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2024-07-24 10:07

NEW YORK, July 24 (Reuters) - Big pharmaceutical companies that make personalized blood cancer treatments are working to cut the manufacturing turnaround time by as much as half in coming years, as they try to deliver them sooner in a patient's disease course. These treatments known as CAR-T therapies are used for the sickest patients for whom standard treatments have failed. They involve removing a patient's T cells - a key component of the immune system - after which they are re-engineered to recognize and attack malignant cells once they are re-infused. Gilead Sciences (GILD.O) , opens new tab, Novartis (NOVN.S) , opens new tab, Johnson & Johnson (JNJ.N) , opens new tab, and Bristol Myers Squibb (BMY.N) , opens new tab have made billions from their treatments, which can extend lives by months or years for patients with aggressive advanced cancers. Trimming days or weeks from the time it currently takes between removing and reintroducing the cells to a patient could open the treatment to those who otherwise would become too sick during the process, according to three doctors, the companies and analysts. Prices for the one-time treatment range from $400,000 to nearly $600,000, and analysts estimate they currently have profit margins of about 50%, so expanding the patient population is not insignificant. Oppenheimer & Co analyst Hartaj Singh said only around 1 in 5 eligible patients receive CAR-T treatments. "It's complex manufacturing using the patient's own cells, but because some of the responses reported are just so long and durable, physicians will go to it," Singh said. "It's the biggest gun out there." Time to treatment, which was as long as 37 days when the first CAR-T therapy was launched in 2017 by Novartis, are now down to 14 days at Gilead. Improvements in automation and regulatory adjustments could help companies further trim that time. Singh said physicians suggested to him that a one-week turnaround could expand these treatments to 2 or 3 out of 5 eligible patients. Improvements in manufacturing time could be a competitive edge when therapies are approved for the same cancer or population and directly compete, and could give companies a leg up on more quickly available treatments such as antibodies or antibody drug conjugates, he added. To make the treatments, a patient's T cells are isolated, frozen and shipped to manufacturers. Once received, the cells are purified, modified and expanded to large enough numbers to treat the patient. They then go through quality control processes before being re-frozen and shipped back for infusion. Gilead is testing new technology it hopes can cut two days from the manufacturing process by using healthier and more potent younger cells. The company is also looking to fully automate some parts of manufacturing that are now semi-automated and gain regulatory approval to shorten the quality control time. Novartis is aiming for 10 days or less in the U.S. for its next generation of treatments through its rapid manufacturing platform T-Charge. Its treatment, Kymriah, currently takes 3 to 4 weeks with a target of 22 days. Novartis said the T-Charge system would shorten the manufacturing time because it allows for the engineered cells to multiply within the patient, reducing the need for extended cell expansion before infusion. 'EVERY DAY MATTERS' Dr. Chijioke Nze of MD Anderson Cancer Center in Houston said a manufacturing time of a week would be ideal. Frailer patients can develop kidney or liver dysfunction while they wait for their therapy to be manufactured or may become too weak to be able to successfully undergo treatment, Nze said. He has prescribed Gilead's Yescarta and Tecartus as well as Bristol Myers' Breyanzi. "The patient population that needs CAR-T cell therapies generally have the more aggressive of an already aggressive disease," he said. Analysts and drugmakers say using CAR-T drugs earlier before doctors first prescribe multiple other treatments that fail to help patients would also expand use. J&J’s Carvykti, for example, was approved in April for patients who did not benefit from just one other treatment for multiple myeloma. Some CAR-T approvals require patients to receive three or four other treatments to fail before using the therapy. Increasing the number of hospitals and health centers offering the treatments also will make it feasible for more patients, they said. Since 2017, over 42,000 people globally have received CAR-T treatments. Six are approved in the U.S. for the treatment of blood cancers, including lymphomas and some forms of leukemia. Lynelle Hoch, who leads Bristol Myers Squibb's cell therapy business, said its current focus is on increasing manufacturing capacity. Still, it said its time to produce the treatments is trending lower and will be helped by its collaboration with Cellares, a development and manufacturing organization with a fully automated cell therapy production platform. J&J in a statement said it doubled its CAR-T manufacturing capacity last year and is striving to double it again in 2024. It said it is working to further reduce treatment times. Cindy Perettie, an executive at Gilead's Kite cell therapy unit, said in an interview that lymphoma patients who have already tried two treatments generally only have months to survive and need to get treated as quickly as possible. "Every day matters for these patients.” Sign up here. https://www.reuters.com/business/healthcare-pharmaceuticals/pharma-aims-deliver-personalized-cancer-therapies-more-quickly-2024-07-24/

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2024-07-24 10:06

A look at the day ahead in U.S. and global markets from Mike Dolan Wall St has suddenly become a tough crowd to please. Much like last week's cool market reception for decent earnings beats from streamer Netflix (NFLX.O) , opens new tab or chipmaker TSMC (2330.TW) , opens new tab, Alphabet's (GOOGL.O) , opens new tab surprisingly muscular second quarter left its stock down 2% overnight - and even the artificial intelligence theme didn't wow the gallery. Tesla (TSLA.O) , opens new tab was a little easier to figure. Its stock diving 8% out of hours after the automaker reported its lowest profit margin in more than five years - missing earnings targets in the second quarter as it cut prices to revive demand while it increased spending on AI projects. In the thick of the earnings season on both sides of the Atlantic, there was a mixed company-to-company picture as always. Shares in UPS (UPS.N) , opens new tab dived 12% on Tuesday while Spotify (SPOT.N) , opens new tab surged 12%. Deutsche Bank (DBKGn.DE) , opens new tab and BNP Paribas (BNPP.PA) , opens new tab topped the list in Europe -- with both stocks were in the red and the former down heavily. But with China's economic woes a factor in many areas, one of the biggest decliners on Wednesday was Europe's luxury sector. LVMH (LVMH.PA) , opens new tab fell nearly 5% after it missed sales estimates on flagging Chinese demand. An additional drag on European markets (.STOXXE) , opens new tab and the euro was a surprise contraction in overall euro zone business activity indicated by early July surveys. The U.S. equivalent is due later on Wednesday. In the blizzard, S&P500 futures are down 0.6% ahead of Wednesday's bell - as the megacaps retreat dominates and broader macro growth jitters start to resurface, not least after another dour home sales report on Tuesday. VIX volatility (.VIX) , opens new tab nudged back higher to 15.5. ELECTION AND UNCERTAINTY And election developments add to the uncertainty as Vice President Kamala Harris' likely nomination to replace Joe Biden in November's White House race has seen her national opinion poll ratings surpass challenger Donald Trump and dragged betting market probabilities on the latter's win back as low as 55%. This appears to have flattened many of the so-called Trump trades for now as markets see the contest unfold and Harris is widely seen as a status quo option in relation to the current administration's economic policy stance. The bond markets are happier, however, and have lapped up the equity wobble, nagging growth doubts and a sharp retreat in crude oil prices this week to their lowest in over a month. Oil prices are now down almost 7% over the past week and the year-over-year change important for inflation calculations has turned negative again for the first time since March. Good investor demand at Tuesday's 2-year Treasury note auction has seen two-year yields slide back to 4.43%, with $70 billion of 5-year paper under the hammer later today. Canada's dollar , meantime, hit its weakest level since April as the Bank of Canada is expected to cut its main policy rate again on Wednesday - two before the Federal Reserve has even moved. Earlier, Asia stocks markets were generally lower, with China's CSI300 and Hong Kong down again. A slightly higher dollar index (.DXY) , opens new tab overall was offset by another sizeable drop in dollar/yen to its lowest since May. The risk of another interest rate hike in Japan and recent rounds of currency intervention have seen speculators closing what had been profitable "carry" trades funded in yen. The Bank of Japan reviews policy next Tuesday and Wednesday. Key developments that should provide more direction to U.S. markets later on Wednesday: * US flash business surveys for July from S&P Global. US June new home sales, June trade balance, June wholesale and retail inventories. Canada June house prices * Bank of Canada policy decision * US corporate earnings: AT&T, IBM, Ford, General Dynamics, Ameriprise Financial, CME, Fiserv, Boston Scientific, Allegion, Align Technology, Newmont, Nextera, Otis, Chipotle, Teradyne, International Paper, United Rentals, Westinghouse, Molina Healthcare, Thermo Fisher Scientific, Edwards Lifesciences, Universal Health etc * Dallas Federal Reserve President Lorie Logan speaks; European Central Bank chief economist Philip Lane speaks * US Treasury sells $70 billion 5-year notes, auctions 2-year floating rates notes Sign up here. https://www.reuters.com/markets/us/global-markets-view-usa-2024-07-24/

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2024-07-24 09:36

TOKYO, July 24 (Reuters) - The Bank of Japan must raise interest rates to prevent excessive declines in the yen, private-sector members of a key government council said at a meeting last week where Governor Kazuo Ueda was present, minutes of the meeting showed on Wednesday. "It's important for monetary policy to more freely move toward normalisation," if the wide U.S.-Japan interest rate gap is causing a weak yen and hurting consumption, Mana Nakazora, a BNP Paribas Japan strategist who is a member of the government's top economic council, was quoted as saying. Takeshi Niinami, another council member who heads brewer Suntory Holding, also said the BOJ's policy was important "from the standpoint of avoiding excessive yen falls and controlling inflation," according to the minutes. "The government should prepare on the assumption that interest rates will rise ahead," he said. The remarks were made at a meeting of the government's top economic council on July 19, where members discussed the government's long-term economic forecasts. Prime Minister Fumio Kishida and his key economic ministers were also present at the meeting, as well as BOJ governor Ueda. The BOJ meets for a two-day policy meeting ending on July 31 when it will debate whether to raise interest rates, and release a detailed plan on how to taper its huge bond buying. Some politicians have called on the BOJ to offer more clarity on its rate hike plan partly to prevent the yen from testing fresh lows against the dollar. While a weak yen gives exports a boost, it has become a source of concern for policymakers by pushing up the cost of imports and hurting consumption. Sign up here. https://www.reuters.com/markets/rates-bonds/some-members-japan-panel-urge-boj-raise-rates-counter-weak-yen-2024-07-24/

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2024-07-24 09:27

MILAN, July 24 (Reuters) - Ferrari (RACE.MI) , opens new tab said on Wednesday it would extend its scheme to accept payments in cryptocurrency for its luxury sports cars to its European dealers network from the end of this month, after starting in the United States last year. The Italian company will also extend the scheme by the end of 2024 to other dealers of its international network, in countries where cryptocurrencies are legally accepted, it said in a statement. Although the vast majority of blue-chip companies have steered clear of crypto as the volatility of bitcoin and other tokens make them impractical for commerce, Ferrari started last year to accept payments in cryptocurrency in the U.S., to meet requests from its wealthy customers. "The entry into the European market follows the successful launch of this alternative payment system in the United States less than a year ago, to support dealers in better addressing the evolving needs of its clients," the company said. It added that most of its dealers in the region have already adopted or are in the process of adopting the new payment system. Patchy regulation and high energy usage have also so far prevented the spread of crypto as a means of payment. Countries where cryptocurrencies are restricted include China. For the launch of its scheme in the U.S. Ferrari had turned to one of the biggest cryptocurrency payment processors, BitPay, and allowed transactions in bitcoin, ether and USDC, one of the largest so-called stablecoins. As part of the scheme Bitpay will immediately turn cryptocurrency payments into traditional currency on behalf of Ferrari's dealers, protecting them from price swings, while excluding fees or surcharges for clients. Ferrari on Wednesday did not provide details on whether it would use other payment processors in Europe and in other regions. Sign up here. https://www.reuters.com/technology/ferrari-extends-cryptocurrency-payment-system-europe-after-us-launch-2024-07-24/

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2024-07-24 07:49

KYIV, July 24 (Reuters) - A Russian drone attack damaged port infrastructure and commercial and residential buildings early on Wednesday, wounding three people in the southern Ukrainian city of Izmail on the River Danube, local officials said. The attack damaged several buildings in the port, caused a fire and also damaged three trucks, Oleh Kiper, governor of the Odesa region, said in a statement. A five-storey residential building was damaged during the attacks that smashed its windows and stairwells, and ruined a part of its facade, officials said. Ukrainian air defences shot down 17 of 23 drones that were launched from Russian territory and the occupied Crimean peninsular, which Moscow seized and annexed in 2014, the air force said. Most of the drones were downed over the southern Odesa region, it said. "The enemy attacked the southern regions with attack drones. Port infrastructure has been their target again," the southern military command said on the Telegram messaging app. Izmail and other ports of the Danube river are important routes for Ukraine to import fuel. Demand for fuel is rising in Ukraine as businesses and residents increasingly depend on generators to produce electricity during extended blackouts. Since March, Russia has intensified its missile and drone attacks on the Ukrainian power sector and other energy infrastructure, knocking out about half of available generation capacity and resulting in long blackouts across the country. Sign up here. https://www.reuters.com/world/europe/russian-drone-strike-hits-danube-port-izmail-wounds-three-ukraine-says-2024-07-24/

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2024-07-24 07:32

July 24 (Reuters) - Spanish steelmaker Acerinox (ACX.MC) , opens new tab expects its third-quarter core profit (EBITDA) to be similar to that of the second quarter, it said on Wednesday, citing a gradual recovery in the European market and a stronger U.S. business. The group reported a 47% year-on-year drop in its second-quarter EBITDA to 125 million euros ($135.55 million), dragged by a five-month strike at its Spanish mill. Acerinox said it recorded an impact of 28 million euros to its April-June core profit from the strike. Workers in the Cadiz steel mill resumed their activities at the end of June after they reached a deal with the company on new contracts that include wage increases. The Acerinox shares were up 2% at 0723 GMT. ($1 = 0.9222 euros) Sign up here. https://www.reuters.com/markets/commodities/acerinox-q2-net-profit-falls-due-spanish-strike-2024-07-24/

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