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CVS Health logo is seen displayed in this illustration taken, May 3, 2022. The regional health insurance provider will still retain CVS Caremark for managing specialty drugs, which are costly medications used to treat complex conditions like cancer and rheumatoid arthritis. Other analysts highlighted difficulties in shifting to a different model than the one offered by companies like CVS - which provide other services including home drug delivery and reimburse pharmacies for patients' prescriptions. Amazon Pharmacy will provide at-home delivery of prescription drugs as well as upfront pricing, while Mark Cuban Cost Plus Drug Company will provide access to generic drugs, Blue Shield said. Blue Shield of California's other partners include privately held Abarca for processing claims related to prescription drugs, while smaller PBM Prime Therapeutics will work to negotiate savings with drugmakers.

Persons: Dado Ruvic, Cigna, UnitedHealth, Mark, Elizabeth Anderson, J.P, Morgan, Lisa Gill, Gill, Blue, Manas Mishra, Mariam Sunny, Bhanvi, Shweta Agarwal, Pooja Desai, Krishna Chandra Eluri, Frances Kerry Organizations: CVS, REUTERS, Amazon, Cigna, UnitedHealth, Evercore ISI, Mark Cuban, Plus, Thomson Locations: Bengaluru

☆ Blue Shield of California drops CVS, taps Amazon and others to lower drug costs
▼ + stars: | 2023-08-17 | by ( ) www.reuters.com time to read: +2 min

CVS Health logo is seen displayed in this illustration taken, May 3, 2022. Blue Shield, whose health plans cover 4.8 million members, said it will now work with five different companies, including Mark Cuban's drug company, to provide "convenient, transparent access to medications while lowering costs." Privately held Abarca will pay prescription drug claims, while Prime Therapeutics will work with Blue Shield to negotiate savings with drugmakers, the company said. Blue Shield will also work with CVS Caremark for specialty pharmacy services. The loss of the Blue Shield pharmacy benefit management contract is another blow to Caremark, which is also set to lose the contract to manage Centene's (CNC.N) $40 billion annual pharmacy needs from next year.

Persons: Dado Ruvic, UnitedHealth, Mark Cuban's, Paul Markovich, Mark, Manas Mishra, Mariam Sunny, Bhanvi, Shweta Agarwal, Pooja Desai Organizations: CVS, REUTERS, Blue, Cigna, UnitedHealth, Pharmacy, Wall Street, Mark Cuban, Plus, Thomson Locations: Blue, Bengaluru

☆ Blue Shield California drops CVS; picks Amazon, others to lower drug price
▼ + stars: | 2023-08-17 | by ( ) www.reuters.com time to read: +1 min

CVS Health logo is seen displayed in this illustration taken, May 3, 2022. Non-profit health plan provider Blue Shield, which has 4.8 million members, said it will work with partners including Amazon.com and Mark Cuban's Cost Plus Drug Company to provide at-home delivery and access to low-cost medications. Privately held Abarca will pay prescription drug claims, while Prime Therapeutics will work with Blue Shield to negotiate savings with drugmakers, the company said. Blue Shield will also work with CVS Caremark for specialty pharmacy services. The loss of Blue Shield marks another blow to Caremark, which is also set to lose the contract to manage Centene's (CNC.N) $40 billion annual pharmacy needs from next year.

Persons: Dado Ruvic, Cuban's, Privately, Manas Mishra, Mariam Sunny, Bhanvi, Shweta Agarwal, Pooja Desai Organizations: CVS, REUTERS, Wall Street Journal, Cigna, UnitedHealth, Company, Thomson Locations: Bengaluru

☆ US FDA approves Pfizer's blood cancer therapy
▼ + stars: | 2023-08-14 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Johanna Geron/File PhotoAug 14 (Reuters) - The U.S. Food and Drug Administration on Monday granted accelerated approval to Pfizer's (PFE.N) therapy for treating patients with a type of blood cancer that is difficult to treat, the company said. Multiple myeloma is a common type of blood cancer, which develops in the bone marrow and can spread throughout the body. The FDA approval is based on data from a mid-stage study that showed that 58% of patients treated with Pfizer's therapy had no signs of cancer or had seen a significant decrease in cancer cells in the body. Pfizer said it will continue testing the therapy in ongoing late-stage trials to expand its use in earlier lines of treatment for patients. The therapy's approval comes with a boxed warning for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively.

Persons: Johanna Geron, Epkinly, Johnson, Pfizer's, Bhanvi Satija, Leroy Leo, Pratik, Shounak Dasgupta Organizations: Pfizer, REUTERS, U.S . Food, Drug Administration, FDA, Thomson Locations: Puurs, Belgium, U.S, Bengaluru

An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. REUTERS/Mike Segar/File PhotoAug 8 (Reuters) - Eli Lilly (LLY.N) on Tuesday raised its annual forecasts after beating estimates for quarterly results, driven by strong demand for its new diabetes drug Mounjaro, ahead of a decision on its use as a weight-loss treatment. The company is leaning on Mounjaro, approved last May in the U.S. for diabetes, to soften the hit from insulin price cuts and competition for cancer therapy Alimta. A decision on Mounjaro to treat obesity, expected later this year, could help the drugmaker tap a multi-billion dollar market. Lilly now expects annual revenue in range of $33.4 billion to $33.9 billion, compared with its prior range of $31.2 billion to $31.7 billion.

Persons: Eli Lilly, Mike Segar, Mounjaro, Wells, Mohit Bansal, Lilly, Bhanvi Satija, Mariam Sunny, Sriraj Organizations: Company, REUTERS, Novo Nordisk, Thomson Locations: Branchburg , New Jersey, U.S, Bengaluru

REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.

Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ Pfizer takes more steps to manage medicine stock at North Carolina plant
▼ + stars: | 2023-08-03 | by ( ) www.reuters.com time to read: +2 min

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. The company's Rocky Mount plant is one of the world's largest factories for sterile injectable medicines. The tornado that struck the site completely destroyed the warehouse, but production facilities there did not suffer major damage, Pfizer had said earlier. Earlier this week, CEO Albert Bourla said the company is still assessing how long it will take to bring the plant back on line. Reporting by Sriparna Roy and Bhanvi Satija in Bengaluru; Editing by Pooja DesaiOur Standards: The Thomson Reuters Trust Principles.

Persons: Albert Bourla, Sriparna Roy, Bhanvi, Pooja Desai Organizations: Pfizer, ABC, WTVD, REUTERS, Pfizer Inc, Thomson Locations: Rocky Mount, North Carolina, U.S, Bengaluru

☆ Pfizer mulls cost cuts on volatile COVID products demand
▼ + stars: | 2023-08-01 | by ( ) www.reuters.com time to read: +2 min

Comirnaty sales declined 83% to $1.49 billion in the second quarter and antiviral treatment Paxlovid revenue tumbled 98% to $143 million. That compared with analysts' estimates of $1.40 billion for the vaccine and $1.08 billion for the pill. However, the company maintained its forecast for annual COVID revenues at about $21.5 billion. Pfizer also trimmed the upper end of its annual revenue forecast by $1 billion to $70 billion while retaining the low end at $67 billion. Total revenue for the second quarter fell 54% to $12.73 billion, compared with analysts' estimates of $13.27 billion, according to Refinitiv data.

Persons: drugmaker, Albert Bourla, Bhanvi, Sriraj Organizations: Pfizer, Thomson Locations: U.S, Bengaluru

☆ US FDA approves second over-the-counter opioid overdose reversal drug
▼ + stars: | 2023-07-28 | by ( ) www.reuters.com time to read: +1 min

July 28 (Reuters) - The U.S. Food and Drug Administration has approved the prescription-free sale of the second opioid overdose reversal drug, its manufacturer Harm Reduction Therapeutics said on Friday. The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021. Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. Harm Reduction Therapeutics has partnered with contract drug manufacturer Catalent Inc (CTLT.N) to manufacture RiVive. Reporting by Sriparna Roy and Bhanvi Satija in Bengaluru; Editing by Pooja DesaiOur Standards: The Thomson Reuters Trust Principles.

Persons: drugmaker, Michael Hufford, Sriparna Roy, Bhanvi, Pooja Desai Organizations: U.S . Food, Drug Administration, Therapeutics, Harm, Catalent Inc, Thomson Locations: U.S, United States, Bengaluru

July 28 (Reuters) - Biogen (BIIB.O) agreed to buy rare disease drugmaker Reata Pharmaceuticals (RETA.O) for nearly $6.5 billion, the first large acquisition under new CEO Christopher Viehbacher as he seeks to return the drugmaker to growth. Through the deal, Biogen said it will gain Texas-based Reata's recently approved drug Skyclarys to treat a rare genetic disorder that causes progressive damage to the nervous system. It already makes Spinraza, a treatment for the rare muscle-wasting disorder called spinal muscular atrophy, and a treatment for a rare type of amyotrophic lateral sclerosis. Biogen said it will pay Reata $172.50 per share in cash, which represents a 58.9% premium to the stock's last closing price. Reuters GraphicsShares of Reata surged nearly 52% to $164.76 in early trading, while Biogen's shares fell marginally to $261.14.

Persons: Christopher Viehbacher, Viehbacher, Biogen, Eisai, Baird, Brian Skorney, Manas Mishra, Bhanvi, Shinjini Organizations: Pharmaceuticals, Reuters, Thomson Locations: Texas, United States, Bengaluru

☆ What are global companies saying about China's economy?
▼ + stars: | 2023-07-28 | by ( ) www.reuters.com time to read: 1 min

July 28 (Reuters) - Major global firms ranging from banks to chipmakers are taking a largely cautious stance on their China business amid a frail recovery at the world's second-largest economy from a pandemic slowdown. Following are comments from firms on their China business during the latest reporting season:Reporting by Savyata Mishra and Arunima Kumar in Bengaluru; Additional reporting by Niket Nishant, Granth Vanaik, Aditya Soni and Bhanvi Satija; Editing by Sriraj Kalluvila, Eileen Soreng and Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

Persons: Savyata Mishra, Arunima Kumar, Niket Nishant, Granth Vanaik, Aditya Soni, Bhanvi, Sriraj Kalluvila, Eileen Soreng, Maju Samuel Organizations: Thomson Locations: China, Bengaluru

☆ Eli Lilly's obesity drug succeeds in two late-stage studies
▼ + stars: | 2023-07-27 | by ( ) www.reuters.com time to read: +1 min

July 27 (Reuters) - Eli Lilly (LLY.N) said on Thursday its experimental obesity drug met the main goals in two late-stage studies, with the drug helping patients reduce 26.6% weight on average in one of the studies following intensive lifestyle changes. The company said both the late-stage studies also achieved all secondary goals. Overall safety of the drug tirzepatide, sold under the name Mounjaro for diabetes, was similar to that observed in previous studies. The results follow strong data for the drug from two earlier trials. Reporting by Bhanvi Satija and Leroy Leo in Bengaluru; Editing by Saumyadeb Chakrabarty and Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

Persons: Eli Lilly, LLY.N, tirzepatide, Lilly, Bhanvi Satija, Leroy Leo, Saumyadeb Chakrabarty, Shounak Organizations: Thomson Locations: Bengaluru

☆ J&J starts share exchange offer for consumer health spin-off Kenvue
▼ + stars: | 2023-07-24 | by ( ) www.reuters.com time to read: +1 min

[1/2] The Johnson & Johnson logo is displayed on a screen on the floor of the New York Stock Exchange (NYSE) in New York, U.S., May 29, 2019. REUTERS/Brendan McDermid/File PhotoJuly 24 (Reuters) - Johnson & Johnson (JNJ.N) said on Monday it had launched an exchange offer under which its stockholders can opt for shares of Kenvue <KVUE.N>, its newly listed consumer health unit. The exchange will allow J&J shareholders to exchange their shares for those of Kenvue at a 7% discount, subject to conditions. Kenvue, which debuted on the New York Stock Exchange in May, has a market capitalization of about $46 billion. ‍Goldman Sachs and J.P. Morgan Securities are serving as dealer managers for the offering, J&J said.

Persons: Johnson, Brendan McDermid, ‍ Goldman Sachs, J.P, J, Bhanvi, Shounak Dasgupta, Anil D'Silva Organizations: New York Stock Exchange, REUTERS, Johnson, Morgan Securities, Thomson Locations: New York, U.S, Kenvue, Bengaluru

☆ J&J expects cancer drugs, medical devices to drive growth in 2023
▼ + stars: | 2023-07-20 | by ( ) www.reuters.com time to read: +2 min

Shares of J&J, which recently spun off its consumer health unit to focus on drugs and medical devices, rose over 1% in premarket trading. The company expects sales at its pharmaceutical unit to grow more in the second half of 2023, compared with the first half. Quarterly sales of its multiple myeloma drug, Darzalex, were $2.43 billion, in line with Wall Street estimates, according to Refinitiv. Second-quarter sales for its medical device unit were $7.79 billion, topping estimates of $7.55 billion. J&J said it now expects adjusted 2023 profit of $10.70 to $10.80 per share, above estimates of $10.65 per share and its prior forecast of $10.60 to $10.70 per share.

Persons: Johnson, Stelara, J, J's, Bhanvi, Anil D'Silva Organizations: Johnson, Wall, Thomson Locations: Kenvue, Bengaluru

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

☆ Pfizer, Flagship Pioneering to invest $100 mln in drug discovery
▼ + stars: | 2023-07-18 | by ( ) www.reuters.com time to read: +2 min

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 18 (Reuters) - Johnson & Johnson (JNJ.N) sued the U.S. government on Tuesday, becoming the latest drugmaker seeking to block enforcement of a program that gives Medicare the power to negotiate drug prices. The pharmaceutical industry says the drug price negotiation program that is part of President Joe Biden's signature Inflation Reduction Act (IRA) will curtail profits and compel them to pull back on developing groundbreaking new treatments. U.S. drugmakers Bristol Myers Squibb (BMY.N), Merck & Co (MRK.N) and the U.S. Chamber of Commerce as well as industry lobbies Pharmaceutical Research and Manufacturers of America have also sued the government over the plan. The Biden administration hopes to save $25 billion annually by 2031 by having Medicare, the government health plan for people 65 and over, negotiate prices for some of its costliest medicines. Reporting by Bhanvi Satija in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

Persons: Johnson, Joe Biden's, Biden, Bhanvi, Krishna Chandra Organizations: Johnson, U.S, drugmakers Bristol Myers Squibb, Merck & Co, U.S . Chamber of Commerce, Pharmaceutical Research, Manufacturers of America, Thomson Locations: Bengaluru

☆ US FDA approves Sanofi-AstraZeneca's preventive RSV therapy for babies
▼ + stars: | 2023-07-17 | by ( ) www.reuters.com time to read: +2 min

July 17 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Monday it had approved Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers. The therapy, branded Beyfortus, was approved for preventing lower respiratory tract disease in infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second such season. The companies plan to make Beyfortus available in the United States ahead of the upcoming RSV season, Sanofi said, adding that it plans to share more information about the therapy's price closer to the season. RSV is a leading cause of hospitalizations in infants and so far Swedish Orphan Biovitrum's (SOBIV.ST) treatment, Synagis, was the only approved preventive therapy in the United States for high-risk infants. The therapy comes with warnings and precautions about serious hypersensitivity reactions, and should be given with caution to infants and children with clinically significant bleeding disorders, the FDA said.

Persons: AstraZeneca's, Sanofi, Beyfortus, Bhanvi Satija, Shinjini Ganguli, Maju Samuel Organizations: U.S . Food, Drug Administration, Sanofi, American Academy of Pediatrics, FDA, Thomson Locations: U.S, United States, Bengaluru

July 14 (Reuters) - UnitedHealth Group's (UNH.N) quarterly profit beat Wall Street estimates on Friday as a smaller-than-expected jump in medical costs allayed fears that a resumption in long-delayed surgical procedures would hit profit growth, sending its shares up 5%. The beat from the industry bellwether lifted the shares of rivals Humana (HUM.N), Cigna (CI.N), CVS Health (CVS.N) and Elevance Health (ELV.N) between 2% and 5%. Chief financial officer John Rex said the company expects medical costs for the third quarter to be "a little bit lower" compared to the second quarter. UnitedHealth's profit of $6.14 per share for the second quarter beat analysts' expectations of $5.99, according to Refinitiv. Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Pooja DesaiOur Standards: The Thomson Reuters Trust Principles.

Persons: John Rex, Stephens, Scott Fidel, UnitedHealth, Humana, Bhanvi Satija, Pooja Desai Organizations: Wall, Humana, CVS Health, Elevance, Health, Medicare, Thomson Locations: Bengaluru

☆ EU probes Novo Nordisk drugs after reports of suicidal thoughts
▼ + stars: | 2023-07-10 | by ( ) www.reuters.com time to read: +2 min

Suicidal thoughts are not currently listed as a side effect in the EU product information of these treatments. Side effects have hobbled several previous attempts by the drug industry to develop lucrative weight-loss drugs. Sanofi's (SASY.PA) Acomplia, which never won a U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts. New weight-loss drugs such as Wegovy, however, regulate appetite by mimicking a gut hormone, and not directly interfere with brain chemistry. Safety data did not show any "causal association" between the suicidal or self-harming thoughts and the drugs, it added.

Persons: Acomplia, Bhanvi, Ludwig Burger, Savio D'Souza, Nivedita Organizations: European Medicines Agency, EMA, Icelandic Medicines Agency, Novo Nordisk, Thomson Locations: Danish, United States, Europe, Novo, Bengaluru, Frankfurt

☆ Nine new African countries to receive millions of malaria vaccines- GAVI
▼ + stars: | 2023-07-05 | by ( ) www.reuters.com time to read: +1 min

July 5 (Reuters) - Global vaccine alliance GAVI said on Wednesday 12 countries in Africa would receive 18 million doses of malaria vaccine over the next two years, expanding access to the shots to nine new countries in the region. Malaria remains one of the continent's deadliest diseases, killing nearly half a million children each year under the age of five. In 2021, Africa accounted for about 95% of global malaria cases and 96% of deaths, according to the World Health Organization (WHO). "At least 28 African countries have expressed interest in receiving the RTS,S (malaria) vaccine," WHO chief Tedros Adhanom Ghebreyesus said at a media briefing, adding that a second malaria vaccine was under review for pre-qualification and if successful, could provide additional supply in the short term. The first doses of the RTS,S vaccine are expected to reach the 12 African countries during the last quarter of 2023, allowing them to start rolling out by early next year.

Persons: GAVI, Tedros Adhanom Ghebreyesus, Raghav Mahobe, Shinjini Organizations: World Health Organization, WHO, GAVI, UNICEF, British, GSK, Democratic, Thomson Locations: Africa, Ghana, Kenya, Malawi, Benin, Burkina Faso, Burundi, Cameroon, Democratic Republic of the Congo, Liberia, Niger, Sierra Leone, Uganda, Bengaluru

☆ US FDA approves BioMarin's gene therapy for hemophilia A
▼ + stars: | 2023-06-29 | by ( Nathan Gomes | ) www.reuters.com time to read: +3 min

It priced the one-time therapy, Roctavian, at $2.9 million. BioMarin said most study participants continued to respond to the gene therapy through year three and beyond, and it would continue to monitor them for 15 years. BioMarin's therapy will compete for market share with Roche's (ROG.S) Hemlibra, an antibody drug which mimics the function of the blood clotting protein missing in hemophilia A patients. In April, BioMarin cut its annual sales forecast range for Roctavian to $50 million to $100 million, from $100 million to $200 million. There are about 16,000 patients in the United States with hemophilia A in which they are missing the factor VIII clotting protein.

Persons: BioMarin, Joel Beatty, Robert W Baird, Roctavian, Beatty, Khushi Mandowara, Bhanvi Satija, Nathan Gomes, Akash Sriram, Deena Beasley, Krishna Chandra Eluri, Maju Samuel, David Gregorio Our Organizations: U.S . Food, Drug Administration, European Union, Los, Thomson Locations: U.S, California, Novato , California, hemophilia, United States, Bengaluru, Los Angeles

☆ Sarepta slumps as concerns emerge around upcoming gene therapy data
▼ + stars: | 2023-06-23 | by ( ) www.reuters.com time to read: +2 min

June 23 (Reuters) - Sarepta Therapeutics shares (SRPT.O) slumped 11% on Friday as some analysts voiced concerns that upcoming confirmatory trial data for its gene therapy to treat Duchenne muscular dystrophy (DMD) may not be enough to secure approval for expanded use. The U.S. health regulator had on Thursday granted Sarepta's Elevidys therapy accelerated approval to treat DMD patients aged between 4 and 5 years who can walk, contrary to the company's application for all patients who can walk. Sarepta's gene therapy is the first of its kind for DMD, an inherited progressive muscle-wasting disorder that almost always affects young boys. Elevidys, a one-time treatment, is expected to change the way that DMD patients are treated as current therapies require regular use. William Blair's Tim Lugo called the treatment "transformational for Duchenne's patients" and "a significant opportunity for Sarepta".

Persons: Sarepta's, Gavin Clark, Gartner, William Blair's Tim Lugo, Leroy Leo, Khushi, Devika Organizations: Sarepta Therapeutics, Food and Drug, BioMarin Pharmaceuticals, Thomson Locations: U.S, Bengaluru

REUTERS/Mike Blake/File Photo/File PhotoJune 14 (Reuters) - Health insurer stocks dropped sharply on Wednesday after UnitedHealth Group (UNH.N) said costs were on the rise for the largest U.S. healthcare provider by market value due to an increase in surgeries among older adults. Shares of industry bellwether UnitedHealth fell 7.3% to $455.11, wiping out roughly $42 billion from the company's market capitalization in the current trading session. Meanwhile, stocks of medical device makers and hospital operators rose, as increased frequency of surgeries mean more revenue for them. The company highlighted strong demand for hip and knee procedures at outpatient centers, as well as for home health services and behavioral services. Elevance Health (ELV.N), CVS Health Corp (CVS.N), Centene Corp (CNC.N) and Cigna Group (CI.N) fell between 6% and 7.5%.

Persons: Mike Blake, bellwether, UnitedHealth, Jefferies, Brian Tanquilut, Zimmer Biomet, Leroy Leo, Bhanvi, Manas Mishra, Shinjini Organizations: REUTERS, UnitedHealth, Medicare, Humana Inc, Reuters Graphics, Elevance, CVS Health Corp, Centene Corp, Cigna, Elevance Health Inc, CVS, Healthcare, Tenet Healthcare, Stryker, Thomson Locations: Santa Ana , California, U.S, Bengaluru

☆ Catalent posts bigger-than-expected loss as production snags persist
▼ + stars: | 2023-06-12 | by ( ) www.reuters.com time to read: +1 min

Companies Catalent Inc FollowJune 12 (Reuters) - Catalent Inc (CTLT.N) on Monday posted a bigger-than-expected loss for the third quarter and cut its annual forecast for a second time, hurt by persistent production challenges at the contract drug manufacturer's major facilities. The company will also amend its annual filing for 2022 to reflect a $26 million deduction caused by a revenue recognition error. Catalent had delayed its quarterly results report thrice in less than a month, pending the adjustments needed on historical financial statements related to its Bloomington operations. In May, Catalent said production snags at three of its facilities - Maryland, Indiana and Brussels - had driven up costs and also contributed to the delay in reporting results. Catalent is yet to provide details of what was behind the production issues.

Persons: Catalent, Bhanvi Satija, Sriparna Roy, Devika Organizations: Catalent, Thomson Locations: Bloomington, Maryland , Indiana, Brussels, Bengaluru

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