'US safety board to scrutinize FAA oversight of Boeing'

 The National Transportation Safety Board on Wednesday opened a hearing to review the Federal Aviation Administration's oversight of Boeing after a 737 MAX 9 mid-air emergency in January raised serious safety questions.

The board is holding the second day of an investigative hearing into the door panel blowout in the new Alaska Airlines jet after the first day focused on Boeing actions before the incident.

NTSB Chair Jennifer Homendy said the board wants to know why the FAA did not take action earlier.

"We have a lot of questions -- there was information known," Homendy said about FAA oversight of Boeing, citing defects, missing and incorrect documents, as well as incorrect policies that "have been issues for years. This is not new."

Homendy has questions about FAA audit procedures and whether Boeing previously received advance notice of reviews and asked if they were too focused on reviewing paperwork.

After the incident, the FAA barred Boeing from expanding production beyond 38 planes per month and announced a 90-day review of the planemaker and has required significant quality and manufacturing improvements before it will allow the planemaker to hike production.

FAA Administrator Mike Whitaker said in June the agency was "too hands off" in Boeing oversight. The FAA's approach before the mid-air accident was "too focused on paperwork audits and not focused enough on inspections," Whitaker added. The FAA has also boosted the number of inspectors at Boeing and Spirit factories.

"We will continue our aggressive oversight of the company and ensure it fixes its systemic production-quality issues," the FAA said Wednesday.

Last week Senate Commerce Committee chair Maria Cantwell and Senator Tammy Duckworth introduced legislation to review and strengthen safety management systems at the FAA.

Cantwell asked the FAA to conduct a thorough review into its oversight of Boeing and said the FAA conducted a combined total of 298 audits of Boeing and fuselage supplier Spirit AeroSystems over the prior two years before the January accident that "did not result in any enforcement actions."

"Clearly, they were doing an audit that meant nothing, because it didn't detect any problems and they said everything was fine," Cantwell said.

https://finance.yahoo.com/news/us-safety-board-scrutinize-faa-100256890.html

Bicycle Therapeutics cut to Neutral from Buy by B. Riley

 Target to $28 from $33

https://finviz.com/quote.ashx?t=BCYC&p=d

Illumina expects full-year sales from core segment to decline on biotech funding crunch

 Gene sequencing machine maker Illumina on Tuesday forecast 2024 sales from its core segment to decline, a sign that subdued demand for its instruments used in genetic tests could extend further into the year.

Illumina has seen sluggish demand for its tools and services, used to develop therapies and vaccines, from key markets such as China and cautious spending from its customers such as biotechnology companies, amid high interest rates.

"Consumable sales remained solid as customers continued to increase their sequencing activity, but instrument demand has softened in a constrained funding environment," CEO Jacob Thaysen said.

The company expects its Core Illumina revenue to decline 2% to 3%, compared to the previous year. Earlier, it had expected full-year revenue from the segment to be flat.

On an adjusted basis, it expects a per-share profit of $3.80 to $3.95 for its core segment for 2024. Analysts expect full-year adjusted profit of $3.91 per share for the whole company.

Of Illumina's two reportable segments, Core Illumina and Grail , the latter was spun off on June 24.

It decided last December to divest cancer diagnostic tests maker Grail after the companies ran afoul of U.S. and European antitrust enforcers for more than two years and faced fierce opposition from activist investor Carl Icahn.

San Diego, California-based Illumina's quarterly revenue was $1.11 billion in the second quarter, compared to analysts' estimate of $1.08 billion.

On an adjusted basis, it earned 36 cents per share of profit during the quarter ended June 30, while analysts' on average expected 90 cents per share.

The company had flagged that it would take a goodwill impairment charge of $1.47 billion in the second quarter related to the Grail spin-off.

https://finance.yahoo.com/news/illumina-expects-full-sales-core-225434859.html

Charles River cuts 2024 forecast on lower demand for drug development services

 Contract drug developer Charles River Laboratories cut its annual forecasts on Thursday as it warned of worsening demand from drugmakers and a persistently low appetite for clinical trials from biotech companies.

Shares of the company crashed 16.2% to $191.84, putting them on track for their worst day in over four years.

Charles River and its peers have been grappling with soft demand for their services from biotech clients due to a funding crunch in the past year amid a high-interest-rate environment.

The company said demand from biotech clients is not expected to improve in the second half of the year, contrary to earlier predictions.

CEO James Foster added bookings and proposals from larger drugmakers declined, likely due to the U.S. Inflation Reduction Act's provision for the government negotiating drug prices, with the trend expected to continue into 2025.

The Massachusetts-based company is also set to implement restructuring initiatives, which is expected to realize $100 million this year. Foster said the company will align its capacity and staffing with the anticipated lower demand.

Charles River expects annual adjusted profit to be between $9.90 and $10.20 per share, compared with its prior expectations of $10.90 to $11.40 per share.

Analysts on average estimate profit for the period at $10.99 per share, according to LSEG data. The company expects full-year revenue to decrease by 2.5% to 4.5%, versus its previous forecast of an increase of 1% to 4%. Charles River's revenue fell 3.1% to $1.03 billion for the second quarter but beat Wall Street estimates of $1.02 billion. On an adjusted basis, the company posted a profit of $2.80 versus estimates of $2.39.

https://uk.finance.yahoo.com/news/charles-river-cuts-2024-forecast-122621340.html

US FDA approves Novartis' kidney disease drug

 The U.S. Food and Drug Administration has approved the use of Novartis' drug to reduce excess protein in the urine of patients with a type of kidney disease, the health regulator's website showed on Wednesday.

The drug, Fabhalta, is already approved to treat adults with paroxysmal nocturnal hemoglobinuria, a rare blood disorder.

With the expanded approval, Novartis' drug entered the IgA nephropathy (IgAN) market and will compete with Swedish drugmaker Calliditas' Tarpeyo and Travere Therapeutics' Filspari.

IgAN — which mostly affects young adults — occurs when clumps of antibodies are deposited in kidneys, causing inflammation that damages their tiny filtering units.

Guggenheim analyst Vamil Divan sees the IgAN market valuing at $10 billion over time as more treatments come to market.

The FDA's latest approval was based on a late-stage trial where Fabhalta showed a 43.8% reduction in proteinuria when compared to placebo.

Proteinuria is excess protein in the urine and can be a sign of the kidney failing to filter properly.

The Swiss drugmaker is also developing two other experimental drugs — zigakibart and atrasentan — for the treatment of IgAN.

The IgAN opportunity is much more tied with the other two drugs than Fabhalta, Divan had told Reuters before the FDA decision.

Otsuka and Vera Therapeutics are also working on treatments for the disease. In April, Vertex Pharmaceuticals had struck a $4.9 billion deal with Alpine Immune Sciences, gaining access to its experimental IgAN drug.

https://www.yahoo.com/news/us-fda-approves-novartis-kidney-182345325.html

'How US public schools became a new religious battleground'

  It is a foundational democratic tenet taught in every basic U.S. history course: the Constitution bars the government from endorsing an official religion or favoring one over others.

But moves by two Republican-governed states - Louisiana's requirement that public schools display the biblical Ten Commandments and Oklahoma's mandate that public schools teach the Bible - take aim at the Constitution's "establishment clause," long understood by courts as separating church and state.

Lawmakers in 29 states have proposed at least 91 bills promoting religion in public schools this year, according to Americans United for Separation of Church and State, an advocacy group backing a lawsuit challenging Louisiana's law. Rachel Laser, its chief executive, said the group tracked 49 similar bills in 2023.

The movement is fueled by opposition to what conservatives call liberal curriculums, including a focus on diversity and LGBT rights, and by the U.S. Supreme Court's willingness to overturn precedent as it moves American law rightward.

Republican Louisiana Attorney General Liz Murrill, whose office is defending the Ten Commandments law in court, said on Monday that legislators frustrated by a lack of discipline in schools turned to the biblical precepts to "start a conversation about order."

"That's the fundamental message that exists in our legal structures about what Moses stood for and what the Ten Commandments stood for," Murrill told a press conference.

When asked how non-religious parents could respond to the law, Republican Louisiana Governor Jeff Landry told the press conference they could tell their children not to look at Ten Commandments posters.

Conservatives are hopeful that legal challenges will give the Supreme Court an opportunity to reconsider longstanding limits on religious expression in public schools.

"They see the writing on the wall of what the Supreme Court is doing," said law professor Steven Green of Willamette University in Oregon, who wrote the book "Separating Church and State: A History."

A week after Louisiana in June became the first state to require schools to display the Ten Commandments since the Supreme Court struck down a similar Kentucky law in 1980, Oklahoma's schools superintendent, Ryan Walters, directed all public schools to teach from the Bible.

Under Oklahoma's guidelines, teachers will be given a copy of the Bible and focus on its historical context in Western society and American history, its literary significance, and its influence on the arts and music. Several Oklahoma school districts have refused to alter their curriculums to accommodate the policy change.

Walters did not respond to a request for comment.

In both states, officials said the religious texts are important to understanding the birth of American government. The claim echoes arguments by some Christian conservatives that the United States was founded as a Christian country, an idea many historians call inaccurate.

CHRISTIAN LAWMAKERS

The National Association of Christian Lawmakers (NACL), founded in 2020, has coordinated legislative efforts across different states. It has produced three dozen "model" bills for introduction in state legislatures, including one on the Ten Commandments and another requiring schools to display "In God We Trust" signs.

Republican Louisiana Representative Dodie Horton, the sponsor of that state's Ten Commandments bill and a member of the association, did not respond to a request for comment.

The next major battleground could be Republican-governed Texas, which passed the first law in the United States last year letting public schools hire chaplains as counselors. Similar bills subsequently were introduced in more than a dozen states.

The Texas board of education will decide in November whether to approve a new elementary school curriculum that includes Bible teachings. Texas Republican lawmakers are likely to revive bills requiring the display of the Ten Commandments in schools and allowing publicly funded vouchers to pay for student tuition at private religious schools.

In an interview last month at the Republican National Convention, the NACL's founder, former Arkansas state Senator Jason Rapert, argued that religious values are disappearing from American public life, imperiling the future.

"The Judeo-Christian history and heritage of the nation has been torn down in many places," Rapert said.

Opinion polls show that while a solid majority of Americans identify as Christians, the number has been declining for decades.

A CONSERVATIVE SUPREME COURT

The Supreme Court in 1962 ruled that school-sponsored prayer in public schools violated the establishment clause. But the court, which now has a 6-3 conservative majority, has taken an expansive view of religious rights in some important cases in recent years.

In 2022, it ruled that a Washington state public school district violated the constitutional rights of a Christian high school football coach who was suspended for refusing to stop leading prayers with players on the field after games. In doing so, it abandoned a 1971 precedent that had outlined how to determine if a law violated the establishment clause.

The ruling galvanized conservative Christians, as did the court's decision days earlier rolling back abortion rights.

The court also has made it easier for religious schools and churches to receive public money; exempted family-owned corporations from having to provide employee insurance coverage for women's birth control on religious grounds; and backed a Christian baker and a Christian web designer who refused to provide services for same-sex weddings.

Rapert called the court's evolving view on religion in public life a "great opportunity."

If new laws on religion and public schools are challenged at the Supreme Court, it will have to answer questions such as whether they make a denominational preference or coerce people to participate in a religion, said law and religion professor Michael Helfand of Pepperdine University in California.

"Should I feel religiously coerced if the state puts up the Ten Commandments in my classroom?" Helfand asked. "I could see a court going either way on that."

https://www.yahoo.com/news/us-public-schools-became-religious-101045622.html

Athletes undercover? Global and U.S. anti-doping agencies clash over tactics

 The global and U.S. anti-doping agencies are at odds over undercover tactics used by the American body to try to catch drug cheats, Reuters has learned.

The World Anti-Doping Agency (WADA) says U.S. agency USADA broke the global code by letting several athletes it had caught between 2011 and 2014 violating drugs rules go undercover and keep on competing without prosecution in exchange for information on other violators.

USADA says the tactic is necessary and allowed, and wants to keep using it. WADA says it is against its code and that athletes caught breaking doping rules should not get to line up in races, potentially winning prize money and medals, without first being publicly prosecuted and sanctioned.

The two agencies are also embroiled in dispute over the global system for policing doping in sport, sparked by the case of 23 Chinese swimmers which has cast a shadow over the Paris Olympics.

"WADA is now aware of at least three cases where athletes who had committed serious anti-doping rule violations were allowed to continue to compete for years while they acted as undercover agents for USADA, without it notifying WADA and without there being any provision allowing such a practice under the (global) code or USADA's own rules," WADA said in a statement to Reuters.

The global agency said the three athletes have since retired but declined to name them, citing security concerns in case they faced retaliation. It issued the statement after Reuters asked if it was aware of the practice, having seen speculation about it by sports fans on social media.

The U.S. agency has defended letting drug rule violators compete so they could act as undercover informants, saying in one case such assistance had provided intelligence to a U.S. federal law enforcement investigation into a human and drug trafficking scheme.

"It's an effective way to get at these bigger, systemic problems," USADA Chief Executive Travis Tygart told Reuters. The agency declined to provide specifics about the incident in which the reliance on USADA's informant had helped U.S. authorities.

Tygart, who is known for driving his agency's prosecution of U.S. cyclist Lance Armstrong, believes using violating athletes to expose more senior ones, as well as gather intelligence on organised criminals involved in sports doping and trafficking is the right thing to do.

"If you've got agents or others who are preying on athletes and trafficking … I think it's totally appropriate."

Under the world anti-doping code, to which USADA is a signatory, an athlete who "substantially" assists with a doping investigation can apply to have a proportion of any ban suspended after prosecution.

There is no specific wording that says athletes who have broken anti-doping rules can continue to compete without first being prosecuted and sanctioned.

EVOLVING BATTLE

The suggestion that the code "can be used to justify a failure to prosecute a case for years while doped athletes are sent back into the field as undercover informants to compete against clean athletes is obviously wrong," WADA said.

Tygart said given WADA's stance, they will refrain from using the tactic again unless the global agency gives it clearance but said WADA had adopted an "anti-clean sport position", and that USADA believed it was allowed under the code.

The fight against drug cheats in sport is a constantly shifting battle with anti-doping agencies trying to keep pace when the substances and technology used to gain unfair advantages keep changing.

Agencies now store samples taken from athletes for 10 years that can be retested later for currently unknown performance-enhancing substances. Retests of samples from the 2008 Beijing and 2012 London Olympics resulted in dozens of disqualifications and medals being reallocated as recently as this year.

WADA told Reuters that in 2021 USADA had informed it that from as early as 2011 it had allowed rule-breaking athletes to act as informants, and the global agency told it to stop the practice immediately.

WADA said that two of the athletes were low-ranking on the running circuit but one was higher profile.

The global agency said that by the time USADA informed it of the practice, the athletes involved had retired and that their safety would be a risk were WADA to pursue an appeal to have their racing results wiped out or prize money returned, given the informant work they had been doing.

The higher-profile athlete's "case was never published (made public), results never disqualified, prize money never returned, and no suspension ever served," WADA said.

WADA said its Intelligence and Investigations department assessed that the risks to the athlete were real enough that it could not refuse USADA's request to close the case.

"Being put in this impossible position, WADA had no choice but to agree," it said.

USADA said in a statement WADA was aware of the cases before 2021 and called the global agency's statement "a smear" made in response to criticism of their handling of the Chinese swimming case.

https://uk.news.yahoo.com/athletes-undercover-global-u-anti-103622430.html