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Thursday, March 31, 2022

Sanofi to list drug ingredients business on May 6

 Sanofi (SASY.PA) expects to list its drug ingredients business EUROAPI on May 6, having received approval from French stock market regulator, the pharmaceutical giant said on Friday.

The listing is set to take place shortly after a May 3 shareholder meeting, at which Sanofi's stakeholders will vote on the listing.

Sanofi said the new shares will be distributed to its shareholders at one EUROAPI share per 23 Sanofi shares.

The company confirmed plans to conserve a 30% stake in the business after the listing while the French state will buy a 12% stake through EPIC Bpifrance for up to 150 million euros ($166 million).

L'Oreal (OREP.PA), Sanofi's largest shareholder with a more than 9% stake, and EUROAPI Chief Executive Karl Rotthier have both agreed to a one-year lock-up period after the listing, it added.

EUROAPI makes active pharmaceutical ingredients (APIs) for medicines and will be based from six production sites in Italy, Germany, Britain, France and Hungary.

Sanofi, which last year accounted for half EUROAPI's revenue, said in January that it expects the business to become the world's second-biggest API player with about 1 billion euros in revenue forecast for this year.

The bulk of EUROAPI's share capital, 58%, will be distributed to Sanofi shareholders through a dividend in kind, in addition to a previously proposed 3.33 euros per share cash payout.

How a Seagen cancer drug with Nobel Prize science might also work in diabetes

 Some diabetes therapies work by ramping up the body’s secretion of insulin to counteract high blood sugar levels. But a team of scientists at the Karolinska Institute believe preserving insulin-producing pancreatic beta cells—rather than overloading them—would be a better diabetes treatment strategy over the long term.

Following that thinking, the team showed that an experimental cancer drug made by Seagen dubbed PX-478 could improve the function of beta cells and restore blood sugar balance in diabetic mice. The results are published in the journal Science Translational Medicine.

Because PX-478 has already been tested in a clinical trial as an anti-cancer drug and was well tolerated in these patients, the Karolinska researchers hope they could quickly move the drug into clinical trials of diabetes after additional animal tests.

PX-478 is an inhibitor of the hypoxia-inducible factor 1-alpha (HIF-1alpha) protein. The 2019 Nobel Prize in physiology or medicine went to three scientists for their discoveries of HIF’s role in how cells respond to low oxygen levels, or hypoxia.

In Type 2 diabetes, continuous insulin resistance sends pancreatic beta cells into overdrive as the cells try to maintain normal blood sugar levels, eventually wearing the cells out. Previous studies have linked the metabolic dysfunction with hypoxia and HIF-1alpha, given the high energy, oxygen-dependent demands of insulin secretion.

Under normal circumstances, HIF-1alpha is quickly degraded. But in diabetic mouse models, HIF-1alpha was stabilized and accumulated in the animals’ pancreatic islets amid hypoxia caused by an increase in metabolic workload, the Karolinska team found.

The researchers treated the diabetic mice with PX-478. In a mouse model of “extreme” Type 2 diabetes marked by early loss of beta cell function, PX-478 prevented the rise of blood glucose. Mice treated with the drug kept plasma insulin concentration elevated, suggesting their beta cells were still working to release insulin to compensate for insulin resistance. By contrast, untreated mice saw their insulin concentration drop.

In another mouse model with reduced functional beta cells, PX-478 treatment brought blood sugar levels under control, whereas hyperglycemia persisted in nontreated mice.

Pancreatic islets isolated from PX-478-treated mice showed hallmarks of improved beta cell function including an increase in insulin content and expression of genes involved in beta cell function and maturity as well as the formation of insulin granules similar to those of nondiabetic control mice.

The drug also showed similar benefits in organoids of human pancreatic cell islets. It cooled the human beta cells down by reducing basal insulin secretion and increasing a response to high blood sugar, the researchers found.

Hypoxia has broad implications in various diseases. And this is not the first time that scientists have found the repurposing potential of PX-478 in a disease beyond cancer. A research team at Yale University previously discovered that PX-478 held promise for lupus nephritis, because it could reduce kidney inflammation from kidney-infiltrating T cells. 

Because insulin production declines during diabetes, therapeutic strategies have so far mainly focused on improving beta cells' insulin production. Other research efforts that have also focused on the preservation of beta cell function, including targeting the protein TXNIP by scientists at the University of Alabama at Birmingham.

“Current therapies targeting beta cells have only a temporary positive effect on insulin secretion,” Per-Olof Berggren, the current study’s co-senior author, said in a statement. “In the long-term, these drugs lead to beta-cell exhaustion.”

Next up, the Karolinska team aims to test PX-478’s effect on human pancreatic beta cell function in a “humanized” mouse model in which immunosuppressed mouse is transplanted with human islets.

After FDA hold, CytoDyn will appeal for pharma partnerships to save leronlimab

 With CytoDyn's lead drug on FDA clinical hold, the troubled biotech will go searching for partners to rescue key programs and keep afloat.

Meanwhile, the board is actively searching for a new CEO to replace Nader Pourhassan, Ph.D., who was ousted in January.

The company provided a sweeping corporate update in a conference call Thursday morning, after announcing at market close the day before that the FDA had placed two separate clinical holds on leronlimab. The regulatory shutdown includes a partial hold on CytoDyn’s HIV work and a full hold on the COVID-19 program, according to an after-market release issued Wednesday.

"We will be focused on setting up the company for future success by restoring credibility and determining our most advantageous path forward with the goal of maximizing shareholder value," said Antonio Migliarese, CFO and interim president, on the call.

Migliarese then listed the priorities, which were many: "We plan on doing this by strengthening our clinical operations and prioritizing patient safety, addressing the concerns noted in the partial clinical hold letter received for HIV and the full clinical hold letter received for COVID-19, enhancing leadership with the board, CEO and Scientific Advisory Board, addressing legal and financial issues."

Not to mention analyzing new data in HIV, revamping the timeline for a biologics license application in the indication, releasing results in non-alcoholic steatohepatitis and finding new partnerships with pharmaceutical companies to fund all this work. All that for a company that does not currently have a CEO.

CytoDyn has touted leronlimab as having potential in multiple indications, but the therapy has struggled in the clinic against COVID, and the company has equally faced difficulties in getting regulatory submissions locked down for HIV. The company said in announcing the holds that clinical trials underway in the COVID program in Brazil would be paused pending results from the data safety monitoring committee.

Chief Medical Officer and Head of Business Development Scott Kelly said the company decided to pause the Brazilian trials in COVID because of two cardiac events. The studies feature very sick patients with cardiac and pulmonary manifestations of the disease, he added.

The study remains blinded, meaning CytoDyn does not know whether the patients who suffered the cardiac events received leronlimab or placebo. 

"We discussed this in depth with the physician investigators in Brazil who have extensive pulmonary and critical care expertise, and they believe the events were consistent with the natural course of COVID and nothing out of the ordinary of their experience and prior COVID-19 trials," Kelly said. 

CytoDyn opted to pause the program "out of an abundance of caution," knowing that the data safety monitoring committee would be meeting anyway in April. 

"I want to be clear that this was our decision. We thought it was the right thing to do," Kelly said. Once the committee clears the trial to continue, CytoDyn plans to resume clinical activities.

As for the holds, Kelly said the agency wants aggregated safety data from all the indications leronlimab has been tested in before any further work can be done in the U.S. He called this a "solvable problem," and pledged to complete the work on an eight- to 10-week timeline. Kelly stressed that the company is not enrolling in the U.S. for the COVID program, and the HIV program at issue is a long-term extension study that has wrapped up. 

For the HIV program, CytoDyn said Wednesday that "these patients will be transitioned to other available therapeutics and no clinical studies can be initiated or resumed until the partial clinical hold is resolved." While the company works with the FDA to resolve the holds, no new studies may be started in the COVID-19 program.

The company will also re-evaluate a biologics license application in HIV, which will mean a "delay in clinical activities," according to Chris Recknor, M.D., senior executive VP of clinical operations. The submission will be on hold while the safety data is compiled for the FDA with a new CRO. 

Regarding the search for a new CEO, Board Chair Tanya Urbach said a search committee has been formed. 

"We are excited about the overall quality of the candidate pool and will continue in our efforts to identify the company's next chief executive officer," she said. 

CytoDyn also provided a broad update to its clinical programs, including plans to advance leronlimab in NASH. The company has also been contacted by multiple academic institutions for access to the drug to conduct preclinical studies in glioblastoma multiforme, Alzheimer's disease and others, according to Kelly. Another study could someday look at using leronlimab in COVID long haulers, and there's been interest in combining the therapy with CAR-T treatments in cancer, he said.

All of these indications have confounded major drugmakers for decades, even companies that specialize in diseases like NASH or Alzheimer's. 

For all or most of these initiatives, CytoDyn needs help. Kelly, and other executives said over and over that they would be seeking partnerships to move programs forward. This will help CytoDyn "advance our development efforts and value creation with minimal investment," according to Migliarese.

"As we all know, in clinical trials, it's very costly, but we believe we can leverage the experience of others that are experts in each chosen field," Kelly said. 

He declined to name names, but said, "We have companies under NDA right now and we are advancing those discussions for multiple different applications for leronlimab." 

Another issue that received scant mention is CytoDyn's many legal battles, which include an investigation from the Department of Justice and the Securities and Exchange Commission. Migliarese said the company is fully cooperating with the investigators and "doing our best to expeditiously wrap up the various other legal matters of the company." That includes a spat with a former contract research organization. 

CytoDyn's remaining leadership has a tough to-do list. But the conference call was markedly more sane compared to those previously held when Pourhassan was in charge. In May last year, he begged investors to stop trashing the FDA after the agency's public smackdown of the company over its leronlimab claims. Pourhassan took a barrage of questions from angry investors. But on today's call, Kelly and the team took pre-screened written questions, mostly those surrounding clinical trial updates or the pharma partnerships.

Missouri House slated to pass sweeping new abortion bill

 The Republican-led Missouri House is set to pass legislation to defund Planned Parenthood, criminalize mail-order abortion medications, and allow wrongful death lawsuits in rare cases when infants are born alive after an abortion attempt and the infant then dies or is injured.

House lawmakers earlier this week blocked an attention-grabbing amendment to make it illegal to “aid or abet” abortions that violate Missouri law, even if they occur out of state.

Instead, the GOP swapped in another amendment that would make it a crime to provide abortion-inducing medications to women. Doctors could still provide those medicines.

Republican Rep. Brian Seitz, who sponsored the medication abortion bill, said the issue with the proposal to penalize helping women travel out of state for abortions was that it has not been vetted through a committee like his measure has.

If Roe v. Wade is overturned and abortion is banned in Missouri, Seitz’s change would prohibit telemedicine abortions through medications.

“It’s very important that states, especially typically pro-life states, have legislation already in place for the possible overturn of Roe v. Wade,” Seitz said.

House members packed the abortion policies together in an omnibus bill Tuesday in hopes of passing the proposals by lawmakers mid-May deadline despite ongoing GOP infighting that’s causing work in the Senate to move at a glacial pace.

Advocates of Planned Parenthood of the St. Louis Region and Southwest Missouri spokeswoman Bonyen Lee-Gilmore in a statement called the legislation “a kitchen-sink approach to banning reproductive freedom in Missouri.”

“It unlawfully blocks Medicaid patients from preventive care at Planned Parenthood, it spreads inflammatory rhetoric, and seeks to ban common medications used for miscarriages, labor and delivery, and abortion,” she said.

Under the amended bill, family members could also file wrongful death suits if infants born alive after an abortion attempt are injured or later die as a result of the attempted abortion. If the pregnancy is the result of rape, the bill would not allow the rapist to sue.

Republican Rep. Hannah Kelly, who sponsored a bill banning fetal tissue donations onto which the other abortion amendments were added, told colleagues during House floor debate Tuesday that the born-alive provision represents a chance for justice.

Democratic Rep. Keri Ingle warned that the threat of lawsuits would pit families against each other.

Instances of babies being born alive after an induced pregnancy termination are extremely rare.

A review by the U.S. Centers for Disease Control and Prevention of infant mortality data from 2003 and 2014 showed 143 deaths were of infants that displayed signs of life after an induced termination. That was a tiny fraction of the 315,000 infant deaths during those 12 years, a period that also included 49 million live births.

In a majority of those cases, the abortion was induced due to a maternal complication or congenital anomaly in the fetus.

Mary Ziegler, a Florida State University law professor, said current homicide laws could already offer protections for infants born alive after abortions.

She said similar proposals nationally and in other state have mostly been used as a way for Republicans to show their opposition to abortion while forcing Democrats to argue against bills with the stated intent of cracking down on infanticide.

“What they’ve been historically designed to do is to frame the debate around issues that are really uncomfortable for supporters of abortion rights,” Ziegler said of similar proposals.

The Missouri measure also includes yet another attempt by Republican lawmakers to strip Planned Parenthood of any public funding, including clinics that do not provide abortions.

Lawmakers were able to stop money from going to Planned Parenthood in the 2019 fiscal year by forgoing some federal funding to avoid requirements that the clinics be reimbursed if low-income patients go there for birth control, cancer screenings and other preventative care. Missouri instead used state money to pay for those services.

But the Missouri Supreme Court in 2020 ruled that lawmakers violated the constitution by making the policy change through the state budget, forcing the state to reimburse Planned Parenthood for health care provided to Medicaid patients.

It’s unclear whether blocking funding through a policy bill instead of the budget will work, but Republican lawmakers have said they’re hopeful enough to try again.

A vote to send the sweeping bill to the GOP-led Senate could come as early as next week.

Jayapal: Federal protections for trans kids ‘cannot wait any longer’

 Rep. Pramila Jayapal (D-Wash.), who is a mother to a transgender child, penned an op-ed published by Teen Vogue on Thursday, International Transgender Day of Visibility, calling for federal protections for transgender children.

“Like hundreds of thousands of parents with transgender kids across the country, I want to do everything I can to support my daughter as she strives to embrace who she is and live as her most authentic self,” Jayapal wrote.

“But I also worry deeply that the world we live in now doesn’t receive her in the same way — that she will face violence and barriers that we know are there for too many transgender people.”

The congresswoman noted the higher degree of harassment and mental illness that transgender children face and accused Republicans of worsening these problems by using transgender youth as a “political wedge issue.”

She pointed to the bill recently passed in Texas that classified gender-affirming care for children as child abuse. Jayapal called the legislation “unconstitutional” and “openly discriminatory and hostile to the well-being of these children.” The bill was halted by a Texas appeals court earlier this month.

The congresswoman also noted a similar bill in Idaho that would make gender-affirming youth health care a felony. The measure was passed in the Idaho state House of Representatives earlier this month, but Idaho Senate Republicans declined to vote on it on the basis that it undermined parental rights and allows the government to interfere in parents’ decisions for their children.

“Both of these bills are fueled by a cocktail of ignorance, transphobia, and malice for trans kids, their parents, and the doctors and the communities who want to help them. The bills are an outrageous violation of human rights,” Jayapal wrote. “That’s why today, as we celebrate Transgender Day of Visibility, I stand with every single trans child and the parents who support them.”

“The suffering of transgender children is not inevitable. It is our job — as leaders, as parents, as legislators — to push back on the attacks and to move us forward again toward true equality and justice,” she added.

How China’s latest Covid lockdowns affect American businesses ihere

 China’s worst Covid wave since the initial shock of the pandemic has cut into annual revenue projections for roughly half of American businesses in the country, a survey showed Friday.

The Beijing-based American Chamber of Commerce in China and its Shanghai counterpart surveyed 167 members operating in China, including 76 manufacturers, this past Tuesday and Wednesday.

The metropolis of Shanghai, where many foreign businesses are located, entered a two-part lockdown this week as municipal authorities sought to control a brewing number of Covid cases. Those measures followed shorter lockdowns in the tech hub of Shenzhen, the manufacturing hub of Dongguan and travel restrictions across the country.

The survey found that 54% of respondents have lowered 2022 revenue projections for the year due to the latest Covid-19 outbreak.

Among manufacturers, more than 80% reported slowed or reduced production, as well as supply chain disruptions.

Nearly all, or 99%, of respondents said the latest outbreak had affected them.

Since the pandemic began in 2020 and China tightened restrictions on international travel, foreign businesses in China have complained of long quarantine requirements upon arrival and difficulties of bringing in senior management or technical staff.

If China’s current Covid-19 restrictions remain in place for the next year, half of respondents to this week’s AmCham survey said they would reduce investment. Nearly 75% of respondents said maintaining those restrictions would reduce their revenue and profit.

And nearly 20% of manufacturers said they would move manufacturing or operations out of mainland China if the Covid-19 restrictions remained.

While just about half of respondents overall were satisfied with China’s efforts to control Covid’s spread, the top three aspects of dissatisfaction were the length of required quarantines, restrictions on travel to China and the lack of flights to China.

The top three recommendations from survey respondents were to allow for home quarantine or other options, simplify requirements for coming to China and allow more flights into the country.

The number of new Covid cases and deaths reported in mainland China remains well below that of major countries.

Groups urge Biden to reject potential WTO 'concept' on COVID-19 vaccine barriers

 Médecins Sans Frontières, Oxfam America, Amnesty International and other top civil society groups on Wednesday called on US President Joe Biden to reject a potential agreement on COVID-19 vaccine intellectual property rights in the World Trade Organization.

In a letter, the groups called the proposal a “rehash” of an EU position that was far from the rights exemption Biden supported in May 2021 to speed up vaccines for developing countries.

“This leaked text … would impose new conditions limiting existing WTO rules, which now allow countries to issue compulsory licenses for patented products,” the organizations said.

They noted that India and South Africa, which had been working on the compromise language with the US and the EU, had not yet formally approved the “concept”.

U.S. Trade Representative Katherine Tai on Wednesday told U.S. lawmakers that there was no agreement on what she called the “concept” of a compromise developed during discussions facilitated by WTO Director-General Ngozi Okonjo-Iweala.

A text for the proposed compromise, which Reuters saw earlier this month, sought to waive IP rights to COVID-19 vaccines and supplies. It must be completed and accepted by the 164 member states of the WTO. Read more

Some critics argue that the potential deal does not go far enough beyond a mandatory vaccine licensing regime, while others see it as hurting large companies’ IP rights.

The groups called on Biden to redouble its efforts to negotiate an “actual exemption” to increase COVID-19 vaccine production.

European civil society groups have expressed similar concerns in a separate letter to EU officials.

The US groups said the potential deal would add burdensome conditions to WTO rules by requiring the identification of all relevant patents, data that were not readily available.

“If adopted as it stands, this text, while continuing to privilege Big Pharma monopolies and profits, will continue to deny access to life-saving COVID-19 vaccines and treatments to millions around the world,” the groups wrote. .

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.

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.

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.


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.

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.

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.