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CVS Health logo is seen displayed in this illustration taken, May 3, 2022. Blue Shield, whose health plans cover 4.8 million members, said it will now work with five different companies, including Mark Cuban's drug company, to provide "convenient, transparent access to medications while lowering costs." Privately held Abarca will pay prescription drug claims, while Prime Therapeutics will work with Blue Shield to negotiate savings with drugmakers, the company said. Blue Shield will also work with CVS Caremark for specialty pharmacy services. The loss of the Blue Shield pharmacy benefit management contract is another blow to Caremark, which is also set to lose the contract to manage Centene's (CNC.N) $40 billion annual pharmacy needs from next year.
Persons: Dado Ruvic, UnitedHealth, Mark Cuban's, Paul Markovich, Mark, Manas Mishra, Mariam Sunny, Bhanvi, Shweta Agarwal, Pooja Desai Organizations: CVS, REUTERS, Blue, Cigna, UnitedHealth, Pharmacy, Wall Street, Mark Cuban, Plus, Thomson Locations: Blue, Bengaluru
CVS Health logo is seen displayed in this illustration taken, May 3, 2022. Non-profit health plan provider Blue Shield, which has 4.8 million members, said it will work with partners including Amazon.com and Mark Cuban's Cost Plus Drug Company to provide at-home delivery and access to low-cost medications. Privately held Abarca will pay prescription drug claims, while Prime Therapeutics will work with Blue Shield to negotiate savings with drugmakers, the company said. Blue Shield will also work with CVS Caremark for specialty pharmacy services. The loss of Blue Shield marks another blow to Caremark, which is also set to lose the contract to manage Centene's (CNC.N) $40 billion annual pharmacy needs from next year.
Persons: Dado Ruvic, Cuban's, Privately, Manas Mishra, Mariam Sunny, Bhanvi, Shweta Agarwal, Pooja Desai Organizations: CVS, REUTERS, Wall Street Journal, Cigna, UnitedHealth, Company, Thomson Locations: Bengaluru
REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.
Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru
July 28 (Reuters) - Biogen (BIIB.O) agreed to buy rare disease drugmaker Reata Pharmaceuticals (RETA.O) for nearly $6.5 billion, the first large acquisition under new CEO Christopher Viehbacher as he seeks to return the drugmaker to growth. Through the deal, Biogen said it will gain Texas-based Reata's recently approved drug Skyclarys to treat a rare genetic disorder that causes progressive damage to the nervous system. It already makes Spinraza, a treatment for the rare muscle-wasting disorder called spinal muscular atrophy, and a treatment for a rare type of amyotrophic lateral sclerosis. Biogen said it will pay Reata $172.50 per share in cash, which represents a 58.9% premium to the stock's last closing price. Reuters GraphicsShares of Reata surged nearly 52% to $164.76 in early trading, while Biogen's shares fell marginally to $261.14.
Persons: Christopher Viehbacher, Viehbacher, Biogen, Eisai, Baird, Brian Skorney, Manas Mishra, Bhanvi, Shinjini Organizations: Pharmaceuticals, Reuters, Thomson Locations: Texas, United States, Bengaluru
Major insurers UnitedHealth Group (UNH.N) and Humana (HUM.N) have already warned of booking higher costs due to a jump in non-urgent surgeries in the United States, highlighting demand for such procedures. HCA Healthcare, which is the biggest for-profit hospital operator in the United States, raised its full-year adjusted core earnings forecast to between $12.3 billion and $12.8 billion, from prior expectations of between $12.1 and $12.7 billion. "We anticipate the market wanted more even though HCA's outlook remains prudent as the healthcare system normalizes," said Citi analyst Jason Cassorla. Shares of rivals Tenet Healthcare (THC.N) and Universal Health Services (UHS.N) fell 2% and 1%, respectively, in morning trading. Profits at hospital operators took a hit following COVID-led lockdowns as people delayed non-urgent surgeries, and as the pandemic deepened a nursing shortage that led to a spike in costs.
Persons: Jason Cassorla, lockdowns, Khushi Mandowara, Manas Mishra, Shinjini Ganguli, Anil D'Silva Organizations: Healthcare Inc, UnitedHealth, HCA Healthcare, Citi, Tenet Healthcare, Universal Health Services, Thomson Locations: United States, Bengaluru
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 13 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women in the country to purchase birth control without prescription. Perrigo will next week share its pricing plan for the pill, which will be available in stores and online in the first quarter of next year. Women should take a progestin-only pill within the same three hours every day to avoid pregnancy. The National Catholic Bioethics Center and other groups have opposed making Opill available without prescription, saying physicians should be involved in health decisions, especially for teenagers, along with parental supervision, to avoid harm. Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.
Persons: Roe, Wade, Xavier Becerra, Opill, Jeffrey Singer, Perrigo, Manas Mishra, Sriparna Roy, Arun Koyyur Organizations: U.S . Food, Drug Administration, Perrigo, Human Services, Cato Institute, FDA, Catholic Bioethics Center, HRA Pharma, Thomson Locations: U.S, Paris, Bengaluru
June 27 (Reuters) - Walgreens Boots Alliance (WBA.O) on Tuesday warned that lower spending by inflation-spooked consumers and a hit from a larger-than-expected drop in COVID product sales would likely persist into next year, sending its shares plunging nearly 9%. Walgreens' shares were at $28.87 in early trading, hitting an over 11-year low after the company slashed its profit forecast for the year. The pharmacy chain also said its newly launched healthcare business, through which it operates doctors' offices, missed Walgreens' target for sales growth. "There are some factors impacting us today that are likely to extend into next year, namely the macroeconomic-driven consumer pressure and COVID headwinds." In the third quarter of the fiscal year, Walgreens reported a 0.2% fall in same-store sales at its retail division, compared with estimates of a 2.1% rise.
Persons: Rosalind Brewer, Brewer, Manas Mishra, Mariam Sunny, Pooja Desai Organizations: Walgreens Boots Alliance, Walgreens, CVS Health, Rite, Thomson Locations: Bengaluru
June 27 (Reuters) - Walgreens Boots Alliance (WBA.O) slashed its profit forecast for the year as persistently high inflation hits sales of consumer healthcare goods and demand for COVID shots and tests wanes, sending its shares plunging 8% on Tuesday. "Our revised guidance takes an appropriately cautious forward view in light of consumer spending uncertainty," CEO Rosalind Brewer said in a statement. Walgreens' shares were trading at $29.21, on track to open at their lowest levels since 2012, if losses held. In the third quarter of the fiscal year, Walgreens reported a 0.2% fall in same-store sales at its retail division, compared with estimates of a 2.1% rise, according to brokerage TD Cowen. Walgreens said its forecast cut reflected "challenging consumer and macroeconomic conditions, and lower COVID-19 vaccine and testing volumes".
Persons: Rosalind Brewer, TD, Walgreens, Manas Mishra, Mariam Sunny, Pooja Desai Organizations: Walgreens Boots Alliance, CVS Health, Walgreens, TD Cowen, Thomson Locations: Bengaluru
Pfizer CEO Albert Bourla has said an obesity pill could eventually be a $10-billion-a-year product for Pfizer. Truist Securities analyst Robyn Karnauskas said Lilly is now ahead in the race for a once-a-day obesity pill. Pfizer said last month that danuglipron helped patients lose weight on par with Novo Nordisk's (NOVOb.CO) Ozempic in a mid-stage study that tested it in patients with Type 2 diabetes. None of the patients in the lotiglipron trials reported liver-related symptoms or side effects, there was no evidence of liver failure and none required treatment, Pfizer said. Liver enzyme elevations observed in lotiglipron trials have not been seen in patients enrolled in danuglipron trials, the company added.
Persons: Albert Bourla, Eli Lilly, LLY.N, Robyn Karnauskas, Lilly, Pfizer, danuglipron, Manas Mishra, Leroy Leo, Michael Erman, Pooja Desai, Jason Neely, Deepa Babington Organizations: Pfizer Inc, Pfizer, NYSE Arca Pharmaceutical, Truist Securities, Novo Nordisk's, Thomson Locations: United States, Bengaluru, New Jersey
REUTERS/Mike Blake/File Photo/File PhotoJune 14 (Reuters) - Health insurer stocks dropped sharply on Wednesday after UnitedHealth Group (UNH.N) said costs were on the rise for the largest U.S. healthcare provider by market value due to an increase in surgeries among older adults. Shares of industry bellwether UnitedHealth fell 7.3% to $455.11, wiping out roughly $42 billion from the company's market capitalization in the current trading session. Meanwhile, stocks of medical device makers and hospital operators rose, as increased frequency of surgeries mean more revenue for them. The company highlighted strong demand for hip and knee procedures at outpatient centers, as well as for home health services and behavioral services. Elevance Health (ELV.N), CVS Health Corp (CVS.N), Centene Corp (CNC.N) and Cigna Group (CI.N) fell between 6% and 7.5%.
Persons: Mike Blake, bellwether, UnitedHealth, Jefferies, Brian Tanquilut, Zimmer Biomet, Leroy Leo, Bhanvi, Manas Mishra, Shinjini Organizations: REUTERS, UnitedHealth, Medicare, Humana Inc, Reuters Graphics, Elevance, CVS Health Corp, Centene Corp, Cigna, Elevance Health Inc, CVS, Healthcare, Tenet Healthcare, Stryker, Thomson Locations: Santa Ana , California, U.S, Bengaluru
Cancer drugmakers rise as industry meet fuels investor interest
  + stars: | 2023-06-05 | by ( ) www.reuters.com   time to read: +2 min
June 5 (Reuters) - Shares of several cancer drug firms surged on Monday after the companies reported positive clinical trial data from their therapies at an ongoing industry conference in Chicago. ImmunoGen Inc's experimental drug, Elahere, to treat a type of ovarian cancer showed 35% reduction in the risk of tumor progression or death compared to chemotherapy in a late-stage study. Shares of Evaxion rose 5.4% to $1.55 after the smaller drug developer said its vaccine to prevent a type of skin cancer met safety goals in an early-stage study. Shares of Blueprint Medicines Corp (BPMC.O) fell 9.4% to $52.76 after analysts flagged potential safety issues about its experimental drug to treat a type of lung cancer. Reporting by Manas Mishra and Mariam Sunny in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.
Persons: William Blair, Manas Mishra, Mariam Sunny, Shailesh Organizations: Immunogen Inc, Evaxion, Therapeutics, American Society of Clinical Oncology, Arcus, Medicines Corp, Thomson Locations: Chicago, Bengaluru
Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer's patients. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July. Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs. To receive Medicare coverage, people will need to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer's and have a qualified physician participating in a registry.
Persons: Biogen, Leqembi, Eisai, Eli Lilly, Co's, Eli Lilly's, Alzheimer's, Sue Peschin, Manas Mishra, Leroy D'souza, Bill Berkrot Organizations: U.S, Eisai Co, FDA, Medicare, Centers, Medicaid Services, CMS, Alzheimer’s Association, Alliance for Aging Research, Thomson Locations: Bengaluru
US FTC expands probe into pharmacy benefit managers
  + stars: | 2023-05-17 | by ( ) www.reuters.com   time to read: +1 min
May 17 (Reuters) - The U.S. Federal Trade Commission said it had sought information from two privately held companies that negotiate drug rebates on behalf of pharmacy benefit managers (PBMs) as part of its probe into how PBMs affect pricing of prescription drugs. The two companies, Zinc Health Services and Ascent Health Services, are group purchasing organizations, that negotiate after-market discounts or rebates with drug manufacturers on behalf of PBMs and hold the contracts that govern those rebates. Zinc Health negotiates rebates for CVS Health Corp (CVS.N) and Ascent Health for Cigna Group's (CI.N) Express Scripts unit and Prime Therapeutics, which is a privately held PBM, the FTC said on Wednesday. PBMs act as middlemen and negotiate rebates and fees with drug manufacturers, create lists of medications that are covered by insurance, and reimburse pharmacies for patients' prescriptions. Reporting by Manas Mishra in Bengaluru Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.
Companies Johnson & Johnson FollowApril 18 (Reuters) - Johnson & Johnson (JNJ.N) on Tuesday cautioned investors over the lingering impact of inflation-driven costs this year as the healthcare conglomerate issued a conservative full-year profit forecast, and its shares fell more than 2%. J&J also said it expected a steep decline in sales of its blockbuster Crohn's disease drug Stelara once it loses U.S. patent protection in late 2023. J&J, the first large drugmaker and medical device manufacturer to report earnings, raised the midpoint of its full-year profit forecast by 10 cents despite beating first-quarter estimates by 18 cents. A recovery in medical procedures after being weighed down by hospital staffing shortages helped the medical device unit post sales of $7.48 billion, topping analysts' estimates of $7.31 billion. Consumer health sales rose 7.4% to $3.85 billion, surpassing estimates of $3.62 billion, powered by price hikes to offset the impact from inflation.
The company's clients have included COVID-19 vaccine makers such as Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N). Catalent said it experienced "productivity issues" at its gene therapy manufacturing site in Harmans, Maryland, and faced similar issues at its drug product and drug substance manufacturing facilities in Bloomington, Indiana and Brussels, Belgium. The issues would impact financial results for the third quarter and Catalent's forecast for the remainder of fiscal 2023, the company said. Catalent named company insider Ricky Hopson as interim CFO and said it had launched the search for a permanent finance chief. The company's shares were trading at $50.77 before the bell.
SVB fall casts shadow on early-stage U.S. biotech
  + stars: | 2023-03-13 | by ( Patrick Wingrove | ) www.reuters.com   time to read: +3 min
March 13 (Reuters) - The collapse of Silicon Valley Bank (SIVB.O) will leave early-stage biotechnology companies with a funding void, investors and analysts said on Monday, but larger, publicly-traded drug companies should escape unscathed. About 50% of U.S. biotech companies, developing drugs for everything from cancer to heart disease and rare conditions, banked with Silicon Valley Bank (SVB), including a large number of private firms, according to WBB financial analyst and managing partner Steve Brozak. Analysts said the direct impact to U.S. biotech companies overall was limited, although several drugmakers such as Axsome Therapeutics Inc (AXSM.O) and Rhythm Pharmaceuticals Inc (RYTM.O) disclosed cash deposits with the bank. Startup-focused lender SVB Financial Group last week became the largest bank to fail since the 2008 financial crisis, sending shockwaves through the global financial system and prompting regulators to step in to contain the fallout. SVB’s demise likely leaves smaller biotech clients without an alternative lender, said Brozak, since other banks will now probably raise their funding thresholds to points that make investment difficult for smaller entities.
Washington-based Seagen is a pioneer of antibody-drug conjugates, which work like "guided missiles" designed for a targeted destructive effect and spare healthy cells. The Pfizer logo is pictured on their headquarters building in the Manhattan borough of New York City, New York, U.S., November 9, 2020. The drugmaker expects more than $10 billion in sales from Seagen products in 2030, and another $15 billion from its other recent acquisitions. Pfizer said antitrust regulators could closely review the deal due to its size but eventually approve it. Pfizer rival Merck & Co Inc (MRK.N) and Seagen were in advanced deal talks last year but those reportedly collapsed over antitrust concerns.
Pfizer signs $43 bln Seagen deal in cancer drug push
  + stars: | 2023-03-13 | by ( Manas Mishra | ) www.reuters.com   time to read: +2 min
The deal, Pfizer's biggest in a string of acquisitions after a once-in-a-lifetime cash windfall from its COVID-19 vaccine and pill, will add four approved cancer therapies with combined sales of nearly $2 billion in 2022. Pfizer will pay $229 in cash per Seagen share, a 32.7% premium to Friday's closing price. The drugmaker expects more than $10 billion in "risk-adjusted" sales from Seagen in 2030. Pfizer's portfolio of oncology therapies includes 24 approved drugs, including breast cancer treatment Ibrance. Pfizer rival Merck & Co Inc (MRK.N) and Seagen were in advanced deal talks last year but that reportedly collapsed over fears of tough antitrust scrutiny.
Feb 28 (Reuters) - A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States. GSK (GSK.L), which is another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts to the FDA on Wednesday. "The population where the vaccine is going to potentially have the biggest impact is less represented in this study," said Hana Sahly, one of the 12 FDA panelists. The FDA is scheduled to decide on the vaccines by May, and typically follows the recommendations of its independent panel of experts. Pfizer's vaccine was 66.7% effective in preventing RSV-related lower respiratory tract illness with over two symptoms, while GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over.
Feb 28 (Reuters) - The frontrunners in a crowded race to develop the first respiratory syncytial virus (RSV) vaccine - Pfizer Inc (PFE.N) and GSK (GSK.L) - will face scrutiny from a panel of experts to the U.S. Food and Drug Administration this week. Merck & Co Inc (MRK.N), Moderna Inc (MRNA.O), Johnson & Johnson (JNJ.N) are conducting trials of their own RSV vaccines. Pfizer and GSK grabbed a lead last year after data from separate late-stage studies showed their shots prevented respiratory disease caused by RSV. GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over, and 94.1% effective in preventing severe disease. Dr. Schaffner expects a positive vote on the vaccines when the advisory panel discusses Pfizer's vaccine on Feb. 28, and GSK's vaccine on March 1.
Pfizer in talks to buy cancer drugmaker Seagen - WSJ
  + stars: | 2023-02-27 | by ( ) www.reuters.com   time to read: +2 min
Feb 27 (Reuters) - Pfizer Inc (PFE.N) is in early-stage talks to acquire cancer drugmaker Seagen Inc (SGEN.O) in a potential multi-billion dollar deal, the Wall Street Journal reported, after advanced discussions between Merck (MRK.N) and Seagen fell through last year. Seagen had a market capitalization of roughly $30 billion, as of Friday's close. Its shares have fallen nearly 10% since July, when the deal talks with Merck were first reported. Pfizer declined to comment on the WSJ report, while Seagen did not immediately respond to a Reuters request for comment. Merck, which bought ADC-maker Imago BioSciences for $1.35 billion in November, is unlikely to show renewed interest in Seagen, analysts said.
The results were similar to data from rival Pfizer Inc (PFE.N), whose COVID pill Paxlovid also failed to prevent infections among household contacts. Merck's late-stage trial enrolled over 1,500 participants, who were household contacts exposed to an individual with at least one symptom and had recently tested positive for COVID-19. Its Lagevrio pill, also known as molnupiravir, was given every 12 hours for five days and was compared with a placebo group. Participants treated with the pill were 23.6% less likely to develop COVID than those given a placebo through day 14, failing to meet the main goal of the trial, Merck said. Pfizer's Paxlovid and Merck's Lagevrio pills were given emergency use authorization in Dec. 2021 for patients with mild-to-moderate COVID that tested positive for the virus, and who were at risk of progressing to severe COVID.
Feb 15 (Reuters) - Biogen Inc (BIIB.O) Chief Executive Officer Christopher Viehbacher said on Wednesday he is banking on high-profile launches of Alzheimer's disease treatment Leqembi and depression drug zuranolone, as well as deals, to help the company return to revenue growth. A controversial approval and problematic launch of previous Alzheimer's disease drug Aduhelm, which like Leqembi was developed with Eisai Co Ltd (4523.T), have further dented investor sentiment. Biogen is also hoping to gain U.S. approval of depression treatment zuranolone this year. Biogen forecast full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a fourth-quarter adjusted profit of $4.05 per share, beating estimates compiled by Refinitiv IBES by 57 cents.
Feb 15 (Reuters) - Biogen Inc (BIIB.O) said on Wednesday that Alzheimer's disease drug Leqembi would bring in modest revenue for the year although it might not be enough to offset costs tied to its launch. Biogen has a 50% share of U.S. profits on Leqembi, which it developed with lead partner Eisai Co Ltd (4523.T). "Over the last couple of years, the company has lost its way somewhat and now it is in a declining revenue," Viehbacher said. Biogen expects full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a Q4 adjusted profit of $4.05 per share, above Refinitiv IBES estimates of $3.48 per share.
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