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Updated vaccines should be available by mid- to late September, she said. The vaccines still need to be authorized by the U.S. Food and Drug Administration and the CDC needs to make its recommendations, she said. "We are likely to see this as a recommendation as an annual COVID shot just like we have an annual flu shot," she said. Pfizer (PFE.N)/BioNTech SE (22UAy.DE), Moderna (MRNA.O) and Novavax (NVAX.O) have all said they expect to have supplies of the updated vaccine ready for the roll out this autumn. Eris is the fasting-growing COVID-19 subvariant in the U.S., estimated to be responsible for around 17% of current COVID cases, according to the CDC.
Persons: Mandy Cohen, Biden, Andy Slavitt's, we've, Cohen, Michael Erman, Lisa Shumaker Organizations: EG, U.S . Centers for Disease Control, U.S . Food, Drug Administration, Pfizer, World Health Organization, CDC, Thomson Locations: United States, China, U.S, New York
Novavax posts quarterly profit on COVID vaccine sales
  + stars: | 2023-08-08 | by ( ) www.reuters.com   time to read: +2 min
Companies Novavax Inc FollowAstraZeneca PLC FollowBioNTech SE Follow Show more companiesAug 8 (Reuters) - Novavax (NVAX.O) reported a second-quarter profit on Tuesday, helped by strong revenue from its COVID-19 vaccines, but still trimmed its annual forecast for sales of the shot. As part of the agreement, Novavax will issue 6.5 million shares to SK Bioscience at $13 per share. Following the agreements, Novavax now owes SK Bioscience $65 million in cash. The company reported revenue of $424 million, compared with analysts' estimates of $240 million, according to Refinitiv IBES data. Novavax lowered the sales forecast for its COVID-19 vaccines to between $1.3 billion and $1.5 billion this year, compared with a previous outlook of $1.4 billion to $1.6 billion.
Persons: Novavax, Leroy Leo, Michael Erman, Varun H, Maju Samuel, Shounak Organizations: AstraZeneca, SK Bioscience, South Korean, South, Thomson Locations: KS, South Korean, United States, Bengaluru, New York
[1/2] Gilead Sciences is seen during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File PhotoCompanies Gilead Sciences Inc FollowAug 3 (Reuters) - Gilead Sciences (GILD.O) on Thursday reported lower second-quarter profit as costs from a legal settlement and sharply lower sales of its COVID-19 treatment offset another strong performance by HIV drugs. The drugmaker raised its full-year revenue forecast, even as it trimmed its estimate for COVID antiviral Veklury due to lower pandemic-related hospitalizations. Wall Street analysts had expected an adjusted profit of $1.64 per share on revenue of $6.44 billion, according to Refinitiv data. The California-based company raised the low end of its 2023 revenue forecast range to $26.3 billion from $26.0 billion, but kept the high end at $26.7 billion.
Persons: Mike Blake, Gilead, Deena Beasley, Michael Erman, Bill Berkrot Organizations: Gilead Sciences, REUTERS, Wall Street, Thomson Locations: Oceanside , California, U.S, Gilead, California
The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. Merck said Keytruda sales for the quarter jumped 19% to $6.3 billion, surpassing analysts' average estimate of $5.9 billion. Sales of Gardasil, which prevents cancers caused by HPV, surged 47% to $2.5 billion, also well above Wall Street estimates of $2.1 billion. There is room for further Gardasil growth as its use expands into treating males and moves into smaller cities, he added. Despite those challenges, Merck raised its full-year sales forecast to $58.6 to $59.6 billion, from its prior view of $57.7 billion to $58.9 billion.
Persons: Brendan McDermid, Merck, Rob Davis, Davis, Keytruda, Caroline Litchfield, Litchfield, Bill Smead, Prometheus, drugmaker, Michael Erman, Leroy Leo, Bill Berkrot Organizations: Merck, Co, REUTERS, Reuters Connect Companies Merck, Merck & Co, Keytruda, Prometheus Biosciences, Analysts, Prometheus, Smead Capital Management, drugmaker, Thomson Locations: Rahway , New Jersey, U.S, United States, China, Europe, Germany, New York, Bengaluru
Companies Merck & Co Inc FollowAug 1 (Reuters) - Merck & Co (MRK.N) posted better-than-expected second-quarter sales on Tuesday on strong demand for its two top-selling products, cancer immunotherapy Keytruda and human papillomavirus (HPV) vaccine Gardasil. Shares of Merck rose about 2% at $108.45 in premarket trading after the company also raised its full-year revenue forecast. Merck said Keytruda sales for the quarter jumped 19% to $6.3 billion, surpassing analysts' average estimate of $5.9 billion. Sales of Gardasil, which prevents cancers caused by HPV, surged 47% to $2.5 billion, also well above Wall Street estimates of $2.1 billion. Merck said it now expects full-year sales of $58.6 to $59.6 billion, up from its prior view of $57.7 billion to $58.9 billion.
Persons: Merck, Rob Davis, Davis, Keytruda, Cantor Fitzgerald, Louise Chen, Prometheus, drugmaker, Michael Erman, Leroy Leo, Bill Berkrot Organizations: Merck, Co, Merck & Co, Merck's, Prometheus Biosciences, Analysts, Prometheus, Thomson Locations: United States, China, U.S, New York, Bengaluru
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
NEW YORK, July 24 (Reuters) - Drugmaker Pfizer Inc (PFE.N) said over 30 drugs, including injections of painkiller fentanyl and anesthetic lidocaine, may see supply disruption after a tornado destroyed a warehouse at its Rocky Mount, North Carolina, plant last week. The company sent a letter late last week to its hospital customers saying it had identified around 64 different formulations or dosages of those more than 30 drugs produced at the plant that may experience continued or new supply disruptions. The company has placed limits on how much supply of those drugs its customers can buy. It said the list was "based on Pfizer market share and inventory levels of less than 3 months across our Pfizer distribution centers and the wholesale chain." The Rocky Mount plant is one of the largest factories for sterile injectable medicines in the world.
Persons: Albert Bourla, Michael Ganio, Michael Erman, Aurora Ellis Organizations: YORK, Drugmaker Pfizer Inc, Pfizer, American Society of Health, System, Thomson Locations: North Carolina
[1/2] The roof of a Pfizer facility shows heavy damage after a tornado passed the area in Rocky Mount, North Carolina, U.S. July 19, 2023. ABC Affiliate WTVD via REUTERSJuly 21 (Reuters) - Most of the tornado damage at Pfizer Inc's (PFE.N) Rocky Mount, North Carolina plant was to the warehouse and not manufacturing facilities, CEO Albert Bourla said on Friday, easing concerns about long-term drug shortages from the plant. Nonetheless, Bourla told a news conference in Rocky Mount that it will be a monumental task to repair the damage. "We are moving full speed to bring this manufacturing plant into action again," Bourla said, noting that crews were working to restore power to the plant. The Rocky Mount plant is one of the largest factories for sterile injectable medicines in the world.
Persons: Albert Bourla, Bourla, Soumi Saha, Saha, Lisa Mulloy, Erin Fox, David Ljunggren, Michael Erman, Shivani Tanna, Rami Ayyub, Doina Chiacu, Cynthia Osterman, Diane Craft Organizations: Pfizer, ABC, WTVD, REUTERS, Pfizer Inc's, U.S, American Society of Health, System Pharmacists, U.S . Food, Drug Administration, FDA, Premier Inc, University of Utah Health, Thomson Locations: Rocky Mount, North Carolina, U.S, Rocky, Bengaluru
July 21 (Reuters) - Pfizer Inc(PFE.N) CEO Albert Bourla said on Friday that tornado damage this week had almost completely destroyed the drugmaker's warehouse at its Rocky Mount, North Carolina, plant, but that production facilities there do not seem to have suffered damage. "It appears that most of the damage sustained at the site was at our warehouse ... the facilities that are producing, (it) doesn't seem that they have suffered any damage." In the meantime, the company is working to identify alternative manufacturing locations for production around the U.S. Nearly 25% of Pfizer's sterile injectables used in U.S. hospitals are produced there, according to the company's website. "There are so many shortages already," said Erin Fox, senior director of drug information at University of Utah Health.
Persons: Albert Bourla, Bourla, Soumi Saha, Saha, Erin Fox, Lisa Mulloy, David Ljunggren, Michael Erman, Rami Ayyub, Doina Organizations: Pfizer Inc, Engineers, U.S, Products, Premier Inc, American Society of Health, System Pharmacists, Pfizer, University of Utah Health, Thomson Locations: North Carolina, Rocky, U.S
July 18 (Reuters) - Johnson & Johnson (JNJ.N) sued the U.S. government on Tuesday, becoming the latest drugmaker seeking to block a program that gives the Medicare government health insurance plan the power to negotiate lower drug prices. The pharmaceutical industry says the drug price negotiation program under President Joe Biden's signature Inflation Reduction Act law will curtail profits and compel drugmakers to curb development of groundbreaking new treatments. The U.S. Centers for Medicare and Medicaid Services (CMS) in September is expected to select the first 10 drugs to target for negotiations with settled prices set to take effect in 2026. The law is on our side," a spokesperson for the U.S. Department of Health and Human Services said in a statement. It broadly follows the other related lawsuits, arguing that the program is unconstitutional and amounts to "confiscation of constitutionally protected property."
Persons: Johnson, Joe Biden's, drugmakers, Biden, Janssen, Bhanvi, Michael Erman, Krishna Chandra Eluri, Susan Heavey Organizations: Johnson, U.S, drugmakers Bristol Myers Squibb, Merck & Co, U.S . Chamber of Commerce, Pharmaceutical Research, Manufacturers of America, Commerce, U.S . Centers, Medicare, Medicaid Services, U.S . Department of Health, Human Services, District of, Thomson Locations: U.S, District of New Jersey, Bengaluru, New Jersey
July 18 (Reuters) - U.S. drugmaker Pfizer (PFE.N) and venture firm Flagship Pioneering on Tuesday said they would invest $100 million together to develop up to 10 new potential drugs for areas including internal medicine, oncology, infectious diseases and immunology. Flagship, which has incubated biotech companies, most famously Moderna Inc (MRNA.O), and Pfizer will each invest $50 million. Flagship's drug discovery initiative Pioneering Medicines will lead the exploration process. Paul Biondi, president of Flagship's Pioneering unit and a former top Bristol Myers Squibb (BMY.N) executive, said the partnership will take advantage of Flagship's abilities to develop novel technologies towards bigger disease areas. Drug developers such as Denali Therapeutics (DNLI.O), Foghorn Therapeutics (FHTX.O) and Sana Biotechnology (SANA.O) are some of the other companies backed by Flagship.
Persons: Paul Biondi, Biondi, Mikael Dolsten, Foghorn, Bhanvi, Michael Erman, Shilpi Majumdar, Alexandra Hudson Organizations: drugmaker Pfizer, Moderna Inc, Pfizer, Flagship's, Bristol Myers Squibb, Flagship, Therapeutics, Foghorn Therapeutics, Sana Biotechnology, Alexandra Hudson Our, Thomson Locations: Bengaluru, New Jersey
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
July 3 (Reuters) - The number of U.S. women who died within a year after pregnancy more than doubled between 1999 and 2019, with the highest deaths among Black women, researchers said on Monday. There were an estimated 1,210 maternal deaths in 2019, compared with 505 in 1999, according to a study published in the medical journal JAMA. Unlike previous U.S. studies of maternal mortality, which focused on national trends, the current study analyzed data state-by-state. To the researchers' surprise, Black women had the highest maternal mortality rates in some Northeast states. "Our findings provide important insights on maternal mortality rates leading up to the pandemic, and it's likely that we'll see a continued increase in the risk of maternal mortality across all populations if we analyze data from subsequent years," Bryant said.
Persons: Dr, Allison Bryant, Brigham, Bryant, Nancy Lapid, Michael Erman Organizations: American Indians, Alaska Natives, Blacks, Pacific Islanders, U.S . Centers for Disease Control, Thomson Locations: Alaska, California, Massachusetts, Boston, Midwest, Great
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
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
Illumina CEO deSouza resigns after proxy battle with Icahn
  + stars: | 2023-06-12 | by ( ) www.reuters.com   time to read: +3 min
The Grail deal "has kept a lot of investors out of the stock" TD Cowen analyst Dan Brennan said. The company's shares have lost about 60% of their value since completing the Grail deal in 2021. Illumina shares closed at $200.53 on the Nasdaq on Friday. Icahn has said he wants former Illumina CEO Jay Flatley to return. He had secured more than twice the number of shareholder votes than his challenger received in the proxy vote, which could have given him enough legitimacy to hang on.
Persons: Francis deSouza, Carl Icahn, Icahn, Illumina, Charles Dadswell, DeSouza, deSouza's, Cowen, Dan Brennan, Francis, John Thompson, Andrew Teno, Jay Flatley, Vicki Hollub, Alan Jope, Management's Nelson Peltz, Lavanya, Caroline Humer, Michael Erman, Anirban Sen, Mark Porter, Marguerita Choy, Edwina Gibbs Organizations: Nasdaq, LinkedIn, Unilever Plc, U.S . Federal Trade Commission, Thomson Locations: Illumina, Occidental, Bengaluru, New York, New Jersey
Illumina CEO deSouza resigns after battle with Icahn
  + stars: | 2023-06-11 | by ( ) www.reuters.com   time to read: +3 min
Analysts said they expect the company's shares to trade up on Monday morning after deSouza's resignation. The Grail deal "has kept a lot of investors out of the stock" TD Cowen analyst Dan Brennan said. The company's shares have lost about 60% of their value since completing the Grail deal in 2021. Illumina shares closed at $200.53 on the Nasdaq on Friday. Icahn has said he wants former Illumina CEO Jay Flatley to return.
Persons: Francis deSouza, Carl Icahn, Illumina, Charles Dadswell, DeSouza, Icahn, deSouza's, Cowen, Dan Brennan, Francis, John Thompson, Andrew Teno, Jay Flatley, Vicki Hollub, Alan Jope, Management's Nelson Peltz, Lavanya, Caroline Humer, Michael Erman, Anirban Sen, Jason Neely, Jan Harvey, Mark Porter, Marguerita Choy Organizations: Nasdaq, LinkedIn, Unilever Plc, U.S . Federal Trade Commission, Thomson Locations: Occidental, Bengaluru, New York, New Jersey
Billionaire George Soros hands control of empire to son Alex
  + stars: | 2023-06-11 | by ( ) www.reuters.com   time to read: +1 min
June 11 (Reuters) - Billionaire financier George Soros is handing control of his massive empire to his son Alexander, a Soros spokesperson said on Sunday. The spokesperson confirmed the details from an interview with Soros published in The Wall Street Journal on Sunday. But speaking of his decision to turn over the foundation and the rest of his $25 billion empire to his 37-year-old son, who goes by Alex, the elder Soros said: "He's earned it." Billionaire investor George Soros speaks to the audience at the Schumpeter Award in Vienna, Austria June 21, 2019. The OSF board elected Alex as its chairman in December, and Alex now directs political activity as president of Soros' political action committee.
Persons: George Soros, Alexander, Soros, Alex, He's, Lisi Niesner, he's, Carolina Mandl, Rami Ayyub, Michael Erman, Mark Porter Organizations: Soros, Society, Billionaire, REUTERS, OSF, Carolina, Thomson Locations: Vienna, Austria, New York, Washington, New Jersey
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
Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects. Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year. Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.
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.
The company has two oral GLP-1 drugs in mid-stage trials, and aims to choose one for a late-stage trial this year. He forecasts GLP-1s or similar drugs topping $100 billion in annual sales early in the 2030s, with Lilly's product accounting for more than $50 billion in sales. Smaller biotechs are also vying for a piece of the obesity market and hope large pharmaceutical companies will pay up for partnerships. "I don't know if it's $90 billion or $80 billion or $50 billion. The current GLP-1 drugs can cause nausea and vomiting.
April 27 (Reuters) - Drugmaker Merck & Co on Thursday posted better-than-expected first-quarter results on the strength of its blockbuster cancer immunotherapy Keytruda and human papillomavirus (HPV) vaccine Gardasil. Sales of Keytruda rose 20% to $5.8 billion in the quarter, topping the average analyst forecast of $5.6 billion. Gardasil sales rose 35% to $2 billion, beating analyst estimates of $1.7 billion. It forecast 2023 sales of $57.7 billion to $58.9 billion, up from its previous forecast of $57.2 billion to $58.7 billion. The company reported nearly $21 billion in Keytruda sales last year.
Bristol Myers posts lower Q1 sales as Revlimid falls
  + stars: | 2023-04-27 | by ( Michael Erman | ) www.reuters.com   time to read: +2 min
April 27 (Reuters) - Drugmaker Bristol Myers Squibb (BMY.N) on Thursday said its first-quarter sales fell from last year, hurt by generic competition for its cancer drug Revlimid. The drugmaker also announced on Wednesday evening that its Chief Executive Officer Giovanni Caforio plans to step down from the role in November, to be replaced by the company's current Chief Commercialization Officer Chris Boerner. Analysts, on average, expected sales of $11.49 billion in the quarter, according to Refinitiv data. Bristol Myers said it earned around $2.05 a share in the quarter, excluding one-time items. Sales of Revlimid, which began facing generic competition last year, fell to $1.75 billion in the quarter, down 37% from $2.8 billion last year.
WASHINGTON, April 20 (Reuters) - Use of the drug misoprostol on its own to terminate pregnancies is on the rise in the United States as providers seek a preemptive alternative while a ban on abortion pill mifepristone is being considered in court. Misoprostol is already part of the only medication abortion protocol approved by the U.S. Food and Drug Administration, but only when taken in combination with mifepristone. The drug, which the FDA first approved in 1988 for gastric ulcers, is often prescribed off-label to treat miscarriages or induce abortions. "If providers are forced to stop providing mifepristone, misoprostol alone is also safe and effective," said Dr. Ushma Upadhyay, a public health professor at the University of California, San Francisco. Because misoprostol is approved for medication abortion in the United States as part of the two-drug combination, prescribing it alone to terminate pregnancies would also be considered off-label.
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