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Wednesday, November 1, 2023

Hundreds Of Foreigners, Including Americans, Allowed To Exit Gaza Into Egypt For 1st Time

 The Israel Defense Forces has said it is in close quarters combat with Hamas as troops push further into Gaza, resulting in an announced Tuesday death toll of eleven. By early Wednesday that figure rose to 13 Israeli soldiers killed, after Israel's defense minister warned of the "heavy toll" which would be paid by troops in the operation to eradicate Hamas.

As the death toll among Gazans approaches 9,000, the EU’s top diplomat Josep Borrell has lashed out at Israel's airstrikes and massive civilian casualties. Borrel says he is "appalled by the high number of casualties following the bombing by Israel of the Jabalia refugee camp." Jabalia camp has reportedly been struck again, a day after the initial massive attack which had killed at least 52 Palestinians, according to the Gaza Health Ministry.

But Israel's military said that its Jabalia strike had taken out a top Hamas commander and other Hamas officers, and said Israeli decision-makers took into account the harm to civilians in the densely populated urban area.

On Wednesday Prime Minister Benjamin Netanyahu expressed condolences for the IDF's fallen soldiers along side other leaders. He said "We are in a tough war. This will be a long war. We have important achievements, but also painful losses."

According to more from his message: "We know that every one of our soldiers is an entire world. All of Israel embraces you, the families, from the bottom of our hearts. All of us are with you during this time of mourning. Our soldiers fell in a war where there was no justice, a war for our home," he said. "I promise you, the citizens of Israel: we will complete the task - we will continue until victory."

IDF troops have begun the slow process of going door to door as they search for the missing Israeli and foreign hostages, which is up to 240, according to new military statements. Hamas has issued new statements claiming Israeli airstrikes killed a group of hostages. "Seven detainees were killed in the Jabalia massacre yesterday, including three holders of foreign passports," said a Hamas statement issued from its military wing.

But the "painful losses" are mounting in much greater numbers for the Palestinian side, and civilians are bearing the brunt of suffering. International outrage and pressure has mounted on Tel Aviv, which has voiced that has warned Gaza civilians they must move to the southern half of the Strip if they want to escape the bombs. According to a fresh Gaza health ministry update as republished in Al Jazeera:

  • The number of people killed in Israeli attacks on Gaza has gone up to 8,796, including 3,648 children and 2,290 women.
  • At least 22,219 people have been wounded.
  • There are 2,030 reports of people missing including 1,020 children buried under the rubble.
  • 130 paramedics and medical crew have been killed, 28 ambulances have been destroyed, and there have been more than 270 attacks on the healthcare system in Gaza.
  • 16 hospitals out of 35 are out of operation, and 51 out of 72 primary healthcare clinics have shut down.
  • In the occupied West Bank, 128 Palestinians have been killed and at least 1,980 have been wounded.

There has meanwhile been a rare positive development on the humanitarian front. For the first time since the start of the war, foreigners and wounded Palestinians have been allowed to exit Gaza through the Rafah crossing into Egypt. 

Some 500 foreign passport holders had reportedly been stuck at Rafah crossing for weeks since the start of the conflict after Oct.7. The area near the crossing had also been bombed by Israeli jets on several occasions. Ambulances have been observed Wednesday ferrying the wounded into Egypt. 

Hundreds are foreign passport holders are also belatedly being let through, among them Americans. "At least five NGO workers who have been confirmed as Americans are listed as approved to cross on Wednesday but it remains to be seen how many of at least 400 American citizens the U.S. State Department says are stuck in Gaza will be able to cross in coming days," CBS News reports. Some have lashed out at Washington over the lack of serious evacuation efforts in place for those dual nationals stuck in Gaza: 

"They started letting foreigners out today but it's not Americans because I guess we're not as important as we thought," Utah resident Susan Beseiso told CBS News on Wednesday.  

"The American Embassy and the State Department haven't called us since the last time we went to the border and got bombed four times. They haven't been communicating with us or doing anything to get us out," Beseiso said.

"It's like they're holding us hostages — not Hamas holding us hostages — it's the IDF soldiers, Egypt and America. They're using us as a human shield in a way."

The fresh evacuees are undergoing security checks on the Egyptian side. Among those exiting include Palestinians holding Austrian, Bulgarian, Indonesian, Japanese Jordanian, Italian, Greek, Australian and Czech citizenships, and many others. Various nationals working for several NGOs are also on the departure list.

According to The Times of Israel, "A source briefed on the development told Reuters that the evacuations were agreed on in a deal mediated by Qatar between Egypt, Israel and Hamas in coordination with the US."

https://www.zerohedge.com/geopolitical/hundreds-foreigners-including-americans-allowed-exit-gaza-egypt-1st-time

Iridex: 10K on local coverage determination

 

Item 8.01

Other Events.

On October 26, 2023, WPS Government Health Administrators, (“WPS”), a Medicare Administrative Contractor (“MAC”) published “Local Coverage Determination L39620 Micro-Invasive Glaucoma Surgery (MIGS)” (the “LCD”), with a future effective date of December 24, 2023. WPS administers Part B Medicare benefits in Kansas, Nebraska, Missouri, Iowa, Indiana, and Michigan.

Four other MACs, including Palmetto GBA, Celerian Group Company, National Government Services and Noridian Healthcare Solutions participated in a Contractor Advisory Committee Meeting on Micro-Invasive Glaucoma Surgery that was held on January 5, 2023, which meeting is believed to have served as a precursor for the WPS LCD. The Company cannot predict whether or when these additional MACs may issue their own local coverage determinations or the scope, outcome, or impact on Iridex’s business of such decisions.

The family of Iridex Laser Systems includes various laser instruments, including the Cyclo G6 Laser System, which have been authorized by the U.S. Food and Drug Administration (“FDA”) to deliver laser energy to soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/otolaryngology, and ophthalmology. With respect to Cyclo G6 Laser System and Probe Delivery Devices for use in ophthalmology, such devices have been cleared by FDA for the intended use of transscleral cyclophotocoagulation of the ciliary processes and for the treatment of glaucoma, including primary open-angle, closed-angle, and refractory.

While Iridex (the “Company”) cannot predict how the WPS LCD will be ultimately interpreted and implemented by Medicare and its contractors, on October 30, 2023, Company consulted with expert external reimbursement advisors in an effort to evaluate the potential impact of the LCD on the Company’s business. Although the LCD does not deny coverage, it imposes additional requirements for reimbursement. Among the issues examined are (i) the intent of the LCD; (ii) the use and application of definitions within the LCD (e.g., how a determination expressly defined as relating to incisional surgical techniques pulled within its scope non-incisional transscleral cyclophotocoagulation); and (iii) the LCD’s failure to recognize any distinctions among (a) endo cyclophotocoagulation and (b) transscleral cyclophotocoagulation, or (x) continuous wave cyclophotocoagulation and (y) micropulse cyclophotocoagulation.

As a result of its consultation with expert external advisors, Iridex currently believes that the LCD will likely be interpreted to materially limit the patient types for which WPS will reimburse cyclophotocoagulation procedures after December 24, 2023 – that is, based the following criteria set forth in the LCD:

“ 4. Cyclophotocoagulation will be considered medically reasonable and necessary for patients with refractory glaucoma when:

 

 1.

Have failed trabeculectomy or tube shunt procedures AND

 

 2.

Minimal useful vision and elevated intraocular pressure AND

 

 3.

Have no visual potential and need pain relief”

Refractory Glaucoma is defined within the LCD as “glaucoma that is difficult to treat and poorly controlled on maximally tolerated medical therapy or failed surgical therapy regardless of stage of disease.”

Prior to the development and release of Iridex’s MicroPulse transscleral laser therapy, the Company marketed and sold its G-Probe Delivery Device, used for continuous-wave transscleral cyclophotocoagulation procedures primarily on refractory glaucoma patients suffering from late-stage symptoms of that disease, including lost vision and pain. Updated versions of the G-Probe are still sold in domestic and international markets and comprise up to 50% of current glaucoma probe sales. In the United States, the updated version of the G-Probe is integrated within the Cyclo G6 Glaucoma Laser System.

Iridex has already been contacted by a number of physicians who communicated concern over the potential limitation in the range of their patients covered for transscleral cyclophotocoagulation laser therapy (“TLT”) treatment, particularly with respect to populations that would have difficulty tolerating more invasive and tissue-damaging surgical procedures. Iridex intends to appeal the scope of the WPS LCD and attempt to engage with the MACs to distinguish between non-incisional transscleral cyclophotocoagulation procedures and the alternative incisional surgical MIGS procedures. Among other unintended consequences, Iridex believes that by limiting application of TLT, the LCD has the potential to direct more patients into higher-risk surgical procedures that both increase the potential of complications for patients and increase the total cost of care. Thus, Iridex believes the LCD is likely to increase overall treatment costs while potentially decreasing overall patient welfare.

At this time, Iridex cannot estimate what impact the WPS LCD or any future local coverage determinations by other MACs will have on its glaucoma business. We and other stakeholders plan to challenge the LCD. According to the American Glaucoma Society approximately 60% of U.S glaucoma patients are covered by Medicare. While the states included in WPS’s MAC jurisdiction comprise approximately 8% of Iridex’s U.S. glaucoma probe sales, if the other MACs adopt similar determinations, this could impact a majority of Iridex’s glaucoma revenue in the U.S. In such a scenario, Iridex would expect physicians to continue to use Iridex’s probes where there is coverage for the devices and related procedures. Additionally, patients that continue to be covered by medicare advantage or private health insurance and those willing to self-pay may continue to utilize the full range of TLT treatment options where available, particularly when such treatment modalities are preferred by physicians and their patients as a superior option to invasive surgery.

https://last10k.com/sec-filings/IRIX/0001193125-23-267486.htm?utm_source=stocktwits&utm_medium=forum&utm_campaign=8K&utm_term=IRIX

Monopar: Tumor Reduction Benefit of Camsirubicin from Ongoing Phase 1b

  Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, will present data from its ongoing Phase 1b open-label, dose-escalating clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS) later today at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting, which is bringing together the world’s leading sarcoma specialists. Monopar’s poster presentation can be found at the following link: https://www.monopartx.com/pipeline/Camsirubicin/mnpr-201-001-clinical-trial.

https://www.globenewswire.com/news-release/2023/11/01/2770950/0/en/Monopar-Presents-Data-Showing-Tumor-Reduction-Benefit-of-Camsirubicin-from-Ongoing-Phase-1b-at-the-2023-Connective-Tissue-Oncology-Society-CTOS-Annual-Meeting.html

EyePoint upcoming milestones

 Positive masked safety data update for EYP-1901 in ongoing PAVIA and DAVIO 2 Phase 2 clinical trials as of October 1, 2023 with no drug related ocular or systemic SAEs reported –

– Topline data for Phase 2 DAVIO 2 trial anticipated in December 2023 and Phase 2 PAVIA trial in 2Q 2024 –

– Management to host a conference call and webcast today at 8:30 a.m. ET –

Financial Outlook

We expect the cash, cash equivalents and investments on September 30, 2023 will enable us to fund our current and planned operations into 2025.

Conference Call Information

EyePoint will host a conference call today, at 8:30 a.m. ET to discuss the results for the third quarter ended September 30, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI3b701846a11841ad855aab9d0b8aff10. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

https://finance.yahoo.com/news/eyepoint-pharmaceuticals-reports-third-quarter-110000684.html

Aldeyra in Agreement with AbbVie for License to Develop and Commercialize Reproxalap

 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that it has entered into an exclusive option agreement with AbbVie Inc. (AbbVie).

Under the terms of the option agreement, AbbVie has the option to acquire a co-exclusive license to develop, manufacture, and commercialize reproxalap in the U.S. and an exclusive license to develop, manufacture, and commercialize reproxalap outside the U.S. Aldeyra will receive a non-refundable option fee of $1 million and an upfront payment of $100 million less option fees if AbbVie chooses to exercise the option. Under the terms of the license agreement, Aldeyra would be eligible to receive up to $300 million in regulatory and commercial milestone payments, inclusive of a $100 million milestone payment upon U.S. Food and Drug Administration approval of reproxalap in dry eye disease; in the United States, Aldeyra and AbbVie would share profits and losses from the commercialization of reproxalap according to a split of 60% for AbbVie and 40% for Aldeyra; and for markets outside the U.S., Aldeyra would be eligible to receive tiered royalties on net sales of reproxalap.

Exercise of the option will also grant AbbVie the right of first negotiation for compounds that are owned or otherwise controlled by Aldeyra in the field of ophthalmology relating to treating conditions of the ocular surface. The right of first negotiation is in addition to a right to review data for any other compounds that are owned or otherwise controlled by Aldeyra in the fields of ophthalmology and immunology before such data is shared with any other third party. Additional details regarding the terms of the option agreement may be found in a Current Report on Form 8-K filed by Aldeyra with the Securities and Exchange Commission.

https://www.businesswire.com/news/home/20231101862243/en/

TG: Strong commercialization of Briumvi in Q3

 Third quarter 2023 total net revenue of $165.8 million, including quarterly BRIUMVI® net sales of $25.1 million in the United States, and license revenue of $140.0 million from the upfront payment received from Neuraxpharm

Approximately 2,200 BRIUMVI prescriptions since launch from 500+ healthcare providers at approximately 350 centers across the U.S.

Payor coverage in place for approximately 95% of covered lives for BRIUMVI

Conference call to be held today, November 1, 2023, at 8:30 AM ET   

The Company will host a conference call today, November 1, 2023, at 8:30 AM ET, to discuss the Company’s financial results from the third quarter, ended September 30, 2023.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. An audio recording of the conference call will also be available for a period of 30 days after the call.

Cellectis Announces Strategic Collaboration and Investment Agreements with AstraZeneca

 

  • Collaboration leverages Cellectis’ gene editing technologies and manufacturing capabilities to develop up to 10 novel cell & gene therapy candidate products

  • Cellectis to receive up to $245M in cash (up to $220M equity investment and $25M upfront payment), with potential for additional milestones, plus tiered royalties