The U.S. Food and Drug Administration on Wednesday approved Eli Lilly's drug for weight loss, giving the U.S. drugmaker official entry into a lucrative market that has captured Wall Street's enthusiasm this year.
The FDA approved tirzepatide, to be sold under the brand name Zepbound, for use by adults with a body mass index (BMI) of at least 30, or a BMI of 27 or more if a patient also has another weight-related health issue, such as heart disease.
"Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” John Sharretts, a director in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Tirzepatide is already approved under the trade name Mounjaro for type 2 diabetes and had been increasingly used "off-label" for weight loss while the obesity approval was pending.
Update(11:45ET): Yemen's Houthis have claimed they've successfully shot down a US MQ-9 reaper drone over "territorial waters" off the Yemeni coast. According to a machine translation of a Houthiarmy statement:
Our air defenses were able to shoot down an American MQ9 aircraft while it was carrying out hostile, monitoring and spying activities in the airspace of Yemeni territorial waters and within the framework of American military support for the Israeli entity.
If confirmed as accurate, this could draw the United States deeper into what could develop into a broader regional conflict. The Pentagon has had aerial assets flying over Gaza, and the Mediterranean and Red Seas. Further US warships have been seeking to intercept ratcheting drone and missile attacks from the Houthis, with one such intercept having already occurred in the opening weeks of the Gaza war, now having reached one month.
There's as yet been no Pentagon or US official confirmation of the alleged MQ-9 drone shootdown.
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President Biden in a phone call this week urged Israeli Prime Minister Benjamin Netanyahu to implement a three-day pause in fighting. This was revealed by multiple sources to Axios Tuesday, and Biden's request appears to have been rejected, given the call took place Monday and Israel has since reaffirmed there will be no truce until the hostages held by Hamas are released.
"According to a proposal that is being discussed between the U.S., Israel and Qatar, Hamas would release 10-15 hostages and use the three-day pause to verify the identities of all the hostages and deliver a list of names of the people it is holding, the U.S. official said," according to the report.
AFP via Getty Images
But Netanyahu on Tuesday gave a speech declaring that his forces were "reaching deeper than Hamas ever imagined" a hailed the killing of thousands of Hamas terrorists and commanders. "There will not be a ceasefire without the return of our kidnapped," he emphasized in a message "to our enemies and our friends alike."
Israel's Defense Minister Yoav Gallant had at the same time declared that the IDF is fighting "in the heart" of Gaza City and is "tightening the noose" around Hamas.
Concerning the Monday phone call, Axios revealed further, "The two U.S. and Israeli officials said Netanyahu told Biden he doesn't trust Hamas' intentions and doesn't believe they are ready to agree to a deal regarding the hostages."
The Israeli leader "also said that Israel could lose the current international support it has for the operation if the fighting stops for three days, the officials said." Netanyahu further voiced to Biden that in 2014 Hamas took advantage of a humanitarian pause to kidnap an Israeli soldier and kidnap others.
The official White House call readout from the Biden-Netanyahu meeting only said the two leaders "discussed ongoing efforts to secure the release of hostages held by Hamas" - but without offering further details.
Of the estimated total 240 captives, Hamas has so far released fourhostages, reportedly in large part through Qatar's mediation, but lately US officials have said progress has stalled since then.
Israel says it was able to free a female soldier during the initial phase of ground operations, while reports have said that in some cases deceased hostages have been found, possibly due to airstrikes.
Hamas has meanwhile continued to publish short videos of what the group says are successful ambush attacks on tanks and armored convoy units, also showing close urban combat, but typically with IDF ground troops nowhere to be seen. The IDF appears to be advancing into Gaza City purely with armor, and presumably with ground infantry troops staying in the rear until a city area is initially prepared through tank, artillery, and airstrikes.
On Wednesday Secretary of State Antony Blinken said the US stands by Israel in rejecting calls for a full ceasefire. "Israel has repeatedly told us that there is no going back to October (7) before the barbaric attacks by Hamas -- we fully agree," he said. He then said of G7 counterparts, "We all agreed humanitarian pauses would advance key objectives."
US Secretary of State Antony Blinken is currently at a Group of Seven summit in Tokyo, where he told a press briefing on the sidelines that "it is clear that Israel cannot occupy Gaza" on a permanent basis.
The comments affirm that Washington has been intensely involved in talks concerning what happens after the war. "Gaza cannot be continued to be run by Hamas. That simply invites repetition of Oct. 7... It's also clear that Israel cannot occupy Gaza," Blinken said after meeting with G7 foreign ministers.
"Now, the reality is that there may be a need for some transition period at the end of the conflict ... We don't see a reoccupation and what I've heard from Israeli leaders, is that they have no intent to reoccupy Gaza."
Earlier this week Israeli Prime Minister Benjamin Netanyahu said that he foresees Israeli troops overseeing the security of Gaza "for an indefinite period" after Hamas is defeated. He appeared to reject headlines suggesting a multinational peacekeeping force would fill the role.
"I think Israel will for an indefinite period have security responsibility," Netanyahu told ABC News. "We’ve seen what happens when we don’t have that… security responsibility, what we have is the eruption of Hamas terror on a scale that we couldn’t imagine."
The words are being widely interpreted as a sign of growing disagreement between the US and Israel over the crisis. The divide is sharpening and becoming more and more public, also after on Monday Netanyahu rejected Biden's request for a three-day humanitarian 'pause' in a phone call. On top of this remains the growing international pressure over the immense civilian death toll in Gaza, having surpassed 10,000 people by the start of the week:
And the mounting death toll and humanitarian crisis have fueled growing outrage. Prime Minister Benjamin Netanyahu's suggestion that Israel would maintain "overall security responsibility" for Gaza when the conflict ends raised new questions over what his country plans, and drew a new warning from the White House.
There was also growing evidence of fallout in the United States, where tensions have been high on city streets and college campuses. House lawmakers censured Rep. Rashida Tlaib, the sole Palestinian American in Congress, over her remarks and actions in response to the Israel-Hamas war.
Meanwhile, IDF troops have been circulating photos like the following from Gaza:
PHOTO: Israel is back in #Gaza - and we ARE HERE TO STAY in our ancestral land and our ancient beaches!!! pic.twitter.com/8vvWnWjp9m
The Biden White House has lately been mulling a plan behind the scenes that would see international peacekeeping forces control the security situation in the Gaza Strip once the war is over, which is premised on the total demise of Hamas, proving no small task especially given the immense network of miles of tunnels the group can utilize.
The post-Hamas "day after" has also been subject of proposals out of some leading Congressmen. There was speculation at first that Israeli leadership might welcome this, but the Netanyahu remarks in the ABC interview reveal different thinking in Tel Aviv and Jerusalem.
This week civilians in Gaza have been seen fleeing from the northern half of the Strip to the south while holding large white flags, after in some prior instances civilians were killed by Israeli airstrikes while traversing north-south roadways.
Via AFP: A Palestinian boy carries a make-shift white flag as he arrives with his mother near the Al-Shifa hospital in Gaza City on November 6, 2023.
As for the G7 meeting, a statement produced from Tokyo said it also supports Ukraine's defense against Russia "for as long as it takes." The G7 statement also took aim at alleged Russian-North Korean weapons transfers, and also heavily criticized China on a range of issues.
Emergency authorities in Texas have issued a 3-county wide shelter-in-place order after a large chemical plant fire has erupted in Shepherd, TX - which is in San Jacinto County - north of Houston in east Texas.
"At this time, the effects of the chemical in the air are unknown," the neighboring Polk County Emergency Management said in a social media post. Area schools have been evacuated and people have been warned to turn off their HVAC systems.
Reports of a fiery explosion at the plant first emerged mid-morning, and initially the shelter-in-place order was issued for a whopping 5-mile radius, but as several emergency crews battled the blaze the shelter radius was later reduced to one mile.
Southwest winds continue to be of serious concern for Texas residents living closer to the Gulf coast, according to reports.
At least one worker has been reported injured in the plant fire burning on FM 1127 in Shepherd - a town with just over 2,000 residents. According to a local ABC news affiliate:
ABC13's investigative reporter Kevin Ozebek spoke to a a current employee who said there was one man who was injured in a "freak accident" that was caused by a forklift incident. The source said the injured employee was taken to Memorial Hermann with second-degree burns to his arms and first-degree burns to his face. The source told us the injured employee is in good spirits and expected to be OK.
A representative from Sound Resource Solutions reported to ABC that all 40 employees are accounted for and only one suffered a minor injury and is being treated for burns.
Huge, thick black clouds of smoke could be observed stretching for several miles.
Limited evacuations of the area continue to take place amid growing concerns over wind gusts possibly sending the chemical plume closer to the ground, and pending an investigation of what precise chemicals have been burning and how dangerous the air quality might be.
Korro will be focused on advancing a wholly owned portfolio of RNA editing programs
Post-transaction cash of approximately $170 million expected to fund operations into 2026
Funds multiple potentially value-creating milestones, including advancing its lead product candidate in Alpha-1 antitrypsin deficiency (AATD) through a clinical trial
Shares to trade on Nasdaq under the ticker “KRRO” commencing on November 6, 2023
Third quarter worldwide revenue increased slightly by 0.8% year-over-year to $38.5 million.
Updated 2023 revenue guidance to approximately $165 million, marking a 2% increase over 2022.
Loss from operations widened to $21.0 million from $10.5 million in the same quarter last year.
Net loss for the quarter expanded to $29.3 million compared to $18.6 million in the year-ago period
On November 7, 2023, Establishment Labs Holdings Inc (NASDAQ:ESTA), a leader in medical technology for women's health, announced its financial results for the third quarter ended September 30, 2023. Despite a modest increase in revenue, the company faced a challenging quarter with a significant increase in operating losses and net losses compared to the same period last year. The financial details were disclosed in conjunction with the company's earnings release and will be further discussed in the quarterly report on Form 10-Q to be filed on November 8, 2023.
Financial Performance Overview
Establishment Labs reported a slight year-over-year revenue increase to $38.5 million in the third quarter, attributing the growth to its diverse product portfolio. However, the company experienced a downturn in demand for breast procedures globally, which impacted its financial performance. The updated revenue guidance for 2023 is set at approximately $165 million, a 2% increase over the previous year, reflecting cautious optimism amidst market challenges.
Operational Challenges and Strategic Focus
CEO Juan Jose Chacon-Quiros acknowledged the industry's cyclical nature and the transient reduced demand. He emphasized the company's strategic focus on growth initiatives, particularly the U.S. and China launch of Motiva and the global rollout of Mia Femtech. Chacon-Quiros expressed confidence in the company's foundation and its $500 million revenue target for 2026.
Our results in the third quarter and updated guidance reflect lower demand for breast procedures globally," said Juan Jose Chacon-Quiros, Chief Executive Officer. "With our core platform and our pipeline of new products, we are taking market share globally and this should continue through the remainder of 2023 and into 2024."
Negotiations via Qatar reportedly have produced a Hamas offer of some hostage releasesifIsrael pauses its offensive in Gaza for three days; the same reports sayPresident Bidenhas privately pushed Israel’sBenjamin Netanyahufor such a cease-fire.
But why hasn’t Biden publicly, repeatedly and forcefully pushed Hamas for releases — especially of the 10 or more US citizens the terrorists seized amid their other Oct. 7 war crimes?
Presumably, he doesn’t expect Hamas to comply, and has no intention of sending in American troops to force the issue.
But he could use other means of pressure, such as threatening to revoke the Obama-era commitments that let Hamas’ top leaders feel safe operating openly in Qatar.
More, as our own Michael Goodwin suggests, he could declare his opposition to the slightest “pause” unless and until Hamas releases the innocent civilians it seized a month ago.
He could also hammer Hamas’ paymasters in Tehran by, say, restoring the sanctions that had crippled its oil revenues until he took office.
Hamas and Iran are responsible for the hostage-taking; you’d expect an American president to hold them responsible — rather than pushing our ally to do the enemy’s will in hopes the war criminals will suddenly play nice.
