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Tuesday, February 21, 2023

Nuclear risk seen rising as Putin unpicks last treaty with U.S.

 The last remaining treaty that limits Russian and U.S. nuclear weapons was already in grave peril before President Vladimir Putin announced on Tuesday that Moscow was suspending its participation.

Now it may be beyond repair, raising the risk of a new arms race - in parallel with the war in Ukraine - in which neither side can rely on the stable, predictable framework that successive nuclear accords have provided for more than 50 years.

Security analysts said that could hugely complicate the delicate calculus that underpins mutual deterrence between the two countries, while also spurring other powers such as China, India and Pakistan to build up their nuclear arsenals.

In a major speech almost a year after his invasion of Ukraine, Putin said Russia was not abandoning the New START treaty - the agreement signed in 2010 that limits the number of Russian and U.S. deployed strategic nuclear warheads.

But nuclear experts noted the treaty contains no provision for either side to "suspend" its participation, as he said Moscow was doing - they only have the option to withdraw.

Putin said Russia would only resume discussion once French and British nuclear weapons were also taken into account - a condition the analysts said was a non-starter, as it was opposed by Washington and would require a complete rewriting of the treaty.

William Alberque, director of strategy, technology and arms control at the International Institute for Strategic Studies, said Russia had decided it could live without New START but was seeking to put the blame on Washington.

"They've already made the calculation the treaty will die. The effort will be to pin the actual loss on the United States," he said in an telephone interview.

The treaty effectively limits the number of warheads per missile that either side can deploy, so its demise could instantly multiply the warhead count several times over, Alberque added.

According to the Federation of American Scientists, Russia has an estimated 5,977 nuclear warheads in total, while the United States has 5,428.

"Both sides could immediately go from 1,550 deployed strategic warheads to 4,000 - that could happen overnight," Alberque said.

That is potentially destabilising because it creates a "use or lose" dilemma in which dense concentrations of the opponent's warheads present more attractive targets, he said.

"HUGE INSTABILITY"

Putin justified the Russian move by saying it was "absurd" for the United States to demand the right to inspect Russian nuclear sites, as the treaty allows, while NATO was helping Ukraine to attack them.

He was apparently referring to what Russia says were Ukrainian strikes in December on its Engels airfield near Saratov, 730 km (450 miles) southeast of Moscow, where Russian strategic bomber planes are based. Putin said, without providing evidence, that NATO specialists had "equipped and modernized" drones to conduct the attacks.

Ukraine has followed a policy of not publicly claiming responsibility for attacks on Russian soil.

James Cameron, a post-doctoral fellow at the Oslo Nuclear Project, said that if New START was abandoned, it would mark a return to Cold War-style guesswork about the adversary's capabilities and intentions.

"So you have a huge instability in the relationship where both sides are acting on the worst-case scenario, adding ever more elaborate systems and plans for their use, and that ultimately leads to a much more unstable situation between the two sides and also greater risk of some kind of nuclear use," he said in a telephone interview.

Both analysts said it was concerning that Putin had flagged the possibility that Russia might resume testing of nuclear weapons, even though he said Moscow would not take that step unless Washington did so first.

They said that could pave the way for Putin to accuse Washington of conducting or preparing a test in order to justify one of his own.

If he did, it would be Moscow's first since 1990, the year before the breakup of the USSR. Alberque noted that the United States and the Soviet Union had used nuclear tests during the Cold War "to signal to each other when they were mad".

Cameron said any Russian test would also be seen as a rung on the ladder of escalation in Ukraine and "an attempt to signal greater readiness to use nuclear weapons" in the context of the war. In the 12 months since the invasion, Putin has repeatedly reminded the West that Russia has weapons of mass destruction and has extended its nuclear umbrella to areas of Ukraine that Moscow has seized and now claims as its territory.

In the event that New START collapsed, or the two sides failed to renew it before it expires in February 2026, it would mark the end of more than half a century of arms control pacts between the two sides, and send a signal to other existing and would-be nuclear powers.

"What would that tell the Indians and Pakistanis, what would China do?" Alberque said. "This could be much more dangerous than the Cold War because you could have many more players racing up to higher numbers, and that would be terrible for global security."

https://www.yahoo.com/news/analysis-nuclear-risk-seen-rising-165354598.html

J&J loses challenge to $302 million judgment over pelvic mesh marketing

 The U.S. Supreme Court on Tuesday let stand a $302 million judgment against Johnson & Johnson in a lawsuit brought by the state of California accusing the company of concealing the risks of its pelvic mesh products.

The court, following its usual practice, did not give any reason for refusing to hear J&J's appeal.

J&J had argued to the Supreme Court that state consumer protection laws like California's are too vague, exposing companies to unpredictable state lawsuits. Business groups including the U.S. Chamber of Commerce backed the company.

California Attorney General Rob Bonta in a statement called the court's decision "a definitive win in our fight for justice."

J&J said in a statement that the Supreme Court's rejection of the case will lead to continued "uneven, unclear and unfair enforcement that harms both consumers and businesses."

California sued New Jersey-based J&J in 2016 in San Diego Superior Court. The case stemmed from a multistate investigation into J&J subsidiary Ethicon Inc's marketing of pelvic mesh devices, which are surgical implants that were used to treat incontinence and other conditions.

J&J and other mesh makers were already facing numerous private lawsuits by women who said they suffered pain, urinary problems, bleeding and other serious injuries from the devices. The lawsuits have resulted in more than $8 billion in settlements.

J&J, which stopped selling pelvic mesh in 2012, has denied wrongdoing. In 2019, the U.S. Food and Drug Administration ordered all pelvic mesh devices off the market.

Later that year, J&J and Ethicon reached a $117 million settlement with 41 states and the District of Columbia to resolve claims that they concealed the products' risks.

California did not take part in that settlement, and its lawsuit resulted in a $344 million judgment in January 2020 following a non-jury trial.

A judge found that Ethicon's marketing materials about the mesh devices, and its instructions for using them, deceived doctors and patients by failing to disclose serious risks, violating the state's unfair competition and false advertising laws.

A California appellate court last year cut $42 million off the award.

https://sports.yahoo.com/j-j-loses-challenge-302-164156214.html

Airlines Turn Market Darlings as Covid Forces Financial Clean Up

 Unloved during the pandemic as their businesses were incapacitated almost overnight, airlines that cut back to survive the crisis are now blowing through profit forecasts and luring back investors.

Virgin Australia, so financially frail when Covid-19 hit in 2020 that it folded in weeks, has undergone a remarkable transformation under new owner Bain Capital. Free of much of its debt after exiting administration and with a scaled down fleet, the airline is making money for the first time in years. It plans to relist in Sydney, possibly this year.

These freshly — and forcibly — streamlined carriers are capitalizing on a surge in travel since virus restrictions fell away. The International Civil Aviation Organization expects passenger demand to recover to pre-Covid levels on most routes this quarter and then to about 3% higher than 2019 levels by year-end.

“Aviation is investible again,” said Jun Bei Liu, a portfolio manager at Tribeca Investment Partners in Sydney who oversees A$1.2 billion ($822 million) in funds. “Asian airlines are going to go through the roof.”

A Bloomberg gauge of 29 airlines from around the world has climbed almost 30% since the end of September.

The reopening of China, the largest outbound travel market before the pandemic, should drive a fresh traffic rebound in and out of favored destinations like the US, Japan and Singapore. In Hong Kong, hammered by China’s shutdown, Cathay Pacific Airways Ltd. will this year make its first profit since 2019, according to analyst forecasts.

It’s an extraordinary turnaround for an industry that suffered losses approaching $200 billion over the past three years. Tens of thousands of pilots, flight crew, ground workers and back-office staff lost their jobs, while facilities in Californian and central Australian deserts filled up with unwanted aircraft.

Carriers will generate profits of $4.7 billion in 2023, according to the International Air Transport Association. While that’s a fraction of the $26.4 billion airlines made in 2019, key financial ratios indicate the industry is on its soundest footing in years.

The ability to repay debt using earnings, for example, is back to pre-pandemic levels and will strengthen through 2025, according to data compiled by Bloomberg. That means airlines are more able to weather periodic demand shocks, like the one that undid Virgin Australia, and less likely to default.

“Considering the doom and gloom forecast during the pandemic, the industry is doing quite well,” said Volodymyr Bilotkach, associate professor in aviation management at Indiana’s Purdue University and author of the book The Economics of Airlines. “Following crises, some airlines emerge in better shape than before.”

The rejuvenation hasn’t been uniform. Norway’s Flyr AS this month filed for bankruptcy less than two years after starting flying. Days earlier, British low-cost carrier Flybe ceased operations after collapsing into administration.

The failures are more closely aligned with Warren Buffett’s assessment of the industry more than a decade ago. “The worst sort of business is one that grows rapidly, requires significant capital to engender the growth, and then earns little or no money,” the Berkshire Hathaway Inc. chairman wrote in an annual investor letter. “Think airlines.”

Supply and Demand Shift

What’s different now is the huge gulf between limited available seats on aircraft and the public’s strong appetite for travel, which is allowing airlines to supercharge fares.

“The supply-demand dynamics are as different than they’ve ever been in my career,” United Airlines Holdings Inc. Chief Executive Officer Scott Kirby said on an earnings call last month. “Every data point keeps demonstrating it over and over again. I think margins across the board are going to be higher.”

Reporting record fourth-quarter revenue last month, American Airlines Group Inc. CEO Robert Isom said navigating the pandemic had made the carrier more efficient — its fleet is simpler and the network focuses on the most profitable flights. “This is our best-ever post-holiday booking period,” he said. “We expect the strong demand environment to continue in 2023.”

The demand surge coincides with constrained labor supply. For many passengers, that’s translated into long queues at understaffed check-in counters or lengthy waits at baggage carousels. For investors, it means some of the airlines they own are generating more than twice as much revenue per worker than they were two years ago.

Ryanair Holdings Plc, Europe’s largest discount airline, returned to profit in the quarter through December and sees no end to its lucrative run. “We will deliver record profits in the current financial year and we would expect to continue to grow profitably into next year and beyond,” Chief Financial Officer Neil Sorahan said in an interview.

The Dublin-based airline ordered dozens of fuel-efficient Boeing Co. Max jets during the slowdown.

Australian Rebound

Virgin Australia provides perhaps the sharpest “then-and-now” contrast.

For the best part of a decade before the pandemic, the airline reported annual losses, burned through shareholder capital each year, and occasionally asked investors for more money.

Under Bain’s ownership, Virgin Australia has cut thousands of jobs, got rid of long-distance planes, and now flies only shorter-haul Boeing 737s. CEO Jayne Hrdlicka — former boss of Qantas’s low-cost airline Jetstar — has reined in spending on lounges and scaled back international routes.

“Their cost management is far superior,” said Neil Hansford, chairman of Australian consultancy Strategic Aviation Solutions. “Virgin is skinnier.”

Now the airline is planning what could be one of Australia’s biggest listings of the year. Bain has picked Goldman Sachs Group Inc., UBS Group AG and Barrenjoey Capital Partners Pty as lead managers for the possible share sale, a person familiar with the matter said last week.

In an email to staff on Jan. 31, Hrdlicka said revenue was about A$2.5 billion in the six months through December, with a profit margin of around 5%. The airline’s first profit in years “is certainly a milestone to quietly celebrate,” she wrote.

https://www.yahoo.com/now/airlines-turn-market-darlings-covid-210000002.html

uniQure: EC OK of the first gene therapy for adults with hemophilia B

 Historic approval represents the first gene therapy in Europe to treat hemophilia B and provides a new treatment option for patients that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy, and generates elevated and sustained factor IX levels ~

~ Approval marks uniQure’s second internally-developed and manufactured gene therapy to achieve licensure in the European Union 

https://www.biospace.com/article/releases/uniqure-announces-the-european-commission-approval-of-the-first-gene-therapy-for-adults-with-hemophilia-b/

Corvus Pharma's HIV Candidate Shows Potential To Prevent Virus Re-Emergence

 

  • Corvus Pharmaceuticals Inc (NASDAQ: CRVS) announced new data demonstrating the potential of CPI-818, an ITK inhibitor, to reduce the need for chronic human immunodeficiency virus (HIV) therapy.

  • For people living with HIV on antiretroviral therapy, HIV can be reduced to levels below detection limits, which enables the restoration and preservation of immune system function, reduces HIV-associated morbidity, and prevents HIV transmission.

  • However, in these individuals, the virus persists in a latent form in CD4 cells, which are white blood cells that are a key component of the immune system that HIV destroys.

  • Viral latency is reversed if therapy is discontinued, leading to a re-emergence of replicating HIV and destroying CD4 cells, necessitating the patients to be on life-long therapy.

  • Previous studies have shown that ITK is involved in several steps in the HIV life cycle. In this study, researchers explored the potential of ITK inhibition with CPI-818 to inhibit the latency reversal of HIV.

  • The cells were simultaneously treated with various concentrations of CPI-818. Each model showed a statistically significant and dose-dependent reduction in the reversal of viral latency, including four HIV patients.

  • In CD4 T cells, CPI-818 inhibited the proliferation of HIV-infected cells more than uninfected cells.

Optinose Submits Supplemental New Drug Application for XHANCE Label Expansion

 Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the submission of its supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to request approval of XHANCE as a treatment for chronic rhinosinusitis. XHANCE® (fluticasone propionate) nasal spray is a drug device combination product combining an anti-inflammatory drug with the innovative Exhalation Delivery System™ (EDS™) that is designed to uniquely deliver drug high and deep into nasal passages. The sNDA submission is based on data from the two Phase 3 clinical trials from the ReOpen Program in patients suffering from chronic sinusitis and was submitted to the FDA on February 16, 2023.

https://finance.yahoo.com/news/optinose-submits-supplemental-drug-application-120000097.html

Ionis' Additional Hereditary Angioedema Data Backs 'Highly Competitive Profile': Blair

 

  • Ionis Pharmaceuticals Inc (NASDAQ: IONS) announced additional interim data from a Phase 2 open-label extension (OLE) study of donidalorsen for hereditary angioedema.

  • Interim data presented in November 2022 showed that treatment with donidalorsen resulted in an overall sustained mean reduction in HAE attack rates of 95% from baseline.

  • In the latest update, patients treated for one year with donidalorsen showed a clinically meaningful 24-point mean improvement in their Angioedema Quality of Life (AE-QoL) total score relative to baseline, with improvements observed in all domains.

  • An improvement of 6 points or more is considered clinically meaningful.

  • William Blair notes donidalorsen showed improvements in all domains, which include functioning, fatigue/mood, fears/shame, and food.

  • The analyst views these additional interim results as highly encouraging for donidalorsen, and believes they continue to support a highly competitive profile in an increasingly crowded space.

  • It reiterates Outperform rating.

  • The analyst says that donidalorsen is a potentially differentiated and wholly-owned growth driver for Ionis if the Phase 2 dataset can be replicated in the larger OASIS studies expected to read out in 2024.

  • Ionis continues to advance a robust mid- and late-stage pipeline while generating significant non-dilutive funds through research collaborations to support internal efforts, which limits capital risk in this uncertain macro environment.