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July 17 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Monday it had approved Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers. The therapy, branded Beyfortus, was approved for preventing lower respiratory tract disease in infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second such season. The companies plan to make Beyfortus available in the United States ahead of the upcoming RSV season, Sanofi said, adding that it plans to share more information about the therapy's price closer to the season. RSV is a leading cause of hospitalizations in infants and so far Swedish Orphan Biovitrum's (SOBIV.ST) treatment, Synagis, was the only approved preventive therapy in the United States for high-risk infants. The therapy comes with warnings and precautions about serious hypersensitivity reactions, and should be given with caution to infants and children with clinically significant bleeding disorders, the FDA said.
Persons: AstraZeneca's, Sanofi, Beyfortus, Bhanvi Satija, Shinjini Ganguli, Maju Samuel Organizations: U.S . Food, Drug Administration, Sanofi, American Academy of Pediatrics, FDA, Thomson Locations: U.S, United States, Bengaluru
UBS upgraded AstraZeneca 's stock to a "buy" rating despite the drugmaker's trial of a lung cancer medication recently delivering poor results. The investment bank said the subsequent drop in the pharma giant's stock price now meant that "investors can come back to the stock for the performance of in-market products." London-listed shares of AstraZeneca dropped by 8% in a single day, the most in years, after releasing the results of the "TropionLung01" trial for drug candidate "Dato-DXd." UBS expects shares of AstraZeneca to rise by 27% to £13 ($16.8) a share over the next 12 months. These include Imfinzi, a drug for bile duct or gallbladder cancer, and Tagrisso, a treatment for non-small cell lung cancer in adults.
Persons: Michael Leuchten, UBS Michael Leuchten AZN Organizations: UBS, AstraZeneca, pharma, DXd, FDA, Johnson Locations: London, Swiss, Tagrisso
BEIJING, July 5 (Reuters) - China's Commerce Minister told foreign pharmaceuticals firms they can expect "more development opportunities" during a roundtable on Wednesday, his ministry said, as drugmakers bemoan government procurement policies pricing them out of the market. Foreign pharmaceuticals firms have struggled to cement any inroads they have made into the world's second-largest economy, with the government maintaining a drug procurement programme that forces them to slash their prices and refusing to approve the use of any foreign COVID-19 vaccines during the pandemic. But as China pursues home-grown modernisation it will also open up "more development opportunities for foreign-funded enterprises, including the pharmaceutical industry," Wang told the meeting. Wang told the meeting on Wednesday that his ministry will expand the channels of communication for responding to and solving concerns, with the meeting resulting in 25 specific suggestions to be taken forward. Reporting by Joe Cash; Additional reporting by Kevin Yao;Editing by Elaine HardcastleOur Standards: The Thomson Reuters Trust Principles.
Persons: Roche, Takeda, Wang Wentao, Wang, Li Qiang, Li, drugmakers, Joe Cash, Kevin Yao, Elaine Hardcastle Organizations: China's Commerce, AstraZeneca, Bayer, Merck, Novo Nordisk, Pfizer, Sanofi, Moderna, Wednesday, Economic, Thomson Locations: BEIJING, China, Tianjin
The pan-European STOXX 600 index (.STOXX) dipped 0.2%, reversing gains of some 0.4%, to kick off the first day of the second half of the year on the back foot. The broader healthcare index (.SXDP) fell 2.0%, leading falls among sectors. The moves helped Italy's financials-heavy benchmark FTSE MIB (.FTMIB) climb 0.8%, a bright spot among other bourses in the region. The broader STOXX 600 had gained 8.7% in the first half of the year, largely due to strong gains early into 2023. "A muted atmosphere prevails across stock markets this afternoon," said Chris Beauchamp, chief market analyst at online trading platform IG.
Persons: Assicurazioni, Delfin, Italy's, Chris Beauchamp, Amruta Khandekar, Shreyashi Sanyal, Matteo Allievi, Nivedita Bhattacharjee, Janane Venkatraman, Conor Humphries Organizations: Miners, AstraZeneca, Generali, British, MIB, European Central Bank, Thomson Locations: China, Bengaluru, Gdansk
July 3 (Reuters) - AstraZeneca (AZN.L) said on Monday an experimental precision drug slowed progression of lung cancer in a late-stage trial, but the company's shares fell as much as 6% as analysts said the benefits may not be as pronounced as hoped. It declined to provide more trial details, saying they would be presented at an as yet undisclosed medical conference. At 0855 GMT, shares in AstraZeneca were down 5.8% at their lowest level in more than three months. Gilead (GILD.O) has pioneered the targeting of TROP2 with an ADC named Trodelvy, approved to treat certain types of breast and bladder cancer. AstraZeneca said that the datopotamab deruxtecan trial would continue as planned to assess the effect of the drug on overall survival of patients, another important efficacy criterion.
Persons: datopotamab, AstraZeneca, British drugmaker, Kelun, Maggie Fick, Ludwig Burger, Sinchita Mitra, Lucy Raitano, Krishna Chandra Eluri, Susan Fenton Organizations: AstraZeneca, Japan's, Merck & Co, Biotech of, Barclays, Thomson Locations: British, Biotech of China, London, Frankfurt, Bengaluru
UK's FTSE 100 edges higher on mining boost
  + stars: | 2023-07-03 | by ( ) www.reuters.com   time to read: +1 min
SummarySummary Companies FTSE 100 up 0.2%, FTSE 250 adds 0.3%July 3 (Reuters) - UK's FTSE 100 gained on Monday led by mining stocks on higher metal prices, while shares of other Chinese-exposed firms gained on rising hopes of more policy support in the world's second-largest economy. By 0715 GMT, the blue-chip FTSE 100 (.FTSE) gained 0.2%, while the more domestically-focussed FTSE 250 midcap index (.FTMC) rose 0.3%. Industrial metal miners (.FTNMX551020) advanced 1.3% as prices of base metals rose, buoyed by improved sentiment. China-exposed banks HSBC (HSBA.L) and Standard Chartered (STAN.L) rose 0.5% and 1.2%, respectively, while insurer Prudential (PRU.L) added 0.9% as hopes of more policy support grew after another weak data point and commentary from Chinese officials. Reporting by Shashwat Chauhan in Bengaluru; Editing by Rashmi AichOur Standards: The Thomson Reuters Trust Principles.
Persons: Drugmaker, Shashwat Chauhan, Rashmi Organizations: HSBC, Standard Chartered, Prudential, Drugmaker AstraZeneca, Thomson Locations: China, Bengaluru
Novo Nordisk shares slip on EMA drug safety signal
  + stars: | 2023-06-22 | by ( ) www.reuters.com   time to read: +2 min
reported that the European Medicines Agency (EMA) had raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. But a "causal association" between semaglutide and thyroid cancer had not been demonstrated in large-scale clinical trials and post-marketing surveillance, he said. EMA's safety signal had also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).
Persons: Lars Otto Andersen, Lange, Andersen, " Andersen, Eli Lilly, Soren Lontoft Hansen, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, Sanofi, Thomson Locations: COPENHAGEN, Novo, Denmark's Novo, Copenhagen
The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. reported the EMA safety signal. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. EMA's safety signal also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).
Persons: Eli Lilly, Ozempic, Lars Otto Andersen, Lange, Andersen, " Andersen, Soren Lontoft Hansen, semaglutide, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Sanofi, Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, FDA, Thomson Locations: Astrazeneca, COPENHAGEN, Denmark's Novo, Copenhagen
WASHINGTON, June 22 (Reuters) - The states of California, New York, Illinois, Minnesota, Washington and Wisconsin have joined a Federal Trade Commission (FTC) lawsuit to stop Amgen's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics (HZNP.O), according to a court filing on Thursday. Washington Attorney General Bob Ferguson said his state had joined the lawsuit because "monopolies harm consumers" and the merger could allow Amgen to "dominate" prescription drug markets. The FTC acquisition marks a change for the agency, which previously had typically flagged therapeutic overlaps in companies and waved deals through after requiring one of the medicines to be divested. Amgen said in a statement last month it was disappointed by the FTC decision and it believed it had "overwhelmingly demonstrated" that the deal had no legitimate competitive issues. The last major pharmaceutical deal approved by the FTC was AstraZeneca's (AZN.L) $39 billion acquisition of Alexion Pharma in April 2021, about two months before FTC Chair Lina Khan was appointed by the Biden administration.
Persons: Bob Ferguson, Rob Bonta, Amgen, Lina Khan, Biden, David Shepardson, Jamie Freed Organizations: Federal Trade Commission, Horizon Therapeutics, . Washington, FTC, Horizon, Alexion Pharma, Thomson Locations: California , New York , Illinois, Minnesota, Washington, Wisconsin, California
London CNN —Italy has imposed several curbs on Pirelli’s biggest shareholder, Sinochem, in a move aimed at blocking the Chinese government’s access to sensitive chip technology. The government order risks inflaming tensions between Europe and Beijing, and follows similar intervention by Germany and the United Kingdom to protect their semiconductor technology. The order sets a host of limitations on Sinochem’s involvement in Pirelli, including a bar on it devising the company’s strategy and financial plans, or appointing a CEO. It requires that Pirelli refuse any requests from Sinochem’s owner — China’s State-owned Assets Supervision and Administration Commission of the State Council — for information sharing, including any information connected to the “know-how” of proprietary technologies. Separately, Rome is also assessing whether to renew its partnership with Beijing on the Belt and Road Initiative — China’s global infrastructure and investment megaproject.
Persons: Pirelli, Antony Blinken, Sinochem, Pirelli’s, , — Laura Organizations: London CNN —, ASML, CNN, Pirelli, Union, Supervision, Administration Commission, State, AstraZeneca, Financial Times, Sequoia Capital, European Commission, Reuters Locations: London CNN — Italy, Europe, Beijing, Germany, United Kingdom, Netherlands, China, Ukraine, — China’s, Rome, Italy, Hong Kong
Companies AstraZeneca PLC FollowJune 18 (Reuters) - Drugmaker AstraZeneca (AZN.L) is drafting a plan to spin off its China business, and listing a separate unit in Hong Kong is being viewed as an option, the Financial Times reported on Sunday. The company would seek to be a patriotic company in China that "loves the Communist Party", its China president said in May. Last year, the country accounted for 13% of AstraZeneca's total sales, and the company is China's biggest drugmaker. The spin off could protect AstraZeneca from tensions between China and other global powers, while the company retained control of the business, the FT's report said. AstraZeneca said it did not comment on "rumours or speculations around future strategy or M&A."
Persons: Bharat Govind Gautam, Rishabh Jaiswal, Chris Reese, Diane Craft Organizations: AstraZeneca, Financial Times, Communist Party, Thomson Locations: China, Hong Kong, Shanghai, Bengaluru
June 12 (Reuters) - Novartis (NOVN.S) has agreed to acquire Seattle-based biotech firm Chinook Therapeutics (KDNY.O) for up to $3.5 billion to boost its late-stage drug development line-up with a new treatment for a rare severe kidney disease. Chinook is also working on zigakibart, another experimental IgAN treatment that is injected, and plans to start a Phase 3 trial in the third quarter of 2023. IgAN is a progressive autoimmune disease that mostly affects young adults and which can lead to dialysis or kidney transplantation. IgAN is the most common cause of kidney failure in Caucasian young adults, the company added. Additional reporting by Miranda Murray; Editing by Kim Coghill and Sonali PaulOur Standards: The Thomson Reuters Trust Principles.
Persons: Swiss drugmaker, Vas Narasimhan, atrasentan, Narasimhan, Kisqali, Soliris, Miranda Murray, Kim Coghill, Sonali Paul Organizations: Novartis, Seattle, Chinook Therapeutics, Chinook, Swiss pharma, Sandoz, Thomson Locations: Swiss, IgAN, United States
Indivior opioid settlement makes purer M&A case
  + stars: | 2023-06-05 | by ( ) www.reuters.com   time to read: +2 min
LONDON, June 5 (Reuters Breakingviews) - Indivior (INDV.L) is one step closer to becoming a takeover target. Litigation risks have weighed down Indivior in the years following the company’s spinoff from Reckitt Benckiser (RKT.L) in 2014. The group still has lawsuits to settle over the same charges with insurers and patients. With its litigation risks easing, Indivior could soon lure larger cash rich pharmaceutical companies keen to access a market that is sadly showing no signs of decline. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.
Persons: Reckitt, Roche, Indivior, Aimee Donnellan, Neil Unmack, Streisand Neto Organizations: Reuters, Suboxone, AstraZeneca, U.S . Centers for Disease Control, Twitter, Toyota, Thomson Locations: U.S
AstraZeneca to leave leading U.S. drug lobby group
  + stars: | 2023-05-16 | by ( Maggie Fick | ) www.reuters.com   time to read: +1 min
LONDON, May 16 (Reuters) - AstraZeneca (AZN.L) has decided to leave the main U.S. drug lobby group, the Pharmaceutical Research and Manufacturers of America (PhRMA), and pursue other ways of engaging in advocacy at the state and federal level, the company said. AstraZeneca decided not to continue its membership after a recent assessment of whether it was "the most productive and effective use of (company) resources", a spokesperson for the British drugmaker said in an emailed statement. PhRMA said in a separate emailed statement that AstraZeneca had decided not to renew its membership for the second half of 2023. AstraZeneca's exit follows those of AbbVie, maker of blockbuster arthritis drug Humira, and Teva, a leading manufacturer of generic drugs. AstraZeneca will redirect the funds previously used on its PhRMA membership to continue U.S. advocacy efforts with state and federal policymakers, its statement read.
Swedish drugmaker finds alluring poison pill
  + stars: | 2023-05-10 | by ( ) www.reuters.com   time to read: +2 min
LONDON, May 10 (Reuters Breakingviews) - Sweden’s rare disease drug maker is experiencing unfortunate deal side effects. On Wednesday, shares in Swedish Orphan Biovitrum (SOBI) (SOBIV.ST) fell 15% after it announced a plan to buy CTI BioPharma (CTIC.O), a specialist in rare blood cancers, for $1.7 billion. The Anglo-Swedish drugmaker refused to tender its shares amid a squabble over the U.S. rights for a respiratory drug. But SOBI’s new deal, which will be funded by a rights issue backed by main shareholder Investor AB (INVEb.ST), suggests Oelkers has support for a solo future. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.
Eli Lilly’s golden ticket is a regrettable winner
  + stars: | 2023-05-03 | by ( Robert Cyran | ) www.reuters.com   time to read: +6 min
NEW YORK, May 3 (Reuters Breakingviews) - Eli Lilly’s (LLY.N) Mounjaro might turn out to be the biggest selling drug ever. The pharmaceutical giant is maximizing the diabetes treatment’s gain by using a golden ticket to speed its U.S. approval for use in a possibly bigger market, obesity. Lilly’s peak sales for treating obesity might be about 10 times as high, Jefferies analysts estimate. At the industry multiple of 5 times revenue, that would pad its $535 billion market value by $30 billion. Lilly may have secured a Willy Wonka-like golden ticket that allows its obesity drug to reach customers quicker.
April 28 (Reuters) - A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AztraZeneca Plc's (AZN.L) experimental treatment, jointly developed with Merck & Co (MRK.N), for a type of prostate cancer. The FDA panel voted 11-1 with one abstention, in favor of Lynparza, in combination with other medications – abiraterone and prednisone or prednisolone – as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients. They were withdrawn last year as second line of treatment for ovarian cancer patients after the FDA limited the use of PARP inhibitors and requested companies to pull the drug. Lynparza is already approved by the FDA to treat a type of breast cancer, ovarian cancer, as well as a different form of prostate cancer. Prostate cancer is the most common form of cancer among men in the United States with about 288,300 new cases in 2023, according to the American Cancer Society's estimates.
European drug discounts will ruffle U.S. funder
  + stars: | 2023-04-28 | by ( ) www.reuters.com   time to read: +2 min
LODNON, April 28 (Reuters Breakingviews) - Europe’s plan to slash prices on pharmaceutical drugs could set off tensions with the U.S. The European Union proposed on Wednesday a legislative overhaul of the sector across the 27-nation bloc. This would incentivise drug makers like AstraZeneca (AZN.L) and GSK (GSK.L) to sell to all European countries at once. And although the U.S. is trying to tackle soaring prices with the Inflation Reduction Act, Europe’s falling drug costs will widen the gap once again. This creates a problem for the U.S. government, which funds more drug development than any other country.
[1/2] The London Stock Exchange Group offices in the City of London, Britain, December 29, 2017. REUTERS/Toby MelvilleSummarySummary Companies FTSE 100 up 0.1%, FTSE 250 off 0.2%April 27 (Reuters) - The UK's FTSE 100 edged higher on Thursday, snapping a three-day losing streak as markets cheered upbeat corporate updates, while shares of Capricorn Energy fell due to a full-year operating loss. The blue-chip index (.FTSE) was up 0.1%, while the mid-cap FTSE 250 (.FTMC) lost 0.2%, as of 0717 GMT. Banks (.FTNMX301010) added 0.7%, led by Barclays (BARC.L) gaining 2.7% after the lender's first-quarter profit exceeded expectations as strong performance from its credit card business offset pressure on other business lines. Unilever (ULVR.L) gained 1.3% after it smashed quarterly sales forecasts as another big rise in prices triggered only a small dip in volumes.
LONDON, April 27 (Reuters) - AstraZeneca (AZN.L) on Thursday beat expectations for its first -quarter profit and revenue, helped by sales of its roster of drugs in emerging markets. The London-listed drugmaker, which reports its results in U.S. dollars, reported adjusted profit of $1.92 per share on sales of about $10.9 billion. Excluding sales of its COVID-19 products, sales grew 22% to $3.1 billion in emerging markets on a constant currency basis. AstraZeneca's best-selling cancer drugs — Tagrisso, Imfinzi and Lynparza — generated $1.4 billion, $900 million and $651 million of sales, respectively, in the quarter. Cowen analysts expected the three drugs to bring in about $1.45 billion, $735 million and $700 million respectively, in quarterly sales.
European shares edge lower as banking jitters resurface
  + stars: | 2023-04-27 | by ( ) www.reuters.com   time to read: +1 min
April 27 (Reuters) - European shares edged lower on Thursday, despite a raft of positive corporate earnings, as troubles at U.S. lender First Republic Bank continued to rattle investors over the global banking sector. The pan-European STOXX 600 index (.STOXX) was down 0.1% by 0720 GMT. The index was dragged lower by media shares (.SXMP), which dropped 1.6%, while Universal Music Group (UMG.AS) fell 4% after it posted a slump in its first-quarter core profit. Worries over the banking sector unnerved investors as shares of First Republic Bank (FRC.N) sank almost 30% on Wednesday, hitting a record low for the second consecutive day. Still, banking shares (.SX7P) rose 0.4%, led by Barclays Plc (BARC.L) that climbed 2.4% on an estimate-beating quarterly profit, as a resilient performance from its consumer bank offset pressure on key other business lines.
Stocks stuck to a holding pattern this week as investors brace for an incoming wave of Big Tech earnings and the Fed's favorite inflation reading. Earnings reports have generally been better than expected so far this first quarter. Humana (HUM) reports before the bell Wednesday; Meta Platforms and Pioneer Natural Resources (PXD) report after the bell Wednesday. ET: Personal Spending & Income (includes PCE Price Index) Club trades this week Just one trade: We added 150 shares of Coterra Energy (CTRA) on Wednesday. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade.
LONDON, April 21 (Reuters) - African countries are lining up to approve a new vaccine for malaria, with 20 million doses available for them to buy this year, the shot’s manufacturer told Reuters. African countries that do not have extensive resources for drug regulation have previously relied on the U.N. agency to initially review new medicines. "We expect many more countries to come through," Mary Hamel, the WHO's malaria vaccine implementation head, told the expert meeting on Tuesday. “We are committed to making the R21 vaccine available to people who need it most,” Poonawalla said. FUNDING DOUBTSThe moves are a further sign that African countries want to exert their own pharmaceutical oversight after COVID-19 exposed inequity in vaccine supply.
Citi is bullish on Merck , saying that the company's drug pipeline is underappreciated by the market. The exclusive license and collaboration agreement for ADC development helps Merck in developing more cancer treatment drugs — and Citi thinks it could rival its competitors' offerings. Citi anticipates further upside for Merck shares from the Inflation Reduction Act. To be sure, Baum noted a key downside risk to his valuation is if the ADC pipeline disappoints. Further risks include lower-than-anticipated value share capture by the company's Melanoma treatment drug Keytruda, and a slowdown in its animal health business.
London's FTSE 100 climbs ahead of Easter break
  + stars: | 2023-04-06 | by ( Sruthi Shankar | ) www.reuters.com   time to read: +2 min
The FTSE 100 (.FTSE) rose 0.5% and is on course to end the holiday-shortened week about 1% higher, with gains in oil & gas and healthcare stocks offering support. Shell (SHEL.L) rose 1.7% as the energy giant forecast higher liquefied natural gas (LNG) output in the first quarter. The midcap FTSE 250 index (.FTMC) rose 0.2%, with London-listed shares of travel firm TUI jumping 7.2% after sharp losses this week. "The report noted mortgage rates have continued to trend downwards, housing transactions have picked up slightly and the employment market remains robust. We still see challenges ahead as affordability remains under pressure," said Derren Nathan, head of equity research at Hargreaves Lansdown.
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