France's Sanofi Offers 1.5 Billion Euro Bond Linked to Access to Medicine

 French healthcare group Sanofi said it had priced a first sustainability-linked bond issue that will be indexed on access to medicines, and worth 1.5 billion euros ($1.7 billion).

The company said the costs of financing would be linked to achieving concrete targets in terms of a cumulative number of patients being provided with essential medicines over the next five years.

The notes are set to be issued in two tranches of 850 million euros and 650 million euros respectively.

"We continue to make progress in our environmental, social and governance activities that are an essential part of our strategy and embedded into our business," said Sanofi chief financial officer Jean-Baptiste de Chatillon.

https://money.usnews.com/investing/news/articles/2022-03-31/frances-sanofi-offers-1-5-billion-euro-bond-linked-to-access-to-medicine

Germany Plans to Relax COVID Quarantine Rules as Cases Soar

 Germany plans to end mandatory quarantine for most people who catch COVID-19, the health ministry proposed on Thursday, as numbers isolating with the infection top four million.

Under the existing rules, people with COVID must quarantine for at least seven days.

But Health Minister Karl Lauterbach wants to change that to a voluntary five days of self-isolation with the recommendation of a COVID test at the end of that period, proposals seen by Reuters showed.

Under the plans, drawn up by his ministry and the Robert Koch Institute for infectious diseases, health workers would still have to isolate for a five days and require a negative PCR test to end their quarantine.

The proposals, which have yet to be discussed with authorities in Germany's 16 federal states, have emerged after COVID cases soared in recent weeks, hitting staffing in hospitals and many other workplaces.

Daily numbers have fallen again in recent days, with the Institute reporting 274,901 new infections on Thursday to take total cases since the pandemic began beyond 21.1 million, with nearly 130,000 deaths.

Separately, Bild said Chancellor Olaf Scholz's government had been forced to drop plans to introduce mandatory COVID-19 vaccines for everyone aged over 18 because it could not muster a majority for it in parliament.

Instead, it was aiming to pass legislation to make vaccinations compulsory for those over 50, the newspaper said.

Asked about the report at a news conference, Scholz said his government was in the process of building a majority in parliament, without giving further details.

https://www.usnews.com/news/world/articles/2022-03-31/germany-plans-to-relax-covid-quarantine-rules-as-cases-soar

Governments want COVID vaccine developers to aim higher in the hunt for better shots

 As governments prepare to live with COVID-19, some are questioning the reliance on drug manufacturers to tailor vaccines to prevent future virus variants that could lead to infections. signs of stress, according to several sources close to the matter. with problem.

Some vaccine experts say government agencies should fund and help develop the new generation of COVID vaccines, and seek innovation from smaller developers, as they did to identify current vaccines.

“We’ve established a research infrastructure that can do this relatively quickly if we prime the pump and create the same kind of plan for a second-generation vaccine as we did for a second-generation vaccine.” with first-generation vaccines,” said Dr. Larry Corey, a virologist. is overseeing US government-backed COVID vaccine trials, told Reuters.

BioNTech and Pfizer (NYSE:), who developed the most widely used COVID vaccine in the West, recently clashed with the European Medicines Agency (EMA) over the best strategy to develop a new vaccine. against the Omicron variant, and whatever may follow, two sources familiar with the matter told Reuters.

An EMA spokesperson said the agency, along with other regulators, is encouraging companies to explore vaccines that target multiple variants.

In January, BioNTech and Pfizer began testing a vaccine designed to specifically target Omicron, believing the best approach would be to tackle one major new variant at a time.

They have said a modified vaccine may not be needed even if the emergence of highly mutant Omicron late last year led to a record increase in infections.

EMA regulators have pressed drugmakers to give equal preference to a vaccine that targets multiple variants, arguing that it would provide broader protection against the diseases. future mutations, the sources said. One of the sources said the EMA would not signal whether current vaccine trials are sufficient to warrant approval even if the companies demonstrate safety and an immune response.

On Wednesday, BioNTech said the companies would expand their testing to test a single shot aimed at Omicron and the original version of the coronavirus.

BioNTech said it decided to test a combination shot to scientifically confirm decisions about the best vaccine strategy for the foreseeable future.

A BioNTech spokesperson declined to comment on the company’s discussions with EMA. A Pfizer spokesperson did not respond to a request for comment.

Moderna (NASDAQ:) Inc, which has also enjoyed great success with its COVID vaccine, is testing an injection that targets Omicron and the original coronavirus, aiming to be available in the fall.

Moderna lead scientist Jacqueline Miller said at a company event this month: “We believe this could lead to the broadest possible protection.

GlaxoSmithKline (NYSE:) is also working with German biotech CureVac on a vaccine that targets multiple coronavirus variants.

‘WE NEED TO DO BETTER’

European and US public health officials are pushing for better tools to fight COVID. Current vaccines are very effective against illness and death, but are no longer able to fight transmission, and immunity tends to wane within months.

Some health officials question whether companies that have raked in tens of billions of dollars from first-generation COVID shots and made billions more from repeat boosters are willing to spend the money to Figuring out whether a vaccine provides broader and longer-lasting protection could take years.

Pfizer and BioNTech say their decisions are guided by scientific findings.

Corey, from Seattle’s Fred Hutchinson Cancer Center, says any new and innovative approach could come from smaller companies that need to fund early development work.

“We need to do better, and we need to fund that,” Corey said, adding that a new generation of COVID vaccine could be backed by about $2 billion in funding. aid. The European Union has bet big on future Pfizer/BioNTech hits in a deal worth up to 35 billion euros ($39.04 billion). That agreement required drugmakers to modify their injections to deal with new variants.

EU member states have also expressed interest in footage targeting multiple variants. “The message they send to companies is ‘give us more options’,” said one of the sources familiar with the matter. The International Coalition for Epidemic Preparedness Innovations, which helped fund early studies on several existing vaccines, has $200 million available for world vaccine research. next system. It has awarded small grants to manufacturers including UK’s DIOSynVax and Israel’s MigVax.

Of the major Western COVID vaccine manufacturers, Pfizer and BioNTech appear farthest in redesigning their injections.

At the end of January, they launched a clinical trial testing the immune response to a vaccine that targets Omicron in unvaccinated people and as a booster in people who have been vaccinated. fully vaccinated. Results are expected in April.

BioNTech has argued that laboratory analyzes by other researchers show that exposure to Omicrons in previously immunized individuals leads to an extensive immune response against previous major coronavirus variants. , sources said.

Lab tests of a previous BioNTech/Pfizer shot targeting the Alpha and Delta variants, they added, yielded a poorer immune response than what would be expected from a single vaccine. variant.

GSK said combination vaccines can pose other difficulties, including exacerbation of temporary side effects when given current vaccines. Cutting the dosage to avoid that could affect effectiveness, but GSK says it’s working on that.

https://newsofmax.com/analysis-government-wants-covid-vaccine-developers-to-aim-higher-in-the-hunt-for-better-shots-according-to-reuters/

U.S. House Approves Bill Setting Strict Cap on Insulin Costs

 The high cost of insulin to treat diabetes would be drastically reduced under legislation the U.S. House of Representatives passed on Thursday, in a rare example of drug price reform gaining traction in Congress.

By a vote of 232-193, with few Republicans supporting the measure, the House approved the bill that would cap patients' out-of-pocket costs at $35 a month for their insulin.

Currently, monthly supplies of the life-sustaining medicine average around $375 and can go as high as $1,000, causing some people to skip needed doses.

"No one should have to ration their insulin to help reduce costs and risk their health and in some cases actually cost them their lives," said Democratic Representative Frank Pallone, who chairs a committee that oversees health policy, during House debate.

The legislation would still have to be considered by the Senate, which is crafting a much broader bill.

The Democratic-led effort, if successful, could have far wider ramifications for lowering prescription drug costs - a goal supported by Americans in the run-up to the Nov. 8 congressional elections, according to public opinion polls.

"It is for us a step in the direction of the secretary (of Health and Human Services) being able to negotiate drug prices beyond insulin," House Speaker Nancy Pelosi said at her weekly news conference on Thursday.

Three companies, Sanofi SA, Eli Lilly and Co, and Novo Nordisk, have long dominated the U.S. insulin market. The trio own some 90% of the market for insulin, which was invented in the 1920s but continues to rise in cost to consumers.

More than 34 million people in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention. Most have type 2, which typically does not require insulin to control blood sugar but can. Nearly 1.9 million Americans with type 1 diabetes must take insulin every day.

Medicare, the U.S. government health insurance program for those age 65 and older and the disabled, could have saved more than $16.7 billion from 2011 to 2017 on insulin purchases had it been allowed to negotiate discounts with drug companies, according to a congressional report released last December.

Republican Representative Cathy McMorris Rodgers dismissed the legislation as a "government drug-pricing scheme; part of a socialized medicine approach that would lead to fewer cures" while raising health insurance premiums.

https://www.usnews.com/news/us/articles/2022-03-31/u-s-house-approves-bill-setting-strict-cap-on-insulin-costs

US warned firms about Russia's Kaspersky software day after invasion

 The US government began privately warning some American companies the day after Russia invaded Ukraine that Moscow could manipulate software designed by Russian cybersecurity company Kaspersky to cause harm, according to a senior US official and 2 people familiar with the matter.

The classified briefings are part of Washington's broader strategy to prepare providers of critical infrastructure such as water, telecoms and energy for potential Russian intrusions.

President Joe Biden said last week that sanctions imposed on Russia for its Feb 24 attack on Ukraine could result in a backlash, including cyber disruptions, but the White House did not offer specifics.

"The risk calculation has changed with the Ukraine conflict," said the senior US official about Kaspersky's software. "It has increased."

Kaspersky, one of the cybersecurity industry's most popular anti-virus software makers, is headquartered in Moscow and was founded by Eugene Kaspersky, who US officials describe as a former Russian intelligence officer.

A Kaspersky spokeswoman said in a statement that the briefings about purported risks of Kaspersky software would be "further damaging" to Kaspersky's reputation "without giving the company the opportunity to respond directly to such concerns" and that it "is not appropriate or just".

The senior US official said Kaspersky's Russia-based staff could be coerced into providing or helping establish remote access into their customers' computers by Russian law enforcement or intelligence agencies.

Eugene Kaspersky, according to his company website, graduated from the Institute of Cryptography, Telecommunications and Computer Science, which the Soviet KGB previously administered. The company spokeswoman said that Kaspersky worked as a "software engineer" during military service.

The Russian cybersecurity firm, which has an office in the United States, lists partnerships with Microsoft, Intel and IBM on its website. Microsoft declined to comment. Intel and IBM did not respond to requests for comment.

On Mar 25, the Federal Communications Commission added Kaspersky to its list of communications equipment and service providers deemed threats to US national security.

It is not the first time Washington has said Kaspersky could be influenced by the Kremlin.

The Trump administration spent months banning Kaspersky from government systems and warning numerous companies to not use the software in 2017 and 2018.

US security agencies conducted a series of similar cybersecurity briefings surrounding the Trump ban. The content of those meetings 4 years ago was comparable to the new briefings, said one of the people familiar with the matter.

Over the years, Kaspersky has consistently denied wrongdoing or any secret partnership with Russian intelligence.

It is unclear whether a specific incident or piece of new intelligence led to the security briefings. The senior official declined to comment on classified information.

Until now no US or allied intelligence agency has ever offered direct, public proof of a backdoor in Kaspersky software.

Following the Trump decision, Kaspersky opened a series of transparency centers, where it says partners can review its code to check for malicious activity. A company blog post at the time explained the goal was to build trust with customers after the US accusations.

But the US official said the transparency centres are not "even a fig leaf" because they do not address the US government's concern.

"Moscow software engineers handle the updates, that's where the risk comes," they said. "They can send malicious commands through the updaters and that comes from Russia."

Cybersecurity experts say that because of how anti-virus software normally functions on computers where it is installed, it requires a deep level of control to discovery malware. This makes anti-virus software an inherently advantageous channel to conduct espionage.

In addition, Kaspersky's products are also sometimes sold under white label sales agreements. This means the software can be packaged and renamed in commercial deals by information technology contractors, making their origin difficult to immediately determine.

While not referring to Kaspersky by name, Britain's cybersecurity centre on Tuesday said organisations providing services related to Ukraine or critical infrastructure should reconsider the risk associated with using Russian computer technology in their supply chains.

"We have no evidence that the Russian state intends to suborn Russian commercial products and services to cause damage to UK interests, but the absence of evidence is not evidence of absence," the National Cyber Security Centre said in a blog post. 

https://www.businesstimes.com.sg/technology/us-warned-firms-about-russias-kaspersky-software-day-after-invasion

Quantum Leap Trial Suggests No Benefit with Addition of Nebulized NRx ZYESAMI in Covid

  Quantum Leap Healthcare Collaborative (QLHC) announced in collaboration with NRx Pharmaceuticals, Inc. (NRx), that the nebulized form of ZYESAMI® (Aviptadil), in the I-SPY COVID Trial of Critical COVID-19 patients has been stopped. The I-SPY COVID Trial, (NCT04488081) is a phase 2, open label, adaptive platform trial designed to rapidly screen potential agents that could substantially improve treatment for severely and critically ill COVID-19 patients. QLHC is the sponsor of the I-SPY COVID TRIAL. The trial is structured to identify those agents with a big impact, those that could have the potential to reduce the time to recovery (defined as reduction in oxygen demand) by approximately 50% or risk of mortality in critically ill COVID-19 patients.

Aviptadil is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) and was selected because of the potential to reduce inflammation and stabilize the air sacs of those hospitalized because of critical injury from acute respiratory distress syndrome (ARDS), which is the major cause of death in those critically ill from COVID-19. The intravenous form of ZYESAMI is currently being tested in the ACTIV-3b Phase 3 trial being conducted by the National Institutes of Health, a separate clinical trial of critically ill patients, which continues enrolling. The nebulized form was selected for inclusion in the I-SPY COVID Trial to determine whether this simpler form of delivery via self-inhalation through a mouthpiece would be effective in speeding recovery from and/or preventing death from COVID-19-related ARDS.

The study enrolled COVID-19 patients, on High Flow Nasal Cannula (COVID Scale 5), Mechanical Ventilation (COVID Scale 6), or Mechanical Ventilation with additional organ failure (COVID Scale 7).

COVID Scale on Day 1	Aviptadil n=51	Control n=67	TOTAL n=118
5	44 (88%)	59 (88.1%)	103 (88%)
6	1 (2%)	7 (10.4%)	8 (6.8%)
7	5 (10%)	1 (1.5%)	6 (5.1%)

The Data Monitoring Committee recommended concluding the open label Aviptadil arm of the I-SPY COVID Trial after 118 patients (51 on study drug and 67 on concurrent controls) were enrolled. Enrollment was stopped because the agent met the predefined futility criterion, with a greater than 90% probability that the hazard rate for recovery is less than 1.5 when compared to standard treatment (Pr(HR < 1.5) ≥ 0.9), and that the chance that the hazard rate for mortality being less than 1 is less than 50% (Pr(HRm<1.0) <0.5). The data from nebulized Aviptadil patients were compared to those from 67 patients concurrently randomized to the control arm, which included treatment with dexamethasone and remdesivir as backbone therapy. Patients assigned to the Aviptadil arm received backbone therapy in combination with 100 micrograms of nebulized Aviptadil for inhalation as an aerosol mist three times per day for up to 14 days. After all patients had reached 28 days of follow-up, the data suggested there was a low probability that the addition of this dose of nebulized Aviptadil to backbone therapy via mouthpiece administration, would improve outcomes in this population. At the time of discontinuation, the hazard ratio for recovery favored placebo (HRr 0.56 (95% CI 0.34-0.89)). The drug was administered across 29 sites active in the trial at the time the drug was released from the trial.

NRx previously concluded a study of intravenous Aviptadil in critically ill COVID-19 patients with positive results. The findings in the current I-SPY study may be due to the difficulty of effectively delivering nebulized medications via mouthpiece to critically ill patients when they are on high flow oxygen (6 liters or more) or nebulized into the breathing circuit for mechanically ventilated patients. Factors including high oxygen flow rates, rapid breathing and mechanical ventilation may reduce nebulized medication delivery to the air sacs. Accordingly, nebulized administration of Aviptadil at the dose used at flow rates above 6L per minute is not appropriate in this patient population.

https://finance.yahoo.com/news/spy-covid-trial-sponsored-quantum-121700107.html

Sorrento: FDA OKs Phase 2/3 Study for Treatment of Severe Covid Pneumonia

 

• Abivertinib is a novel oral small molecule tyrosine kinase inhibitor that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) as well as Bruton's tyrosine kinase (BTK) and potentially can reduce cytokine storm associated with acute respiratory distress syndrome (ARDS) in severe hospitalized COVID-19 patients.

• Sorrento will be starting a multicenter, multinational Phase 3 study with a Phase 2 run-in to identify the recommended Phase 3 dose (RP3D) and to demonstrate the safety and efficacy of Abivertinib in patients with respiratory compromise due to COVID-19.

• This clearance follows the successful completion of parallel phase 2 studies in the US and Brazil, both of which indicated that a high-risk population of patients requiring oxygen support by non-invasive ventilation or high flow oxygen appeared to be more likely to benefit from Abivertinib therapy than those receiving low flow oxygen in reducing progression of respiratory failure.

https://finance.yahoo.com/news/sorrento-reports-fda-clearance-commencement-130000837.html