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Friday, February 7, 2025

Bristol Myers backs out of Dupixent fight, axing allergy asset despite phase 3 win

 Bristol Myers Squibb has continued its ruthless cost-cutting push, dropping plans to commercialize a rival to Dupixent despite meeting its phase 3 goals and pumping the brakes on a would-be Sotyktu successor.

The Big Pharma has dropped a series of internal and partnered programs since Chris Boerner, Ph.D., took over as CEO. Boerner initially targeted $1.5 billion in savings. With that cost-cutting push underway, the CEO added another $2 billion to the target this week. BMS is looking to make some of the savings by setting a higher bar for investments.

Cendakimab fell short of the bar. The antibody hits IL-13, one of the interleukins targeted by Regeneron and Sanofi’s blockbuster Dupixent. Last year, BMS reported a phase 3 trial in eosinophilic esophagitis met both co-primary endpoints, positioning the drugmaker to challenge Dupixent and Takeda’s Eohilia for the market.

Yet, BMS quietly removed cendakimab from the pipeline in its fourth-quarter update. Adam Lenkowsky, chief commercialization officer at BMS, explained the removal on an earnings call with analysts Thursday.

“Given the data that we have seen, we've made the decision not to commercialize cendakimab,” Lenkowsky said. “We're going to continue to prioritize investments and opportunities where we have a competitive advantage. We can deliver the highest return for the company in areas where we believe that we have an opportunity to deliver potentially transformational outcomes for patients.”

Similar thinking underpinned BMS’ decision on investing in TYK2. BMS completed a phase 2 trial of its second-generation TYK2 inhibitor BMS-986322 in psoriasis in August. The drug candidate is still listed in BMS’ pipeline but an analyst questioned the lack of progress since the phase 2 trial wrapped up, leading Samit Hirawat, M.D., head of development at BMS, to explain why the program has stalled.

“We have to decide within our pipeline where we are going to really focus and prioritize,” Hirawat said. “At the current time, our focus is truly squarely on Sotyktu and maximizing that opportunity from a development and commercial perspective. So, at this time, that TYK2 is not in development.”

BMS is barreling ahead in other areas, pulling forward an anticipated readout from a phase 3 study of iberdomide in multiple myeloma after adding minimal residual disease (MRD) as a co-primary endpoint. Hirawat said BMS discussed the switch with the FDA and will talk to regulators once it has results to learn “how they will see that data and what else they would need.” Further use of MRD is on the cards.

“Newer endpoints are needed,” Hirawat said. “We are continuing to evaluate the potential to leverage an earlier MRD endpoint readout to accelerate the development of our multiple myeloma assets across the board, but it will all depend on the timing, the population, as well as how the event accrual is occurring.”

BMS remains open to deals amid the cost cutting. The drugmaker moved into radiopharmaceuticals as part of a deal spree, inking a deal to buy RayzeBio for $4.1 billion late in 2023, and Boerner said the team is looking for opportunities to enhance the acquisition. BMS will consider business development to achieve that goal if “it makes sense for us, both financially and scientifically,” the CEO said.

https://www.fiercebiotech.com/biotech/bristol-myers-backs-out-dupixent-fight-axing-allergy-asset-despite-phase-3-win

Lithuania cuts Russian power grid ties as Baltics prepare to link with EU

  Lithuania said on Saturday it had disconnected its electricity system from Russia's power grid, part of a plan which the three Baltic states say will integrate them more closely with the European Union and boost security.

Latvia and Estonia are expected to follow suit by 0700 GMT on Saturday and, subject to last-minute tests, the three countries will synchronise with the EU's grid on Sunday after operating on their own in the meantime.

https://www.msn.com/en-ie/news/world/lithuania-cuts-russian-power-grid-ties-as-baltics-prepare-to-link-with-eu/ar-AA1yDhex

US judge declines to block Elon Musk's DOGE from Labor Department systems

 A federal judge on Friday declined to block Elon Musk's government cost-cutting department from accessing the U.S. Department of Labor's systems, an initial setback for the government employee unions resisting his efforts to shrink the federal bureaucracy.

The temporary ruling by U.S. District Judge John Bates in Washington, D.C., is the first step in a lawsuit against the Labor Department by one of the largest U.S. labor unions, which alleges billionaire Musk could obtain sensitive information about investigations into his own companies and competitors by accessing government computer systems.

Bates ruled that "although the Court harbors concerns about defendants’ alleged conduct," the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) had not shown it was harmed by the Labor Department's actions.

AFL-CIO President Liz Shuler said in a statement that the decision was "a setback, but not a defeat," and that the union would provide more evidence to support its claims. A Department of Labor spokesperson did not immediately respond to a request for comment sent late on Friday.

President Donald Trump has deputized Musk, the world's richest person and owner of electric vehicle company Tesla, space technology company SpaceX and other businesses, with leading the so-called Department of Government Efficiency, or DOGE, to identify fraud and waste in the government.

Musk's efforts have alarmed lawmakers and advocacy groups who say he is overstepping his authority by seeking to dismantle agencies responsible for critical government programs and fire federal workers en masse.

Another group of federal employee unions and retirees has sued the Treasury Department to block what it says is the unlawful transmission of sensitive payment records to DOGE personnel. Treasury temporarily agreed on Wednesday not to give further access while the case plays out.

In the Labor Department lawsuit, the AFL-CIO asked the court to block what it said was Musk's imminent plan to access department systems.

The union, which represents roughly 800,000 government workers, said that would potentially give Musk access to non-public information from the Occupational Safety and Health Administration's probes into SpaceX, Tesla and his tunneling company, The Boring Company, as well as investigations into his competitors.

The union also said that in the absence of court intervention, DOGE could access Bureau of Labor Statistics data about the health of the economy and sensitive information about government employees, including the identities of those who have filed worker compensation claims or sought protection for wage and hour complaints.

The White House has said Musk will recuse himself from matters in which he has a conflict of interest. As a so-called special government employee, he is subject to some but not all conflict-of-interest and ethics rules for federal workers.

Musk's rapid takeover of U.S. government agencies has enabled the South African-born businessman to exert unprecedented control over America's 2.2-million-member federal workforce and begin a dramatic reshaping of government.

Musk has already moved to shut down the U.S. Agency for International Development and says USAID is canceling scores of government consulting contracts and underutilized leases.

https://www.yahoo.com/news/us-judge-declines-block-elon-040115653.html

Healthcare and Biotech IPO Hopefuls

 Healthcare has been one of the IPO market’s most resilient sectors in terms of activity, a trend we expect will continue in 2025. A plethora of biotechs are lining up to go public, including several focused on obesity. Other IPO candidates include companies which make wearable devices and medical supplies. Here are some of the healthcare companies most likely to go public in 2025.


Hinge Health: Wearable device maker Hinge Health has been waiting to go public since at least 2023, when it said it was aiming for an IPO when conditions improve. The company, last valued at over $6 billion, reportedly tapped a number of major banks last fall for a listing that could come early in 2025.

Kallyope: Within the first few weeks of 2025, a number of sizable biotechs filed for IPOs, and our private backlog suggests many more are waiting in the wings. Weight loss-focused biotech Kallyope may capitalize on recent investor interest in the field to go public. Backed by nearly half a billion dollars in funding, the unicorn reportedly hired JP Morgan for a listing last January.

Omada Health: Digital health unicorn Omada Health, which provides online programs for diabetes, hypertension, and other health conditions, has teased an IPO for nearly five years. After it reportedly confidentially filed for an IPO this past summer, 2025 could finally be the year it goes public.

Medline Industries: Private equity-owned Medline Industries ranks among the world’s largest medical supplies manufacturers. Last summer, its owners began working with banks on an IPO that could raise $5 billion, and value it at $50 billion. This past December, it announced it had confidentially filed for a listing that could come as soon as the second quarter of 2025.

Wildcards: One of the most highly-valued healthcare startups, blood test developer Freenome, might have been higher on this list if not for the abrupt resignation of its CEO last year, but the two-year high of close peer Guardant may push it to get its team in shape for a listing. Other IPO wildcards include digital health and wellness platforms Noom and Included Health.  

Pentagon doubles number of news outlets to 'rotate' out from office spaces

 The U.S. Defense Department on Friday doubled the number of news organizations that must vacate their Pentagon office spaces to be replaced by other media outlets under a new "annual media rotation program."

The department said in a memo it was adding CNN, the Washington Post, the Hill and the War Zone to the outlets that must give up their dedicated space. Those organizations did not immediately respond to requests for comment.

In the first round, the Defense Department said a week ago the New York Times (NYSE:NYT), NBC News, Politico and the National Public Radio had to vacate their dedicated workspaces at the Pentagon.

Incoming media outlets include the New York Post, Breitbart, the Washington Examiner, the Free Press, the Daily Caller, Newsmax, the Huffington Post and One America News Network, most of whom are seen as conservative or favoring Republican President Donald Trump, who took office on January 20.

Outgoing outlets will remain members of the Pentagon Press Corps, the memo said, adding that the rotation expressed a desire to make room for other media outlets.

More than two dozen news organizations operate out of the Pentagon, including Reuters, reporting on the daily activities of the U.S. military.

The Pentagon Press Association, which represents journalists who cover the Defense Department, said it was "shocked and deeply disappointed by the Defense Department's decision to double the number of news organizations it is removing in two weeks from their dedicated workspaces in the Pentagon from four to eight."

https://www.investing.com/news/world-news/pentagon-doubles-number-of-news-outlets-to-rotate-out-from-office-spaces-3857726

US cities, counties challenge Trump's 'sanctuary' city crackdown

 A coalition of U.S. cities and counties on Friday filed a lawsuit challenging President Donald Trump's executive order seeking to force so-called sanctuary jurisdictions to cooperate with his immigration crackdown and mass deportations.

Cities and counties led by San Francisco and the county of Santa Clara, California, said in a lawsuit in California federal court that the Republican president's administration was unlawfully trying to force local officials to cooperate by threatening them with a loss of funding and prosecution.

"This is the federal government coercing local officials to bend to their will or face defunding or prosecution," San Francisco City Attorney David Chiu, a Democrat, said in a statement. "That is illegal and authoritarian."

Other local governments that joined the lawsuit included Portland, Oregon; New Haven, Connecticut; and King County, Washington.

The lawsuit came a day after the U.S. Department of Justice sued the state of Illinois and city of Chicago, alleging the Democratic strongholds were unlawfully interfering with Trump's crackdown and seeking a court order blocking so-called sanctuary laws.

Sanctuary laws prevent state and local law enforcement from assisting federal civil immigration officers.

Supporters of such laws have said that cooperation with federal immigration enforcement would discourage immigrants who are living in the country illegally from coming forward as victims or witnesses to crimes.

Friday's lawsuit challenged an executive order Trump signed that threatened to cut off federal funding to sanctuary jurisdictions that limit or refuse to cooperate with federal immigration law enforcement, including Immigration and Customs Enforcement.

The lawsuit also challenged memos from the Department of Justice, including one on February 5 from newly confirmed U.S. Attorney General Pam Bondi, that instructed prosecutors to investigate state and local officials who impede or obstruct immigration enforcement.

https://www.marketscreener.com/news/latest/US-cities-counties-challenge-Trump-s-sanctuary-city-crackdown-48999612/

TikTok to give package kits on its website for US Android users to download app

 Social media app TikTok said on Friday it was making Android package kits available on its website so that U.S. Android users can download the app and connect on it.

Apple and Google have still not reinstated TikTok to the App Stores.


https://ca.finance.yahoo.com/news/tiktok-package-kits-website-us-023038975.html