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Eli Lilly, along with Sanofi (SASY.PA) and Novo Nordisk (NOVOb.CO) make up 90% of the U.S. market for insulin. Biden, a Democrat, on Tuesday called on Congress and other manufacturers to lower the price of insulin as Lilly had done. The list price for Lispro, a cheaper version of its Humalog insulin, is currently $82.41 for 100 units/mL vials. List prices for drugs often differ from what patients actually pay, including after insurance and other assistance programs. Ricks said the company's insulin price cuts had been planned for some time and were accounted for in Eli Lilly's December financial forecast, which projected 2023 revenue of at least $30.3 billion.
The stock had dropped 26.2% to $6.83 around 8:55 ET (13:55 GMT), while its Frankfurt-listed shares slumped more than 27%. The company - whose COVID vaccine is its only marketed product after 35 years in business - on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. As of last close, Novavax's U.S.-listed shares are down 97% from their February 2021 record high of $331.68.
Lilly to cut U.S. insulin prices by 70% from fourth quarter
  + stars: | 2023-03-01 | by ( ) www.reuters.com   time to read: +2 min
March 1 (Reuters) - Eli Lilly and Co (LLY.N) will cut list prices by 70% for its most commonly prescribed forms of insulin, Humalog and Humulin, beginning from the fourth quarter of this year, the drugmaker said on Wednesday. Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association. Eli Lilly, along with Sanofi (SASY.PA) and Novo Nordisk (NOVOb.CO) make up 90% of the U.S. market for insulin. Drugmakers had previously priced insulin at more than $275 a vial, representing a 1,200% increase in price over the past 20 years, according to the advocacy group Insulin Initiative. Reporting by Bhanvi Satija in Bengaluru; Additional reporting by Susan Heavey, Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.
The setbacks were likely to put Merck further behind in its quest to develop a treatment for advanced forms of the most common cancer type in the United States. It had in January stopped a late-stage study of the drug in some prostate cancer patients. An interim analysis showed the combination therapy did not extend survival or help extend the time a patient lives without the disease worsening compared to placebo, Merck said. Merck was testing its blockbuster immunotherapy in combination with androgen deprivation therapy and Xtandi, made by Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T), in patients with an advanced form of treatment-resistant prostate cancer. Additionally, Merck said another combination treatment with Keytruda did not meet the main goal in a separate late-stage study for a type of lung cancer that can spread to other parts of the body.
Feb 28 (Reuters) - Merck & Co (MRK.N) said on Tuesday it will stop a late-stage trial evaluating a combination therapy with its cancer drug Keytruda in patients with a type of advanced prostate cancer. The U.S. drugmaker said the decision was based on an interim analysis of data from the study which showed the combination therapy did not improve overall survival in prostate cancer patients compared to placebo. Merck said another combination treatment with Keytruda did not meet the main goal in a separate late-stage study evaluating it for a type of lung cancer. Reporting by Bhanvi Satija in Bengaluru; Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.
U.S. FDA declines to approve Cytokinetics' heart drug
  + stars: | 2023-02-28 | by ( ) www.reuters.com   time to read: 1 min
Feb 28 (Reuters) - Cytokinetics Inc (CYTK.O) said on Tuesday the U.S health regulator declined to approve its oral drug for a type of heart failure, citing lack of sufficient data to show the drug was effective. The U.S. Food and Drug Administration's decision comes after a panel of outside experts in December recommended against allowing the use of the drug due to safety concerns. Reporting by Pratik Jain and Bhanvi Satija in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.
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.
Feb 27 (Reuters) - Lucira Health (LHDX.O) said on Monday the U.S. Food and Drug Administration (FDA) had granted emergency use authorization for its combination diagnostic test for COVID-19 and the flu, making it the first to be available over-the-counter. The test — called Lucira COVID-19 & Flu Home Test — is a single-use, at-home rapid test kit that provides results from self-collected nasal swab in about 30 minutes. Shares of the medical test maker rose more than four-fold to 66 cents in premarket trade. Lucira is also seeking a strategic or financial partner to resume the manufacturing and development of additional home diagnostic tests. Reporting by Bhanvi Satija and Sriparna Roy in Bengaluru; Editing by Shailesh Kuber and Uttaresh VenkateshwaranOur Standards: The Thomson Reuters Trust Principles.
[1/2] Pfizer company logo is seen at a Pfizer office in Puurs, Belgium, December 2, 2022. REUTERS/Johanna GeronFeb 17 (Reuters) - Drugmaker Pfizer Inc (PFE.N) and France's Valneva (VLS.PA) will stop testing a Lyme disease vaccine in roughly half of U.S. patients in a late-stage study, the companies said, citing a breach of clinical trial guidelines by a third-party contractor. Pfizer still expects to submit marketing applications for the experimental vaccine in the United States and Europe in 2025. The trial was expected to include around 6,000 participants aged 5 and older across Europe and United States, where Lyme disease is highly endemic. Paris-listed shares of Valneva fell nearly 10% to 5.72 euros following the news and U.S.-listed shares of Pfizer were down marginally in premarket trading.
Feb 15 (Reuters) - Emergent BioSolutions Inc's (EBS.N) over-the-counter version of opioid overdose reversing drug received unanimous support from U.S. Food and Drug Administration's panel of advisers, sending shares of the contract drugmaker up nearly 16% after market. The vote puts the naloxone-based treatment Narcan on track to potentially become the first opioid overdose drug to be sold OTC nationwide. Naloxone rapidly reverses or blocks the effects of an overdose, restoring normal respiration. However, most panelists emphasized that OTC use of the nasal spray was safe and proposed ways to improve its labeling, to avoid using the drug wrong. Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.
Globally, IPOs across all sectors nosedived last year after a blockbuster 2021, as aggressive interest rate hikes by central banks to curb inflation put an end to the era of cheap money. In the biotech sector, there were only 47 IPOs last year that raised a total of about $4 billion, compared with 152 offerings in 2021 that had raised over $25 billion. While the XBI is still trading 50% below its February 2021 closing high, analysts believe the downturn in biotech has bottomed out. All we need is one or two biotech IPOs to get good interest and the floodgates will open." Reuters GraphicsThe second half of 2023 is more likely to see a significant step-up in biotech IPOs instead of the first half, as markets await further clarity on potential rate cuts, analysts said.
U.S. government to buy 1.5 mln more Novavax COVID vaccine doses
  + stars: | 2023-02-13 | by ( ) www.reuters.com   time to read: +1 min
Feb 13 (Reuters) - The U.S. government has agreed to buy 1.5 million more doses of Novavax Inc (NVAX.O) COVID-19 vaccine, the company said on Monday, adding that the modified agreement includes funds for development of an updated vaccine by fall this year. Sales of the company's vaccine have been hurt by a global supply glut and waning demand, with Novavax cutting its full-year revenue forecast for the shots twice last year. The protein-based vaccine was expected to convince those skpetical of the new mRNA-based vaccines against the virus from rivals such as Pfizer Inc (PFE.N) and Moderna (MRNA.O). The U.S. Food and Drug Administration is also in the process of simplifying its COVID-19 vaccine policy as it considers whether to recommend that Americans get an annual booster shot for the virus. Shares of the vaccine maker rose 3.2% before the bell on Monday after the Wall Street Journal first reported the news.
Feb 9 (Reuters) - Tenet Healthcare Corp (THC.N) on Thursday beat Wall Street estimates for fourth-quarter results as growth in its outpatient service business put concerns around the hospital operator's weak 2023 forecast at bay. HCA Healthcare also recently forecast lower-than-expected 2023 profit, but bet on improved staffing trends and lower labor costs to drive growth for the year. "As expected, the 2023 forecast came in below consensus estimates, but we believe investors had already priced that in," SVB Securities analyst Whit Mayo said. Tenet is betting on growth in its ambulatory care unit, which deals with patients who are not bedridden and don't require overnight hospitalization. On an adjusted basis, Tenet reported a net income of $1.96 per share for the quarter ended Dec. 31, beating estimates of $1.23 per share.
Feb 9 (Reuters) - Medical device maker Baxter International (BAX.N) on Thursday forecast 2023 profit well below Wall Street estimates and said it would cut up to 5% of its global workforce. Baxter, which is in the process of spinning off its kidney care units, is also exploring alternatives for its biopharma solutions business, including a potential sale. Baxter expects to save over $300 million through its cost reduction plans, including the layoffs, in 2023. The company said it expects to earn profit in the range of $2.75 per share and $2.95 per share, below analysts' expectations of $3.56, according to Refinitiv. As of Dec.31, Baxter had about 60,000 employees globally, according to its latest annual regulatory filing.
Companies CVS Health Corp FollowFeb 8 (Reuters) - CVS Health (CVS.N) beat quarterly profit estimates on Wednesday, as a decline in hospitalizations from COVID-19 helped bring down medical costs at its Aetna insurance business. The company posted an adjusted profit of $1.99 per share, above estimates of $1.92 per share, according to Refinitiv IBES data. CVS reaffirmed its full-year adjusted profit forecast of between $8.70 and $8.90 per share. Reporting by Raghav Mahobe and Bhanvi Satija in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.
CVS digs into primary care with $9.5 bln Oak Street Health deal
  + stars: | 2023-02-08 | by ( ) www.reuters.com   time to read: +2 min
Feb 8 (Reuters) - CVS Health Corp (CVS.N) said on Wednesday it would buy Oak Street Health Inc (OSH.N) for about $9.5 billion in cash, expanding its healthcare services by adding hundreds of primary care clinics mostly for older people. Shares of the primary care firm rose 5% before the bell. The Oak Street deal echoes similar moves by rivals into primary care. Walgreens Boots Alliance (WBA.O) and Cigna (CI.N) have made investments in primary care provider VillageMD, and Amazon (AMZN.O) announced a $3.49 billion deal last year to buy One Medical (ONEM.O) to expand into the space. UnitedHealth Group Inc (UNH.N) also runs urgent care, primary care and surgical care centers.
In 2023, it expects revenue to be $67 billion to $71 billion. Excluding the COVID-19 drugs, Pfizer expects 2023 revenue to grow 7% to 9%. Pfizer developed its COVID-19 vaccine with German partner BioNTech , and the companies split the profits. The U.S. drugmaker forecast 2023 sales of $13.5 billion from the shot, below Refinitiv estimates of $14.39 billion, and projected $8 billion in sales of Paxlovid, short of analysts' expectation of $10.33 billion. After that transition, the company hopes to roughly quadruple the U.S. price of the COVID-19 vaccine.
Pfizer forecasts weak 2023 sales of COVID products
  + stars: | 2023-01-31 | by ( ) www.reuters.com   time to read: +1 min
REUTERS/Eric GaillardCompanies Pfizer Inc FollowJan 31 (Reuters) - Pfizer Inc (PFE.N) on Tuesday forecast a steeper-than-expected drop in sales of its COVID-19 vaccine and pills in 2023, intensifying investor concerns over demand for the products as governments reduce orders. The forecast casts some uncertainty over future sales of Pfizer's biggest selling products this year, which are expected to come under pressure as government spending on COVID vaccines and treatments declines. The U.S. drugmaker said it expects sales of $13.5 billion from the vaccine for 2023, below Refinitiv estimates of $14.39 billion, and projected $8 billion in sales of its antiviral pill, Paxlovid, short of analysts' expectation of $10.33 billion. That compared with sales of $37.81 billion for the vaccine and $18.93 billion for Paxlovid in 2022. Reporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Sriraj Kalluvila and Maju SamuelOur Standards: The Thomson Reuters Trust Principles.
Drugmaker Amgen lays off 300 U.S. employees
  + stars: | 2023-01-30 | by ( ) www.reuters.com   time to read: 1 min
Jan 30 (Reuters) - Drugmaker Amgen Inc (AMGN.O) said on Monday that it let go about 300 U.S. employees or about 1.2% of its total workforce, citing recent organizational changes to its commercial team. The company had about 24,200 staff members in over 50 countries, as of December 31, 2021, according to its latest annual regulatory filing with the U.S. Securities and Exchange Commission. Big Tech firms and Wall Street titans have led a string of layoffs across corporate America in recent weeks. Amgen's move to trim its workforce shows how rapid interest rate hikes and a fading boom in demand post pandemic has begun to weigh on the healthcare sector. Reporting by Bhanvi Satija in Bengaluru; Editing by Savio D'Souza and Rashmi AichOur Standards: The Thomson Reuters Trust Principles.
Walmart, CVS Health adjust pharmacy hours amid labor crunch
  + stars: | 2023-01-27 | by ( ) www.reuters.com   time to read: +2 min
REUTERS/Mike Segar/File PhotoJan 27 (Reuters) - Walmart Inc (WMT.N) said on Friday it would adjust working hours for its U.S. pharmacy team and implement it nationwide in 4,600 locations, with drugstore operator CVS Health Corp (CVS.N) doing the same for about two-thirds of its retail pharmacies, amid a tight labor market. The United States has been experiencing a nationwide labor shortage since the COVID-19 pandemic which has forced retailers to offer attractive incentives and pay increases. Earlier on Friday, the Wall Street Journal first reported CVS Health Corp and Walmart were cutting pharmacy hours. CVS said the new hours of operation, which begin in March, at impacted pharmacies will vary, adding it periodically reviews operating hours to make sure peak customer demand was being met. Walgreens said in a statement that at times it had to adjust store or pharmacy hours at some places after staffing challenges impacted retailers and healthcare entities, among others, over the last 12 months.
But COVID-19 vaccine sales exceeded diminished expectations and demand for cancer drug Darzalex helped drive the fourth-quarter profit beat. The company reported $689 million in quarterly COVID-19 vaccine sales from outside the United States. J&J said it expects U.S. sales of Stelara to be flat to lower in 2023 due to competition from less expensive biosimilars in certain regions. It forecast adjusted 2023 earnings of $10.45 to $10.65 per share, above analysts' estimates of $10.35. Excluding items, J&J earned $2.35 per share for the quarter, topping analysts' estimates by 12 cents, according to IBES data from Refinitiv.
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J&J forecasts 2023 profit above expectations on pharma strength
  + stars: | 2023-01-24 | by ( ) www.reuters.com   time to read: +2 min
Shares of the drugmaker, however, fell 1% to $166.12 in premarket trading as fourth-quarter sales missed analysts' estimates due to lower demand for its medical devices. J&J expects to earn between $10.45 and $10.65 per share on an adjusted basis for 2023, above analysts' estimates of $10.35 per share profit at the midpoint. The higher 2023 profit forecast also reflects better-than-expected cost controls by J&J, Edward Jones analyst John Boylan said. Darzalex sales were $2.08 billion, while analysts were expecting $2.02 billion, according to Refinitiv. Excluding items, J&J earned $2.35 per share, above analysts' average estimates of $2.23 per share, according to IBES data from Refinitiv.
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J&J forecasts strong 2023 profit on strength in pharma unit
  + stars: | 2023-01-24 | by ( ) www.reuters.com   time to read: 1 min
Jan 24 (Reuters) - Johnson & Johnson (JNJ.N) on Tuesday forecast annual profit above Wall Street estimates as it bets on stronger demand for its pharmaceuticals products and a recovery in its medical devices business. J&J said it was expecting to earn between $10.45 and $10.65 per share on an adjusted basis for 2023, above analysts' estimates of $10.35 per share profit at midpoint. The healthcare conglomerate also beat estimates for fourth-quarter profit on Tuesday as increased sales of pharmaceutical products helped it weather a hit from a stronger dollarExcluding items, J&J earned $2.35 per share, above analysts' average estimates of $2.23 per share, according to IBES data from Refinitiv. Reporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.
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Teladoc Health cuts 300 jobs to shave costs
  + stars: | 2023-01-18 | by ( ) www.reuters.com   time to read: +1 min
Companies Teladoc Health Inc FollowJan 18 (Reuters) - Teladoc Health Inc (TDOC.N) said on Wednesday it has removed "redundant roles" and cut 300 jobs, or 6% from its non-clinician global workforce, as the company plans to prioritize its commercial businesses in a challenging demand environment. These job cuts have resulted from a combined implementation of the telehealth company's restructuring plans and previously announced cost-saving measures, some of which were implemented in the fourth quarter of 2022. The restructuring process has also resulted in a reduction of office spaces in certain markets, and Teladoc will further review its real estate footprint under the cost-management drive. Teladoc said it will record $4.4 million of the total $21.4 million of charges related to these measures taken in the fourth quarter, but does not expect them to have a material impact on its annual results. Reporting by Khushi Mandowara and Bhanvi Satija in Bengaluru; Editing by Nivedita Bhattacharjee and Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.
Companies Pfizer Inc FollowJan 17 (Reuters) - U.S. drugmaker Pfizer Inc (PFE.N) said on Tuesday it will offer its full portfolio of drugs, including off-patent medicines such as chemotherapies and oral cancer treatments, on a not-for-profit basis to 45 low-income countries in the world. In an expansion of the company's "An Accord for a Healthier World" program, which is aimed at increasing access to innovative treatments in some of the world's poorest countries, Pfizer said it will now offer a total of 500 products. When the drugmaker launched the program in May 2022, it offered only its patented medicines including COVID-19 treatment Paxlovid and its big-selling breast cancer drug, Ibrance, at a not-for-profit price. Reporting by Bhanvi Satija in BengaluruOur Standards: The Thomson Reuters Trust Principles.
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