U.S. News: FDA Clears Blood Cancer Treatment, Tested in China

"U.S. drug regulators approved a new customized, cell-based treatment for blood cancer from Johnson & Johnson that is the first such therapy in the U.S. to be developed initially in China.

The Food and Drug Administration on Monday cleared the therapy, named Carvykti, for the treatment of multiple myeloma in adult patients whose disease has worsened despite prior treatments with other drugs.

The approval suggests a possible path forward for Western drugmakers seeking to bring China-developed drugs to the U.S. amid concerns about the quality of the drugs' development: conducting separate, confirmatory studies in Americans.

In one of J&J's U.S. studies, about 98% of the 97 multiple-myeloma patients treated with Carvykti had a significant reduction in the proteins that signal the presence of myeloma, and 83% had a complete remission, indicating no detectable cancer cells, at a median of 22 months after treatment.

Joseph Mikhael, chief medical officer of the International Myeloma Foundation, said the effectiveness demonstrated in the study was "really unprecedented. That's why there's so much excitement around it."

Multiple myeloma is a cancer affecting plasma cells, and although other treatments have extended patients' survival in recent years, it is estimated to cause more than 12,400 deaths each year in the U.S., according to the American Cancer Society.

J&J's Carvykti belongs to a class of therapies known as CAR-T, short for chimeric antigen receptor T cell. CAR-T is a complex treatment that starts with extracting a patient's own T-cells, the infection-fighting white blood cells that are part of the immune system.

The patients' T-cells are genetically engineered in laboratories, so that when they are injected back into the patient about four weeks later, these modified T-cells target and kill cancer cells.

Development of some CAR-T therapies has also sparked safety concerns, which have forced companies to halt some trials. CAR-Ts can cause serious side effects such as overstimulating the immune system, and medical centers need to be specially trained to monitor patients after treatment.

On Monday, a Belgian company, Celyad Oncology SA, said it paused a study of an experimental CAR-T in people with colorectal cancer after two patients died. Celyad said it is investigating the deaths.

Carvykti is now the sixth CAR-T therapy cleared for use in the U.S., after Novartis AG, Bristol-Myers Squibb Co. and Gilead Sciences Inc. introduced others, all for blood cancers.

Uptake of the medicines hasn't been explosive partly because of the complexity of manufacturing and administering them to patients. In some cases, there has been a squeeze on the supply of a virus that is used in the production process. Combined sales of CAR-Ts have risen to $1.7 billion in 2021 from $340 million in 2018, according to the companies' earnings reports.

J&J has said Carvykti alone could eventually generate at least $5 billion in sales a year world-wide.

The therapies are some of the most expensive new drugs, some priced at more than $400,000 per patient. Drug-price watchdogs have called the pricing excessive, which could put them out of reach for some patients.

The companies note that CAR-Ts are given as a one-time treatment, have been found to be effective and are costly to develop and manufacture.

J&J's Carvykti carries a price tag of $465,000 per patient for the one-time treatment. The company expects most insurers and Medicare will cover the treatment, a spokesman said.

The previously approved CAR-T therapies were largely based on research and testing in Western countries." [1]

1. U.S. News: FDA Clears Blood Cancer Treatment
Loftus, Peter. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Mar 2022: A.2.

Energijos milžinai yra Putino apsaugos tinklas

 „Pirmadienį Rusijos finansų sistema buvo apgulta, tačiau šalis vis dar pumpuoja ir eksportuoja didžiulius kiekius naftos ir gamtinių dujų į likusį pasaulį, gaudama grynuosius pinigus Vakarų sankcijų akivaizdoje ir finansinę pagalvę prezidentui Vladimirui Putinui. Šios strategijos širdyje glūdi du į Londono biržos sąrašus įtraukti energetikos milžinai.

 

    Dujų eksportuotojas PJSC „Gazprom“ ir naftos milžinas „Rosneft PJSC“ finansuoja didelę Rusijos valstybės dalį ir yra vieni didžiausių šalies darbdavių. Nei vienai, nei kitai nebuvo taikomos didelės Vakarų sankcijos, o tai rodo jų svarbą pasaulinėse energijos rinkose. „Rosneft“ teigia, kad ji yra didžiausia Rusijos mokesčių mokėtoja, įnešanti penktadalį biudžeto pajamų. „Gazprom“ 2020 metais į Rusijos biudžetą sumokėjo 2,3 trilijono rublių arba 27,43 mlrd. JAV dolerių, pranešė bendrovė. Remiantis Tarptautinio valiutos fondo duomenimis, tai sudaro apie 6% biudžeto pajamų.

 

    Dviejų kompanijų akcijos pirmadienį smuko dėl platesnio Rusijos rinkos neramumų, kurį sukėlė pastarosiomis dienomis Maskvai įvestos Vakarų sankcijos. Rublio kursas krito, o Rusijos centrinis bankas smarkiai padidino palūkanų normas. Londone listinguojamos „Gazprom“ akcijos atpigo 53%, o „Rosneft“ – daugiau nei 42%.

 

    BP PLC sekmadienį pareiškė, kad pasitrauks iš beveik 20% „Rosneft“ akcijų po Didžiosios Britanijos vyriausybės, kuri nurodė Rusijos bendrovės ryšius su Kremliumi ir apkaltino ją, skatinant spaudimą Ukrainai. Pirmadienį „Shell PLC“ pareiškė pasitrauksianti iš bendrų įmonių su „Gazprom“, nurodydama Rusijos invaziją.

 

    Europoje „mes kariaujame ir turime laikyti tas bendroves Rusijos valstybės tęsiniu“, – sakė energetikos ekspertas ir „Sciences Po Paris“ profesorius Thierry Bros.

 

    „Gazprom“ ir „Rosneft“ į prašymus komentuoti neatsakė.

 

    Rusijos energijos pardavimo sutrikimas turėtų plačių pasekmių pasaulio ekonomikai: nuo smogimo Europos verslui ir vartotojams iki pakenkimo JAV klientams, perkantiems kurą automobiliams. Europos Sąjunga importuoja apie 40 % dujų ir daugiau nei ketvirtadalį naftos iš Rusijos.

 

    Rusijos vyriausybei ir jos kontroliuojamoms įmonėms priklauso daugiau, nei 50% „Gazprom“ akcijų. „Gazprom“ buvo įkurta 1989 m., kai Sovietų Sąjungos Dujų pramonės ministerija buvo paversta korporacija, išlaikant didžiąją dalį savo turto.

 

    Jai vadovauja Aleksejus Milleris, artimas V. Putino sąjungininkas. Kai 2018 metais jį asmeniškai nukentėjo nuo JAV sankcijų, J. Milleris pasakė: "Pagaliau aš įtrauktas. Taigi mes darome viską teisingai".

 

    Praėjusiais metais, kai Europoje dėl mažų atsargų ir padidėjusios paklausos dėl ekonomikos atsigavimo po pandemijos dujų kainos labai išaugo, Europos pareigūnai teigė, kad „Gazprom“ tyčia neparduoda papildomų dujų trumpalaikių neatidėliotinų produktų rinkoje.

 

    Europos įstatymų leidėjai paragino ištirti, ar tai buvo manipuliavimas rinka. „Gazprom“ taip pat eksploatuoja „Nord Stream 2“ – šiuo metu įšaldytą dujotiekio į Vokietiją projektą, kuris būtų leidęs Rusijai apeiti Ukrainos tranzito sistemą.

 

    Bendrovė ir Kremlius tvirtino, kad vykdė sutartinius įsipareigojimus. Rusijos valstybinė žiniasklaida pranešė, kad „Gazprom“ pirmadienį pareiškė, kad ir toliau reguliariai tiekia dujas į Europą vamzdynais Ukrainoje.

 

    Europos priklausomybę nuo Rusijos naftos ir dujų atspindi Rusijos priklausomybė nuo žemyno, kaip didžiausio energijos pirkėjo.

 

    Tačiau „Gazprom“ pastaraisiais metais siekė atsitraukti nuo Europos. Kaip dalis Kremliaus siekio užmegzti gilesnius santykius su Kinija, „Gazprom“ 2019 metais pradėjo tiekti gamtines dujas Kinijai per 55 mlrd. vertės "Sibiro galybės" dujotiekį.

 

    Be dujų, bendrovė remia įvairias sporto komandas Rusijoje ir užsienyje. Vokietijos futbolo klubas „Schalke 04“ ketvirtadienį paskelbė, kad po Rusijos invazijos į Ukrainą pašalins bendrovės logotipą nuo marškinėlių.

 

    Maskva jau seniai bandė padidinti savo geopolitinį ppoveikį per „Rosneft“. Bendrovė veržėsi į tokias šalis, kaip Irakas, Kinija, Kuba, Vietnamas ir Venesuela. Trumpo administracija 2020 metais įtraukė į juodąjį sąrašą „Rosneft“ dukterines įmones, kurios tariamai padėjo Venesuelai parduoti naftą, pažeidžiant JAV sankcijas. JAV pareigūnai apkaltino „Rosneft“, kad ji atviroje jūroje naudojo pavojingus perpumpavimus iš laivo į laivą, siekdama nuslėpti savo veiksmus, o jų geografinės padėties nustatymo atsakikliai buvo išjungti, kad būtų išvengta aptikimo.

 

    „Rosneft“ neigė pažeidusi JAV sankcijas Venesuelai, nors pavadino jas neteisėtomis, ir teigė, kad šalyje veikė gerokai prieš jų įvedimą. Vėliau bendrovė pareiškė, kad sustabdys visą veiklą Venesueloje ir parduos visą savo turtą, susijusį su veikla šioje šalyje.“ [1]

 

Kadangi Ukraina dabar tampa prorusiška, Rusijai „Nord Stream 2“ nebereikia. Vokiečiai galėtų panaudoti šį dujotiekį, kad vištas ten auginti, sumokant nedidelį mokestį Gazpromui.

 

1. The Ukraine Crisis: Energy Giants Are Putin's Safety Net

Kantchev, Georgi. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Mar 2022: A.11.  

Energy Giants Are Putin's Safety Net

"Russia's financial system was under siege on Monday, but the country is still pumping and exporting vast amounts of oil and natural gas to the rest of the world, delivering cash in the face of Western sanctions and a financial cushion for President Vladimir Putin. At the heart of it lie two London-listed energy giants.

Gas exporter Gazprom PJSC and oil giant Rosneft PJSC fund a large chunk of the Russian state and are among the country's largest employers. Neither has been targeted by major Western sanctions, a sign of their importance in the global energy markets. Rosneft says it is Russia's biggest taxpayer, contributing a fifth of budget revenue. Gazprom paid 2.3 trillion rubles, or $27.43 billion, to Russia's budget in 2020, the company said. That amounts to around 6% of budget revenue, based on International Monetary Fund data.

The two companies' shares plunged Monday amid a wider Russian market rout triggered by Western sanctions imposed on Moscow in recent days. The ruble tumbled and Russia's central bank raised interest rates sharply. London-listed shares of Gazprom fell 53% and Rosneft shed over 42%.

BP PLC on Sunday said it would exit its nearly 20% stake in Rosneft following pressure from the British government, which had cited the Russian company's links to the Kremlin and accused it of fueling the advance into Ukraine. On Monday, Shell PLC said it would exit its joint ventures with Gazprom, citing Russia's invasion.

In Europe, "we are at war and we need to consider those companies as an extension of the Russian state," said Thierry Bros, an energy expert and professor at Sciences Po Paris.

Gazprom and Rosneft didn't respond to requests to comment.

A disruption in Russia's energy sales would have widespread repercussions for the global economy, from hitting European businesses and consumers to hurting customers at the pump in the U.S. The European Union gets around 40% of its gas imports and more than one-quarter of its oil from Russia.

The Russian government and companies controlled by it own more than 50% of shares in Gazprom. Gazprom was created in 1989 when the Soviet Union's Ministry of the Gas Industry was converted to a corporation, retaining most of its assets.

It is run by Alexei Miller, a close ally of Mr. Putin. When he was personally hit by U.S. sanctions in 2018, Mr. Miller said, "Finally, I've been included. So we are doing everything right."

Last year, when gas prices soared in Europe because of low inventories and a surge in demand because of the economic recovery from the pandemic, European officials said Gazprom was deliberately not selling extra gas on the short-term spot market.

European lawmakers called for a probe into whether this amounted to market manipulation. Gazprom also operates Nord Stream 2, the now-frozen pipeline project to Germany that would have enabled Russia to circumvent Ukraine's transit system.

The company and the Kremlin have maintained that they have been meeting their contractual obligations. Gazprom on Monday said it continues regular supply to Europe via pipelines in Ukraine, Russian state media reported.

Europe's dependence on Russian oil and gas is mirrored by Russia's reliance on the continent as its biggest energy customer.

But Gazprom has sought to pivot away from Europe in recent years. As part of the Kremlin's bid for deeper relations with China, Gazprom began delivering natural gas to China through the $55 billion Power of Siberia pipeline in 2019.

Beyond gas, the company sponsors various sports teams in Russia and abroad. German soccer club Schalke 04 on Thursday said it would remove the company's logo from its jerseys following Russia's invasion of Ukraine.

Moscow has long tried to increase its geopolitical reach through Rosneft. The company has pushed into countries such as Iraq, China, Cuba, Vietnam and Venezuela. The Trump administration in 2020 blacklisted Rosneft subsidiaries for allegedly helping Venezuela sell its oil in violation of U.S. sanctions. U.S. officials accused Rosneft of using dangerous ship-to-ship transfers on the high seas in an effort to hide its actions, with their geolocation transponders turned off to evade detection.

Rosneft has denied breaking U.S. sanctions against Venezuela, despite calling them illegal, and said it was active in the country long before their imposition. Later, the company said it would halt all activities in Venezuela and sell all its assets related to activities in the country." [1]

 

Since Ukraine is ending up pro-Russian now, Russia does not need Nord Stream 2 anymore. Germans could use the pipeline to grow chickens there paying some small fee to the Gazprom.

 

1. The Ukraine Crisis: Energy Giants Are Putin's Safety Net
Kantchev, Georgi. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Mar 2022: A.11.  

 

Vardan Ukrainos Vakarai vienijasi

    „Vakarų lyderių strategija („Why Putin Is Outfoxing the West“, Walter Russell Mead, Global View, vasario 22 d.) Ukrainos atžvilgiu primena tai, ką komikas Patas Paulsenas pasakė, kai kandidatavo į JAV prezidentus 1968 m.: „Vieningi mes sėdime!"

 

     Davidas J. Grossas

 

     Šv. Augustinas, Fla.“ [1]

1. For Ukraine, the West Unites
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Mar 2022: A.22.

For Ukraine, the West Unites

"The strategy of Western leaders ("Why Putin Is Outfoxing the West" by Walter Russell Mead, Global View, Feb. 22) with regard to Ukraine reminds me of something comedian Pat Paulsen said when he ran for president in 1968: "United we sit!"

David J. Gross

St. Augustine, Fla." [1]

1. For Ukraine, the West Unites
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Mar 2022: A.22.

Uždrausti Rusijos karo lėktuvų skrydžius virš Ukrainos? Partizaninis karas Ukrainoje?

  „Hipotezės, kad V. Putino invazija kelia grėsmę ne tik Ukrainos suverenitetui, bet ir „pasaulinei demokratijai“ ar pačiai laisvei, kai kuriuos verčia siūlyti neeilinius atsakymus. Evelyn N. Farkas, buvusi atsakinga už Euraziją Obamos administracijoje, paragino tarptautinę koaliciją, kad virš Ukrainos būtų nustatyta neskraidymo zona. Iki šiol Bideno administracija apdairiai ignoravo šį ir kitus panašius variantus, pripažindama, kad Amerikos interesai Ukrainoje nepateisina rizikos kariauti su branduoline ir gerai ginkluota Rusija. 

 

Eliotas Cohenas pasiūlė, kad JAV apginkluotų hipotetinį Ukrainos sukilimą, kurį, kaip pranešama, svarstė Bideno administracija, kad padidintų Rusijos išlaidas ir atgrasytų kitas tautas, kurios, galbūt, svarsto panašią veiklą. Tačiau Ukraina plokščia šalis, netinkama partizaniniam karui. Sukilimo rėmimas gali įžiebti platesnį JAV ir Rusijos konfliktą ir padidinti smurtą Ukrainos civiliams“. [1]

 

1. The U.S. Shouldn't Interfere While Putin Loses in Ukraine
Hannah, Mark. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Mar 2022: A.23.

Guerrilla warfare in Ukraine? No-fly zone over Ukraine?

"The hypothesis that Mr. Putin's invasion poses a threat not only to Ukrainian sovereignty but to "global democracy" or freedom itself leads some to propose extraordinary responses. Evelyn N. Farkas, who served as deputy assistant secretary of defense for Russia, Ukraine and Eurasia in the Obama administration, has called for an international coalition to enforce a no-fly zone over Ukraine. So far, the Biden administration has prudently ignored this and other such options, recognizing that America's interests in Ukraine don't justify risking war with a nuclear-armed Russia.

 

Eliot Cohen has proposed that the U.S. should arm a hypothetical Ukrainian insurgency -- which the Biden administration has reportedly considered -- to raise the costs for Russia and deter other nations that might be considering similar activities. But Ukraine is a flat country unsuited to guerrilla warfare. Backing an insurgency could ignite a wider conflict between the U.S. and Russia, and increase the violence inflicted on Ukrainian civilians." [1]

 

1. The U.S. Shouldn't Interfere While Putin Loses in Ukraine
Hannah, Mark. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Mar 2022: A.23.