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☆ US FDA panel votes against use of Medtronic's blood pressure treatment device
▼ + stars: | 2023-08-23 | by ( ) www.reuters.com time to read: +2 min

The same panel on Tuesday voted in favor of rival ReCor's device for use in a surgery called renal denervation in patients whose high blood pressure cannot be controlled by drugs. Separately, while all panel members voted the device was safe to use, 6 of 13 voted against its effectiveness. Japan-based Otsuka Holdings' (4578.T) unit ReCor's device was shown to provide a benefit in lowering blood pressure in clinical trials. Medtronic's device helped to lower blood pressure at the doctor's clinic but not at home, which is considered a more accurate measure of blood pressure monitoring. The company was seeking the health regulator's nod for the device indicated for patients whose hypertension, or high blood pressure, cannot be controlled with drugs.

Persons: Andrew Kelly, Jason Weidman, Sriparna Roy, Krishna Chandra Eluri Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Wednesday, Otsuka Holdings, Thomson Locations: White Oak , Maryland, U.S, Japan, Europe, Bengaluru

☆ BioXcel to cut over 50% of jobs as it pivots focus to agitation drug
▼ + stars: | 2023-08-14 | by ( ) www.reuters.com time to read: +2 min

Companies BioXcel Therapeutics Inc FollowAug 14 (Reuters) - BioXcel Therapeutics Inc (BTAI.O) said on Monday it will reduce its workforce by more than 50% to 80 employees from about 190, as the drugmaker shifts its focus towards developing its agitation treatment. The drug, sold under the brand name Igalmi in the U.S., is already approved for use in hospital settings to treat agitation in adult patients with schizophrenia or bipolar disorder. The company plans to reduce in-hospital commercialization expenses, and suspend trials that it no longer deems core to its business. With the job cuts, BioXcel aims to reduce more than 50% of its cash burn to about $80 million on a go-forward annualized basis. Its cash and cash equivalents totaled to $127.5 million as of June 30, compared with $165.5 million as of March 31.

Persons: Sriparna Roy, Krishna Chandra Organizations: BioXcel Therapeutics, BioXcel Therapeutics Inc, Oaktree Fund Administration, Qatar Investment Authority, Thomson Locations: U.S, Bengaluru

☆ BioXcel announces job cuts to focus on agitation related treatment
▼ + stars: | 2023-08-14 | by ( ) www.reuters.com time to read: 1 min

Companies BioXcel Therapeutics Inc FollowAug 14 (Reuters) - BioXcel Therapeutics Inc (BTAI.O) said on Monday it will reduce its workforce to 80 employees from about 190, as the drugmaker shifts its focus to treatments for agitation. The company said it will prioritize development of its drug BXCL501, being evaluated for use in at-home settings for treatment of agitation related to schizophrenia, bipolar disorders and in patients with mild-to-moderate dementia due to probable Alzheimer's disease. Shares of the company were halted during premarket trading. Reporting by Sriparna Roy in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

Persons: Sriparna Roy, Krishna Chandra Organizations: BioXcel Therapeutics, BioXcel Therapeutics Inc, Thomson Locations: Bengaluru

☆ Emergent BioSolutions to lay off about 400 employees
▼ + stars: | 2023-08-08 | by ( ) www.reuters.com time to read: +1 min

A nurse demonstrates the application of the NARCAN nasal spray medication at a outpatient treatment center in Indiana, Pennsylvania, U.S. August 9, 2017. REUTERS/Adrees Latif/File PhotoAug 8 (Reuters) - Emergent BioSolutions (EBS.N) on Tuesday decided to cut 400 jobs and scale back operations at some its facilities, pivoting its focus on core products such as overdose reversal nasal spray Narcan and anthrax vaccines. Smaller biotech companies have been struggling to finance drug development programs and that has hampered their ability to deliver on contract research services for over a year. The company had nearly 2,500 employees as of Dec.31, according to its regulatory filing. Emergent expects to incur an estimated cost of between about $19 million and $21 million in the third quarter of 2023.

Persons: Adrees Latif, Sriparna Roy, Shounak Dasgupta, Arun Koyyur Organizations: REUTERS, Thomson Locations: Indiana , Pennsylvania, U.S, Bayview, Baltimore, Canton , Massachusetts, Bengaluru

☆ FDA approves oral pill for postpartum depression for first time
▼ + stars: | 2023-08-05 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people. Analysts have anticipated that the stocks of both companies would fall if the drug was approved only for postpartum depression, due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.

Persons: Andrew Kelly, Zurzuvae, Biogen, Sage, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler, William Mallard Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, U.S . Drug Enforcement Administration, Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ US FDA approves Biogen-Sage Therapeutics pill for postpartum depression
▼ + stars: | 2023-08-04 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder), or clinical depression, as well as postpartum depression (PPD), which affect millions of people. Analysts were anticipating the stocks of both companies to fall if the drug was approved only for postpartum depression due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an IV injection. Postpartum depression (PPD) affects around one in seven women who give birth.

Persons: Andrew Kelly, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, 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

☆ Tenet Healthcare lifts annual forecast, bets on rebound in surgical procedures
▼ + stars: | 2023-07-31 | by ( ) www.reuters.com time to read: +2 min

July 31 (Reuters) - Tenet Healthcare Corp (THC.N) on Monday raised its annual core earnings forecast after a strong second quarter, betting on a recovery in surgical procedure volumes and improved contract labor costs as staffing shortage eases. The hospital operator sees its 2023 core earnings in the range of $3.31 billion to $3.46 billion, compared with its previous forecast of $3.2 billion to $3.4 billion. It expects adjusted profit per share in the range of $5.18 to $6.03 in 2023, compared with a prior forecast of $4.92 to $6.09. Larger rival, HCA Healthcare (HCA.N), the biggest for-profit hospital U.S. operator, also raised its full-year adjusted core earnings forecast to between $12.3 billion and $12.8 billion, from prior expectations of between $12.1 and $12.7 billion. On an adjusted basis, Tenet reported a net income of $1.44 per share for the quarter ended June, beating estimates of $1.25 per share.

Persons: Tenet, Sriparna Roy, Maju Samuel Organizations: Tenet Healthcare Corp, Tenet, UnitedHealth, HCA Healthcare, Thomson Locations: United States, U.S, Texas, 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

☆ U.S. orders antiviral drugs worth $138 million from SIGA Tech
▼ + stars: | 2023-07-27 | by ( ) www.reuters.com time to read: +1 min

Companies SIGA Technologies Inc FollowJuly 27 (Reuters) - SIGA Technologies Inc (SIGA.O) on Thursday said it has won a new contract for its antiviral drug, Tpoxx, from the U.S. Department of Health and Human Services, sending the company's shares up about 20% after the bell. The order is for delivery of about $113 million worth of oral Tpoxx treatment courses and about $25 million worth of the intravenous formulation of the treatment, SIGA said. SIGA expects to fully deliver the order of oral Tpoxx drugs in 2023 and expects to start delivering IV TPOXX in 2024. Prior to the delivery of the IV drugs, it will focus on fulfilling a prior IV order, the company said. The U.S. Centers for Disease Control and Prevention expanded its use to help tackle the spread of mpox in 2022.

Persons: SIGA, Phil Gomez, Sriparna Roy, Devika Organizations: SIGA Technologies, U.S . Department of Health, Human Services, U.S . Food, Drug Administration, U.S . Centers for Disease Control, U.S . Department of Defense, World Health Organization, Thomson Locations: mpox, Bengaluru

☆ Drugmaker Mallinckrodt in talks with hedge funds to avoid opioid settlements, Wall Street Journal reports
▼ + stars: | 2023-07-26 | by ( ) www.reuters.com time to read: +1 min

Law Firms Mallinckrodt and Mallinckrodt FollowJuly 26 (Reuters) - Drugmaker Mallinckrodt (MNK.A) is talking to hedge funds about filing for bankruptcy and avoiding payments intended to help people addicted to opioids, the Wall Street Journal reported on Wednesday. Mallinckrodt, which is one of the largest manufacturers for opiods, had filed for bankruptcy protection nearly three years ago. It reached a $1.7 billion nationwide settlement as part of its bankruptcy reorganization plan and emerged from Chapter 11 last year. The company in June said it was considering a second bankruptcy filing and other options after its lenders raised concerns over the $200 million payment related to opioid-related litigation. Reporting by Sriparna Roy in Bengaluru; Editing by Devika SyamnathOur Standards: The Thomson Reuters Trust Principles.

Persons: Mallinckrodt, Sriparna Roy, Devika Organizations: Wall Street, Silver Point, Thomson Locations: Greenwich, Bengaluru

July 26 (Reuters) - The private equity owners of popular emergency contraception pill Plan B, Foundation Consumer Healthcare, have hired advisors to explore options including a potential sale of the company, a person familiar with the matter told Reuters. A sale could value the company at more than $4 billion, the source said, adding that the process is at an early stage. Foundation Consumer Healthcare also owns brands such as Breathe Right nasal strips, Dimetapp, which is a medicine for cough and cold for children and allergy drug Alavert. Foundation Consumer Healthcare or its private-equity owners Kelso & Co and Juggernaut Capital Partners did not immediately respond to a Reuters' request for comment. The report on the potential sale was first reported by Bloomberg News.

Persons: Roe, Wade, Mariam Sunny, Sriparna Roy, Abigail Summerville, Shilpi Majumdar, Arun Koyyur Organizations: Foundation Consumer Healthcare, Reuters, Kelso & Co, Juggernaut Capital Partners, Teva Pharmaceutical Industries, Consumer Healthcare, Bloomberg News, Thomson Locations: United States, Israel, Bengaluru, New York

Companies Gilead Sciences Inc FollowJuly 21 (Reuters) - Gilead Sciences Inc (GILD.O) said on Friday it was stopping a late-stage trial of its blood cancer combination treatment following an analysis that showed it would not be effective. Gilead, whose shares dropped over 1% in after-market trading, recommended that treatment with magrolimab in patients with MDS should be stopped. The company gained access to magrolimab with its $4.9 billion buyout of Forty Seven Inc in March 2020. Magrolimab is also in development for other types of cancer such as acute myeloid leukemia and solid tumours. Reporting by Sriparna Roy in Bengaluru Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

Persons: Gilead, Robert W, Baird, Brian Skorney, Magrolimab, Sriparna Roy, Vinay Dwivedi Organizations: Gilead Sciences, Gilead Sciences Inc, Seven Inc, Thomson Locations: Bengaluru

☆ Pfizer plant in North Carolina damaged by tornado
▼ + stars: | 2023-07-20 | by ( ) www.reuters.com time to read: +1 min

[1/4] 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. July 19 (Reuters) - Drugmaker Pfizer Inc (PFE.N) said on Wednesday its plant in Rocky Mount, North Carolina, which is one of the largest sterile injectable product facilities in the world, has suffered heavy damage from a tornado. A company spokesperson in an emailed statement confirmed that the Rocky Mount facility was damaged and the drugmaker was assessing the situation to determine the impact on production. The Rocky Mountain facility employs over 4,500 professionals, according to Pfizer's website. Reporting by Sriparna Roy in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

Persons: Rocky, Sriparna Roy, Shailesh Organizations: Pfizer, ABC, WTVD, REUTERS, Drugmaker Pfizer Inc, Thomson Locations: Rocky Mount, North Carolina, U.S, Bengaluru

July 14 (Reuters) - Eli Lilly and Co (LLY.N) said on Friday it will buy privately held Versanis for potentially up to $1.93 billion to strengthen its position in the fast-growing market for weight-loss treatments. Shares of Eli Lilly rose 3% after the deal that gives it access to an experimental obesity drug being tested along with rival Novo Nordisk's (NOVOb.CO) weight-loss treatment in a mid-stage study. Analysts expect the market for weight-loss drugs to reach up to $100 billion within a decade, with early movers such as Eli Lilly and Novo Nordisk grabbing a large chunk of the market. "One of the key concerns with weight loss medications is the loss of lean mass. The goal is to lose more fat vs. muscle, but with any weight loss program calorie restriction could impact both," said BMO Capital Markets analyst Evan Seigerman.

Persons: Eli Lilly, Novo, Evan Seigerman, Lilly, Sriparna Roy, Arun Koyyur Organizations: Novo Nordisk's, Novo Nordisk, Capital, Novartis, Thomson Locations: Swiss, Bengaluru

☆ Roivant in talks to sell bowel disease drug to Roche in over $7 bln deal - WSJ
▼ + stars: | 2023-07-13 | by ( ) www.reuters.com time to read: +1 min

July 13 (Reuters) - Biotech company Roivant Sciences (ROIV.O) is nearing a deal to sell an experimental drug to treat inflammatory bowel diseases including ulcerative colitis and Crohn's disease to Roche (ROG.S) in a deal that could be valued at more than $7 billion, the Wall Street Journal reported on Thursday. The sale of the drug could be announced in the coming days, the report said, citing people familiar with the matter. Roivant's experimental drug, RVT-3101, is under clinical trials for the treatment of moderate-to-severe ulcerative colitis, a long-term condition where the colon and rectum become inflamed, as well as a type of inflammatory bowel disease known as Crohn's disease. Roivant declined to comment, whereas Roche did not immediately respond to a Reuters request for comment. Reporting by Shivani Tanna and Sriparna Roy in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

Persons: Roche, Roivant, Shivani Tanna, Sriparna Roy, Shailesh Organizations: - Biotech, Roivant Sciences, Wall Street, Thomson Locations: Bengaluru

July 13 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women in the country to purchase birth control without prescription. Perrigo will next week share its pricing plan for the pill, which will be available in stores and online in the first quarter of next year. Women should take a progestin-only pill within the same three hours every day to avoid pregnancy. The National Catholic Bioethics Center and other groups have opposed making Opill available without prescription, saying physicians should be involved in health decisions, especially for teenagers, along with parental supervision, to avoid harm. Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.

Persons: Roe, Wade, Xavier Becerra, Opill, Jeffrey Singer, Perrigo, Manas Mishra, Sriparna Roy, Arun Koyyur Organizations: U.S . Food, Drug Administration, Perrigo, Human Services, Cato Institute, FDA, Catholic Bioethics Center, HRA Pharma, Thomson Locations: U.S, Paris, Bengaluru

☆ Thermo Fisher to acquire CorEvitas for about $913 million
▼ + stars: | 2023-07-06 | by ( ) www.reuters.com time to read: +2 min

Thermo Fisher has been on an acquisition spree in recent years as it strives to become a one-stop shop for biopharma services. CorEvitas is expected to boost Thermo Fisher's annual adjusted earnings per share by 3 cents next year. The data provider also has the potential to generate $110 million of revenue in 2023, Thermo Fisher said. CorEvitas' data intelligence platform would be added to Thermo Fisher's laboratory products and biopharma services unit, upon completion of the deal. Shares of Massachusetts-based Thermo Fisher were down 1.3% at $514 in early trading.

Persons: Fisher, CorEvitas, Puneet, Sriparna Roy, Shilpi Majumdar Organizations: SVB Securities, Audax Private Equity, Massachusetts, Thomson Locations: U.S, Boston, Bengaluru

☆ 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

☆ US FDA declines to approve Amneal's Parkinson's drug over safety concerns
▼ + stars: | 2023-07-03 | by ( ) www.reuters.com time to read: +2 min

July 3 (Reuters) - The U.S. Food and Drug Administration (FDA) has declined to approve Amneal Pharmaceuticals' (AMRX.N) drug designed to help control symptoms in Parkinson's disease patients for a longer duration, citing inadequate safety data. The complete response letter comes as a surprise, said Barclays analyst Balaji Prasad. The decision does not impact 2023 forecast as it did not include the revenue from the drug, the company said. Amneal has another Parkinson's drug, Rytary, on the market but has been struggling to gain a foothold in the treatment space. Only 4% of patients use the drug since its approval in 2015, as per company estimates.

Persons: Balaji Prasad, Amneal, Raghav Mahobe, Khushi, Sriparna Roy, Pooja Desai, Shweta Agarwal, Sriraj Organizations: U.S . Food, Drug Administration, Amneal Pharmaceuticals, FDA, Barclays, Thomson Locations: 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

The company reported a larger-than-expected quarterly loss and cut its annual revenue forecast for the second time, but strength in its biologics unit drove quarterly sales past tempered Wall Street estimates. Catalent's "results cleared an admittedly low bar", Stephens analyst Jacob Johnson said. "After a number of shoes dropping and a lot of noise recently, today was a good first or second step." Catalent reported a third-quarter loss of 9 cents per share, compared with Wall Street estimates for a loss of 3 cents, according to IBES data from Refinitiv. The company will also amend its 2022 results filing with a $26 million deduction caused by a revenue recognition error at its Bloomington plant.

Persons: Stephens, Jacob Johnson, Alessandro Maselli, Maselli, Catalent, Bhanvi Satija, Sriparna Roy, Devika Organizations: Novo Nordisk's, Thomson Locations: Maryland, Brussels, Indiana, Bloomington, Bengaluru

☆ FibroGen's neuromuscular disorder drug fails in late-stage study
▼ + stars: | 2023-06-07 | by ( ) www.reuters.com time to read: 1 min

June 7 (Reuters) - FibroGen Inc (FGEN.O) said on Wednesday its drug to treat a type of neuromuscular disorder failed to meet the main goal in a late-stage study, sending the company's shares down about 14% in premarket trading. The treatment was generally safe and well tolerated for patients with Duchenne muscular dystrophy (DMD). DMD is a progressive degenerative disorder that hampers muscle movement and affects one in 3,600 newborn boys, most of whom die by the age of 30. Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar and Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

Persons: Sriparna Roy, Shilpi Majumdar, Shounak Organizations: FibroGen, Thomson Locations: Bengaluru

☆ Pfizer says its experimental antibiotic combo can treat some superbug infections
▼ + stars: | 2023-06-01 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Johanna Geron/File PhotoJune 1 (Reuters) - Pfizer Inc (PFE.N) said on Thursday data from late-stage trials showed its experimental combination of antibiotics was effective in treating deadly infections caused by drug-resistant bacteria. Deaths from antibiotic-resistant bacteria, also known as superbugs, have been on the rise globally, and health regulators have called for the development of newer treatments as resistance to older antibiotics grows. The late-stage studies compared the experimental combination of the antibiotics aztreonam-avibactam (ATM-AVI) and existing generic drug metronidazole with a combination of two older antibiotics - meropenem and colistin - to treat complicated intra-abdominal infections and types of hospital-acquired pneumonia. Pfizer said the data from the studies shows the antibiotic combination of ATM-AVI is effective and well-tolerated in treating infections caused by gram-negative bacteria. For patients with types of hospital-acquired pneumonia and ventilator‐associated pneumonia, the cure rate was 45.9% for Pfizer's antibiotic combination with metronidazole, versus 41.7% for other, older treatments.

Persons: Johanna Geron, Leroy Leo, Sriparna Roy, Pooja Desai Organizations: Pfizer, REUTERS, Pfizer Inc, Disease Control, Thomson Locations: Puurs, Belgium, United States, Bengaluru

Catalent, one of the top contract manufacturers for pharmaceutical companies, said a drop in revenue from COVID vaccine manufacturing had coincided with higher-than-expected costs and production challenges at its facilities in Indiana and in Brussels. Adding to woes, its cost-cutting plans have been delayed due to regulatory inspections and subsequent corrective actions, the company said. Despite Friday's gain in shares, Catalent's stock is down 19% since it first disclosed production challenges at its three major production plants in April. Catalent cut its full-year revenue to a range of $4.25 billion to $4.35 billion, from its prior forecast of $4.63 billion to $4.88 billion. It also slashed its annual adjusted net income forecast to between $187 million and $228 million, from between $567 million and $648 million previously.

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