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☆ US FDA Identifies Recall of ResMed's Respiratory Devices as Most Serious
▼ + stars: | 2024-01-11 | by ( Jan. | At P.M. | ) www.usnews.com time to read: +1 min

(Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of certain respiratory masks made by ResMed as most serious as their use could cause major injuries or death. ResMed was recalling some models of its continuous positive airway pressure (CPAP) masks, AirFit and AirTouch, due to possible magnetic interference with certain medical devices and implants which might disrupt their function or position and cause serious harm or death, the FDA said. The FDA said ResMed was recalling these masks to update the labels and add more warnings and information. The California-based medical device maker started the recall process on Nov. 20 and has recalled over 20 million devices in the United States. The health regulator said there has been six reported injuries and no reports of death due to the devices.

Persons: ResMed, Mariam Sunny, Maju Samuel Organizations: Reuters, U.S . Food, Drug Administration, FDA Locations: U.S, California, United States, Bengaluru

☆ US life expectancy climbs in 2022 after COVID retreat
▼ + stars: | 2023-11-29 | by ( Mariam E Sunny | ) www.reuters.com time to read: +3 min

The study estimated babies' life expectancy if mortality conditions when they were born were to persist throughout their lives. "There were positive outcomes all around ... all the groups by race and sex experienced increases in life expectancy," Arias said. Life expectancy increased by 1 year for Asian non-Hispanic infants to 84.5 years, and by 0.8 year for White non-Hispanic babies to 77.5. In all groups, previous declines in mortality due to COVID explained more than 80% of the increases in life expectancy, according to the report. Declines in deaths from heart disease, unintentional injuries, cancer, and homicide also contributed to longer life expectancy overall, but their impact varied.

Persons: Octavio Jones, Elizabeth Arias, Arias, COVID, Mariam Sunny, Nancy Lapid, Bill Berkrot Organizations: Department of Health Sarasota COVID, REUTERS, U.S . Centers for Disease Control, Prevention, White, Thomson Locations: Sarasota , Florida, U.S, Alaska, Bengaluru

☆ Biogen cuts annual profit forecast on persistent higher costs
▼ + stars: | 2023-11-08 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Dado Ruvic/Illustration Acquire Licensing RightsNov 8 (Reuters) - Biogen (BIIB.O) cut its annual profit forecast below Wall Street expectations on Wednesday, on rising costs related to the recent acquisition of rare disease drugmaker Reata Pharmaceuticals and the launch of its Alzheimer's treatment Leqembi. Biogen is banking on the success of Leqembi and tuck-in deals like its recent $6.5 billion buyout of Reata Pharmaceuticals to grow its revenue. The drugmaker expects full-year adjusted profit per share in the range of $14.50 to $15.00 compared with $15 to $16 forecast previously. On an adjusted basis, Biogen earned $4.36 per share, beating analysts' average estimate of $3.97, according to LSEG data. Reporting by Mariam Sunny and Bhanvi Satija in Bengaluru; Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.

Persons: Dado Ruvic, Eisai, Christopher Viehbacher, Biogen, Mariam Sunny, Bhanvi, Arun Koyyur Organizations: REUTERS, Pharmaceuticals, Reata Pharmaceuticals, Thomson Locations: Bengaluru

People walk by a CVS pharmacy store in Manhattan, New York City, New York, U.S., November 17, 2021. REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsCompanies CVS Health Corp FollowNov 1 (Reuters) - CVS Health Corp (CVS.N) beat Wall Street estimates for quarterly profit on Wednesday as strength in its drugstores and pharmacy benefit management business offset higher-than-expected medical costs at its insurance unit. CVS' medical benefit ratio, or the percentage of claims paid compared to premiums collected, was 85.7% in the third quarter, compared with analysts' estimates of 85.1%. CVS' pharmacy and consumer wellness segment recorded 6% revenue growth to $28.87 billion, boosted by higher drug prices and prescription volume. The company reported an adjusted profit of $2.21 per share, beating estimates of $2.13 per share, according to LSEG data.

Persons: Andrew Kelly, Julie Utterback, Mariam Sunny, Leroy Leo, Saumyadeb Chakrabarty, Vinay Dwivedi Organizations: REUTERS, CVS Health, CVS Health Corp, CVS, Morningstar, PBMs, Revenue, Walgreens, Thomson Locations: Manhattan , New York City , New York, U.S, United States, Bengaluru

☆ Labcorp beats quarterly profit estimates on strength in routine testing segment
▼ + stars: | 2023-10-26 | by ( ) www.reuters.com time to read: +2 min

The logo for Labcorp, Laboratory Corporation of America, a life sciences company is displayed on a screen on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., June 22, 2023. REUTERS/Brendan McDermid/File Photo Acquire Licensing RightsOct 26 (Reuters) - Laboratory Corporation of America (LH.N) topped Wall Street expectations for quarterly adjusted profit on Thursday, as strength in its routine diagnostics business more than offset weak COVID test sales. Peer Danaher (DHR.N) also beat profit expectations earlier this week on the back of strong demand for its diagnostic tests for respiratory diseases. Labcorp reported adjusted profit of $3.38 per share, beating analysts' average estimate of $3.33 per share. The life sciences company also tightened its annual profit per share outlook to between $13.25 and $13.75, from $13 to $14 forecast earlier.

Persons: Brendan McDermid, Danaher, Labcorp, Mariam Sunny, Vinay Dwivedi Organizations: Laboratory Corporation of America, New York Stock Exchange, REUTERS, Quest Diagnostics, Thomson Locations: New York City, U.S, Bengaluru

☆ Royalty Pharma to pay $1 bln for Roche's SMA drug royalties
▼ + stars: | 2023-10-19 | by ( ) www.reuters.com time to read: +1 min

The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann/File Photo Acquire Licensing RightsOct 19 (Reuters) - Royalty Pharma (RPRX.O) said on Thursday it has purchased additional royalties on Roche (ROG.S) and PTC Therapeutics' (PTCT.O) oral spinal muscular atrophy (SMA) drug for an upfront payment of $1 billion. Spinal muscular atrophy, a leading genetic cause of infant deaths, prevents the body from producing a protein necessary for neuromuscular development. The deal also includes options for PTC to sell up to all of its retained royalties on Evrysdi for up to $500 million at a later date, Royalty Pharma said. Royalty Pharma expects to fund the transaction with a combination of existing cash and about $350 million from its revolving credit facility.

Persons: drugmaker Roche, Arnd, Roche, Mariam Sunny, Shilpi Majumdar Organizations: REUTERS, Royalty Pharma, PTC Therapeutics, U.S . Food, Drug Administration, PTC, Thomson Locations: Basel, Switzerland, Bengaluru

☆ Thermo Fisher Scientific to buy Olink in $3.1 billion deal
▼ + stars: | 2023-10-17 | by ( ) www.reuters.com time to read: +2 min

A company flag flies outside the offices of Thermo Fisher Scientific offices in Waltham, Massachusetts, U.S., August 2, 2023. The deal lifted Olink's U.S.-listed shares nearly 67% in early trading, while shares of Thermo Fisher were down over 1%. Olink's acquisition will help Thermo Fisher's customers in the biotech industry "to meaningfully accelerate discovery and scientific breakthroughs," Thermo Fisher CEO Marc Casper said. Thermo Fisher said it would pay Olink shareholders $26 per share, an about 74% premium to the U.S.-listed stock's closing price on Monday. The deal is a good fit for Thermo Fisher and "checks the box strategically," Evercore ISI analyst Vijay Kumar wrote in a note.

Persons: Brian Snyder, Fisher, Marc Casper, Vijay Kumar, Mariam Sunny, Krishna Chandra Eluri, Shilpi Majumdar Organizations: REUTERS, Olink, U.S, Thomson Locations: Waltham , Massachusetts, U.S, Sweden, Bengaluru

☆ Drug retailer Rite Aid files for bankruptcy amid rising debt, opioid litigation
▼ + stars: | 2023-10-16 | by ( Abinaya V | ) www.reuters.com time to read: +2 min

A woman shops inside a Rite Aid store underneath a DeepCam security camera in New York City, New York, U.S., June 25, 2020. Rite Aid, which began as a thrift shop in 1962, became the third largest U.S. chain of drugstores in less than two decades with more than 2,000 retail stores in 17 states. Rite Aid had a total debt of $8.60 billion as of June 3, according to a filing with the U.S. Bankruptcy Court for the District of New Jersey, some of which is due in 2025. It said it will transfer employees at underperforming stores that would be closed to other locations where possible. Rite Aid joins several companies, including Mallinckrodt, that have filed for bankruptcy due to lawsuits over the U.S. opioid crisis.

Persons: Lucas Jackson, Jeffrey Stein, Elizabeth Burr, Leroy Leo, Abinaya Vijayaraghavan, Mariam Sunny, Simon Cameron, Moore, Arun Koyyur Organizations: REUTERS, Rite, U.S, Bankruptcy, District of, Aid, Thomson Locations: New York City , New York, U.S, United States, District of New Jersey, Bengaluru

Rite Aid, one of the largest U.S. pharmacy retailers, stumbled under its high debt, revenue declines, increased competition, and opioid litigation, according to its court filings. Founded in 1962, Rite Aid employs 45,000 people at more than 2,000 retail stores in 17 states, and will remain open for business during the bankruptcy. Rite Aid, which has denied wrongdoing, said it hopes to reach an "equitable" settlement of opioid litigation in bankruptcy. A woman shops inside a Rite Aid store underneath a DeepCam security camera in New York City, New York, U.S., June 25, 2020. Rite Aid closed 200 stores before its bankruptcy, and it expects to close more as its Chapter 11 case proceeds.

Persons: Lucas Jackson, McKesson, Jeffrey Stein, Elizabeth Burr, Leroy Leo, Abinaya Vijayaraghavan, Mariam Sunny, Arun Koyyur, Marguerita Choy, Bill Berkrot Organizations: Rite Aid, Rite, Endo International, REUTERS, Bankruptcy, District of, MedImpact Healthcare Systems, Elixir ., Rite Aid . Rite, Aid, Thomson Locations: U.S, New York City , New York, District of New Jersey, Bengaluru

☆ Drug retailer Rite Aid files for bankruptcy, gets $3.45 bln commitment
▼ + stars: | 2023-10-16 | by ( ) www.reuters.com time to read: +2 min

A woman shops inside a Rite Aid store underneath a DeepCam security camera in New York City, New York, U.S., June 25, 2020. The bankruptcy process will allow Rite Aid to resolve litigation claims in an "equitable manner", the company said. Rite Aid has appointed Jeffrey Stein as its new CEO and chief restructuring officer, replacing interim CEO Elizabeth Burr. Rite Aid has also reached an in-principle agreement with some of its senior secured noteholders that would significantly reduce its debt. MedImpact will serve as the 'stalking horse bidder' in a court-supervised sale process, Rite Aid said.

Persons: Lucas Jackson, Jeffrey Stein, Elizabeth Burr, Stein, Burr, noteholders, Abinaya Vijayaraghavan, Mariam Sunny, Sriparna Roy, Shweta Agarwal, Pooja Desai Organizations: REUTERS, Rite Aid Corp, U.S, Aid, Walgreens Boots Alliance, CVS Health, MedImpact Healthcare Systems, Solutions, Rite Aid, Bankruptcy, District of, Thomson Locations: New York City , New York, U.S, District of New Jersey, Bengaluru

[1/2] A UnitedHealth Group health insurance card is seen in a wallet in this picture illustration October 14, 2019. REUTERS/Lucy Nicholson/Illustration/File Photo Acquire Licensing RightsOct 13 (Reuters) - UnitedHealth (UNH.N) reported a third-quarter profit on Friday ahead of analysts' estimates, helped by a lower-than-feared rise in medical costs at the company's health insurance unit. UnitedHealth's profit beat and slight raise in annual forecast set the stage for other insurers in the industry that suffered a nearly $60-billion wipeout in market value in June, on fears of a spike in medical costs. UnitedHealth said in July it expects quarterly medical costs to be "a little bit lower" sequentially. In the third quarter, the company's medical loss ratio, the percentage of spend on claims compared to premiums collected, was 82.3%, versus 83.2% in the second quarter.

Persons: Lucy Nicholson, Stephens, Scott Fidel, UnitedHealth, Mariam Sunny, Bhanvi, Shounak Dasgupta Organizations: REUTERS, Humana, Thomson Locations: COVID, Bengaluru

☆ UnitedHealth beats quarterly profit estimates on easing medical costs
▼ + stars: | 2023-10-13 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Lucy Nicholson/Illustration/File Photo Acquire Licensing RightsOct 13 (Reuters) - UnitedHealth (UNH.N) reported a third-quarter profit on Friday that beat analysts' estimates, helped by lower-than-expected medical costs for the healthcare conglomerate. UnitedHealth said in July it expects medical costs for the third quarter to be "a little bit lower" compared with the second quarter. The company's medical loss ratio for the quarter, the percentage of spend on claims compared to premiums collected, was 82.3%, compared with analysts' estimates of 82.82%, according to LSEG data. UnitedHealth reported an adjusted profit of $6.56 per share for the third quarter, compared with estimates of $6.32. The company now expects an adjusted profit between $24.85 and $25.00 per share, compared with its previous outlook of $24.70 to $25.00.

Persons: Lucy Nicholson, UnitedHealth, Mariam Sunny, Bhanvi, Shounak Dasgupta Organizations: REUTERS, Thomson Locations: Bengaluru

☆ Shares of dialysis providers drop after Ozempic's early kidney trial success
▼ + stars: | 2023-10-11 | by ( ) www.reuters.com time to read: +2 min

The outdoor sign seen at the DaVita Dialysis clinic in Denver February 16, 2016. U.S.-listed shares of Fresenius fell 16.4%, to $17.5, and Davita fell about 16%, to $76.7, in premarket hours. Shares of U.S.-based Baxter International (BAX.N), which makes products used by dialysis therapy providers, also fell about 9%, to $33.99 premarket. Davita and U.S.-listed shares of Fresenius Medical are among the top percentage losers on the New York Stock Exchange. As of Tuesday's close, U.S.-listed shares of Fresenius were up about 28.2%, Davita's shares were up 22.2%, while Baxter's shares were down about 27% so far this year.

Persons: Rick Wilking, Ozempic, Danish drugmaker, Veronika Dubajova, Davita, Eli Lilly's, Akash Tewari, Fresenius, Mariam Sunny, Janane Venkatraman, Pooja Desai Organizations: REUTERS, Novo Nordisk's, Citi, Baxter, Jefferies, Fresenius, New York Stock Exchange ., Thomson Locations: Denver, Danish, Fresenius, New York Stock Exchange . Frankfurt, U.S, Bengaluru

☆ Alnylam gives up on expanded use of heart-disease drug in US after FDA declines approval
▼ + stars: | 2023-10-09 | by ( Mariam E Sunny | ) 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. The FDA, in 2019, approved Pfizer's (PFE.N) oral drug tafamidis, sold under the brand names Vyndaqel and Vyndamax, to treat transthyretin amyloid cardiomyopathy in the United States. Alnylam said it will focus on another drug candidate, vutrisiran, an under-the-skin injection in late-stage trials to treat ATTR amyloidosis-related cardiomyopathy. Branded as Amvuttra, vutrisiran is also approved in the U.S. to treat nerve damage in adult patients with hereditary ATTR amyloidosis. William Blair analyst Myles Minter estimates peak U.S. sales of $2.2 billion for vutrisiran as an ATTR cardiomyopathy treatment.

Persons: Andrew Kelly, patisiran, ATTR amyloidosis, Alnylam, Luca Issi, ATTR, William Blair, Myles Minter, Mariam Sunny, Pooja Desai Organizations: Food and Drug Administration, FDA, REUTERS, Alnylam Pharmaceuticals, RBC, Thomson Locations: White Oak , Maryland, U.S, Massachusetts, United States, Bengaluru

☆ Amgen completes $27.8 bln Horizon Therapeutics deal
▼ + stars: | 2023-10-06 | by ( ) www.reuters.com time to read: +1 min

An Amgen sign is seen at the company's office in South San Francisco, California in this October 21, 2013 photo. Amgen, which has gained Horizon's two key products Tepezza and Krystexxa, said it will provide an updated annual forecast during its third-quarter earnings call. RBC Capital Markets analyst Gregory Renza expects Amgen's updated forecast to weave in revenue from Horizon's drugs, which could partially offset the company's "maturing product line". Tepezza could be a "core driver" for Amgen, Renza said, adding that the drug can bring in $3.9 billion in peak sales. Reporting by Mariam Sunny and Sriparna Roy in Bengaluru; Editing by Anil D'Silva and Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.

Persons: Robert Galbraith, Gregory Renza, Renza, Mariam Sunny, Sriparna Roy, Anil D'Silva, Sherry Jacob, Phillips Organizations: Horizon Therapeutics, U.S . Federal Trade Commission, FTC, RBC Capital Markets, Thomson Locations: South San Francisco , California, Bengaluru

☆ Amgen completes $27.8 billion Horizon deal
▼ + stars: | 2023-10-06 | by ( ) www.reuters.com time to read: +1 min

An Amgen sign is seen at the company's office in South San Francisco, California in this October 21, 2013 photo. REUTERS/Robert Galbraith/File Photo Acquire Licensing RightsOct 6 (Reuters) - Amgen (AMGN.O) said on Friday it had completed the $27.8 billion acquisition of Horizon Therapeutics (HZNP.O) after it received the go-ahead from the U.S. Federal Trade Commission (FTC) last month on certain conditions. Under the settlement terms with the FTC following its lawsuit to block the deal, Amgen is prevented from using anticompetitive tactics to extend the market dominance of Horizon's thyroid eye disease treatment Tepezza and gout drug Krystexxa. The deal closure was within the fourth-quarter timeline set by the two companies. Reporting by Mariam Sunny in Bengaluru; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

Persons: Robert Galbraith, Mariam Sunny, Anil D'Silva Organizations: Horizon Therapeutics, U.S . Federal Trade Commission, FTC, Thomson Locations: South San Francisco , California, Bengaluru

☆ FDA staff reviewers raise concerns over BrainStorm Cell's ALS therapy
▼ + stars: | 2023-09-25 | 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. Brainstrom's therapy, NurOwn, is being reviewed for the treatment of ALS, also known as Lou Gehrig's Disease, which affects nerve cells in the brain and spinal cord. The FDA had in November last year refused to accept the application for the therapy after BrainStorm failed to meet the main goal in a late-stage study. Over the last one year, the FDA has given accelerated approvals to Amylyx Pharmaceuticals' (AMLX.O) drug Relyvrio and Biogen's (BIIB.O) Qalsody for treatment of ALS. A panel of external advisors to the FDA is set to vote on the effectiveness of the therapy in ALS patients on Wednesday.

Persons: Andrew Kelly, Lou Gehrig's Disease, Amylyx, Mariam Sunny, Leroy Leo, Krishna Chandra Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug, Cell Therapeutics, Amylyx Pharmaceuticals, ALS Association, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ US government restarts delivery of free COVID tests
▼ + stars: | 2023-09-20 | by ( ) www.reuters.com time to read: 1 min

People walk next to coronavirus disease (COVID-19) testing sites in New York City, New York, U.S., December 12, 2022. REUTERS/Eduardo Munoz/File photo Acquire Licensing RightsSept 20 (Reuters) - The U.S. Department of Health and Human Services (HHS) said on Wednesday it will deliver COVID-19 tests for free to households across the country. Beginning Sept. 25, households will again be able to order four free tests through COVIDTests.gov, the health agency said, adding that the tests can detect currently circulating COVID-19 variants and are intended for use through the end of 2023. HHS also announced an investment of $600 million in 12 domestic COVID-19 test manufacturers. Reporting by Mariam Sunny and Seher Dareen in Bengaluru; Editing by Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

Persons: Eduardo Munoz, Mariam Sunny, Seher, Shounak Dasgupta Organizations: REUTERS, U.S . Department of Health, Human Services, HHS, Thomson Locations: New York City , New York, U.S, Bengaluru

☆ Musk's Neuralink to start human trial of brain implant for paralysis patients
▼ + stars: | 2023-09-19 | by ( ) www.reuters.com time to read: +2 min

Neuralink logo and Elon Musk photo are seen in this illustration taken, December 19, 2022. REUTERS/Dado Ruvic/Illustration Acquire Licensing RightsSept 19 (Reuters) - Billionaire entrepreneur Elon Musk's brain-chip startup Neuralink said on Tuesday it has received approval from an independent review board to begin recruitment for the first human trial of its brain implant for paralysis patients. It is not known how many patients the FDA ultimately approved. Musk has grand ambitions for Neuralink, saying it would facilitate speedy surgical insertions of its chip devices to treat conditions like obesity, autism, depression and schizophrenia. Reporting by Mariam Sunny in Bengaluru; Editing by Pooja DesaiOur Standards: The Thomson Reuters Trust Principles.

Persons: Elon, Dado Ruvic, Elon Musk's, Neuralink, Musk, Mariam Sunny, Pooja Desai Organizations: REUTERS, Billionaire, U.S . Food, Drug Administration, FDA, BCI, Thomson Locations: Bengaluru

☆ US CDC Expects 'Tripledemic' Hospitalizations to Remain High This Year Vs Pre-Pandemic Levels
▼ + stars: | 2023-09-14 | by ( Sept. | At P.M. | ) www.usnews.com time to read: +1 min

(Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said on Thursday it expects the total number of hospitalizations from COVID-19, respiratory syncytial virus infections and flu this year to be similar to last year, higher than pre-pandemic levels. The government health agency also said it expects flu and RSV infections to increase over the fall and winter seasons. Vaccines for all three major respiratory viruses – COVID-19, flu, and RSV – will be available this fall, the CDC said. Higher levels of vaccination across the population will help reduce the number of hospitalizations and risk of straining the country's hospitals, CDC added. A surge in cases of RSV infections coinciding with an increase in COVID transmission and an earlier-than-normal flu season has raised the specter of a so-called 'tripledemic' of respiratory illness across the United States.

Persons: Mariam Sunny, Shailesh Kuber Organizations: Reuters, U.S . Centers for Disease Control, Prevention, CDC, Pfizer Locations: COVID, United States, Bengaluru

☆ FDA warns CVS, others against selling unapproved eye products
▼ + stars: | 2023-09-12 | by ( ) www.reuters.com time to read: +2 min

CVS Health logo is seen displayed in this illustration taken, May 3, 2022. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsSept 12 (Reuters) - The U.S. Food and Drug Administration on Tuesday warned eight companies, including pharmacy giants CVS Health Corp (CVS.N) and Walgreens Boots Alliance (WBA.O), against manufacturing or marketing unapproved eye products. Some of the these eye products were labeled to contain silver, the FDA said, adding that long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray. CVS and Walgreens said they have stopped the sale of the unapproved eye drops, and that customers who purchased these products could return them for a full refund. The FDA warned that failure to correct the violations may result in legal action, including product seizure and court orders requiring the companies to stop manufacturing and distributing an unapproved product.

Persons: Dado Ruvic, Similasan, Leroy Leo, Mariam Sunny, Christy Santhosh, Pooja Desai, Maju Samuel Organizations: CVS, REUTERS, U.S . Food, Drug Administration, CVS Health Corp, Walgreens Boots Alliance, FDA, Walgreens, Reuters, Thomson Locations: U.S, Swiss, Bengaluru

☆ US FDA panel says popular decongestant used in cold medicines ineffective
▼ + stars: | 2023-09-12 | by ( ) www.reuters.com time to read: +1 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 Acquire Licensing RightsSept 12 (Reuters) - An outside panel of experts to the U.S. Food and Drug Administration on Tuesday refused to back the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, an ingredient widely used in cold and cough syrups. The panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise. The FDA usually follows the recommendations of its expert panel but is not obligated to do so. Phenylephrine was substituted for pseudoephedrine in many non-prescription cold and allergy medicines after the latter was restricted amid reports of abuse.

Persons: Andrew Kelly, Jennifer Schwartzott, Phenylephrine, Mariam Sunny, Devika Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, GSK, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ US FDA authorizes Pfizer-BioNTech and Moderna's updated COVID shots
▼ + stars: | 2023-09-11 | by ( ) www.reuters.com time to read: +2 min

[1/3] Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. A third shot, made by Novavax (NVAX.O), is still under review by the FDA. But obviously that requires that FDA have decided the data supports it," said Jesse Goodman, a professor at Georgetown and former FDA chief scientist. Moderna and Pfizer, which is partnered with German biotech firm BioNTech SE (22UAy.DE), said the updated vaccines were expected to be available the United States in the coming days. An endorsement by CDC Director Mandy Cohen, expected shortly, should clear the way for the new shots.

Persons: Andrew Kelly, Novavax, Jesse Goodman, —, Mandy Cohen, Cohen, Sriparna Roy, Mariam Sunny, Michael Erman, Shinjini Organizations: Food and Drug Administration, FDA, REUTERS, Pfizer, Moderna, U.S . Food, Drug Administration, for Disease Control, Prevention, Georgetown, EG, CDC, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru, New York

☆ Drug retailer Rite Aid prepares to file for bankruptcy - WSJ
▼ + stars: | 2023-08-25 | by ( ) www.reuters.com time to read: +1 min

Aug 25 (Reuters) - Rite Aid Corp (RAD.N) is preparing to file for bankruptcy in coming weeks to address lawsuits the company is facing over its alleged role in the sale of opioids, the Wall Street Journal reported on Friday, citing people familiar with the plan. Rite Aid did not immediately respond to a Reuters request for comment. Regionally focused Rite Aid operates more than 2,330 stores in 17 U.S. states, although it is much smaller than rivals like Walgreens Boots Alliance (WBA.O) and CVS Health (CVS.N). Along with other pharmacy chains, Rite Aid has been named a defendant in lawsuits that alleged they helped fuel the opioid crisis in the United States. The U.S. Department of Justice in March sued Rite Aid, accusing the pharmacy chain of missing "red flags" as it illegally filled hundreds of thousands of prescriptions for controlled substances, including opioids.

Persons: Mariam Sunny, Khushi, Pooja Desai, Maju Samuel Organizations: Rite Aid Corp, Wall Street, Aid, Walgreens Boots Alliance, CVS Health, U.S . Department of Justice, U.S . Centers for Disease Control, Thomson Locations: U.S, United States, Bengaluru

☆ Mallinckrodt second bankruptcy would cut $1 billion from opioid settlement
▼ + stars: | 2023-08-23 | by ( ) www.reuters.com time to read: +2 min

The agreement announced Wednesday would reduce Mallinckrodt's debt by about $1.9 billion and cancel existing equity shares. The new deal would leave opioid creditors with $1 billion less than the $1.7 billion settlement that Mallinckrodt agreed to pay as part of its 2022 exit from the company's earlier bankruptcy. Mallinckrodt failed to make a $200 million payment to the opioid trust due in June, prompting the company to launch a negotiation with its stakeholders. Mallinckrodt said that its current level of creditor support should allow the company to complete its second bankruptcy by the end of 2023. Drug manufacturers, drug distributors and pharmacy chains have agreed to pay more than $50 billion in settlements to resolve lawsuits related to the U.S. opioid crisis.

Persons: Hydrocodine, Mallinckrodt, George Frey, Siggi Olafsson, Pratik Jain, Mariam Sunny, Khushi, Dietrich Knauth, Maju Samuel, Shinjini Ganguli, Alexia Garamfalvi Organizations: REUTERS, Thomson Locations: Provo , Utah, U.S, Ireland, Bengaluru, New York

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