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Monday, December 18, 2023

LNG Vessels Begin to Reroute Away From Red Sea on Rising Tension

 

Liquefied natural gas tankers are diverting their routes from the Red Sea as violence linked to the Israel-Hamas war threatens longer journeys and delays of the super-chilled fuel.

At least five ships have changed course since Friday away from waters off the coast of Yemen, an unavoidable waypoint for ships using the Suez Canal that links Europe and Asia, according to ship-tracking data compiled by Bloomberg. It isn’t immediately clear if all ships were diverted due to the tension.

https://www.bloomberg.com/news/articles/2023-12-19/lng-vessels-begin-to-reroute-away-from-red-sea-on-rising-tension

Wasted wind power adds £40 to household energy bills, says think tank

 Wasted wind power will add £40 to the average UK household's electricity bill in 2023, according to a think tank.

That figure could increase to £150 in 2026, Carbon Tracker has estimated.

When it is very windy, the grid cannot handle the extra power generated. Wind farms are paid to switch off and gas-powered stations are paid to fire up. The cost is passed on to consumers.

The government said major reforms will halve the time it takes to build energy networks to cope with extra wind power.

Energy regulator Ofgem announced new rules in November, which it said would speed up grid connections.

Bottleneck

Most of the UK's offshore wind farms are in England - Dogger Bank off the coast of Yorkshire is the largest in the world. Meanwhile, around half of onshore wind farms are in Scotland but most electricity is used in south-east England.

Carbon Tracker said the main problem in getting electricity to where it is needed is a bottleneck in transmission between Scotland and England.

The practice of switching off wind farms and ramping up power stations is known as "wind curtailment" and the costs are passed on to consumers, it said.

Carbon Tracker researches the impact of climate change on financial markets. It said since the start of 2023, wind curtailment payments cost £590m, adding £40 to the average consumer bill.

It warned those costs were set to increase to add £180 per year to bills by 2030, due to wind farms being built faster than the power cabling needed to transmit the electricity.

"The problem is, there are not enough cables. The logical solution would be to build more grid infrastructure," said Lorenzo Sani, analyst at Carbon Tracker.

"It's not even that expensive," he added, compared with mounting wind curtailment costs.

Industry group RenewableUK said that grid constraints "reflect a chronic lack of investment in the grid".

"We need to move from an antiquated grid which wastes power to one that's fit for purpose in the 21st Century as fast as possible," said Barnaby Wharton, RenewableUK's director of future electricity systems.

However, historically it has taken between 10 and 15 years for new transmission cables to be approved.

The government is offering people living next to new pylons and electricity substations up to £1,000 off energy bills for 10 years, and councils money for projects in local areas.

Last year Ofgem approved four projects to help ease transmission issues, including an undersea cable between Peterhead in Aberdeenshire and Drax in Yorkshire.

But Carbon Tracker warned wind generation capacity in Scotland was set to be four times greater by 2030, but cabling would only double in that time, under current plans.

'Zombie projects'

In November, the government set out a plan to reduce the time it takes to build new infrastructure from 14 to seven years, "speeding up grid connections, supporting thousands of jobs and reducing electricity bills for households across Great Britain", a spokesperson said.

Energy regulator Ofgem said there was a "long queue" of energy projects "which could generate almost 400GW of electricity - well in excess of what is needed to power the entire British energy system".

The watchdog said new rules "will allow stalled or speculative 'zombie' projects to be forced out of the queue, meaning viable projects can be connected quicker".

Mr Sani from Carbon Tracker said it was unclear how much difference these projects would make before 2030.

https://www.bbc.com/news/business-67494082

Panbela: US WorldMeds NDA Approval for Eflornithine (DFMO) in Pediatric Neuroblastoma

 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that US WorldMeds®1 (USWM), a Kentucky-based specialty pharmaceutical company to whom it divested certain assets in its eflornithine pediatric neuroblastoma program, received FDA approval of its New Drug Application (NDA) for the use of eflornithine as a maintenance therapy for high-risk neuroblastoma patients who have achieved at least a partial response to certain prior therapies.

The approval of USWM’s NDA for the use of eflornithine for the treatment of patients with high-risk neuroblastoma marks the first FDA approval of an NDA for any polyamine targeted therapy in a cancer indication. “This approval highlights the role polyamines can play in cancer therapy as we look forward to data from our ongoing programs in metastatic pancreatic cancer, colorectal cancer, non-small cell lung cancer, and prostate cancer and the advancement of pre-clinical programs in ovarian and multiple myeloma,” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.

In July 2023, Panbela divested its pediatric neuroblastoma program to USWM in an arrangement entitling Panbela to up to approximately $9.5 million of non-dilutive funding, including payments upon USWM’s successful completion of milestones related to eflornithine's clinical development, regulatory approval, and commercial sales.

https://www.globenewswire.com/news-release/2023/12/18/2797829/37414/en/Panbela-Therapeutics-Announces-US-WorldMeds-NDA-Approval-for-Eflornithine-DFMO-in-Pediatric-Neuroblastoma.html

March-in rights to address drug prices would kill future world-changing innovations

 The Bayh-Dole Act is widely credited with kickstarting a new era of American innovation involving the launch of 17,000 startup companies and some 495,000 inventions.

Yet despite this success, Bayh-Dole now finds itself vulnerable — and from a surprising source.

Back in 1980, a young senator from Delaware named Joe Biden was among those who supported Bayh-Dole in the Senate Judiciary Committee. His “yes” contributed to the bill’s 91-4 approval in the Senate. Later in his Senate career, Biden voted against then-Rep. Bernie Sanders’ attempt to amend the law so the government could second-guess the pricing of successfully commercialized inventions. As president, his administration issued one of the strongest denials of attempts to misuse the law for the same purpose.

But last week, the administration changed course, announcing plans to radically reinterpret Bayh-Dole.

The law hasn’t changed. So the move can only be explained by politics.

As the executive director of the Bayh-Dole Coalition, which works to inform policymakers and the public of the Bayh-Dole Act’s many benefits, I shudder to imagine a future in which the law is upended. What world-changing innovations might never come to fruition? Technologies to fight climate change? A cure for cancer? The answer to food insecurity?

The Bayh-Dole Act was a response to the malaise of the late 1970s when American industry struggled to keep up with international competitors.

Part of the problem was that universities, small companies, and federal labs were making breakthrough discoveries with government funding — but they were rarely commercialized.

That’s because, at the time, government agencies retained the patent rights on discoveries made in whole or part with federal support. Since the government could license these patents to anyone, investors lacked the incentives needed to risk turning early-stage inventions into useful products.

In fact, according to the Government Accountability Office, fewer than 5% of the 28,000 patents held by federal agencies before Bayh-Dole were ever licensed.

In light of these facts, Sens. Birch Bayh, a Democrat, and Bob Dole, a Republican, conceived a plan. Under their act, universities, federal research labs, and small companies would retain the patent rights to their discoveries if they had received federal grants or contracts.

Universities could then license those patents to private companies. This change ignited an unprecedented innovation revolution, catapulting the U.S. to dominance.

The law aligned the incentives of private companies with those of universities. It also rewarded taxpayers, who now benefited from the commercialization of discoveries made with federal funding.

Countless products we take for granted wouldn’t exist without Bayh-Dole — including Google, touchscreen phones, and a host of breakthrough medicines. Bayh-Dole is helping today’s innovative companies bring tomorrow’s technologies to the market in fields like quantum computing, robotics, and AI.

Sens. Bayh and Dole foresaw potential pitfalls in their legislation and created safeguards against them.

One possibility was the prospect of a deep-pocketed corporation licensing research, not with the intent of developing it, but simply to keep a rival from using it.

Suppose one of the big three automakers bought exclusive rights to commercialize electric-car technology, only so it could shelve the concept and keep selling gas-guzzlers?

The answer was what would come to be known as “march-in.” If a patent-holder failed to commercialize a discovery in a timely way, or the university was trying to license it on unreasonable terms, the government could “march in” and force the university to license the technology to someone else on reasonable terms.

The government could also march in if the product wasn’t being manufactured domestically as the licensee had agreed to do or produced in sufficient quantity to meet health or safety needs or to meet federal regulatory requirements. But in 43 years, Washington has never had to exercise its march-in authority, because universities diligently enforce licensing agreements.

This hasn’t stopped the law’s opponents from claiming to have found a hidden meaning in the law’s march-in provision. In 2002, two academics took to the Washington Post to claim that the law could be used to regulate drug prices. Never mind that the law says no such thing. Bayh and Dole even replied to the op-ed by declaring, “Bayh-Dole did not intend that government set prices on resulting products.”

Nonetheless, ever since then, critics of Bayh-Dole have argued that price should trigger march-in. Every administration has rejected this claim. Until now.

That includes the Obama administration, the Trump administration, and even the Biden administration, which in March 2023 rejected activists’ petition to relicense patents on Xtandi, the prostate cancer drug.

What every administration understood is that if patent protections can be yanked for subjective reasons, then Bayh-Dole’s foundation becomes shaky, with patent licensing deals left vulnerable to bureaucratic whim.

But now the Biden administration has changed course. Last week, it proposed a framework that, if codified, would allow government agencies to exercise march-in if someone doesn’t like how a successfully commercialized product is priced. That’s a completely capricious concept.

This radical reinterpretation would discourage public-private partnerships and prevent transformational discoveries from reaching consumers.

Why would anyone assume the expense and risk of commercializing a federally supported invention if, at any time, Washington could give the fruits of your labor to copiers?

Even if entrepreneurs were themselves willing to shoulder those risks, they’d struggle mightily to raise capital, since any federally backed patent would effectively have a scarlet letter attached. The framework would allow political activists and rival companies, or even our foreign competitors, to petition the government at any time and for any reason. And even if these petitions are ultimately rejected, they cast a cloud over the technology and would hamstring the entrepreneurial small companies which drive our economy just as they are most vulnerable.

Why would administration officials permit such a body blow to the world’s best innovation system? The recently released march-in guidelines were heralded as a potent weapon to lower drug costs. They are no such thing; the vast majority of drugs are protected by multiple patents, most of which were made by the developer at their own expense, so not susceptible to march-in. And the impact would be felt across all industries, including energy, agriculture, computing, and so much else.

A full seven in 10 university patent licenses go to small companies. They are the ones who now have a target on their backs.

For 43 years, Bayh-Dole has been a driver of our economy and the source of incredible public benefits. This simply cannot be lightly jeopardized just to score political points.

Joseph P. Allen is executive director of the Bayh-Dole Coalition.

https://www.statnews.com/2023/12/15/march-in-rights-bayh-dole-act-drug-prices-biden/

Kronos: AML data does not support continuing to phase 2

 Phase 1b portion of phase 1b/2 lanraplenib study in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia completed; review of data does not support continuing to phase 2

New development candidate KB-9558 inhibits the KAT domain of p300 and thereby modulates IRF4, a key driver of multiple myeloma; IND-enabling studies underway for expected completion in Q4 2024

Kronos Bio’s first development candidate, KB-0742, cleared 80 mg dose in dose escalation portion of the phase 1/2 trial; trial progresses in solid tumor expansion cohorts

Expected cash runway maintained into 2026 

https://www.globenewswire.com/news-release/2023/12/18/2798137/0/en/Kronos-Bio-Announces-Pipeline-Update-and-p300-KAT-Inhibitor-Development-Candidate.html

More Kids Under Age 4 Have Severe Obesity: Study

 Severe obesity among preschool-age children from low-income families is on the rise in the U.S., according to a new analysis of federal data.

An estimated 2% of children ages 2 to 4 years old had severe obesity in 2020, up from 1.8% in 2016, according to the report that appeared Monday in Pediatrics, a journal published by the American Academy of Pediatrics. 

The increase is "small but significant," a group of experts not involved in the research wrote in a companion commentary published alongside the research.

The new data put an end to hopes that childhood obesity was on the retreat following a small decrease in rates from 2010 to 2016. Instead, the researchers noted that the new childhood obesity figures reflect those of the general population. About 20% of children and teens in the U.S. are obese, and about 42% of adults in the U.S. are obese, according to the CDC.

This latest study looked for severe obesity, which was defined as being well above the 95th percentile for the combined height-weight measure known as body mass index. The figures are important because rates of severe obesity among young children can foreshadow health problems that may occur on a scale to warrant concerns among public health officials, policymakers, and health care professionals.

Compared to children who have moderate obesity, children with severe obesity "are at a greater risk of various health complications, including cardiovascular disease, metabolic syndrome, type 2 diabetes, fatty liver disease, and premature death," the study authors wrote.

The largest increases from 2016 to 2020 in severe obesity were observed among 4-year-olds and among Hispanic children. When looking at state-level data, Alaska was the only state to report a decline in severe obesity among young child children from 2016 to 2020.

The new estimates were drawn from data on children enrolled in the federal Special Supplemental Nutrition Program for Women, Infants, and Children, also known as WIC.

"WIC is a federal assistance program that provides healthy foods, nutrition education, health care referrals, and other services to millions of low-income pregnant and postpartum women, as well as infants and children up to age 5, who are at nutritional risk," the researchers summarized.

The new figures indicate 16.6 million children ages 2 to 4 years old have severe obesity. Having severe obesity at these early ages is "nearly irreversible," the authors of the commentary article noted, adding that little research exists that indicates how to effectively treat obesity before age 6.

"The study underscores the need for ongoing monitoring... post-pandemic of children's health status," a news release from the American Academy of Pediatrics stated. "It also further supports the need for children and families from households with lower incomes across the nation to have access to early clinical detection, such as healthcare screenings and referrals to effective family-based interventions to support healthy growth."

Sources:

Pediatrics: "Trends in Severe Obesity Among Children Aged 2 to 4 Years in WIC: 2010 to 2020," "Severe Obesity in Toddlers: A Canary in the Coal Mine for the Health of Future Generations."

CDC: "Prevalence of Childhood Obesity in the United States," "Adult Obesity Facts," "BMI Percentile Calculator for Child and Teen."

American Academy of Pediatrics: "New Study Shows Recent Upward Swing in Severe Obesity Among Children in WIC."

https://www.medscape.com/s/viewarticle/more-kids-under-age-4-have-severe-obesity-study-2023a1000vu1

Ionis: Euro licensing agreement with Otsuka in hereditary angioedema

 

  • Otsuka to leverage strong commercial infrastructure and rare disease experience to reach European HAE patients
  • Ionis plans to independently bring donidalorsen to U.S. patients if approved
  • Donidalorsen Phase 3 results expected in the first half of 2024