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The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland January 30, 2020. REUTERS/Arnd Wiegmann/File Photo Acquire Licensing RightsZURICH, Dec 4 (Reuters) - Roche (ROG.S) agreed to take over obesity drug developer Carmot Therapeutics (CRMO.O) for $2.7 billion, joining a list global contestants seeking to challenge the dominant makers of weight-loss drugs Novo Nordisk (NOVOb.CO) and Eli Lilly. After encouraging Phase I trial results, the drug is ready to be tested on humans in the second of three trial stages, Roche added. Among recent deals to acquire obesity drug development projects, AstraZeneca (AZN.L) last month agreed to pay up to $2 billion for the rights to an experimental pill from China's Eccogene. Roche will obtain access to Carmot's current R&D portfolio including all clinical and preclinical assets.

Persons: drugmaker Roche, Arnd, ROG.S, Eli Lilly, Swiss drugmaker, Roche, . New Roche, Thomas Schinecker, Ludwig Burger, Noel Illien, Rachel More, Louise Heavens Organizations: REUTERS, Rights, Carmot Therapeutics, Novo Nordisk, AstraZeneca, Pfizer, Thomson Locations: Basel, Switzerland, Swiss, ., Alzheimer's

☆ Roche’s late obesity punt offers wider market cure
▼ + stars: | 2023-12-04 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Arnd Wiegmann Acquire Licensing RightsLONDON, Dec 4 (Reuters Breakingviews) - Roche’s (ROG.S) foray into the prospective $100 billion obesity market can bring wider benefits. On Monday, the $224 billion Swiss pharma group said it had agreed to take over weight-loss drug developer Carmot Therapeutics for $2.7 billion. Market leader Novo Nordisk (NOVOb.CO) is already selling obesity drugs in the U.S. and parts of Europe. Still, Schinecker’s obesity bet could turn successful if it ends up undercutting obesity pioneers on prices. With over 1 billion people globally classed as seriously overweight, other drugmakers will follow Roche on the obesity bandwagon.

Persons: drugmaker Roche, Arnd, Eli Lilly’s, Thomas Schinecker, Eli Lilly, Eccogene, Roche, Aimee Donnellan, Neiman Marcus, Lisa Jucca, Oliver Taslic Organizations: REUTERS, Reuters, Swiss pharma, Carmot Therapeutics, Novo Nordisk, U.S . Food, Drug Administration, AstraZeneca, Novo, X, Saks, Thomson Locations: Basel, Switzerland, U.S, Europe, Hong Kong

☆ Bayer examines break-up options and prepares to cut management jobs
▼ + stars: | 2023-11-08 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

Bayer will remove multiple layers of management and coordination for a "significant reduction" in the workforce, it said. "We are redesigning Bayer to focus only on what’s essential for our mission – and getting rid of everything else," said Anderson. Analysts have said Bayer shares are trading at a massive discount to rivals in agriculture, pharmaceuticals and consumer health activities, partly weighed down by a preference among many financial investors for pure-play companies. Bayer reported third-quarter earnings before interest, tax, depreciation and amortisation (EBITDA) and adjusted for one-off effects fell 31% to 1.685 billion euros, hit by lower earnings at its Crop Science division. Bayer added that it expects a "soft growth outlook and continued challenges" to profitability next year.

Persons: Wolfgang Rattay, Bill Anderson, Anderson, Bayer, Werner Baumann, Ludwig Burger, Miranda Murray, David Goodman Organizations: Bayer AG, REUTERS, Rights, Bayer, Consumer, Roche, Science, Thomson Locations: Leverkusen, Germany

☆ Siemens Healthineers reviews options for diagnostics unit -source
▼ + stars: | 2023-11-03 | by ( ) www.reuters.com time to read: +1 min

A staffer works on a magnetic resonance imaging machine at a production line of Siemens Healthineers in Shenzhen, China May 25, 2018. REUTERS/Bobby Yip/File Photo Acquire Licensing RightsMUNICH/FRANKFURT, Nov 3 (Reuters) - German medical equipment maker Siemens Healthineers (SHLG.DE) is in the early stages of weighing options for its diagnostics business, which has little overlap with other units, a person familiar with the situation told Reuters. The review could lead to a sale of the unit but all options remain open, the source said. The diagnostics business is also in the middle of restructuring. The listed Siemens subsidiary ranks number two worldwide behind Swiss Roche (ROG.S) in the business of laboratory lines for blood tests.

Persons: Bobby Yip, Alexander Huebner, Victoria Farr, Utkarsh, Bill Berkrot, Jason Neely Organizations: Siemens, REUTERS, Reuters, Bloomberg, Swiss Roche, Thomson Locations: Shenzhen, China, FRANKFURT, Swiss, Munich, Emma, Frankfurt, Bengaluru

☆ Sanofi loses $21 bln in market value after dropping 2025 profit target
▼ + stars: | 2023-10-27 | by ( Ludwig Burger | ) www.reuters.com time to read: +6 min

Under a push to spend more on immunology and inflammation drug development, the company abandoned a target for a 32% operating profit margin for 2025 to focus on "long-term profitability". EPS would see a strong rebound in 2025 but not enough to sustain the previous margin target. CONSUMER STAND-ALONECEO Hudson said the core innovative drugs business had improved enough to soon do without the more predictable cash flows from consumer products. The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. The timing of the potential consumer listing, which Sanofi said would be in the fourth quarter of 2024 or later, would be set to maximize shareholder value.

Persons: Hudson, Sanofi, drugmaker, Paul Hudson, Terence McManus, Johnson, we've, Gonzalo Fuentes, Roche, Dupixent, Ludwig Burger, Sherry Jacob, Phillips, Mark Potter, Sharon Singleton Organizations: Sanofi, Bellevue Asset Management, Reuters, Barclays, Johnson, GSK, Pfizer, Bayer, Polyclonals, REUTERS, Provention, Merck & Co, Thomson Locations: France, Bellevue, Lyon, Paris

☆ Investors reject Sanofi's cure to sickly valuation
▼ + stars: | 2023-10-27 | by ( ) www.reuters.com time to read: +3 min

LONDON, Oct 27 (Reuters Breakingviews) - Sanofi (SASY.PA) investors dislike CEO Paul Hudson’s prescription to reinvigorate the pharmaceutical group’s weak valuation. Analysts polled by LSEG expect the division to hit an EBIT of 1.6 billion euros this year. On listed rival Haleon’s 15.6 times multiple, that business could be worth 25 billion euros. The rest of the Sanofi business may generate EBIT of 11.4 billion euros. The problem is that investors don’t appear to want to take the harsh medicine that leads to a cure.

Persons: Paul Hudson’s, Ernst & Young, Sanofi, EBIT, Roche, Karen Kwok, Francesco Guerrera, Streisand Neto Organizations: Reuters, Sanofi, Ernst, LSEG, Novartis, Novo Nordisk, GSK, AstraZeneca, X, Unilever, Thomson

New Roche CEO Thomas Schinecker is keen to restore Roche's battered drug development record after major late-stage trial setbacks in the areas of Alzheimer's and cancer immunotherapy last year. The acquired drug, against inflammatory bowel disease such as ulcerative colitis and Crohn's disease, belongs to a class of new treatments known as anti-TL1A antibodies which has attracted major deal activity in the pharma industry. Merck & Co (MRK.N) in April agreed to buy anti-TL1A antibody developer Prometheus Biosciences for $10.8 billion. Inflammatory bowel disease is a group of chronic gastrointestinal disorders with almost 8 million people diagnosed worldwide and 80% of all individuals not experiencing lasting remission, Roche said. "We strongly believe this novel TL1A directed antibody has the transformational potential to make a significant difference for patients living with inflammatory bowel disease and potentially other diseases," said Roche CEO Schinecker.

Persons: drugmaker Roche, Arnd, New Roche, Thomas Schinecker, Schinecker, Roche, John Revill, Ludwig Burger, Friederike Heine, Jason Neely Organizations: REUTERS, Roivant Holdings, Pfizer Inc, pharma, Sanofi, Merck & Co, Prometheus Biosciences, Thomson Locations: Basel, Switzerland, ZURICH, FRANKFURT, Swiss, U.S, Japan, Zurich, Frankfurt

☆ Roche's $7 bln deal is pricey and partial cure
▼ + stars: | 2023-10-23 | by ( ) www.reuters.com time to read: +2 min

Roche tablets are seen positioned in front of a displayed Roche logo in this photo illustration shot January 22, 2016. REUTERS/Dado Ruvic/Illustration Acquire Licensing RightsNEW YORK, Oct 23 (Reuters Breakingviews) - Roche (ROG.S) has taken a small step towards curing its drug pipeline problem. JPMorgan analysts estimate that the drug’s U.S. sales could peak at 2.4 billion Swiss francs ($2.7 billion), but will take until 2037 to get there, assuming a 2028 launch. Analysts expect Roche’s pharmaceutical division to generate revenue of almost 45 billion Swiss francs this year, according to estimates compiled by LSEG. With expected free cash flow of around 16 billion Swiss francs this year and next, Roche can afford to buy a little more diversification.

Persons: Roche, Dado Ruvic, Thomas Schinecker, Peter Thal Larsen, Jean, Pierre Mustier, Atos, Jonathan Guilford, Aditya Sriwatsav Organizations: REUTERS, Reuters, Pfizer, U.S, New, JPMorgan, Merck, Prometheus Biosciences, Analysts, LSEG, X, News Corp, Thomson Locations: Swiss, U.S

☆ Bristol Myers' injectable form of Opdivo meets main goal in kidney cancer trial
▼ + stars: | 2023-10-19 | by ( ) www.reuters.com time to read: +2 min

Test tubes are seen in front of a displayed Bristol Myers Squibb logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsOct 19 (Reuters) - Bristol Myers Squibb (BMY.N) said on Thursday the injectable form of its blockbuster cancer drug Opdivo met the main goal in trial that had patients with a type of kidney cancer. "We believe this new option, given as a single injection administered in less than five minutes, could transform the treatment experience for both patients and physicians," Gina Fusaro, an executive at Bristol Myers Squibb, said. The trial also showed a non-inferior response rate to the subcutaneous drug, compared to its intravenous form. Bristol Myers now plans to discuss with regulators the next steps for submission and approval of subcutaneous injections for multiple types of cancers.

Persons: Bristol Myers, Dado Ruvic, Opdivo, Gina Fusaro, Roche, Johnson, Helen Torley, Leroy Leo, Anil D'Silva, Shinjini, Shounak Organizations: Bristol, Bristol Myers Squibb, REUTERS, Therapeutics, U.S, Thomson Locations: Bengaluru

☆ Royalty Pharma to pay $1 bln for Roche's SMA drug royalties
▼ + stars: | 2023-10-19 | by ( ) www.reuters.com time to read: +1 min

The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann/File Photo Acquire Licensing RightsOct 19 (Reuters) - Royalty Pharma (RPRX.O) said on Thursday it has purchased additional royalties on Roche (ROG.S) and PTC Therapeutics' (PTCT.O) oral spinal muscular atrophy (SMA) drug for an upfront payment of $1 billion. Spinal muscular atrophy, a leading genetic cause of infant deaths, prevents the body from producing a protein necessary for neuromuscular development. The deal also includes options for PTC to sell up to all of its retained royalties on Evrysdi for up to $500 million at a later date, Royalty Pharma said. Royalty Pharma expects to fund the transaction with a combination of existing cash and about $350 million from its revolving credit facility.

Persons: drugmaker Roche, Arnd, Roche, Mariam Sunny, Shilpi Majumdar Organizations: REUTERS, Royalty Pharma, PTC Therapeutics, U.S . Food, Drug Administration, PTC, Thomson Locations: Basel, Switzerland, Bengaluru

☆ Merck KGaA says MS drug has blockbuster potential; key data expected in December
▼ + stars: | 2023-10-19 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

Merck, seen as leading the race to win approval for a more targeted type of MS drug, said in April that U.S. regulators had paused enrolment of new patients into a trial testing the drug, evobrutinib, knocking the German drugmaker's share price. "The readout of our Phase 3 study is going to happen in December," she added of the pivotal study in the clinical trials process. Novartis (NOVN.S), also in the race, said in April that no signs of liver damage had been seen in trials testing its anti-inflammatory drug candidate remibrutinib so far. Roche (ROG.S) said in May that its BTK inhibitor against MS, reduced brain lesions associated with the disease in a mid-stage trial and that no new safety concerns had emerged. Reporting by Ludwig Burger Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

Persons: Germany's Merck, Belen Garijo, ROG.S, Ludwig Burger, Bill Berkrot Organizations: Germany's, Merck, U.S . Food, Drug Administration, Reuters, Rivals, Sanofi, Novartis, Thomson Locations: FRANKFURT, U.S, Darmstadt

☆ Roche's Q3 sales down 3% on currency headwinds, drop in COVID sales
▼ + stars: | 2023-10-19 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

Quarterly sales came in at 14.3 billion Swiss francs ($15.9 billion), the Swiss drugs and diagnostics maker said in a statement, broadly in line with analyst estimates. A high-dose version of Eylea for less frequent injections won U.S. approval in August, creating doubt among analysts that a string of forecast-beating Vabysmo sales can continue. CEO Thomas Schinecker - who is keen to restore Roche's drug development record - said he was looking to acquire drug assets in all stages of development but that there was no rush. He pointed to 10% sales growth during the quarter, excluding currency headwinds and the slump in COVID sales. However, it predicted a less pronounced decline in sales of COVID-19 products of about 4.5 billion Swiss francs, from a previous estimate of a drop of 5 billion francs.

Persons: drugmaker Roche, Arnd, Roche, Regeneron, Thomas Schinecker, Schinecker, Ludwig Burger, Friederike Heine, Elaine Hardcastle Organizations: REUTERS, Bayer, Thomson Locations: Basel, Switzerland, COVID, Swiss

☆ Blood tests needed for widespread Alzheimer's diagnosis on the way
▼ + stars: | 2023-10-11 | by ( Deena Beasley | ) www.reuters.com time to read: +6 min

Several Alzheimer's blood tests are in the works – and one is already being sold to consumers – but none have been established as accurate, formally approved by regulators or reimbursed by insurers. Researchers have been working for years on blood tests for Alzheimer's that can replicate these diagnostic tools. The need for blood tests has become more pressing since the FDA approved Leqembi in July. Accurate blood tests are expected to help identify which dementia patients actually have Alzheimer’s, the most common but not the only cause of dementia. "When there are widely available, scalable, sensitive and specific blood tests it will be an absolute game changer for Alzheimer's patients."

Persons: Denis Balibouse, Eli Lilly, Dr, Sarah Kremen, Eliezer Masliah, Eisai, Michael Irizarry, Roche, Bruce Jordan, Russ Paulsen, Deena Beasley, Caroline Humer, Bill Berkrot Organizations: Memory Centre, of Readaptation, University Hospital, REUTERS, FDA, Sinai Medical Center, Wednesday, Quest Diagnostics, National Institute, Aging, U.S . National Institutes of Health, C2N Diagnostics, Roche Diagnostics, Alzheimer's Association, RAND, Thomson Locations: Geneva, Switzerland, Leqembi, Eisai, Los Angeles, U.S

☆ Pakistan probes distributors of Roche cancer drug after patients go blind
▼ + stars: | 2023-09-25 | by ( Mubasher Bukhari | ) www.reuters.com time to read: +3 min

REUTERS/Arnd Wiegmann/File Photo Acquire Licensing RightsLAHORE, Pakistan, Sept 25 (Reuters) - Pakistan said on Monday it was investigating two local distributors of Swiss pharmaceutical company Roche's (ROG.S) Avastin cancer drug after 12 diabetic patients injected with the drug went blind. The Drug Regulatory Authority of Pakistan (DRAP) said the health authorities in Punjab, the most populous province, had launched the investigation into local use of the drug Avastin, which is licensed for use in Pakistan. On its website, Roche said Avastin was approved in more than 130 countries, including the United States, to treat several types of cancer. Cancer drug Avastin, when used at much lower doses, is similar to eye drug Lucentis and is used in many countries as a low-cost option to treat certain blindness-causing conditions. In its statement, Roche said: "Avastin is not approved for any use in the eye.

Persons: drugmaker Roche, Arnd, Javed Akram, Akram, Roche, Avastin, Alam, Mubasher Bukhari, Ariba Shahid, Ludwig Burger, Miral Fahmy, Alex Richardson Organizations: REUTERS, Rights, Drug Regulatory Authority of Pakistan, Reuters, U.S ., Thomson Locations: Basel, Switzerland, Rights LAHORE, Pakistan, Swiss, Punjab, United States, counterfeits, Avastin, Lahore, Karachi, Frankfurt

A few compounds picked by AI are now in development, but those bets will take years to play out. Reuters interviews with more than a dozen pharmaceutical company executives, drug regulators, public health experts and AI firms show, however, that the technology is playing a sizeable and growing role in human drug trials. The U.S. Food and Drug Administration (FDA) said it had received about 300 applications that incorporate AI or machine learning in drug development from 2016 through 2022. Without AI, Bayer said it would have spent millions more, and taken up to nine months longer to recruit volunteers. Finding real-world patients by mining electronic patient data can be done manually, but using AI speeds up the process dramatically.

Persons: Dado Ruvic, Jeffrey Morgan, Amgen, Badhri Srinivasan, Sameer Pujari, drugmaker Bayer, Bayer, Blythe Adamson, Roche, Richard Pazdur, Gen Li, John Concato, Natalie Grover, Martin Coulter, Julie Steenhuysen, Josephine Mason, David Clarke Organizations: Pharmaceutical Research, REUTERS, Pharmaceutical, Bayer, Novartis, Deloitte, U.S . Food, Drug Administration, Reuters, World Health, Flatiron Health, FDA, European Medicines Agency, FDA's Oncology, Excellence, Medical, FDA's Center, Drug, Research, Thomson Locations: U.S, Johannesburg, Texas, Finland, United States, London, Chicago

FRANKFURT, Sept 14 (Reuters) - Bayer's (BAYGn.DE) new CEO plans to cut management jobs to speed up decision-making as a first step to overhaul the embattled German industrial group, which is facing investor pressure to break up, three people familiar with the matter said. But the new CEO will likely have only a short respite period to come up with concrete strategic proposals. Anderson has been tasked with reviving Bayer's share price, which has underperformed rivals, weighed down by the lingering costs of U.S. weedkiller litigation. Anderson said last month he was not ruling out any options as part of his review of the company's strategy and structure, saying he was "leaving no stone unturned". He added he would provide an initial update in the coming months and detailed plans in early 2024.

Persons: Bill Anderson, Anderson, Roche, Oliver Kohlhaas, Kohlhaas, Werner Baumann, Ludwig Burger, Patricia Weiss, Emma, Victoria Farr, Josephine Mason, David Holmes Organizations: Bayer, McKinsey, Artisan Partners, Reuters, Bluebell Capital Partners, Thomson Locations: FRANKFURT, Frankfurt

A view of the United Nations Climate Change Conference flags at the venue, in Bonn, Germany, June 6, 2023. "What we want to see, all of us, is a real sense of urgency about reducing CO2 emissions," Roche Vice-Chair Andre Hoffmann said. We need to show action, and I'm not sure that what I've read so far of the COP28 will be strong enough for that." Despite rapidly falling prices for renewable energy, Roche's (ROG.S) Hoffmann said much faster action was needed. "If the change is going to be that big then financial institutions, business people will reshape and they'll say my goodness there's going to be new technological institutions, there's going to be new factories, there's going to be a new economy.

Persons: Jana Rodenbusch, Hoffmann, November's, Roche, Andre Hoffmann, I'm, Eelco van der Enden, Elvis Presley, it's, Celine Herweijer, we've, Herweijer, It's, Andrew Steer, Steer, Richa Naidu, Gloria Dickie, Clara Denina, Iain Withers, Helen Reid, Alexander Smith Organizations: United Nations, REUTERS, Reuters IMPACT, Global, HSBC, Reuters, Fund, Thomson Locations: Bonn, Germany, Asia, Dubai, American, Paris

☆ England to rollout world-first seven-minute cancer treatment jab
▼ + stars: | 2023-08-29 | by ( ) www.reuters.com time to read: +2 min

Boxes of Tecentriq from Genentech are seen at the Huntsman Cancer Institute at the University of Utah in Salt Lake City, Utah, U.S., July 22, 2022. REUTERS/George Frey/File Photo Acquire Licensing RightsAug 29 (Reuters) - Britain's state-run national health service will be the first in the world to offer an injection that treats cancer to hundreds of patients in England which could cut treatment times by up to three quarters. The treatment is currently offered by transfusion to NHS patients with a range of cancers, including lung, breast, liver and bladder. NHS England said it expected the majority of around 3,600 patients starting the treatment of atezolizumab every year in England to switch onto the time-saving injection. But added that patients receiving intravenous chemotherapy in combination with atezolizumab may remain on the transfusion.

Persons: George Frey, Dr Alexander Martin, atezolizumab, Marius Scholtz, Genentech, Roche, Farouq Suleiman, Sandra Maler Organizations: Huntsman Cancer Institute, University of Utah, REUTERS, Medicines, Healthcare, Agency, Foundation Trust, Roche Products, Thomson Locations: Genentech, Salt Lake City , Utah, U.S, England, West Suffolk

Traders work on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., August 15, 2023. Traders in the U.S. equity options market are bracing for a larger-than-usual swing in Nvidia shares following the chipmaker's earnings, which are due after markets close on Wednesday. ET, Dow e-minis were up 34 points, or 0.1%, S&P 500 e-minis were up 4.25 points, or 0.1%, and Nasdaq 100 e-minis were up 4.75 points, or 0.03%. Peloton Interactive (PTON.O) shares plunged 27% after the fitness equipment maker forecast first-quarter revenue below estimates. Reporting by Amruta Khandekar and Shristi Achar A; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

Persons: Brendan McDermid, Foot, Susannah Streeter, Hargreaves Lansdown, Jerome Powell, Roche, Armour, Amruta Khandekar, Shinjini Organizations: New York Stock Exchange, REUTERS, Nvidia, Sports, Dow, Nasdaq, Wall, Hargreaves, Traders, Reuters, Federal Reserve, Treasury, Dow e, Biosciences, Merck & Co, Sport, Nike, Thomson Locations: New York City, U.S, Swiss

BERLIN, Aug 23 (Reuters) - Roche (ROG.S) inadvertently published positive lung cancer drug trial data from an interim analysis, boosting the Swiss drug maker's shares even though more data will be needed to confirm the treatment's efficacy. Roche said on Wednesday that market participants had made it aware of the inadvertent disclosure of an interim data analysis on new immunotherapy tiragolumab, part of an experimental class of drugs known as anti-TIGIT. The data lifted Roche shares by 5% and sent shares of other companies testing anti-TIGIT drugs higher. J.P. Morgan analysts said the interim data suggested a survival benefit was within reach in the final analysis, but the clinical relevance remained uncertain. The unintended disclosure regards the second interim analysis of a Phase III trial known as Skyscraper 1.

Persons: Roche, tiragolumab, Morgan, Roche's, TIGIT, Paul Arnold, Christy Santhosh, Jason Neely, Friederike Heine, Mark Potter Organizations: Merck & Co, Gilead Sciences, iTeos Therapeutics, Arcus Biosciences, Thomson Locations: U.S, Zurich, Bengaluru

☆ US FDA approves Pfizer's blood cancer therapy
▼ + stars: | 2023-08-14 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Johanna Geron/File PhotoAug 14 (Reuters) - The U.S. Food and Drug Administration on Monday granted accelerated approval to Pfizer's (PFE.N) therapy for treating patients with a type of blood cancer that is difficult to treat, the company said. Multiple myeloma is a common type of blood cancer, which develops in the bone marrow and can spread throughout the body. The FDA approval is based on data from a mid-stage study that showed that 58% of patients treated with Pfizer's therapy had no signs of cancer or had seen a significant decrease in cancer cells in the body. Pfizer said it will continue testing the therapy in ongoing late-stage trials to expand its use in earlier lines of treatment for patients. The therapy's approval comes with a boxed warning for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively.

Persons: Johanna Geron, Epkinly, Johnson, Pfizer's, Bhanvi Satija, Leroy Leo, Pratik, Shounak Dasgupta Organizations: Pfizer, REUTERS, U.S . Food, Drug Administration, FDA, Thomson Locations: Puurs, Belgium, U.S, Bengaluru

☆ Regeneron expects FDA decision on higher-dose Eylea this year
▼ + stars: | 2023-08-03 | by ( Khushi Mandowara | ) www.reuters.com time to read: +2 min

The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid/File PhotoAug 3 (Reuters) - Regeneron Pharmaceuticals (REGN.O) expects a U.S. decision on a higher-dose version of its blockbuster eye disease drug Eylea in the third quarter, much earlier than market expectations, sending its shares up 5% on Thursday. The U.S. Food and Drug Administration declined to approve the higher-dose version in June following an inspection at third-party manufacturer Catalent (CTLT.N). Regeneron said it has been submitting manufacturing data required by the FDA on a rolling basis, and expects to finish the submissions by mid-August. Regeneron said the higher-dose Eylea was manufactured on the same line as pozelimab, its experimental drug being reviewed to treat a rare blood disease.

Persons: Brendan McDermid, Regeneron, Wells, Mohit Bansal, Bayer, Sanofi, Khushi, Sriraj Organizations: Regeneron Pharmaceuticals, REUTERS, U.S . Food, Drug Administration, FDA, Thomson Locations: Westchester, Tarrytown , New York, U.S, Eylea, Bengaluru

☆ Focus: Drugmakers go under the skin, skirting early US Medicare price negotiations
▼ + stars: | 2023-07-28 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

Each year, Medicare will add more drugs to the list, the names of which have not yet been disclosed. Faspro, launched in 2020, already accounts for more than 80% of Darzalex revenue, which is due to rise to $9.5 billion this year. Merck previously told Reuters it expects this version of Keytruda could replace the more time consuming infusion for most patients. Keytruda revenue is expected to top $24 billion this year and could exceed $30 billion as soon as 2026, according to analyst estimates. The company has said its expects revenue from subcutaneous drugs containing hyaluronidase to drive its growth going forward.

Persons: Srdjan, Johnson, drugmakers, Bristol Myers, Roche, Biden’s, Michael DiFiore, DiFiore, Joseph Wolk, Faspro, Halozyme, Helen Torley, hyaluronidase, Michael Erman, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: U.S, REUTERS, Wall Street, Merck & Co, Halozyme Therapeutics, Reuters, Bristol, Bristol Myers Squibb, Medicare, U.S . Centers, Medicaid Services, J, Reuters Graphics Merck, Merck, Thomson Locations: Ljubljana, Darzalex, Diego

☆ Biogen to cut 1,000 jobs to save costs as Alzheimer's drug launch gathers pace
▼ + stars: | 2023-07-25 | by ( ) www.reuters.com time to read: +2 min

Investors have pinned their hopes on Leqembi as sales of multiple sclerosis drug Tecfidera take a hit from cheaper generic rivals while spinal muscular atrophy drug Spinraza faces rival treatments by Novartis (NOVN.S) and Roche (ROG.S). "Biogen's business is in transition," said CEO Christopher Viehbacher, who was hired in November to help power up growth and put behind a series of setbacks for older Alzheimer's drug Aduhelm. Multiple sclerosis treatments Avonex and Vumerity, as well as SMA therapy Spinraza, beat analyst estimates, while Tecfidera missed expectation as it faced generic rivals. "We see no unexpected surprises in Q2 results, allowing investors to focus on Alzheimer's," said Wells Fargo analyst Mohit Bansal. Reporting by Manas Mishra and Mariam Sunny in Bengaluru; Editing by Sriraj KalluvilaOur Standards: The Thomson Reuters Trust Principles.

Persons: Roche, Christopher Viehbacher, Tecfidera, Wells, Mohit Bansal, Manas Mishra, Mariam Sunny, Sriraj Organizations: Biogen, Novartis, Thomson Locations: Massachusetts, Bengaluru

July 25 (Reuters) - Further deterioration in demand for glyphosate-based weed killers led Bayer (BAYGn.DE) to cut its full-year earnings outlook and announce a 2.5 billion euro ($2.8 billion) write-down on glyphosate-related assets. That was lower than a previous 2023 outlook of 12.5 billion euros, or slightly higher. Free cash flow would come in at zero, down from a previous prediction of 3 billion euros, the company said. "Based on the anticipated market development, in particular with respect to the glyphosate business, Bayer also expects to record a goodwill impairment of approximately 2.5 billion euros," it said. That would result in a second-quarter net loss of 2 billion euros.

Persons: Bayer, Bill Anderson, Roche, Markus Manns, Anderson, Hurricane Ida, Werner Baumann, Thomas Escritt, Ludwig Burger, Jonathan Oatis, Susan Fenton, Kirsten Donovan Organizations: Union Investment, Barclays, FMC, BASF, Bayer, Thomson

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