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☆ US senators push drugmakers for details on low-cost insulin programs
▼ + stars: | 2023-08-31 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

Democratic Senators Maggie Hassan and Tina Smith sent a letter asking the drugmakers for information on eligibility criteria for the programs, including whether a patient’s insurance status or income barred them from joining, and the steps insulin users had to take to sign up. Novo, Lilly and Sanofi, which account for 90% of the U.S. insulin market, pledged in March to lower the list prices of many of their insulin products by 70%-78% later this year or in 2024. The White House on Tuesday announced that a Novo insulin was among the 10 high-cost prescription drugs selected for the first-ever price negotiations by the U.S. Medicare health program that covers 66 million people. Hassan and Smith argued that to enroll in the drugmakers’ insulin programs, patients had to go through a lengthy and complicated process that required them fill out five to 10 pages of documentation and wait an unknown amount of time for approval. Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association.

Persons: George Frey, Eli Lilly, Maggie Hassan, Tina Smith, Lilly, Biden, Elizabeth Warren, Hassan, Smith, Patrick Wingrove, Bill Berkrot Organizations: Novo Nordisk Pharmaceutical, REUTERS, Novo Nordisk, Sanofi, Democratic, U.S, Democrat, American Diabetes Association, Thomson Locations: Provo , Utah, U.S, United States

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

☆ Explainer: Why the US is negotiating the price of 10 drugs
▼ + stars: | 2023-08-29 | by ( Patrick Wingrove | ) www.reuters.com time to read: +4 min

What are the Medicare drug price negotiations? The Medicare agency, known as the Centers for Medicare & Medicaid Services (CMS), was previously forbidden by law from bartering prices with manufacturers. The negotiations must end by Aug. 1, and Medicare will publish its list of new prices on Sept. 1. The process will begin again in February of 2025, when CMS selects another 15 costly prescription drugs for negotiations, with new prices on those going into effect in 2027. All the lawsuits seeking to avoid drug price negotiations argue that the new law is unconstitutional.

Persons: Joe Biden, Kevin Lamarque, Joe Biden’s, Patrick Wingrove, Bill Berkrot Organizations: Major Economies, White, REUTERS, U.S, Merck, Co's, Bristol Myers Squibb, Pfizer, Medicare, Medicaid Services, CMS, U.S . Chamber of Commerce, Thomson Locations: Energy, Washington , U.S

Aug 21 (Reuters) - The U.S. Food and Drug Administration on Monday approved Pfizer's (PFE.N) respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies. An FDA panel of outside experts backed the safety and effectiveness of Pfizer's RSV vaccine for women in their second and third trimesters earlier in May. RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalization. Infants are at greatest risk for severe illness from RSV. An estimated 58,000 to 80,000 children below the age of five years are hospitalized every year due to RSV infection in the U.S., according to government data.

Persons: Pfizer, Mariam Sunny, Bhanvi, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: U.S . Food, Drug Administration, FDA, Pfizer, U.S . Centers for Disease Control, Sanofi, AstraZeneca, GSK, Thomson Locations: U.S, United States, Bengaluru, New York

Circuit Court of Appeals stopped short of ruling that the drug must be pulled off the market altogether, as a lower court had done. A spokesperson for the U.S. Department of Justice said that the Biden administration will appeal the ruling to the U.S. Supreme Court. President Joe Biden, a Democrat, supports abortion rights and last year ordered the federal health agency to expand access to mifepristone. [1/2]Used boxes of Mifepristone, the first pill in a medical abortion, line a trash can at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 20, 2023. The U.S. Supreme Court last year overturned its landmark Roe v. Wade ruling that had legalized abortion nationwide.

Persons: Biden, Joe Biden, Matthew Kacsmaryk, Kacsmaryk, Erin Hawley, Susan B, Anthony Pro, Alexis McGill Johnson, Evan Masingill, Evelyn Hockstein, James Ho, mifepristone, telemedicine, Jennifer Walker Elrod, Wade, Brendan Pierson, Patrick Wingrove, Nate Raymond, Sharon Bernstein, Trevor Hunnicutt, Cynthia Osterman Organizations: Circuit, U.S . Department of Justice, U.S, Supreme, Alliance, Hippocratic Medicine, FDA, Alliance Defending, Planned Parenthood Federation of America, U.S . Food, Alamo Women's, REUTERS, Guttmacher Institute, American College of Obstetricians, American Medical Association, Reuters, Thomson Locations: U.S, New Orleans, Amarillo , Texas, Alamo, Carbondale , Illinois, New York, Boston, Sacramento , California, Washington

☆ Amazon Pharmacy automates discounts to help insulin patients get pledged prices
▼ + stars: | 2023-08-15 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

Aug 15 (Reuters) - Amazon.com (AMZN.O) said on Tuesday its online pharmacy will automatically apply manufacturer-sponsored coupons to more than 15 insulin and diabetes medicines to help patients access discounts pledged by the drug industry. Vin Gupta, Amazon Pharmacy's Chief Medical Officer, said the report highlighted the need to make it easier for patients to get their insulin at the lowest possible prices. Amazon Pharmacy will also automatically apply available discounts to diabetes-related medical devices from manufacturers Dexcom and Insulet, including continuous glucose monitors and pumps, as well as to other cardiometabolic medicines such as Novo's powerful weight-loss drug Wegovy. American Diabetes Association Chief Executive Officer Charles Henderson said Amazon's automated discounting would help the 37 million Americans with diabetes more easily access the treatments they need. So, we're going to create options that gives them access to these medications," Amazon Pharmacy Vice President John Love told Reuters.

Persons: Eli Lilly, Lilly, Elizabeth Warren, Vin Gupta, Wegovy, Charles Henderson, John Love, Patrick Wingrove, Sandra Maler Organizations: Amazon Pharmacy, Novo Nordisk, Sanofi, Amazon, Congress, American Diabetes Association, Walgreens, Reuters, Thomson Locations: New York

☆ Obesity drug data could boost companies' case for US coverage, analysts say
▼ + stars: | 2023-08-10 | by ( Patrick Wingrove | ) www.reuters.com time to read: +5 min

Wegovy prescriptions were up 300% at their peak, according to data from Barclays, before supply issues began to hamper sales. A COMPELLING CASEAnalysts said the data made a compelling case for long-term health benefits of the drug. Analysts were divided on whether Medicare could potentially cover Wegovy as a cardiovascular treatment without a new law passing. Three doctors specializing in obesity treatment, including a cardiologist, were not sure whether such an indication would allow for Medicare coverage. Companies that provide healthcare insurance have begun pulling back on coverage of weight loss drugs because of the high cost of the medicines.

Persons: Read, Eli Lilly, Stacie Dusetzina, Wegovy, Eli Lilly's Mounjaro, Evan Seigerman, Eugene Yang, Morningstar, Damien Conover, Tom Carper, Eli Lilly's, Dusetzina, Patrick Wingrove, Elissa Welle, Ahmed Aboulenein, Caroline Humer Organizations: Novo Nordisk, U.S, Vanderbilt University, Medicare, Barclays, University of Washington Medicine, Companies, Democratic, Novo, Reuters, Democrat, Republican, Thomson Locations: New York, Danish, Washington

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 increasingly popular Wegovy has transformed the weight-loss market since its U.S. launch in June 2021, capturing the attention of patients, investors and celebrities worldwide. Novo's news lifted shares in Europe's second-most valuable listed company after LVMH (LVMH.PA) by more than 17% to record highs. Novo said the eagerly-awaited study results, which have not been peer reviewed, showed that patients on Wegovy had a 20% lower incidence of heart attack, stroke or death from heart disease compared to those on a placebo. Lilly's shares rose nearly 15% in early U.S. trading, boosted by its upbeat quarterly results and Novo's trial data.

Persons: Jim Vondruska, Novo, Wegovy, Jeff Levin, Willis, Willis Towers Watson, Martin Holst Lange, Novo's, Eli Lilly, Mounjaro, Soren Lontoft Hansen, Maggie Fick, Nikolaj Skydsgaard, Jacob Gronholt, Ludwig Burger, Patrick Wingrove, Terje Solsvik, Josephine Mason, Sharon Singleton, Kirsten Donovan, Jan Harvey, Alexander Smith Organizations: REUTERS, COPENHAGEN, Novo Nordisk, Willis Towers, U.S, Union, Pfizer Inc, Amgen Inc, World Health Organization, Barclays, Reuters, Pedersen, Thomson Locations: Chicago , Illinois, U.S, LONDON, Europe's, Europe, United States, Novo, Wegovy, Germany, Denmark, Norway, Copenhagen, Frankfurt, New York, Oslo

COVID vaccine makers Moderna and Pfizer are pinning their hopes on private markets sales and strong demand for their new updated shots targeting XBB.1.5 variant to turn around a slump in sales of the products that had bumper growth during the peak of the pandemic. The company sees between $2 billion and $4 billion in the vaccine sales from commercial contracts in the United States and other places. However, it said $1 billion of a total $5 billion in sales from signed government contracts would be deferred to next year. Pfizer on Tuesday warned that sales of COVID vaccines were uncertain, adding that the COVID vaccination rates this fall should be a good predictor for annual rates. For Moderna, second-quarter COVID vaccine sales slumped 94% to $293 million, which was still higher than analysts' average estimate of $233.6 million, according to Refinitiv data.

Persons: Dado Ruvic, Leroy Leo, Patrick Wingrove, Shinjini Organizations: REUTERS, Moderna Inc, Moderna, Pfizer, Thomson Locations: United States, Bengaluru, New York

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

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

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

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

Wegovy is a weekly injection that can help patients shed 15% of their weight alongside diet and exercise changes. Walgreens (WBA.O), one of the biggest U.S. pharmacies, is experiencing supply shortages for the higher strengths, spokesperson Erin Loverher confirmed. Doctors in six U.S. states told Reuters patients are reporting problems filling their prescriptions for the higher doses. Three of the doctors said supply delays at pharmacies had resulted in patients missing their Wegovy injections at the prescribed weekly interval. "Patients are often having to delay their injections because it's harder for pharmacies to get Wegovy in stock," he said.

Persons: Erin Loverher, Novo, Alicia Shelly, Shelly, Robert Kushner, Wegovy, Kushner, Denise Wells, Wells, Holly Lofton, New York University Langone, Disha Narang, Narang, Maggie Fick, Patrick Wingrove, Elissa Welle, Caroline Humer, Bill Berkrot Organizations: Reuters, Walgreens, Wellstar, Northwestern University's Feinberg School of Medicine, Amazon Pharmacy, New York University, Northwestern Medicine, Barclays Research, Novo, Thomson Locations: U.S, Danish, Georgia, Chicago, Michigan, Chicago , New York, San Francisco, Detroit, Atlanta, Charlottesville , Virginia, London, New York

☆ Uninsured US patients pay up to $330 for Eli Lilly’s $25 insulin, Senator Warren says
▼ + stars: | 2023-07-13 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

Warren’s survey of chain and independent pharmacies across all 50 states, carried out between June 9 and 28, found a third of drug stores charged $164 or more to uninsured patients for Lilly’s Insulin Lispro. Lilly said at the time it would drop the price of its Lispro insulin injection, a generic version of its own branded Humalog, to $25 a vial. The senator’s office found chain stores charged uninsured customers an average of $123 per vial for the generic insulin, compared to $63 at independent pharmacies. “This is a deeply troubling finding, revealing that the pharmacies offering the most affordable Insulin Lispro were the least likely to have it in stock,” the report said. Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association.

Persons: Eli Lilly, George Frey, Eli, Elizabeth Warren’s, Lilly, Joe Biden’s, drugmaker, Warren, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Company, REUTERS, Novo Nordisk, Sanofi, U.S, National Community Pharmacists Association, Democrat, Walgreens Boots Alliance, Walmart, Rite, CVS Health, Aid, CVS, Walgreens, Rite Aid, American Diabetes Association, Thomson Locations: Provo , Utah, U.S, Indianapolis, United States, New York

☆ 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

June 30 (Reuters) - The U.S. government on Friday revised its guidance for its Medicare drug price negotiation process, allowing drug companies to publicly discuss the talks, but did not make major changes likely to convince drugmakers to end their suits seeking to halt the program. In September, the U.S. Centers for Medicare and Medicaid Services (CMS) will select 10 of the Medicare program's costliest prescription medicines and negotiate price cuts to go into effect for 2026. That guidance precluded drug makers from talking about the negotiations and required them to eventually destroy data received from CMS. Industry group the Pharmaceutical Research and Manufacturers of America (PhRMA) made an additional claim that the price negotiation program violates the U.S. Constitution's Eight Amendment, which protects against excessive fines. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for the drugs most costly to Medicare.

Persons: drugmakers, Joe Biden, Chiquita Brooks, LaSure, Bristol Myers, Merck, PhRMA, Tahir Amin, Amin, Michael Erman, Mark Potter, Nick Zieminski Organizations: U.S, U.S . Centers, Medicare, Medicaid Services, Merck & Co, Bristol Myers Squibb, U.S . Chamber of Commerce, CMS, Merck, Bristol, Industry, Pharmaceutical Research, Manufacturers of America, Reuters, Initiative for Medicines, Biden, Thomson Locations: U.S

☆ Obesity drug Wegovy's popularity has US employers rethinking insurance coverage
▼ + stars: | 2023-06-27 | by ( Patrick Wingrove | ) www.reuters.com time to read: +6 min

[1/2] A selection of injector pens for the Saxenda weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. A new and more expensive version of the drug specifically for weight loss, called Wegovy, had been approved in 2021 by U.S. health regulators. Employers that cover weight-loss drugs have required medical practices to document patients’ need for Wegovy since it was approved. The federal Medicare healthcare program for Americans aged 65 and older cannot cover weight loss treatments by law. Only 16 states – the most populous being California, Pennsylvania and Michigan – cover Wegovy and other obesity drugs under their Medicaid plans for low-income patients.

Persons: Jim Vondruska, Shawnte, Aon, Mercer, Willis Towers Watson, Eli Lilly, Jeff Levin, Levin, Scherz, Michael Manolakis, William Yancy, Manolakis, Patrick Wingrove, Michele Gershberg, Suzanne Goldenberg Organizations: REUTERS, New, Warner Bros, Warner Bros Discovery Inc, Reuters, Marsh & McLennan, Employers, Barclays Research, Novo Nordisk, Duke University, Thomson Locations: Chicago , Illinois, U.S, New York, Marsh, Wegovy, California, Pennsylvania, Michigan

☆ Merck sues US government to halt Medicare drug price negotiation
▼ + stars: | 2023-06-06 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

NEW YORK, June 6 (Reuters) - Merck & Co (MRK.N) sued the U.S. government on Tuesday, seeking to halt the Medicare drug price negotiation program contained in the Inflation Reduction Act (IRA), which it argues is violates the Fifth and First Amendments to the U.S. Constitution. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for Medicare. Merck called the talks with CMS coercive and forces drugmakers to participate in "political Kabuki theater" by pretending negotiations are voluntary. The first ever Medicare drug price reduction process is due to begin in September when CMS identifies its 10 most costly drugs. Merck's top selling drug, cancer immunotherapy Keytruda, could be subject to negotiations as soon as 2028.

Persons: drugmakers, Merck, Ameet, Robin Feldman, Wells, Mohit Bansal, Xavier Becerra, Chiquita Brooks, Michael Erman, Patrick Wingrove, Edwina Gibbs, Nick Zieminski Organizations: YORK, Merck & Co, U.S, U.S . Constitution, Biden, Medicare, District of Columbia, Merck, Reuters, CMS, Harvard Medical School, UC College of the, Supreme, U.S . Department of Health & Human Services, Centers, Medicaid Services, LaSure, HHS, Thomson Locations: U.S ., U.S, San Francisco

☆ 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

The Biden Administration’s signature drug pricing reform, part of the Inflation Reduction Act (IRA), aims to save $25 billion through price negotiations by 2031 for Americans who pay more for medicines than any other country. The first ever Medicare drug price reduction process begins in September, when the Centers for Medicare and Medicaid Services(CMS) identifies its 10 most costly drugs. Reuters has seen responses to CMS from five of the world's top drugmakers raising legal concerns with the law and the agency's proposed roadmap. Former CMS head Andy Slavitt, who now works at a venture capital company focused on healthcare, said the Medicare agency would have consulted lawyers. One said the Medicare roadmap, which did not go through a formal process with proposed and final rules, could be challenged in court for being unlawful as well.

May 4 (Reuters) - Moderna Inc (MRNA.O) on Thursday reported stronger-than-expected sales of $1.9 billion for its COVID-19 vaccine in the first quarter, driven by a surge of revenue deferred from 2022, but left its 2023 sales expectations unchanged. Moderna said it continued to expect COVID vaccine sales of $5 billion for the year based on advance purchase agreements. Moderna expects an additional $3 billion in deferred vaccine revenue in the second half of 2023. The results came two days after the company's rival Pfizer reported better-than-expected COVID vaccine sales for the first quarter and maintained its expectations for full-year sales. Moderna had generated around $36 billion in sales over the last two years from its COVID vaccine, its only commercial product and one of the most widely used shots for the virus.

☆ Novavax cut $50 million in costs, plans to slash more, CEO says
▼ + stars: | 2023-04-12 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

April 12 (Reuters) - Novavax Inc (NVAX.O) cut about $50 million in costs in the first quarter of 2023 and plans to slash more, Chief Executive John Jacobs said in an interview on Wednesday. “We’re looking at everything from buildings, leases, land, headcount, and contractors, every aspect of our company and the way we work,” he told Reuters. Jacobs said Novavax would seek funding for its COVID/influenza combination shot, including a potential partnership, depending on whether the upcoming data is positive. The CEO added that the company did not expect to launch its individual flu vaccine this year, and will focus on the COVID vaccine. Global regulators expect vaccination campaigns to be conducted once a year, similar to annual flu inoculations.

☆ As weight-loss drugs hit the U.S. market, doctors debate how to use them
▼ + stars: | 2023-03-30 | by ( Patrick Wingrove | ) www.reuters.com time to read: +6 min

[1/2] The American Medical Association logo is seen at their office in Washington, D.C., U.S., August 30, 2020. REUTERS/Andrew Kelly/March 30 (Reuters) - As powerful new obesity drugs enter the U.S. market, medical associations are keen to advise their members on how to best use them for patients. "These new compounds are game changers, there's no doubt about it," said Anthony Comuzzie, chief executive of The Obesity Society. The group last provided obesity treatment guidelines in 2013 alongside the American Heart Association and American College of Cardiology. OBESITY AS A DISEASEThe American Medical Association, the nation’s largest medical group, recognized obesity as a disease in 2013.

If successful, Amgen would claim ownership of all antibodies that inhibit the PCSK9 protein, the mechanism of action for both Repatha and Praluent. Other companies could then do the same with their own antibody treatments in other disease areas. The case might also affect newer technologies used in medicine, such as CRISPR gene editing and messenger RNA, she said. A Washington, D.C.-based federal appeals court that covers U.S. patent cases invalidated Amgen's patent claiming ownership of all PCSK9 inhibitors as a whole in 2021. Amgen sued Sanofi and Regeneron in 2014.

[1/3] CEO of Moderna Stephane Bancel looks up at the session "State of the Pandemic" during the World Economic Forum (WEF) in Davos, Switzerland, January 18, 2023. Moderna (MRNA.O) CEO Stephane Bancel was called to testify after the company flagged plans to raise the vaccine's price to as much as $130 per dose, drawing the ire of Democratic U.S. Senator Bernie Sanders, who chairs the influential Committee on Health, Education, Labor and Pensions (HELP). The government in May plans to end the COVID public health emergency, putting much of the vaccine purchasing in the hands of the private sector. Moderna in February forecast $5 billion in COVID vaccine sales this year, far less than the $18.4 billion windfall in 2022, due to decreasing demand for the shots.

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