BridgeBio Pharma said on Tuesday it will stop development of its experimental therapy for a genetic disease that affects the adrenaline-producing gland.
The drugmaker said the results of its early-to-mid stage study testing the therapy did not meet the threshold to warrant additional capital investment.
https://kfgo.com/2024/09/10/bridgebio-to-stop-development-of-therapy-for-genetic-disorder/
Novo Nordisk's highly anticipated experimental weight-loss pill amycretin was safe and tolerable for patients in an early-stage trial, with mild-to-moderate side effects, the company said on Wednesday.
The maker of blockbuster drugs Wegovy and Ozempic said in March that a Phase I trial of the pill version of amycretin showed participants lost up to 13.1% of their weight after 12 weeks, prompting shares to surge more than 8%.
That compared to weight loss of about 6% after 12 weeks and 15% after 68 weeks in trials of Wegovy.
Novo is due to present full data from the Phase I study at the European Association for the Study of Diabetes meeting in Madrid later on Wednesday.
"What we see in the study period is a 13.1% weight loss with a side effect profile comparable to what we normally see with incretin-based therapy, so primarily gastrointestinal side effects," Martin Holst Lange, Novo's head of development, said in an interview ahead of the presentation.
Amycretin targets the same gut hormone that Wegovy mimics, known as GLP-1, but also a pancreas hormone called amylin that affects hunger.
In the study, overweight or obese patients without diabetes received increasing doses of amycretin, starting from 3 milligrams and up to a final dose of two 50 mg pills, Novo said.
Patients who took 50 mg of amycretin at the end of the 12-week trial reduced body weight by 10.4% on average, while those taking the maximum dose of 2x50 mg lost 13.1% of their starting weight, the company said. That compared to an average weight loss of 1.1% among those taking a placebo.
Side-effects were mainly mild to moderate in severity, including nausea and vomiting, the company said.
The data warrants further clinical development, Lange said.
A decision on whether to skip a Phase II trial for amycretin and proceed directly to phase III - typically the final stage of human testing before seeking approval - will be taken once data from an early study on a subcutaneous version of the drug is ready next year.
Existing obesity drugs like Wegovy and Eli Lilly's Zepbound are injectable. Pills require larger amounts of active ingredients, which makes them more costly to produce but are often favoured by patients.
Novo's shares have increased more than three-fold since June 2021, when it launched Wegovy in the United States, but have shed 15% since peaking in June this year.
Around 40% of Novo's valuation is pinned to its pipeline of experimental drugs, analysts at Berenberg said last week.
Last year, Novo become Europe's most valuable listed company, ahead of LVMH.
https://www.yahoo.com/news/novo-nordisk-experimental-obesity-pill-220733123.html
UnitedHealth Group said on Tuesday it will remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement as of Jan. 1, 2025, and recommend less expensive biosimilar versions of the medicine instead.
UnitedHealth said Amgen's Amjevita will be among the biosimilars covered on its lists for commercial health plans, which are managed by its pharmacy benefits unit, Optum Rx.
Optum is the last of the three largest U.S. pharmacy benefits managers to announce Humira's exclusion. The three benefits managers together control around 80% of the U.S. prescription drug market.
Cigna announced last month that it would remove Humira from some of its lists in 2025, following similar action by CVS Health's Caremark unit in April. CVS's move led more patients to switch to Sandoz's biosimilar version of Humira in three weeks than had switched in the prior 15 months.
Cigna has said Boehringer Ingelheim's Cyltezo, Simlandi from Teva and Alvotech and an unbranded version of Sandoz's Hyrimoz will be covered on its lists in place of Humira next year.
UnitedHealth said patients will have a way to get coverage for Humira until the preferred biosimilars on its plans are designated interchangeable by the U.S. Food and Drug Administration, meaning they can be substituted for the original without consulting the prescriber. The FDA is expected to grant that designation in 2025, United said.
The U.S. Federal Trade Commission in July criticized pharmacy benefit managers, which negotiate fees and volume-based discounts on behalf of payers with drugmakers and pharmacies, for exercising outsized influence over prescription drug prices.
The Pharmaceutical Care Management Association - an industry lobbying group - said in response that the companies provide value to the U.S. health system by reducing prescription drug costs and increasing access to medicines.
AbbVie has retained most of the U.S. market for Humira this year, despite the launch of 10 biosimilar alternatives to the drug since January 2023 from companies including Pfizer. AbbVie negotiated favorable positions on insurance drug coverage lists managed by pharmacy benefits managers.
The U.S. market share for Humira biosimilars stands at nearly 20%, compared with 2.2% in the first quarter of this year, Barclays analysts said in a note on Monday.
AbbVie did not immediately respond to a request for comment, but said earlier this year that it expects to retain a lower share of the Humira market in 2025.
https://www.yahoo.com/news/unitedhealth-remove-abbvies-humira-us-162815795.html
Kyiv said on Tuesday it could cut ties with Tehran if Russia used ballistic missiles supplied by Iran to attack Ukraine, and it denounced any such delivery of the weapons as "unacceptable".
Earlier, U.S. Secretary of State Antony Blinken said Russia received the missiles from Iran 2-1/2 years after the full-scale invasion. He said he expected Moscow to use the weapons in the coming weeks. Iran has denied supplying the arms.
Ukraine, which has already been grappling with an increase in Russian missile and drone attacks, has said there would be devastating consequences for its bilateral ties with Iran if reports of the missile supplies are confirmed.
"I will not say now exactly what is meant by devastating consequences, so as not to weaken our diplomatic position. But I can say that all options, including the one you mentioned, are on the table," foreign ministry spokesman Heorhiy Tykhyi said, when asked if Kyiv could cut ties with Tehran.
President Volodymyr Zelenskiy made no direct reference to Iran in his nightly video address, but pledged to coordinate a strong world-wide response to any power helping Russia and President Vladimir Putin.
"I want to say to everyone in the world who still wants somehow to help Putin," Zelenskiy said.
"We will do everything not just to defend our state and people, but to truly consolidate the world for strong responses to the incitement of war or any attempts to prolong it."
Ukraine's allies, including the U.S., have said the delivery amounts to a substantial escalation and that they will impose further sanctions on Iran.
While describing such sanctions as a "positive step", Ukraine's top presidential official, Andriy Yermak, said it would not be enough on its own.
"We also need authorisation to use Western weapons against military targets on Russian territory, the provision of longer-range missiles, and the enhancement of our air defence systems," Yermak said on X.
The Kremlin has yet to comment on Blinken's statements. On Monday, it said it was developing all-round dialogue with Iran.
Ukraine downgraded ties with Iran in 2022 over Tehran's supply of unmanned Shahed attack drones to Russia, which Moscow troops have since used for regular long-range attacks.
Until now, Iranian military support for Moscow has been most visible in the supply of those drones, which carry a smaller payload and are easier to shoot down because they travel at a fraction of the speed of ballistic missiles.
Reuters reported in August that Russia expected a delivery of hundreds of Fath-360 close-range ballistic missile from Iran and that dozens of troops had received training to fire them.
https://www.yahoo.com/news/ukraine-presses-allies-over-permission-130104119.html
The violent Venezuelan migrant gang Tren de Aragua has taken over a hotel in the Texas border city of El Paso — turning into a hub of fighting, drinking and hard-partying behavior, authorities say.
The cops have been called nearly 700 times to the Gateway hotel.
Surveillance footage shows one man wielding a hatchet, others were spotted with knives and at least one man was seen firing a gun inside, the El Paso County Attorney said.
Much of this activity happened while children were present.
Local officials are now working to shut down the hotel and take back control of the business, which they say has become a blight on the city 680,000.
And it’s not just the Gateway.
El Paso is a known waypoint for Tren de Aragua members after they cross into the US — before they head to cities like New York, Chicago and Denver, law enforcement sources told The Post.
Gang members have also sought refuge at another hotel in El Paso, a Motel 6, the sources said is “notoriously used by transnational criminal organizations in the smuggling/harboring of illegal aliens and illegal drugs attempting to make it further into the United States.”
Two Venezuelan migrants believed to be linked to Tren de Aragua ran off to the El Paso motel in June, three days after allegedly taking part in a violent jewelry store robbery in Denver.
On Monday, a judge granted a temporary order that force all residents of the hotel to leave by Thursday — and prevent owner Howard Yun from letting people stay there, according to KVIA-TV.
According to filings by County Attorney Christina Sanchez, surveillance footage the inside the Gateway shows “people partying … drinking, smoking and dancing provocatively while children are present … at least one gun being shot, … men holding knives and another man with a hatchet assaulting people and causing damage to the hotel in front of a security guard.”
Other images taken inside the condemned hotel show men crowding the hallways, some armed with knives, engaging in fights and one seen bleeding from multiple stab wounds, many of these instances happening while children are around, per the court documents.
“There should be concern due to the establishment and rise of the Venezuelan Criminal Organization ‘Tren de Aragua’ at the Gateway Hotel. We discovered several Venezuelans have the tattoo identifiers of Tren de Aragua,” one El Paso cop said of the conditions, according to local news outlet KVIA.
The county attorney described the state of the establishment as “deplorable,” and argued that it should be shut down once and for all.
Yun, who’s owned the building since 2015, had been working for years to get the hotel up to code, according to the court documents.
In 2018, he filed for a temporary occupancy permit, which expired months later, and there’s no indication he’s filed a new one since then.
The building was previously owned by an individual who was convicted for smuggling and money laundering in a federal case in 2011, according to the court documents.
https://nypost.com/2024/09/10/us-news/el-paso-gateway-hotel-overrun-by-migrants-tren-de-aragua-gang/
Former President Donald Trump appears to have made remarkable gains of about 14 points among independents and 19 points with Latino voters relative to Vice President Kamala Harris in a new poll.
Trump, 78, jumped ahead of Harris with a three-point lead among independents in a multi-candidate contest, 49% to 46%, gaining significant ground since the August poll in which he trailed Harris, 59, by 11 points, 48% to 37%, according to fresh polling from NPR/PBS News/Marist.
In between the August and September polls, Robert F. Kennedy Jr. — who notched 12% support in the prior survey — dropped out of the race and endorsed Trump. Additionally, Harris’ “honeymoon” from her abrupt ascension to the nomination appears to have begun leveling out.
A police legal defense fund shared Vice President Kamala Harris' soft-on-crime record ahead of the debate.
Using stats from the California Open Justice Data Portal, the Law Enforcement Legal Defense Fund counted an eye-popping 73% increase in rape over the course of Harris' time as the state's attorney general from 2010 to 2016.
Gun assaults were up 22%, and motor vehicle theft and theft of items over $400 was up 16% over the six-year period.
Meanwhile, aggravated assaults were up 9% and homicide and violent crime were both up 7%.
Harris left the attorney general's office to run for the US Senate, where she served for less than a full six-year term before being tapped as Joe Biden's vice presidential pick.
