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☆ Jim Cramer's quick thoughts on 5 stocks: Chevron, Snap, Intel, AbbVie and Colgate
▼ + stars: | 2024-04-26 | by ( Matthew J. Belvedere | ) www.cnbc.com time to read: +1 min

Jim Cramer's daily rapid fire looks at stocks in the news outside the CNBC Investing Club portfolio. "I've been itching to buy Devon " again for the CNBC Investing Club portfolio . Snap : The social media company reported a much better-than-expected quarter with higher revenue and active users. Colgate-Palmolive : The consumer products giant had a strong quarter with organic sales up 9.8% and a full-year sales guidance raise. I admit that," Cramer said, referring to Procter & Gamble , which is a stock owned by the Investing Club.

Persons: Jim Cramer's, Jim Cramer, Cramer, Chevron, Botox, Colgate, — Organizations: CNBC, Club, Chevron, Intel, Colgate, Palmolive, Procter, Procter & Gamble, Investing Locations: Devon

☆ Pfizer is betting big on cancer drugs to turn business around after Covid decline – here's what to know
▼ + stars: | 2024-03-10 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +13 min

Now, the company is betting on cancer drugs to help it regain its footing after a rocky year marked by the rapid decline of its Covid business. That $43 billion Seagen acquisition doubled Pfizer's oncology drug pipeline to 60 different experimental programs. Some analysts noted that it might take a few years for some of Pfizer's cancer drugs in mid-stage development to show pivotal clinical trial data and become less risky. Revenue from the blockbuster breast cancer drug Ibrance and prostate cancer treatment Xtandi, which Pfizer shares with Astellas Pharma, has declined over the past year. They are among the most expensive prescription drugs in the U.S. Before the Seagen deal, 94% of Pfizer's cancer products were small-molecule drugs.

Persons: Wall, Seagen, Chris Boshoff, Boshoff, David Ryder, Trung Huynh, Joe Biden's, Chris Schott, Suneet Varma, RemeGe, Merck, Padcev, Guggenheim, Pfizer's, Pfizer hasn't, Dr, Mikael Dolsten, Irfan Khan Organizations: Nurphoto, Getty, Pfizer, Astellas Pharma, Guggenheim, Bloomberg, UBS, Medicare, Drug Administration, FDA, ADC, JPMorgan, Drugs, CNBC, CVS Pharmacy, Los Angeles Times Locations: Covid, Bothell , Washington, U.S, biologics, China, Eagle Rock , California

Shanker also raised his price target to $80 from $75, suggesting nearly 34% downside from Friday's close. — Spencer Kimball 8:16 a.m.: Loop Capital upgrades Corteva, touts growth acceleration in 2025 Corteva's stronger-than-expected 2024 full-year guidance will jumpstart a period of strong growth, according to Loop Capital. The firm upgraded the agricultural chemicals company to buy from hold and increased its price target to $65 from $57. Analyst Jay Sole upgraded Urban to neutral from sell and upped his 12-month price target by $20 to $41. Kaufman's $183 price target indicates roughly 6.3% downside for shares, which have fallen more than 18% over the past year.

Persons: headwinds, Morgan Stanley downgrades XPO, Morgan Stanley, Ravi, Shanker, — Michelle Fox, Julien Dumoulin, Smith, Duke's, — Spencer Kimball, Chris Kapsch, Kapsch, Brian Evans, Cassie Chan, they'll, Chan, —, Jay Sole, URBN, Sole, Urban's, — Pia Singh, Filippo Falorni, Falorni, Hershey, Stanley, Pamela Kaufman, Kaufman's, Hershey's, Kaufman, Graham Doyle, Doyle, Piper Sandler, David Amsellem, Amsellem, Amsellam, Christopher Horvers, Jan, Horvers, Fred Imbert, Dan Levy, Levy Organizations: CNBC, Barclays, Automotive, JPMorgan, Corp, Bank of America, Bank of America downgrades Duke Energy, Duke Energy, Duke, Wall, America, UBS, Urban Outfitters, Free People, Urban, Citi, PepsiCo, Citi Research, Pepsi, Hershey, GE Healthcare Technologies, UBS GE Healthcare Technologies, Pharmaceutical, Teva Pharmaceutical, Federal, Barclays downgrades Rivian, Rivian Automotive, North American EV Locations: Bank of America downgrades, GEHC, David Amsellem U.S

☆ Big pharma is at a crossroads, as J&J, Merck and others prepare to lose heaps of revenue from blockbuster drugs
▼ + stars: | 2024-01-28 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +12 min

Bristol Myers Squibb's Eliquis is a blood thinner used to prevent clotting, to reduce the risk of stroke. Bristol Myers Squibb's Opdivo is an immunotherapy used to treat cancers, including melanoma and lung cancer. Investors will get updates on Merck and Bristol Myers Squibb's plans for the years ahead when they report earnings on Thursday and Friday, respectively. That's unlike generics, which are cheaper copycats of small-molecule drugs like Bristol Myers Squibb's Eliquis. Bristol Myers Squibb is also testing a new form of Opdivo, which is currently administered into a patient's veins.

Persons: Johnson, William Blair, Matt Phipps, Bristol Myers, Johnson's, Merck's Keytruda, J's Stelara, Opdivo, Phipps, biosimilars, Eliquis, Biosimilars, Humira, JB Reed, Samsung's, Piper Sandler, Christopher Raymond, AbbVie, Raymond, Chris Schott, Schott, Robert Davis, Keytruda, Davis, JPMorgan's Schott, Bristol Myers Squibb, George Frey, J, Amgen, J confidentially, Mike Perrone, It's, Anna Moneymaker Organizations: New York Stock Exchange, Johnson, NYSE Big, Bristol Myers Squibb, Merck, Biden, William Blair & Company, CNBC, Guggenheim, Bristol, Leerink Partners, Bloomberg, Getty, Bioepis, JPMorgan, JPMorgan Health Care, Moderna, Bristol Myers, Karuna Therapeutics, Hardy, Huntsman Cancer Institute, University of Utah, Reuters, Teva Pharmaceuticals, Pharma, U.S . Department of Health, Human Services Locations: drugmakers, EY, Europe, U.S, Cambridge , Massachusetts, Arda, EY's Americas, Bristol, Salt Lake City , Utah, Washington , DC

☆ Tyson Foods drops CVS for upstart pharmacy benefit manager, as industry upheaval over cost concerns spreads
▼ + stars: | 2024-01-24 | by ( Bertha Coombs | ) www.cnbc.com time to read: +1 min

Tyson Foods will become one of the first Fortune 100 companies to stop using the nation's traditional large pharmacy benefits managers, as it looks to cut spending on high-cost drugs. After putting its benefits contract up for bid, Tyson dropped CVS Health 's Caremark and chose PBM startup Rightway to manage drug benefits for its 140,000 employees starting this year, the companies said Wednesday. Tyson made the decision as it saw pharmacy costs soar. "We were going anywhere between 12% to 14% increases for pharmacy — and on a $200 million spend that's quite a bit. And then I wanted to understand what Tyson was paying for that; it was very difficult to get to those numbers," she said.

Persons: Tyson, Renu Chhabra, Chhabra, couldn't Organizations: Fortune, CVS

☆ AbbVie to buy cancer drugmaker ImmunoGen for $10 billion as Humira faces heat
▼ + stars: | 2023-11-30 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Brian Snyder/File Photo Acquire Licensing RightsNov 30 (Reuters) - AbbVie (ABBV.N) will buy ImmunoGen (IMGN.O) for $10.1 billion in cash, it said on Thursday, the latest major drugmaker to buy a developer of 'guided missile' cancer therapies as the company's top-seller Humira grapples with fierce competition. ImmunoGen's Elahere belongs to a new class of treatments called antibody-drug conjugates (ADC) that precisely targets cancer cells, potentially reducing toxicity for other cells. The drug, approved for ovarian cancer patients who have received previous therapies, is also being tested in earlier lines of treatment. AbbVie will also get access to Immunogen's follow-on pipeline of ADCs, including early-stage ovarian cancer candidate IMGN-151 and a mid-stage drug pivekimab sunirine for a rare type of blood cancer. Meanwhile, AbbVie's cancer drugs sales declined more than 8% in the third quarter to $1.51 billion, primarily due to increased competition to Imbruvica.

Persons: Brian Snyder, ImmunoGen's Elahere, AbbVie, IMGN, pivekimab, Immuogen stock's, Immunogen's, Elahere, Imbruvica, Manas Mishra, Leroy Leo, Shinjini Ganguli Organizations: REUTERS, Pfizer, Merck, U.S, Thomson Locations: Cambridge , Massachusetts, U.S, Bengaluru

The logo for AbbVie is displayed on a screen at the New York Stock Exchange (NYSE) in New York City, New York, U.S., November 17, 2021. Morningstar analyst Damien Conover said he had already factored in a hit to Imbruvica from the Medicare price negotiations, so the update on impairment was not "overly significant to our view." Humira's global third-quarter sales fell 36% to $3.55 billion, but topped analysts' estimates of $3.48 billion, according to LSEG data. AbbVie in July trimmed its 2023 view for Humira sales erosion to 35%, from 37% earlier. The company's newer immunology drugs Skyrizi and Rinvoq generated sales of $2.13 billion and $1.11 billion, respectively, ahead of analyst expectations of $2.10 billion and $1.02 billion.

Persons: Andrew Kelly, girding, AbbVie, Imbruvica, Morningstar, Damien Conover, Humira, Piper Sandler, Christopher Raymond, Ingelheim, Leroy Leo, Christy Santhosh, Maju Samuel, Bill Berkrot Organizations: New York Stock Exchange, REUTERS, U.S, Medicare, Analysts, Sandoz, AbbVie, Thomson Locations: New York City , New York, U.S, The Illinois, Bengaluru

☆ Novartis' Sandoz valued at $11.2 bln in market debut
▼ + stars: | 2023-10-04 | by ( ) www.reuters.com time to read: +1 min

A sign marks the Novartis Institutes for BioMedical Research facility in Cambridge, Massachusetts, U.S., June 16, 2021. REUTERS/Brian Snyder/File Photo Acquire Licensing RightsOct 4 (Reuters) - Sandoz (SDZ.S) made its market debut with a lower-than-expected valuation of 10.3 billion Swiss francs ($11.2 billion) on Wednesday, after the generic and biosimilar drugmaker was spun off from Swiss pharmaceutical company Novartis (NOVN.S). Deutsche Bank had said Sandoz, which accounted for 11% of Novartis' group operating profit in 2022, would likely be valued at $11-$13 billion, while brokerage Berenberg had forecast $17-$26 billion. The shares, which opened at 24 Swiss francs, became members of the Swiss Performance Index and the Swiss Leader Index, among other stock market gauges, and American depositary receipts also started trading on Wednesday. Novartis shareholders received one Sandoz share for every five Novartis shares they held as part of the transaction.

Persons: Brian Snyder, drugmaker, Sandoz, Berenberg, Vas Narasimhan, Ludwig Burger, Tristan Veyet, Clarence Fernandez, Mark Potter Organizations: Novartis, Research, REUTERS, Sandoz, Analysts, Deutsche Bank, Swiss, Thomson Locations: Cambridge , Massachusetts, U.S, Swiss, generics

☆ Novartis unit Sandoz starts trading at 24 Swiss francs after completing spinoff
▼ + stars: | 2023-10-04 | by ( Elliot Smith | ) www.cnbc.com time to read: +1 min

Novartis said in August that it plans to spin off its generics unit Sandoz to sharpen its focus on its patented prescription medicines. Novartis on Wednesday completed the spinoff of its generics and biosimilars business Sandoz, whose shares began trading at 24 Swiss francs in the early minutes of the company's debut on the SIX Swiss Exchange. The Swiss drugmaker initially announced intentions to spin off the business in August, offering stakeholders one Sandoz share for every five Novartis shares via a dividend-in-kind distribution. Pure play companies refer to entities that target a single product or industry sector. Novartis shares climbed more than 3% in early trade in Zurich to lead the pan-European Stoxx 600 index .

Persons: Sandoz, Narasimhan, we've, CNBC's Julianna Tatelbaum Organizations: Novartis, Wednesday, SIX Swiss Exchange, CNBC Locations: Swiss, Zurich

☆ Stocks making the biggest moves premarket: Cal-Maine Foods, Intel, Apple & more
▼ + stars: | 2023-10-04 | by ( Pia Singh | ) www.cnbc.com time to read: +2 min

Intel — Shares popped 2.5% after the chipmaker announced it would be operating its programmable chip unit as a standalone business complete. Intel plans to conduct an initial public offering for the unit within the next two to three years. The firm is bullish on the stock thanks to progress on legacy projects and said Fluor is on the brink of a company turning point. Sunrun , Sunnova Energy International — Shares of Sunrun and Sunnova dropped 3% and 2.8%, respectively, after Truist Securities downgraded the solar panel installers to hold from buy on Wednesday. Cal-Maine Foods — The stock plunged 11.6% after the company came out with disappointing sales figures due to lower prices.

Persons: Fluor, Sunnova, Moderna, StreetAccount, — CNBC's Brian Evans, Lisa Han Organizations: Intel, UBS, Apple, Sunnova Energy, Truist Securities, Moderna, pharma, Bank of America, Novartis —, Swiss drugmaker, Sandoz, SIX Swiss Exchange, Maine Foods, Revenue Locations: United States, Israel, Swiss, Cal

☆ Barclays says this women's health pharma company could rally 48%
▼ + stars: | 2023-09-21 | by ( Hakyung Kim | ) www.cnbc.com time to read: +2 min

Organon is an undervalued global play and leader in women's specialty health, according to Barclays. The company, with a portfolio of about 60 treatments and products focused on women's health, was spun off from Merck in 2021 . Barclays analyst Balaji Prasad initiated coverage on Organon with an overweight rating. The company could also generate more than $1 billion in annual free cash flow during that span, he added. Organon's prescription birth control Nexplanon is the key driver to its women's health portfolio as the Nexplanon "pipeline continues to progress toward commercialization," he added.

Persons: Balaji Prasad, Prasad, Nexplanon, — CNBC's Michael Bloom Organizations: Barclays, Merck, Health Locations: Wednesday's

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

☆ CVS pushes into making cheaper versions of complex drugs with new discount Humira
▼ + stars: | 2023-08-23 | by ( Bertha Coombs | ) www.cnbc.com time to read: +4 min

CVS Health is partnering with drugmaker Sandoz to produce a near identical version of the blockbuster arthritis treatment Humira that will sell for 80% below the price of the brand-named drug. The move is part of the company's new venture focused on securing, and in some cases co-producing, biosimilar drugs, which are the equivalent of generic versions of complex gene or protein-based therapies known as biologics. CVS is already one of the leading players when it comes to sourcing generic drugs through Red Oak, its joint venture with Cardinal Health . Abbvie reported more than $4 billion in Humira sales in its most recent quarter, which was slightly better than expected. Correction: CVS Health subsidiary Cordavis will partner with Sandoz on biosimilar drugs.

Persons: drugmaker Sandoz, We've, it'll, Prem Shah, drugmaker, Amgen's Amjevita, Murdo Gordon, Abbvie, Cuban's, John Ransom, Raymond James, Ransom, Sandoz Organizations: CVS Health, CVS, Cardinal Health, Novartis Pharmaceuticals, Sandoz, Novartis, FDA, Blue, Drug Company, Amazon Pharmacy Locations: U.S, Red, California

☆ US FDA approves Regeneron's ultra-rare blood disease drug
▼ + stars: | 2023-08-18 | by ( Pratik Jain | ) www.reuters.com time to read: +2 min

REUTERS/Brendan McDermid/File Photo Acquire Licensing RightsAug 18 (Reuters) - Regeneron Pharmaceuticals (REGN.O) said on Friday the U.S. health regulator approved its drug to treat a rare blood disease. The drug pozelimab, branded as Veopoz, would treat CHAPLE disease in adult and pediatric patients 1 year of age and older. Regeneron said the disease has fewer than 10 patients identified in the U.S. and estimates less than 100 patients worldwide. With Veopoz's approval, the company said the pre-approval inspection issues related to the marketing application of the higher dose of its blockbuster eye disease drug Eylea, or aflibercept, has been addressed. The FDA had in June declined to approve the higher-dose version following an inspection at third-party manufacturer Catalent (CTLT.N).

Persons: Brendan McDermid, Veopoz, Regeneron, 8mg, Evan Seigerman, Seigerman, Vaibhav Sadhamta, Khushi, Shilpi Majumdar Organizations: Regeneron Pharmaceuticals, REUTERS, U.S . Food, Drug Administration, Reuters, BMO Capital, FDA, Thomson Locations: Westchester, Tarrytown , New York, U.S, Bengaluru

☆ Biocon Biologics is well-placed to take advantage of opportunities in the biosimilars space: CEO
▼ + stars: | 2023-08-14 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailBiocon Biologics is well-placed to take advantage of opportunities in the biosimilars space: CEOShreehas Tambe of Biocon Biologics discusses why he is optimistic about the prospects for the company.

Persons: Shreehas, Biocon Biologics

July 27 (Reuters) - AbbVie (ABBV.N) on Thursday raised its annual profit forecast after beating analysts' estimates for second-quarter earnings on a lower-than-expected fall in sales of blockbuster arthritis drug Humira and strong sales of newer treatments. Global Humira sales tumbled 25.2% to $4.01 billion while analysts had expected $3.94 billion, according to Refinitiv data. Still, Humira sales are expected to drop 37% in 2023, and the company has been leaning on newer immunology drugs Skyrizi and Rinvoq to drive growth. Excluding one-off items, AbbVie reported a profit of $2.91 per share, beating the average analyst estimate of $2.81. The company raised its 2023 adjusted profit forecast to $10.90 to $11.10 per share from $10.57 to $10.97 earlier.

Persons: Evan Seigerman, Richard Gonzalez, Leroy Leo, Patrick Wingrove, Sriraj Kalluvila, Jonathan Oatis Organizations: Global, BMO Capital, Reuters, Thomson Locations: U.S, Amgen, Bengaluru, New York

☆ Launch of arthritis drug biosimilars ramps up US pressure on pricing 'middlemen'
▼ + stars: | 2023-07-25 | by ( Patrick Wingrove | ) www.reuters.com time to read: +5 min

Seven drugmakers this month launched their own versions, known as biosimilars, of AbbVie's (ABBV.N) flagship arthritis drug Humira, once the world's top-selling prescription medicine. Three have kept their list price within 5%-7% of AbbVie's, two priced at an 85% discount and two have offered both types of prices. For insured patients who are often on the hook for co-pays of 10% to 25% of the list price, the savings have been minimal. Reuters GraphicsThe Biden administration has made lowering drug prices a priority. Amgen offered 5% and 55% discounts to AbbVie's $6,922 per month Humira price tag, and both were included on drug coverage lists at two large PBMs.

Persons: Dado Ruvic, Humira, Ameet Sarpatwari, Biden, PBMs, Cigna, UnitedHealth, Amgen, Robin Feldman, Ron Wyden, Wyden, Chuck Grassley, Grassley, Patrick Wingrove, Moira Warburton, Josephine Walker, Caroline Humer, Bill Berkrot Organizations: REUTERS, Association for Accessible Medicines, Harvard Medical School, Reuters, Lawmakers, Federal Trade Commission, FTC, CVS, Biosimilars, Healthcare, Novartis, Sandoz, Reuters Graphics Reuters, University California College of the, Democratic, Republican, Thomson Locations: U.S, Humira, San Francisco, New York, Washington

☆ Mark Cuban's online pharmacy set to launch Humira biosimilar
▼ + stars: | 2023-07-05 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

July 5 (Reuters) - Mark Cuban Cost Plus Drugs, an online pharmacy launched by the billionaire to sell drugs directly to customers at low prices, should soon begin selling Coherus BioSciences's (CHRS.O) biosimilar version of AbbVie Inc's (ABBV.N) blockbuster rheumatoid arthritis drug Humira, Cuban said on Wednesday. Cost Plus Drugs will sell Yusimry for $569.27 plus dispensing and shipping fees. Coherus introduced its Humira biosimilar in the U.S. market this month alongside offerings from other drugmakers such as Boehringer Ingelheim, Sandoz and Organon (OGN.N). Cuban's Cost Plus Drugs aims to drive down the cost of drugs broadly by selling them at a 15% markup over its cost, plus pharmacy fees. Cuban said the company hopes to provide other biosimilar drugs as well.

Persons: Humira, Cuban, Coherus, AbbVie, Michael Erman, David Holmes Organizations: Cuban, Plus, Sandoz, Cuban's, Thomson Locations: U.S, Organon, Cuban

☆ Coherus BioSciences launches biosimilar version of AbbVie's blockbuster Humira
▼ + stars: | 2023-07-03 | by ( ) www.reuters.com time to read: +1 min

July 3 (Reuters) - Coherus BioSciences (CHRS.O) said on Monday it has launched a copycat version of AbbVie's (ABBV.N) Humira in the United States at a discount of more than 85% to the blockbuster arthritis drug. Coherus is the latest to launch a biosimilar to Humira in the U.S. market this month after Boehringer Ingelheim, Sandoz and Organon (OGN.N). Coherus said last month it would sell the biosimilar, branded as Yusimry, at $995 per carton, compared with the current list price of Humira of $6,922 per carton. The company has also partnered with billionaire entrepreneur Mark Cuban's pharmaceutical startup to sell the biosimilar at $569.27 plus dispensing and shipping fees. Usually prices fall, often dramatically, when multiple copycat versions of a widely-used medication enter the market.

Persons: Coherus, Boehringer Ingelheim, Mark, Sriparna Roy, Leroy Leo, Shounak Dasgupta, Arun Koyyur Organizations: Coherus BioSciences, Sandoz, Thomson Locations: United States, Humira, U.S, Organon, Bengaluru

☆ Sandoz launches rival version of AbbVie's arthritis drug Humira
▼ + stars: | 2023-07-01 | by ( ) www.reuters.com time to read: +2 min

[1/2] The logo of Swiss drugmaker Novartis and its divisions Sandoz and Alcon are seen at an office building in Rotkreuz, Switzerland, January 29, 2020. REUTERS/Arnd Wiegmann/Fle PhotoJuly 1 (Reuters) - Swiss drugmaker Sandoz said on Saturday it had launched a biosimilar version of AbbVie Inc's (ABBV.N) big selling arthritis treatment Humira, adding to U.S. competition for the drug that started in January. The Novartis (NOVN.S)-owned company said its drug, Hyrimoz, will be priced at a 5% discount off Humira’s current list price of $6,922 per month, but that it was also offering an unbranded version of Humira at an 81% discount. The lower-priced version may attract healthcare systems that act as both an insurer and a provider and typically do not seek after-market discounts, as pharmacy benefit managers do. Rival Amgen Inc (AMGN.O) was the first to launch a biosimilar of Humira earlier this year, which debuted at a 5% and 55% discount to Humira, depending on who was purchasing.

Persons: Arnd, drugmaker Sandoz, drugmakers, Patrick Wingrove, Edwina Gibbs Organizations: Swiss, Novartis, Sandoz, REUTERS, Amgen, Pfizer Inc, Thomson Locations: Rotkreuz, Switzerland, KS, United States

☆ US FDA declines to approve Regeneron's higher-dose Eylea, shares tumble
▼ + stars: | 2023-06-27 | by ( ) www.reuters.com time to read: +2 min

The Food and Drug Administration cited an ongoing review of inspection findings at a third-party filler of the higher dose for the decision. Eylea, which recorded $9.65 billion in global sales last year, has been hit since Roche's (ROG.S) rival treatment Vabysmo was approved last year for wet AMD. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 milligrams at longer intervals without any additional safety issues. The two trials included treatment of patients with wet AMD and diabetic macular edema (DME). An estimated 1.1 million people in the U.S. have wet AMD, while 1.2 million are estimated to have DME, according to Regeneron.

Persons: Vabysmo, Regeneron, Eylea, Raghav Mahobe, Krishna Chandra Eluri, Maju Samuel, Sriraj Organizations: Regeneron Pharmaceuticals, Drug Administration, FDA, AMD, biosimilars, Thomson Locations: U.S, Bengaluru

☆ Analysis: Stelara patent deal puts J&J back on path to $57 bln 2025 revenue forecast
▼ + stars: | 2023-06-05 | by ( Patrick Wingrove | ) www.reuters.com time to read: +4 min

Stelara, introduced in 2009, has been J&J’s top-selling drug since 2019, with sales reaching $9.7 billion in 2022. J&J is forecasting $57 billion in pharmaceutical sales by 2025 after reducing its previous view of $60 billion in April, citing currency dynamics that hurt its pharmaceutical business in 2022. That would add around $4.6 billion to average estimates for pharmaceutical sales, as long as no biosimilars enter the market before 2025. Amgen said last month the confidential settlement it signed with J&J will allow it to sell its Stelara biosimilar no later than Jan. 1, 2025. “If no Stelara biosimilars enter in 2024, I think growth should continue at around 4% in 2023 and 2024,” Huynh said.

Persons: Johnson, Amgen, ”, Vamil, Trung Huynh, ” Huynh, Teva, biosimilar, Divan, Alvotech, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Amgen Inc, Analysts, Stelara, Reuters Graphics Reuters, Reuters, New, J, Credit Suisse, Food and Drug Administration, Alvotech’s, Thomson Locations: New Brunswick , New Jersey, Alvotech’s Reykjavik

REUTERS/Robert GalbraithCompanies Novartis AG FollowAmgen Inc Follow(Reuters) - Amgen Inc sued Novartis AG's Sandoz in New Jersey federal court Monday, accusing Sandoz's proposed versions of its multibillion-dollar bone-strengthening drugs Prolia and Xgeva of infringing several patents. Amgen asked the court to block Sandoz's biosimilars of the drugs until its patents expire. Thousand Oaks, California-based Amgen sold $3.6 billion worth of Prolia and $2 billion worth of Xgeva last year, according to a company report. The FDA accepted Sandoz's application for biosimilar versions of the Amgen biologic drugs — which are derived from living cells, unlike traditional small-molecule drugs — in February. Amgen said the proposed biosimilars infringe 21 patents covering Prolia and Xgeva.

☆ AbbVie's weak newer drug sales fan worries as Humira faces rivals
▼ + stars: | 2023-04-27 | by ( ) www.reuters.com time to read: +2 min

April 27 (Reuters) - AbbVie Inc (ABBV.N) on Thursday missed quarterly revenue estimates for its newer treatments, fueling concerns over the drugmaker's attempts to cushion the blow to sales from blockbuster Humira losing patent exclusivity. The company's shares tumbled 6% in premarket trade as investors shrugged off a raised annual profit forecast. In the first quarter, Humira recorded sales of $3.54 billion, compared with analysts' average estimate of $3.58 billion. That helped Abbvie beat sales expectations. AbbVie had trimmed its full-year profit expectations earlier this month by 8 cents, citing a $150 million hit from acquired in-process research and development (IPR&D) and milestone expenses.

☆ Drugmaker AbbVie trims profit forecasts on IPR&D expenses
▼ + stars: | 2023-04-05 | by ( Reuters Staff | ) www.reuters.com time to read: +1 min

REUTERS/Brian Snyder(Reuters) -AbbVie Inc on Wednesday lowered its full-year and first-quarter profit expectations, citing a $150 million hit from acquired in-process research and development (IPR&D) and milestone expenses. The company estimated first-quarter adjusted earnings to be between $2.31 and $2.41 per share from an earlier range of $2.39 to $2.49. It now sees 2023 adjusted earnings to be between $10.62 and $11.02 per share, compared with its prior forecast of $10.70 to $11.10. Analysts on average were expecting full-year earnings of $11.07 per share, according to Refinitiv IBES data. AbbVie is scheduled to report first-quarter earnings on April 27.

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