Israel To Conduct COVID Genetic Scanning For All Inbound Air Passengers

 The world's most "ultra-vaxxed nation" Israel is continuing to struggle to keep its coronavirus infections down, despite enacting some of the most stringent rules and requirements on its population, including rolling out one of the earliest versions of a vaccine passport to visit public venues, which has to be "updated" each six months or so based on a booster shot timeline. 

Now Israel will go so far as to conduct "genetic scanning" for travelers arriving in the country. It's considered a huge and experimental high tech step in screening inbound passengers for coronavirus infections at Ben Gurion International Airport in Tel Aviv.

Prime Minister Naftali Bennett made the announcement at a meeting of his cabinet on Sunday, confirming plans to eventually deploy it at Ben Gurion. "We are working on a scanning system for everyone who comes into Israel," Bennett said. The statements were reportedly not intended to be made public, but were leaked to local Israeli media.

"Israel will thus become the radar for the virus," he added. However, no further details on how the 'genetic scanning' will work were given, nor whether there might be an opt-out mechanism. Thus a Covid passport, which Israel calls its "green pass" - may be linked to an eventual regimen of forced genetic testing at international travel points.

The technology, which will no doubt be hugely controversial given privacy concerns, is being discussed as part of Israeli efforts to keep further Covid variants from entering the country, as The Times of Israel describes:

Bennett expressed support for Social Equality Minister Meirav Cohen, who had warned that "the next variant will come to Israel through Ben Gurion," saying the proposed genetic testing would help prevent that from happening.

Conventionally since the start of the pandemic airports have often monitored passengers' temperatures with a quick and simple thermometer scan of their foreheads, but Israeli health officials are now seeking a method which might given greater certitude over whether someone has the virus or not, and especially whether they are carrying a variant.

Again though it remains unclear precisely how the genetic scanning will work, it brings up the question over just what genetic data/DNA will be preserved on each individual. The initiative suggests that for any foreign traveler entering Israel, they will have to agree to hand over their personal genetic data to potentially be stored by the Israeli government for all time. 

https://www.zerohedge.com/covid-19/israel-conduct-covid-genetic-scanning-all-inbound-air-trave

Illumina: Britain begins world's largest trial of blood test for 50 types of cancer

 Britain's state-run National Health Service will on Monday begin the world's biggest trial of Grail Inc's flagship Galleri blood test that can be used to detect more than 50 types of cancer before symptoms appear.

The Galleri test looks at the DNA in a patient's blood to determine if any come from cancer cells. Earlier diagnosis of cancers leads to dramatically increased survival rates.

The NHS said it wanted to recruit 140,000 volunteers in England to see how well the test worked as part of a randomised control trial. Half of the participants will have their blood sample screened with the Galleri test right away.

"We need to study the Galleri test carefully to find out whether it can significantly reduce the number of cancers diagnosed at a late stage," said Peter Sasieni, professor of cancer prevention at King's College London.

"The test could be a game changer for early cancer detection and we are excited to be leading this important research."

Lung cancer is by far the most common cause of cancer death in the United Kingdom, accounting for around a fifth of all cancer deaths. Lung, bowel, prostate and breast cancers account for 45% of the United Kingdom's cancer deaths, the NHS said.

U.S. life sciences company Illumina Inc said last month it had completed its $7.1 billion acquisition of Grail. Illumina said it will operate Grail separately from its existing business. 

https://www.marketscreener.com/quote/stock/ILLUMINA-INC-9659/news/Illumina-Britain-begins-world-s-largest-trial-of-blood-test-for-50-types-of-cancer-36407240/

Vaccine maker Valneva's shares slump after UK ends COVID-19 deal

 Valneva shares plunged around 40% in early Monday trading after the British government ended a COVID-19 vaccine supply deal with the French company, alleging a breach of obligations that Valneva denies.

The company's COVID-19 vaccine candidate VLA 2001 relies on inactivated virus, similar to flu vaccines, and is seen by some as having the potential to win over people who are wary of some current vaccines using new mRNA technology.

The British government "has alleged that the company is in breach of its obligations under the supply agreement, but the company strenuously denies this," Valneva said in a statement, without giving further details.

"Valneva has worked tirelessly, and to its best efforts, on the collaboration ... including investing significant resources and effort," it added.

The British government had no immediate comment.

Despite Monday's steep fall, Valneva's shares are still up by around 50% since the start of 2021.

The company said it was still continuing its development plan for VLA 2001.

"Valneva believes that initial approval for VLA2001 could be granted in late 2021," the company added.

https://www.marketscreener.com/quote/stock/VALNEVA-SE-54466/news/Valneva-Vaccine-maker-Valneva-s-shares-slump-after-UK-ends-COVID-19-deal-36407810/

BeiGene : FDA Accepts BLA For Tislelizumab In Esophageal Squamous Cell Carcinoma

 BeiGene Ltd. (BGNE) said Monday that the U.S. Food and Drug Administration accepted for review a Biologics License Application or BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma or ESCC after prior systemic therapy.

The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022.

The accepted BLA, filed in collaboration with Novartis, is supported by the positive global Phase 3 RATIONALE 302 trial in patients with previously treated, advanced or metastatic ESCC and safety data from tislelizumab's broad clinical program, BeiGene said in a statement.

In addition to the United States, tislelizumab is also under regulatory review in China as a treatment for patients with locally advanced or metastatic ESCC who have disease progression following or are intolerant to first-line standard chemotherapy.

https://www.nasdaq.com/articles/beigene-%3A-fda-accepts-bla-for-tislelizumab-in-esophageal-squamous-cell-carcinoma-2021-09

Relief Therapeutics updates on treatment for respiratory deficiency due to severe COVID

 RELIEF THERAPEUTICS Holding SA (SIX: RLF)(OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that it has received scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) relating to its lead investigational drug, RLF-100 ^TM (aviptadil), for the treatment of respiratory deficiency due to severe COVID-19. The guidance, which was provided in the context of a recent meeting that Relief held with the MHRA, included advice on the appropriate pathway for submission of an application for conditional marketing approval (CMA) ^[1] for the intravenous formulation of RLF-100, subject to provision of all data from the U.S. Phase 2b/3 study conducted by Relief's collaboration partner, NeuroRx, Inc. ("NeuroRx") According to the MHRA, a CMA through rolling review or expedited review process would be an appropriate pathway to ensure speedy access to beneficial treatments for patients infected with COVID-19. A rolling review allows the MHRA to start review of various sections of a submission as they are completed by Relief and provided to the MHRA.

Relief also reported today that it has held discussions with the European Medicines Agency (EMA) pertaining to the regulatory path forward for RLF-100 in the European Union. Relief has informed EMA that it will proceed with further dialogue with the MHRA once it has compiled critical information related to the study conduct, clinical data and the drug product.

Relief also reported that, to date, NeuroRx has not provided it with all of the data from its U.S. Phase 2b/3 study evaluating intravenously administered aviptadil for the treatment of respiratory failure in critically ill patients with COVID-19. There can be no assurance that NeuroRx will provide the required information.

https://www.biospace.com/article/releases/relief-therapeutics-provides-update-on-regulatory-interactions-in-the-united-kingdom-and-european-union-relating-to-lead-drug-candidate-rlf-100-aviptadil-/

HUTCHMED Gets Breakthrough Tag in China for Follicular Lymphoma Med

 HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma (“FL”), a subtype of non-Hodgkin’s lymphoma (“NHL”).

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (NDA). This indicates that the development and review of amdizalisib for relapsed or refractory FL may be expedited, to address patients' unmet needs more quickly.

Updated preliminary results from the ongoing Phase Ib expansion study in China will be presented as a Proffered Paper at the 2021 ESMO (European Society for Medical Oncology) Congress on September 20, 2021. To date, amdizalisib has been shown to be well tolerated, exhibiting dose-proportional pharmacokinetics (“PK”), a manageable toxicity profile, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients. Additional details may be found at clinicaltrials.gov, using identifier NCT03128164.

https://finance.yahoo.com/news/hutchmed-receives-breakthrough-therapy-designation-060000420.html

More people have now died from 9/11 illnesses than during Sept. 11 attacks

 More people are believed to have died from 9/11-related illnesses than those killed Sept. 11 in the terror attacks, the Justice Department and its Victims Compensation Fund acknowledged for the first time last week.

There were 2,996 victims killed on 9/11, while federal statistics show that 3,311 people enrolled in the CDC’s World Trade Center Health Program have died, although the agency doesn’t cite an exact cause of death.

The Victims Compensation Fund said it has received nearly 3,900 claims for deaths linked to 9/11-related illnesses.

“It is … sobering to see that more people are now believed to have died of 9/11-related illnesses than were lost on September 11, 2001,” the VCF wrote in its 20th anniversary “special report” released Sept. 7.

The VCF has issued $8.95 billion in compensation to 9/11 survivors and victims’ families, according to the report, which notes a “fairly significant increase” in claims filed by survivors in recent years, 48 percent of whom have cancer.

The Department of Justice and Victims Compensation Fund confirmed that more people are believed to have died from 9/11 related illnesses than directly from the attacks.

Photo by Mario Tama/Getty Images

About 10,000 emergency personnel and civilians rely on the VCF to cover the cost of their serious health issues caused by exposure to toxins and carcinogens from the terror attacks, according to advocates for Ground Zero first-responders at an event last week.

The Victims Compensation Act was permanently extended in 2019 after cancer-stricken retired NYPD Detective Luis Alvarez gave emotional testimony before Congress pushing for the move. The extension will ensure that all eligible claims will be paid until the deadline of Oct. 1, 2090.

The FDNY was by far the first-responder organization that was hardest hit by 9/11, with 343 members killed at the World Trade Center and 253 later dying of illnesses, according to union leaders.

FDNY firefighters near Ground Zero after the terror attacks on September 13, 2001.

AP Photo/Beth A. Keiser, File

John Feal, a 9/11 health advocate who was a demolition supervisor at Ground Zero, said the VCF report was the first time the federal government has acknowledged more Americans have died from 9/11 medical illnesses than during the terror attacks.

But he said it comes as no surprise, adding that the number of deaths will grow exponentially in the coming years given the latency period for certain cancers.

“These 20 years have been rough on the 9/11 survivor community. But the next 10 to 20 years will be devastating. It’s going to get worse,” Feal said.

A firefighter working at Ground Zero on September 14, 2001.

U.S. Navy Photo by Preston Keres/Getty Images

He estimated that 4,000 to 5,000 responders and other survivors exposed to contaminants from the World Trade Center site have already died.

Attorney Michael Barasch, whose law firm helps 9/11 survivors process claims for medical benefits with the September 11th Victims Compensation Fund, said many of his clients have died and he expects the number of victims to grow.

“We are going to see an explosion of new cases,” Barasch told The Post.

https://nypost.com/2021/09/12/more-people-have-now-died-from-9-11-illnesses-than-during-the-attacks/