Egyptian Intelligence Warned 'Something Big' Was Coming, But This Was Ignored: Israeli Media

Egypt is trying to have a "told ya so" moment, as on Monday the government said that Egyptian intelligence tried to repeatedly communicate to Israel that 'something big' was coming, prior to the massive jihadist militant attack out of Gaza which killed hundreds of Israelis.

A top Egyptian official was cited in Israeli media as saying, "Egypt cautioned about the situation's escalation, but unfortunately, these warnings were disregarded by Israel."

The official said the warning communicated to the Israeli government was that "something big" was in the planning stages, but didn't elaborate further. 

Egypt frequently plays the role of mediator between Hamas and Israeli authorities, so this fresh statement is being taken seriously by Israeli pundits.

According to more via The Times of Israel:

"We have warned them an explosion of the situation is coming, and very soon, and it would be big. But they underestimated such warnings," the official, who spoke on condition of anonymity because he wasn’t authorized to discuss the content of sensitive intelligence discussions with the media, told The Associated Press.

As of Monday, the total death toll among both sides has soared past 1,100. Currently, Israel's military is engaged in its biggest bombing campaign of the Gaza Strip in history, having also declared a total 'seizure' and blockade in progress.

Qatar has said it is seeking to mediate, also on the question of Israeli hostages in Hamas captivity. Likely Egypt is also seeking to engage both sides as the situation continues to deteriorate.

Meanwhile, there's ongoing speculation as a to how such a major Hamas operation, clearly long in planning, was "missed". 

https://www.zerohedge.com/geopolitical/egyptian-intelligence-warned-something-big-was-coming-was-ignored-israeli-media

Ideaya Development Candidate Nomination of Werner Helicase Inhibitor in Collaboration with GSK

 

• Selected a Werner Helicase Inhibitor Development Candidate in collaboration with GSK
• Observed monotherapy complete responses preclinically in multiple in vivo xenograft MSI-High models and pharmacological sensitivity in therapy-refractory CRC organoid models
• Earned $3 million milestone from GSK in connection with IND-enabling studies with potential for up to an additional $17 million aggregate milestones through early Phase 1
• Targeting an IND in 2024 to enable first-in-human clinical evaluation of Werner Helicase Inhibitor Development Candidate for patients having tumors with MSI-High
• Subject to IND submission and clearance, GSK will lead clinical development and the global research and development costs will be shared between GSK (80%) and IDEAYA (20%)
• IDEAYA will be eligible to receive additional development milestones of up to $465.0 million and commercial milestones of up to $475.0 million and 50% of U.S. net profits
• ­IDEAYA is hosting an Investor R&D Day in Q4 2023, with participation of GSK

https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-development-candidate-nomination-of-a-werner-helicase-inhibitor-in-collaboration-with-gsk-and-investor-rd-day-301950165.html

GSK Partners With Zhifei to Boost Shingles Vaccine Availability in China

 

https://finance.yahoo.com/m/e22abfb1-cdaa-31d9-bda8-7e01db0255bd/gsk-partners-with-zhifei-to.html

Alnylam gives up on expanded use of heart-disease drug in US after FDA declines approval

 The regulator, in its so-called complete response letter, said the drug patisiran did not meaningfully improve the condition of patients with heart muscle issues or cardiomyopathy caused by ATTR amyloidosis, characterized by abnormal deposits of transthyretin proteins in organs and tissues.

Patisiran, also branded as Onpattro, is already approved in the U.S. to treat nerve damage in adult patients with hereditary ATTR amyloidosis. The FDA's decision would not impact Onpattro's commercial availability, Alnylam said.

The rejection was a rare instance of the regulator going against its advisory panel's backing for a drug. The FDA's outside panel of experts had last month backed patisiran's expanded use, but also raised concerns about the meaningfulness of its benefits.

"We are surprised" by the FDA's decision, RBC capital analyst Luca Issi said in a note.

The FDA, however, did not identify any issues with the drug's safety, quality, study conduct, or manufacturing, the company said.

The FDA, in 2019, approved Pfizer's oral drug tafamidis, sold under the brand names Vyndaqel and Vyndamax, to treat transthyretin amyloid cardiomyopathy in the United States.

Alnylam said it will focus on another drug candidate, vutrisiran, an under-the-skin injection in late-stage trials to treat ATTR amyloidosis-related cardiomyopathy.

Branded as Amvuttra, vutrisiran is also approved in the U.S. to treat nerve damage in adult patients with hereditary ATTR amyloidosis.

William Blair analyst Myles Minter estimates peak U.S. sales of $2.2 billion for vutrisiran as an ATTR cardiomyopathy treatment.

https://finance.yahoo.com/news/1-us-fda-declines-approval-114925124.html

Protalix on security in Israel

 Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today issued the following statement by Dror Bashan, Protalix's President and Chief Executive Officer, regarding the current security situation in Israel.

"The Protalix family is horrified by the unconscionable events in Israel over the past weekend which are currently ongoing and the scope of which is yet to be determined. On a personal level, we are heartbroken and pray for the victims as well as their families, friends and other loved ones. At Protalix, we are dedicated to helping our own families, friends and colleagues cope with this devastating situation and to provide them with any support they need.

At the same time, we wish to reaffirm our employees, partners and stockholders that Protalix's operations have not been adversely affected by this situation despite our personal grieving. Hostilities have not taken place where Protalix's facilities are located and we do not anticipate any disruption to the supply of Elfabrio® or Elelyso®. We thank all of our partners and stockholders that have reached out to express their support and best wishes, and are grateful for their continued confidence in Protalix."

https://finance.yahoo.com/news/protalix-biotherapeutics-issues-statement-regarding-105000458.html

AnaptysBio's skin disease drug meets main goal in late-stage study

The drug developer plans to submit marketing application for the drug, imsidolimab, to the U.S. Food and Drug Administration by the third quarter of 2024.

The drug also demonstrated a favourable safety in patients with no serious adverse events reported during the study, the company said.

Generalized Pustular Psoriasis (GPP) is a rare skin disease, in which pus-filled blisters often cover large areas of the body and typically cause fever, shivers, intense itching and joint pain.

The company said it intends to license the drug and use the potential proceeds to strengthen the development of its autoimmune and inflammatory diseases portfolio.

AnaptysBio's shares were placed on a trading halt.

https://finance.yahoo.com/news/1-anaptysbios-skin-disease-drug-122708129.html

EU regulators to order Illumina to sell Grail

 European Union regulators are set to order Illumina to sell cancer detection test maker Grail, which it had acquired for $7.1 billion in 2021, the Financial Times reported on Monday citing three people with knowledge of the matter. 

https://finance.yahoo.com/news/eu-regulators-order-illumina-sell-121559425.html