suffering on the Palestinian people,” repeated fake Hamas causality numbers and condemned “Islamophobia,” but said nothing about the widespread outbreak of anti-Semitism.

Then again, Democrats are increasingly incapable of even talking about anti-Semitism without diluting any condemnation with mention of “Islamophobia.”

You might recall a few years back a certain Democratic congresswoman was going on about “Benjamin”-grubbing rootless cosmopolitans hypnotizing the world for their evil. After a handful of Jewish Democrats complained about her rhetoric, then-House Speaker Nancy Pelosi finally agreed to pass a resolution condemning Rep. Ilhan Omar. By the end of debate, of course, the resolution was teeming with platitudes and condemnations of a rainbow of thought crimes, with references to Alfred Dreyfus, Leo Frank, Henry Ford, and “anti-Muslim bigotry,” but not Omar.

“We all have a responsibility to speak out against anti-Semitism, Islamophobia, homophobia, transphobia, racism, and all forms of hatred and bigotry, especially as we see a spike in hate crimes in America,” is how Sen. Kamala Harris whitewashed the rising anti-Jewish pronouncements of her party. Which is to say, for years now, Democrats have been downplaying anti-Semitism as it creeped into college campuses, Congress, the Women’s March, Black Lives Matter, and now the mainstream.

And now, here we are. We have a president who can’t make a moral distinction between bigots and their targets.

https://www.zerohedge.com/political/joe-biden-says-there-are-very-fine-people-both-sides-oct-7-debate

UnitedHealth says hackers potentially stole a third of Americans' data

Hackers who breached UnitedHealth's tech unit in February potentially stole a third of Americans' data, the largest U.S. health insurer's CEO told a Congressional committee on Wednesday.

Two Congressional panels grilled CEO Andrew Witty about the cyberattack on the company's Change Healthcare unit, which processes around 50% of all medical claims in the U.S.

The breach has caused widespread disruptions in claims processing, impacting patients and providers across the country.

Witty fielded heated questions from Senators on the House Energy and Commerce Committee about the company's failure to prevent the breach and contain its fallout.

Pressed for details on the data compromised, Witty said "maybe a third" of Americans' protected health information and personally identifiable information was stolen.

"We continue to investigate the amount of data involved here," he added. "We do think it's going to be substantial."

The cybercriminal gang AlphV hacked into Change on Feb. 12 using stolen login credentials on an older server that did not have multi-factor authentication, Witty said.

"It was ... a platform which had only recently become part of the company was in the process of being upgraded," Witty said, referring to UnitedHealth's $13 billion acquisition of Change in 2022.

The platform also did not have the security measures prescribed in a joint alert issued by the FBI and U.S. cyber and health officials in December 2023 to specifically warn about AlphV, or BlackCat, targeting healthcare organisations.

UnitedHealth paid the gang around $22 million in bitcoin as ransom, Witty said, adding that however there was no guarantee that the breached data was secure and could not still be leaked. Another hacking group claiming to be an offshoot of AlphV said last month it had a copy of the data, though the company has not verified that claim.

The Senate Finance panel probed the outsized influence of UnitedHealth - which has a market capitalization of $445 billion and annual revenue of $372 billion - on American healthcare. But Witty said the company's problems were not a threat to the broader economy.

Senator Bill Cassidy said senators on the panel "would have to ask, is the dominant role of United too dominant because it is into everything and messing up United messes up everybody?"

"My point is, the size of United becomes a it's almost a too big to fail and sure, because if it fails, it's going to bring down far more than it ordinarily would," Cassidy said.

Witty said in response, "I don't believe it is because actually despite our size, for example, we have no hospitals in America, we do not own any drug manufacturers."

Yet, Change processes medical claims for around 900,000 physicians, 33,000 pharmacies, 5,500 hospitals and 600 laboratories in the U.S.

U.S. military members' data was also stolen in the hack, Witty revealed, without saying how many of them were impacted.

Senate Finance Committee Chairman Ron Wyden called the hack a national security threat.

"I believe the bigger the company, the bigger the responsibility to protect its systems from hackers. UHG was a big target long before it was hacked," he added.

"UnitedHealth Group has not revealed how many patients' private medical records were stolen, how many providers went without reimbursement, and how many seniors are unable to pick up their prescriptions as a result of the hack," said Wyden.

In letters to both congressional committees, the American Hospital Association said an internal survey of its members found that 94% of hospitals reported damage to cash flow, and more than half reported "significant or serious" financial damage due to Change's inability to process claims.

Similarly, 90% of respondents to an American Medical Association survey of doctors said they continue to lose revenue because of the hack, according to the group's written testimony to the Senate Finance Committee.

https://www.yahoo.com/news/unitedhealth-ceo-testifies-u-senate-132513974.html

Novo Nordisk raises outlook fuelled by obesity drug demand

 Novo Nordisk raised its 2024 outlook on Thursday and delivered better-than-expected quarterly profits as the Danish drugmaker races to boost output of its hugely popular weight-loss drug Wegovy and fend off competition from rival Eli Lilly.

The company has quadrupled its U.S. supply of starter doses Wegovy since December, Senior Vice President Negelle Morris told Reuters this week.

At least 20,000 new U.S. patients are starting on the weekly injection each week, reflecting the company's efforts to ramp up output, she said.

The small raise to the outlook and forecast-beating results underscore Wegovy's success and Novo's lead in the fast-growing obesity drug market.

Novo's growth on the back of the phenomenal success of Wegovy has nonetheless been held back by its ability to meet runaway demand for the weekly injection.

The company also faces fierce competition from U.S. rival Eli Lilly as it rolls out its Zepbound therapy in new markets. It launched in the United States in December and in Germany, Poland and Britain this year.

The company said it now expects sales growth this year of between 19% and 27% in local currencies, compared to the previously guided range for 18% to 26% growth.

Operating profit growth this year is now seen at between 22% and 30% in local currencies, slightly up from its previous forecast of 21% to 29%.

Novo reported first-quarter earnings before interest and taxation (EBIT) of 31.8 billion Danish crowns ($4.57 billion), above the 29 billion forecast by analysts in a LSEG poll this week and up 27% from a year ago.

Sales of Novo's obesity care products, including Wegovy, rose 41% in local currencies in the first quarter, to 11 billion crowns.

Wegovy sales totalled 9.4 billion Danish crowns between January and March, down from 9.6 billion crowns in the previous quarter and 107% higher than the same quarter a year ago, in local currencies.

The boost to starter U.S. doses comes as the company spends billions to boost output of Wegovy and keep up with explosive demand.

A year ago, Novo began limiting the number of U.S. patients who can start treatment by reducing the supply of the lowest three doses of the appetite-suppressing weekly injection.

In January, Novo said it was more than doubling supply of lower strength or "starter" Wegovy doses in the U.S. that month compared with recent ones. Still, shortages in the U.S. persist.

https://www.yahoo.com/news/obesity-drugmaker-novo-nordisks-q1-053403065.html

US official urges China, Russia to declare only humans, not AI, control nuclear weapons

 A senior U.S. official on Thursday urged China and Russia to match declarations by the United States and others that only humans, and never artificial intelligence, would make decisions on deploying nuclear weapons.

State Department arms control official Paul Dean told an online briefing that Washington had made a "clear and strong commitment" that humans had total control over nuclear weapons, adding that France and Britain had done the same.

"We would welcome a similar statement by China and the Russian Federation," said Dean, principal deputy assistant secretary in the Bureau of Arms Control, Deterrence and Stability.

"We think it is an extremely important norm of responsible behaviour and we think it is something that would be very welcome in a P5 context," he said, referring to the five permanent members of the United Nations Security Council.

Dean's remarks come as the administration of U.S. President Joe Biden tries to deepen separate discussions with China over both nuclear weapons policy and the growth of artificial intelligence.

The Chinese defence ministry did not immediately respond to a request for comment.

The spread of artificial intelligence technology surfaced during sweeping talks between U.S. Secretary of State Antony Blinken and China's Foreign Minister Wang Yi in Beijing on April 26.

The two sides agreed to hold their first bilateral talks on artificial intelligence in the coming weeks, Blinken said, adding that they would share views on how best to manage risks and safety surrounding the technology.

As part of normalising military communications, U.S. and Chinese officials resumed nuclear weapons discussions in January, but formal arms control negotiations are not expected any time soon.

China, which is expanding its nuclear weapons capabilities, urged in February that the largest nuclear powers should first negotiate a no-first-use treaty between each other.

https://www.yahoo.com/news/us-official-urges-china-russia-044924612.html

Taiwan says may be hard to attend WHO assembly, Blinken offers support

It will be hard for Taiwan to attend this year's World Health Organization annual assembly, and it hopes more countries will support its presence, the island's foreign minister said on Thursday after the United States pressed for an invite.

Taiwan is excluded from most international organisations because of objections by China, which considers the democratically governed island its own territory.

Taiwan attended the World Health Assembly (WHA) as an observer from 2009 to 2016 under the administration of then-President Ma Ying-jeou, who signed landmark trade and tourism agreements with China. But Beijing began blocking Taiwan's participation in 2017 after President Tsai Ing-wen won office.

Speaking to reporters in parliament, Taiwan Foreign Minister Joseph Wu noted a Wednesday statement from U.S. Secretary of State Antony Blinken in which he said the United States "strongly encourages" the WHO to reinstate Taiwan's invitation.

"When it comes to attending this year's WHA there may be some difficulties, but we are continuing to work hard, as before, to get more countries to support us," Wu said, without elaborating on those problems.

This year's WHA starts May 27, just a week after Taiwan president-elect Lai Ching-te takes office. China has a strong dislike of Lai, who it believes is a dangerous separatist and has rebuffed his repeated calls for talks.

Taiwan, which is allowed to attend some technical WHO meetings, says its exclusion hindered efforts to fight the COVID-19 pandemic.

Blinken's statement said the United States commended the WHO for taking steps to engage Taiwan more meaningfully in its technical work over the past year and for improving lines of communication.

"Yet Taiwan's continued exclusion from this preeminent global health forum undermines inclusive global public health cooperation and security," he added. "Inviting Taiwan to observe the WHA is a critically important step toward affirming the WHO's goal of 'Health for All'."

Neither China's foreign ministry nor the WHO immediately responded to a request for comment.

China has in recent years ramped up diplomatic and military pressure against Taiwan to force the island to accept Chinese sovereignty.

Taiwan's government rejects China's claims and says only the island's 23 million people can decide their future, and that Beijing has no right to speak for or represent Taiwan on the international stage.

https://www.yahoo.com/news/taiwan-says-may-hard-attend-023223023.html