Search This Blog

Tuesday, October 1, 2024

Dozens of Iran missile impacts reported across Israel after hundreds of deadly explosives launched at it

 An Iranian ballistic missile barrage overwhelmed Israel’s defenses — with dozens of strikes seen on Tel Aviv and other population centers Tuesday night.

Footage of the harrowing barrage shows numerous missiles hitting Israel and exploding in a fiery blaze within the span of 10 seconds, local KANN News reports.

Similar videos on social media showed missiles or shrapnel hitting Tel Aviv, Jerusalem and other population centers. Impact sites have been reported in the cities as well as in the south and in Sharon.

Tel Aviv, which houses the IDF’s headquarters and Nevatim Air Base, appeared to bear the brunt of the attack.

The Israeli military said Iran was targeting 10 million civilians in Israel with its attack.

00:00
03:57

All Israelis were ordered to take shelter in bunkers across the country.

People take cover behind vehicles under a bridge along the side of a highway in Tel Aviv on October 1, 2024.AFP via Getty Images
An Israeli woman comforts children as they take cover from the Iranian missile attack in Shoresh on Oct. 1, 2024.AP Photo/Ohad Zwigenberg

Sirens flared Tuesday afternoon as Iranian missiles targeted central and southern Israel in Tehran’s first direct attack on the Jewish state since April, according to the Israeli military.

The attacks are coming in waves, with reporters from the Guardian reporting a second assault flying overhead in Jerusalem less than 10 minutes after the first set of missile strikes.

Iran’s Islamic Revolutionary Guard Corps (IRGC) said Tuesday’s attack was in direct response to the recent assassinations of Hezbollah’s top officials, including its chief, Hassan Nasrallah.

“If the Zionist regime reacts to the operation, it will face heavy attacks,” the IRGC warned.

The Iranian Mission to the United Nations defended the attack, saying Tehran’s response over Israel’s airstrikes in the region has been carried out.

“Iran’s legal, rational, and legitimate response to the terrorist acts of the Zionist regime — which involved targeting Iranian nationals and interests and infringing upon the national sovereignty of the Islamic Republic of Iran — has been duly carried out,” the group said in a statement.

The attack concluded at 8:32 p.m. local time, with the IDF vowing revenge against the Islamic Republic.

“This fire will have consequences,” Israel Defense Forces spokesman Rear Adm. Daniel Hagari said. “We have plans, and we will act in the time and place that we choose.”

The IDF said all the explosions being heard across the country are either “interceptions or impacts.”

At least two people were injured as a result of the attack, with Israel’s Magen David Adom reporting that two individuals were hit by shrapnel in Tel Aviv.

There are roughly 10 million civilians living in the areas where the missiles have targeted, according to the IDF.

Israeli Prime Minister Benjamin Netanyahu and his security cabinet are taking shelter in a bunker complex where they convened minutes before the attack.

People take shelter in Israel amid the missile strikes.REUTERS

According to reports, Iran was planning to use only ballistic missiles, which are capable of reaching Israel in 12 minutes.

Videos quickly began circulating on social media of missiles or fragments soaring over Israel, with several streaks of light spotted crashing in Tel Aviv.

“All Israeli civilians are in bomb shelters as rockets from Iran are fired at Israel,” the IDF said in a statement at 7:30 p.m. local time.

President Biden and Vice President Kamala Harris have convened in the White House to discuss the Iranian attack and America’s defense of the Jewish state.

Projectiles being intercepted by Israel above Tel Aviv on October 1, 2024.AFP via Getty Images

“This morning, @VP and I convened our national security team to discuss Iranian plans to launch an imminent missile attack against Israel,” Biden wrote on X.

“We discussed how the United States is prepared to help Israel defend against these attacks, and protect American personnel in the region.”

The US has moved additional military assets, including fighter jets, to the region — and vowed to help defend the Jewish state against the attack.

“We are actively supporting defensive preparations to defend Israel against this attack,” the official said. “A direct military attack from Iran against Israel will carry severe consequences for Iran.”

In April, Tehran fired more than 330 drones and missiles against Israel — nearly all of which were intercepted, with help from the US and Jordan.

Israel’s Arrow and David Sling missile defense system are not designed to intercept such a huge volume of missiles.

Rockets fly in the sky amid cross-border hostilities between Hezbollah and Israel.REUTERS

The more famous Iron Dome system is designed to guard against shorter-range rockets fired from Gaza or Lebanon.

Just moments before Tuesday’s attack, eight people were fatally shot and seven others wounded in a suspected terrorist attack in Tel Aviv, Israeli police said.

The deadly ordeal unfolded when two gunmen jumped off a train in the central Israeli city of Jaffa and started firing just after 7 p.m. local time, according to authorities.

If Iran uses only ballistic missiles this time, it would give the US and its allies less time to intercept the attack, a US official told Axios.

Ballistic missiles also fly higher and faster and are much harder to shoot down.

“The attack from Iran may be on a wide scale,” the IDF warned — and urged Israelis to follow directions on taking shelter.

The US previously mobilized more troops in the area, as well as extending the deployment of the USS Abraham Lincoln aircraft carrier group, to help deflect any incoming attacks from Iran.

Missiles fly over Tel Aviv.Reuters
Missiles seen over Tel Aviv.Reuters

At least one additional aircraft squadron had already arrived in the region as of 10 a.m. Tuesday, with two others arriving later in the day, according to US Central Command. The planes include F-15E and F-16 fighter jets, which are capable of intercepting missiles, as well as A-10 attack aircraft.

IDF spokesman Hagari said Israel is aware of the warning. He said there were no aerial threats fired from Iran as of Tuesday morning.

Hagari said the IDF is ready to engage in defensive and offensive strategies in the face of such an attack, echoing America’s warning about consequences.

The IDF and Netanyahu have urged the Jewish nation’s residents to follow the “Home Front Command,” a safety protocol calling on civilians to stay within 90 seconds of protective shelters in case of an attack.

Locations of Israeli bomb shelters

The directive was issued for all of central Israel and Jerusalem on Tuesday, and it will stay in effect until Oct. 5, according to the IDF.

“What I ask of you is two things,” Netanyahu said in a statement to the public. “One, to strictly obey the directives of the Home Front Command. It saves lives.

“And second, to stand together,” he added. “We will stand firm together in the trying days ahead. Together we will stand, together we will fight, and together we will win.”

The US Embassy in Jerusalem urged all Americans in Israel to “shelter in place until further notice,” according to a security alert issued Tuesday.

The alert said the embassy may also “further restrict or prohibit U.S. government employees and their family members from traveling to certain areas of Israel,” including Jerusalem and the West Bank, as events unfold.

Missiles seen above Tel Aviv’s skyline.Reuters

“The US Embassy in Jerusalem reminds US citizens of the continued need for caution and increased personal security awareness as security incidents, including mortar and rocket fire and unmanned aircraft system UAS intrusions, often take place without warning,” the embassy said.

“The security environment remains complex and can change quickly depending on the political situation and recent events.”

Nearly two dozen border communities in Lebanon were evacuated by Tuesday — before the IDF began its operations in that country.

While the terror group denied that Israeli troops have crossed the border, the IDF said it is active in the area while revealing it had already carried out raids in Lebanon going back nearly a year.

Israel has backed up its claims with videos of such operations, but the IDF’s past and current missions in Lebanon have yet to be independently verified as people flee the conflict zone.

Hagari said the operations are “localized ground raids” aimed at dismantling Hezbollah’s missile launching facilities and weapons cache, with the troops staying in southern Lebanon.

“We’re not going to Beirut,” he said. “We’re only going to areas next to our border and will do what is necessary to dismantle and demolish Hezbollah infrastructure.”

The goal of the raids is to ensure Hezbollah no longer has the means to continue its daily missile strikes against northern Israel that have displaced tens of thousands since Oct. 8.

https://nypost.com/2024/10/01/world-news/iran-launches-ballistic-missile-attack-on-israel-civilians-ordered-into-bomb-shelters/

Aeon Positive Outcome from FDA Biosimilar Advisory Meeting

 – Company is aligned with the FDA on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product –

– Comparative analytical studies anticipated to commence in Q4 2024 –

– Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to review the results from the analytical studies and confirm remainder of proposed study package –

https://www.globenewswire.com/news-release/2024/09/30/2955158/0/en/AEON-Biopharma-Announces-Positive-Outcome-from-FDA-Biosimilar-Advisory-Meeting.html

Ascendis Application to FDA for the Treatment of Adult Growth Hormone Deficiency

 Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH (marketed as SKYTROFA® (lonapegsomatropin-tcgd) in the U.S. for pediatric growth hormone deficiency) for the treatment of adults with growth hormone deficiency (GHD).

https://www.globenewswire.com/news-release/2024/09/30/2955194/0/en/Ascendis-Pharma-Announces-Submission-of-Supplemental-Biologics-License-Application-to-FDA-for-TransCon-hGH-for-the-Treatment-of-Adults-with-Growth-Hormone-Deficiency.html

Merus Starts Phase 3 Trial Evaluating Petosemtamab with Pembrolizumab in 1L r/m HNSCC

  Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab as first line (1L) therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), referred to as the LiGeR-HN1 trial.

Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab.

“Based on our strong phase 2 clinical data reported previously for petosemtamab in HNSCC both as monotherapy and in combination with pembrolizumab, I continue to be confident that petosemtamab has the opportunity to become a new standard of care across r/m HNSCC and potentially beyond,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Our recently announced alignment with the FDA on phase 3 dose, and excellent execution to date has allowed us to promptly initiate our registration trials in 1L and 2/3L HNSCC.” \

More details of the trial can be found at clinicaltrials.gov. 

https://www.globenewswire.com/news-release/2024/09/30/2955131/37568/en/Merus-Announces-First-Patient-Dosed-in-LiGeR-HN1-a-Phase-3-Trial-Evaluating-Petosemtamab-in-Combination-with-Pembrolizumab-in-1L-r-m-HNSCC.html

Kezar Life Sciences suspends subject enrolment in trial of lupus nephritis drug

US-based biopharmaceutical company Kezar Life Sciences has suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis.

The decision to suspend the trial was made following recommendations from an independent data monitoring committee (IDMC) after it had reviewed safety data from the trial.

According to the safety findings, four Grade Five (fatal) serious adverse events (SAEs) were reported during the trial in subjects enrolled in Argentina and the Philippines.

The IDMC's review indicated that three of the fatalities shared a pattern of symptoms and occurred close to the time of dosing.

https://finance.yahoo.com/m/5477554f-a83d-357a-852b-09dc038c51dd/kezar-life-sciences-suspends.html