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He said that once implemented, the prices on negotiated drugs will decrease for up to 9 million seniors who currently pay as much as $6,497 in out-of-pocket costs per year for these prescriptions. This kicks off the negotiation process for the 10 drugs whose new prices will go into effect in 2026. U.S. laws had prohibited Medicare from negotiating pharmaceutical prices as part of its prescription drug program that began about 20 years ago. CMS Director Dr. Meena Seshamani said Medicare plans to use a review process to make sure insurance companies keep clinically appropriate access to negotiated drugs. Two analysts said they expect the negotiated prices to move beyond Medicare and affect commercial markets for these drugs by 2026, when they come into effect.
Persons: Joe Biden, Jonathan Ernst, Biden, Joe Biden’s, Januvia, Xarelto, Johnson, Boehringer Ingelheim, Eli Lilly's, Jardiance, Mohit Bansal, Entresto, Eli Lilly, Merck, Bristol Myers, Giovanni Caforio, Caforio, enrollees, Meena Seshamani, Stelara, Amgen, Evan Seigerman, Patrick Wingrove, Mike Erman, Manas Mishra, Nandita Bose, Caroline Humer, Bill Berkrot Organizations: Social Security, University of Tampa, REUTERS, U.S, Bristol Myers Squibb, Pfizer, Merck, Co's, Johnson, Novo Nordisk, NYSE Arca Pharmaceutical, U.S . Centers, Medicare, Medicaid Services, Reuters Graphics Wells, Novartis, AstraZeneca, Bristol, J, U.S . Department of Health, Human Services, BMO Capital, Thomson Locations: Tampa , Florida, U.S, Amgen's, Jardiance, Germany, Bengaluru, Washington
FILE PHOTO: A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. The trial with 529 volunteers focused on a heart condition known as preserved ejection fraction, or HFpEF, where heart muscles stiffen and draw in less blood, mainly affecting overweight people. HFpEF accounts for about half of heart failure cases, with symptoms including shortness of breath and swelling of extremities. Showing specific medical benefits is crucial for Novo's push to move Wegovy beyond its image as a lifestyle drug. It is unclear, though, what conclusions regulators and physicians will draw from the STEP HFpEF results because other heart failure treatments are emerging.
Persons: Jim Vondruska, Wegovy, , Martin Lange, Danish drugmaker, Farxiga, Lars Fruergaard Jorgensen, Ludwig Burger, Jason Neely, Mark Potter Organizations: REUTERS, Novo Nordisk, Novartis, Reuters, Thomson Locations: Chicago , Illinois, U.S, Danish, Novo, United States, Europe, Germany
[1/2] Sanofi logo at the company's headquarters during the annual results news conference in Paris, France, February 4, 2022. REUTERS/Benoit Tessier/File PhotoCompanies AstraZeneca PLC FollowSanofi SA FollowAug 3 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said its advisory panel on Thursday recommended use of Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers. The Advisory Committee on Immunization Practices unanimously recommended nirsevimab for preventing lower respiratory tract disease in newborns and infants below eight months of age born during or entering their first RSV season. It also recommended its use in children aged 8-19 months who remain vulnerable to severe RSV disease through their second such season. The therapy, branded as Beyfortus, will be available in the U.S. ahead of the upcoming 2023-24 RSV season, Sanofi said.
Persons: Benoit Tessier, AstraZeneca's, Sanofi, Mrinmay Dey, Mariam Sunny Organizations: Sanofi, REUTERS, Companies AstraZeneca, U.S . Centers for Disease Control, Prevention, U.S . Food, Drug Administration, Thomson Locations: Paris, France, U.S, Bengaluru
[1/2] FILE PHOTO-Test tubes are seen in front of a displayed AstraZeneca logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/Illustration/File PhotoJuly 28 (Reuters) - AstraZeneca (AZN.L) said on Friday its unit Alexion has agreed to buy U.S. drugmaker Pfizer's <PFE.N> early-stage rare disease gene therapy portfolio for up to $1 billion, plus royalties on sales. AstraZeneca bought Alexion in 2021. It focuses on rare diseases and plans to close the deal in the third quarter, the British drugmaker said. AAV capsids have been shown to be an effective mechanism for delivering therapeutic gene cargos for gene therapy and gene editing, the company said.
Persons: Dado Ruvic, Alexion, drugmaker, AAV, Yadarisa, Nivedita Organizations: AstraZeneca, REUTERS, Thomson Locations: Bengaluru
AstraZeneca's chief financial officer on Friday said that geopolitical tensions are not impacting the company's China operations, following a report that the pharma giant is considering spinning off its business in the country. So I think we're just in a very unique space and we don't really see geopolitics playing a role in doing business in China," Aradhana Sarin told CNBC's "Squawk Box Europe." The Financial Times reported on June 18 that AstraZeneca had drawn up plans to spin off its China business and potentially list it in Hong Kong, in order to shield it from China's strained relationship with the U.S. and Europe. "China has actually been a great business for us," Sarin said, observing that the company's China branch had recorded four successive quarters of growth. The company's China revenues expanded by 7%, slightly above the 6% recorded in Europe, but below the 10% growth in the U.S., including Covid-related figures.
Persons: There's Organizations: pharma, Financial Times, AstraZeneca, U.S Locations: China, Hong Kong, Europe, Shanghai, U.S
Saxenda is Novo's older GLP-1 drug and has lower effectiveness than its newer obesity treatment Wegovy, which contains semaglutide. Novo told Reuters it had received a request on Monday from the MHRA about the agency's review of potential suicidal and self-harming thoughts related to GLP-1 drugs. The MHRA said AstraZeneca's GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review. The MHRA said that two other GLP-1 drugs, Sanofi's (SASY.PA) lixisenatide and Eli Lilly's (LLY.N) dulaglutide, were also included. It is also investigating GLP-1 drugs for possible risk of thyroid cancer.
Persons: Novo, AstraZeneca's GLP, lixisenatide, Eli Lilly's, Sanofi, Eli Lilly, liraglutide, Alison Cave, Novo's, MHRA, Ozempic, GLP, Maggie Fick, Josephine Mason, Mark Potter, Jane Merriman Organizations: Novo Nordisk, European Union, The Medicines, Healthcare, Agency, Reuters, AstraZeneca, European Medicines Agency, Thomson Locations: Britain, Europe, United States
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
CNBC Daily Open: Tesla roars in a quiet market
  + stars: | 2023-07-04 | by ( Yeo Boon Ping | ) www.cnbc.com   time to read: +2 min
This report is from today's CNBC Daily Open, our new, international markets newsletter. CNBC Daily Open brings investors up to speed on everything they need to know, no matter where they are. Muted marketsMajor U.S. indexes inched up fractionally Monday, in a quiet start to the second half of the year. Electrifying growthTesla shares popped 6.9% yesterday after the company reported a staggering 83% year-over-year growth in deliveries during the second quarter. Rivian shares jumped 17.4% after the company reported 12,640 deliveries during the second quarter, up 59% from the previous quarter.
Persons: Elon Musk, Thierry Breton, Bluesky, Jack Dorsey, Tom Lee, Lee Organizations: SpaceX, Tesla, Twitter, Viva Technology, CNBC, U.S, AstraZeneca's, European Union Locations: Paris, France, Japan, South Korea, China
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
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
LONDON, June 4 (Reuters) - AstraZeneca's lung cancer therapy, Tagrisso, cut the risk of death by more than half in patients with a certain form of lung cancer who were diagnosed early enough to have their tumour surgically removed, trial data showed. The drug has regulatory approvals across multiple geographies for certain patients with so-called non small cell lung cancer (NSCLC) who have a mutation of the EGFR gene. In the trial, Tagrisso or a placebo was given to patients to assess whether the AstraZeneca therapy could keep their cancer at bay. An estimated 88% of patients treated with Tagrisso were alive at five years compared to 78% on placebo, trial data also showed. AstraZeneca is also expecting to provide details on the impact of combining Tagrisso with chemotherapy in patients with advanced EGFR-mutated lung cancer later this year.
Persons: Tagrisso, Susan Galbraith, Dave Fredrickson, Natalie Grover, Angus MacSwan Organizations: American Society of Clinical Oncology, AstraZeneca, Reuters, Thomson Locations: Swedish, London
BEIJING, May 19 (Reuters) - Global drugmaker AstraZeneca will seek to be a patriotic company in China that "loves the Communist Party", its China president said at an event on Friday. While many local companies have in recent years publicly pledged allegiance to the ruling Chinese Communist Party as President Xi Jinping strengthened the party's role throughout Chinese society and its economy, such messaging is still unusual from foreign companies. "Build a local, transnational company that loves the Communist Party and loves the country," Wang said in his presentation to an audience of a few hundred participants, with the words flashed across the screen behind him. Last year, China accounted for 13% of AstraZeneca's total sales and the company is China's biggest drugmaker. Reporting by Joe Cash in Beijing and Brenda Goh in Shanghai; Editing by Kim CoghillOur Standards: The Thomson Reuters Trust Principles.
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.
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.
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.
REUTERS/ Albert GeaCompanies AstraZeneca PLC FollowBARCELONA, April 18 (Reuters) - AstraZeneca is confident that its new version of COVID-19 antibody treatment could protect immunocompromised patients against all known virus variants, its vaccines head said. AstraZeneca plans, pending more positive data and regulatory approval, to make the antibody available by the end of 2023. In January, the U.S. health regulator withdrew its emergency use authorization for AstraZeneca's original COVID-19 antibody cocktail Evusheld, as new dominant variants made it obsolete. AstraZeneca's AZD3152, it new COVID-19 antibody, was acquired through a $157 million deal last year with British biotech start-up RQ Bio. However, demand for COVID-19 vaccines have dramatically declined with competition from mRNA vaccines and given many countries already have an oversupply of COVID-19 shots.
The Swiss firm's shares jumped 5.8% on Monday to a four-week high by 0734 GMT, after it said a panel of independent supervisors recommended stopping the trial early because an interim analysis had shown a clear benefit. Kisqali has been approved to treat hormone-driven breast cancer that has spread to other body parts, where it has taken market share from Pfizer's (PFE.N) Ibrance. Rival drug Verzenio by Eli Lilly (LLY.N) has approval in the early setting for women at high risk of recurrence after surgery. Kisqali, which saw sales gain 31% to $1.2 billion last year, is one of two new drugs with a particularly important role for the group's future sales growth. Detailed trial results will be presented at a medical conference, Novartis said, without identifying the meeting or its timing.
The U.S. Food and Drug Administration's (FDA) committee is scheduled to meet on April 28. The companies' are seeking approval of the drug Lynparza in combination with other medications – abiraterone and prednisone or prednisolone – for the treatment of a type of treatment-resistant prostate cancer in adult patients. Lynparza was approved in March last year by the FDA as a treatment for patients with early-stage breast cancer with certain mutations. The drug is also approved in the United States as a standalone treatment for another 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 of prostate cancer in 2023, according to the American Cancer Society’s estimates.
Bayer's new CEO has a full in-tray as investors push for change
  + stars: | 2023-02-09 | by ( ) www.reuters.com   time to read: +5 min
February 9 - By Ludwig Burger and Patricia WeissFRANKFURT (Reuters) - Bayer's incoming CEO is inheriting a full in-tray from his predecessor: Thousands of lawsuits claiming its weedkiller causes cancer, an underwhelming drug development pipeline and disgruntled investors looking for major change. "The most important task for Bill Anderson is to regain investors' trust," said Markus Manns, a portfolio manager at Germany's Union Investment, a top 20 shareholder. Bayer's shares lag those of its global rivals, having fallen about 40% - knocking about 30 billion euros off its market valuation - since it bought Monsanto in 2018 for about $63 billion. Baumann's early exit has stirred debate about what the 56-year-old Anderson can do to restore investor trust and boost Bayer's shares. A stand-alone pharmaceuticals business, with 18.3 billion euros in 2021 sales, could also become a takeover target.
The company also predicted a return to growth in China, one of its key markets, after reporting a second consecutive quarter of growth even as prices remain under pressure. Sales of its best-selling cancer drugs — Tagrisso, Imfinzi and Lynparza — came in just below estimates from Cowen analysts. Sales started to pick up in the second half of 2022 and in the fourth quarter grew by 3% at constant currency rates. Of key interest to investors is the experimental cancer drug, datopotamab deruxtecan, being evaluated in a keenly anticipated late-stage trial involving lung cancer patients. Partner Daiichi Sankyo (4568.T) this month said results of that study have been delayed to the second quarter from the first quarter of 2023.
[1/2] The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, U.S., March 22, 2021. REUTERS/Rachel Wisniewski/Companies AstraZeneca PLC FollowLONDON, Feb 9 (Reuters) - Britain's business climate is deterring biopharma companies from investing in the country, AstraZeneca (AZN.L) chief Pascal Soriot said on Thursday, highlighting his company's decision to shift plans for a new manufacturing plant to Ireland. He highlighted AstraZeneca's recent decision to build a manufacturing facility in Ireland instead of the UK as evidence of Britain becoming less attractive for drugmakers. The decision, made in 2021, was also linked to the UK government's Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), a company spokesperson added. Reporting by Natalie Grover and Maggie Fick Editing by Tomasz Janowski, Barbara Lewis and Susan FentonOur Standards: The Thomson Reuters Trust Principles.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailAstraZeneca hopes to trial 'blockbuster' products that will make over a billion in revenue: CFOAradhana Sarin, AstraZeneca's chief financial officer, discusses the company's growth plans and its pipeline of products.
AstraZeneca Q4 revenue just shy of analyst estimates
  + stars: | 2023-02-09 | by ( ) www.reuters.com   time to read: +1 min
Companies AstraZeneca PLC FollowLONDON, Feb 9 (Reuters) - AstraZeneca (AZN.L) on Thursday posted fourth-quarter revenue just shy of analyst estimates, with slightly lower-than-expected sales of its best-selling oncology and rare blood disorder drugs. The London-listed drugmaker, which reports its results in U.S. dollars, reported an adjusted profit of 1.38 cents per share on sales of about $11.2 billion. Analysts were expecting $1.34 per share on sales of about $11.3 billion, according to company-compiled consensus estimates. Sales of AstraZeneca's best-selling cancer drugs — Tagrisso, Imfinzi and Lynparza — generated $1.34 billion, $752 million, $689 million in the quarter respectively. Cowen analysts expected the three drugs to bring in about $1.4 billion, $760 million and $695 million respectively.
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