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REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsNov 29 (Reuters) - Cigna (CI.N) and Humana (HUM.N), two of the biggest U.S. health insurers, are in talks for what could be the largest merger announced in 2023, according to a source familiar with the matter. A Humana and Cigna combination would give the merged company the scale to rival UnitedHealth Group (UNH.N) and CVS Health (CVS.N). In July 2016, the Justice Department filed lawsuits against two health insurance mergers on the same day, saying they would lead to less competition and higher prices for Americans. Health insurers have been facing higher medical costs as people return for procedures they had put off during the pandemic. Humana in February said that it would sell its commercial business but keep its Medicare Advantage products.

Persons: Andrew Kelly, Cigna, Cigna's, Aetna, Bill Baer, Andre Barlow of Doyle, Barlow, Mazard, Bernstein, Lance Wilkes, Craig Garthwaite, Manas Mishra, Diane Bartz, Deena Beasley, Caroline Humer, Bill Berkrot Organizations: Humana Inc, REUTERS, Street Journal, UnitedHealth, CVS Health, Humana’s, Medicare, Affordable, Justice Department, Humana, U.S ., Reuters, Northwestern University, Thomson Locations: Queens , New York City, U.S, Cigna, Bengaluru, Washington, Los Angeles

☆ China says no unusual pathogens found after WHO queries respiratory outbreaks
▼ + stars: | 2023-11-23 | by ( ) www.reuters.com time to read: +5 min

The WHO had asked China for more information on Wednesday after groups including the Program for Monitoring Emerging Diseases (ProMED) reported clusters of undiagnosed pneumonia in children in north China. No unusual pathogens have been detected in the capital of Beijing and the northeastern province of Liaoning. The U.N. health agency had also asked China for further information about trends in the circulation of known pathogens and the burden on healthcare systems. WHO China said it was "routine" to request information on increases in respiratory illnesses and reported clusters of pneumonia in children from member states, such as China. The WHO said that while it was seeking additional information, it recommended that people in China follow measures to reduce the risk of respiratory illness.

Persons: Dado Ruvic, pneumoniae, Ben Cowling, Deena Beasley, Andrew Silver, Jennifer Rigby, Emma Farge, Urvi, Robert Birsel, Miyoung Kim, Josie Kao Organizations: REUTERS, World Health Organization, WHO, International, National Health Commission, FTV News, Hong Kong University, Health Commission, Xinhua, Influenza, Thomson Locations: China, Beijing, Liaoning, Wuhan, WHO China, Taiwan, Los Angeles, Shanghai, London, Geneva, Bengaluru

A 0.25 mg injection pen of Novo Nordisk's weight-loss drug Wegovy is shown in this photo illustration in Oslo, Norway, August31, 2023. The U.S. Food and Drug Administration on Wednesday said Eli Lilly (LLY.N) could begin selling its drug tirzepatide for weight loss, making it the second obesity drug in a class known as GLP-1s. Studies of Novo's Wegovy showed that it led to 15% weight loss over 68 weeks, while Lilly's drug, which also targets a second hormone called GIP, demonstrated weight loss of more than 22% over 72 weeks. Drugstore chain Walgreens is seeing "enormous demand" for GLP-1s, said John Driscoll, president, U.S. healthcare at Walgreens Boots Alliance (WBA.O). Much has been made of the impact the new weight loss drugs might have on consumer habits such as snack food purchases, but Driscoll said Walgreens has not seen that yet.

Persons: Victoria Klesty, Eli Lilly, Novo, Novo's Wegovy, Lawrence Tabak, John Driscoll, Tabak, Driscoll, Walgreens, Julie Steenhuuysen, Caroline Stauffer, Deena Beasley, Jamie Freed Organizations: REUTERS, Rights, Reuters, Total Health, U.S . Food, Drug Administration, U.S . National Institutes of Health, Walgreens, Walgreens Boots Alliance, Thomson Locations: Oslo, Norway, August31, Victoria, Chicago, U.S, satiety

☆ Amgen sales rise, but shares off as investors await obesity data
▼ + stars: | 2023-10-31 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

Third quarter sales of Horizon's gout drug Krystexxa rose to $253 million from $192 million. Amgen raised its post-acquisition forecast for full-year sales to between $28 billion and $28.4 billion from a previous estimate of $26.6 billion to $27.4 billion. Total revenue for the quarter rose 4% to $6.9 billion, in line with analyst expectations. Sales of cancer drug Lumakras fell 31% to $52 million and sales of psoriasis drug Otezla fell 10% to $567 million. Sales of Amjevita, Amgen's new biosimilar version of AbbVie's (ABBV.N) blockbuster arthritis drug Humira, rose 30% to $152 million.

Persons: Robert Galbraith, Amgen, Jefferies, Michael Yee, Bill Smead, Tepezza, We're, we've, Peter Griffith, AMG340, William Blair, Matt Phipps, Lumakras, Otezla, Deena Beasley, Leroy Leo, Bill Berkrot Organizations: REUTERS, Horizon Therapeutics, Smead Capital Management, Wall Street, U.S . Federal Trade Commission, Thomson Locations: South San Francisco , California, California, Los Angeles, Bengaluru

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS/File Photo Acquire Licensing RightsBOSTON, Oct 25 (Reuters) - An injected version of Eisai (4523.T) and Biogen's (BIIB.O) Alzheimer's drug Leqembi works as well as the current intravenous version at removing toxic brain plaques, according to an analysis presented by Eisai on Wednesday. The Japanese drugmaker's review compared data for 72 patients with early Alzheimer's given Leqembi by subcutaneous injection to prior pivotal trial results from 898 patients who received the drug by infusion. Blood concentration levels of the drug were 11% higher with subcutaneous Leqembi than the IV version. Roll-out of IV Leqembi, which has an annual list price of $26,500, has been slow.

Persons: Eisai, Leqembi, ”, Eric Reiman, Priya Singhal, Biogen, Michael Irizarry, Alzheimer's, Julie Steenhuysen, Deena Beasley, Bill Berkrot, Leslie Adler Organizations: Reuters, REUTERS, Rights, Banner Alzheimer's Institute, ARIA, Thomson Locations: Handout, Boston, Los Angeles

☆ Blood tests needed for widespread Alzheimer's diagnosis on the way
▼ + stars: | 2023-10-11 | by ( Deena Beasley | ) www.reuters.com time to read: +6 min

Several Alzheimer's blood tests are in the works – and one is already being sold to consumers – but none have been established as accurate, formally approved by regulators or reimbursed by insurers. Researchers have been working for years on blood tests for Alzheimer's that can replicate these diagnostic tools. The need for blood tests has become more pressing since the FDA approved Leqembi in July. Accurate blood tests are expected to help identify which dementia patients actually have Alzheimer’s, the most common but not the only cause of dementia. "When there are widely available, scalable, sensitive and specific blood tests it will be an absolute game changer for Alzheimer's patients."

Persons: Denis Balibouse, Eli Lilly, Dr, Sarah Kremen, Eliezer Masliah, Eisai, Michael Irizarry, Roche, Bruce Jordan, Russ Paulsen, Deena Beasley, Caroline Humer, Bill Berkrot Organizations: Memory Centre, of Readaptation, University Hospital, REUTERS, FDA, Sinai Medical Center, Wednesday, Quest Diagnostics, National Institute, Aging, U.S . National Institutes of Health, C2N Diagnostics, Roche Diagnostics, Alzheimer's Association, RAND, Thomson Locations: Geneva, Switzerland, Leqembi, Eisai, Los Angeles, U.S

Nicknamed "Pirola" on social media, the BA.2.86 Omicron subvariant is being tracked by both the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC). As of Aug. 30, CDC said the BA.2.86 variant was detected in at least four U.S. states in people or wastewater. Delaware on Tuesday said it had detected a BA.2.86 infection at a hospital. Moderna on Wednesday said clinical data showed that its retooled COVID vaccine generated a nearly 9-fold increase in human antibodies that can neutralize BA.2.86. Pfizer said on Wednesday that its updated COVID shot showed neutralizing activity against BA.2.86 and EG.5 in studies conducted on mice.

Persons: Emily Elconin, David Dowdy, Dowdy, Dan Barouch, David Ho, Deena Beasley, Julie Steenhuysen, Bill Berkrot Organizations: REUTERS, Moderna, Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, CDC, EG, Omicron, East, Johns Hopkins Bloomberg School of Public Health, Center, Virology, Vaccine, Beth Israel Deaconess Medical, Columbia University, U.S . Food, Drug Administration, Thomson Locations: Waterford , Michigan, U.S, Europe, Asia, Delaware, East Coast, Boston, Sweden, China

☆ Analysis: FTC settlement could shelter Amgen from US price cuts, taxes
▼ + stars: | 2023-09-05 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. With Horizon, Amgen acquires drugs that won't be affected by new U.S. negotiation requirements for blockbuster medications as well as possible tax advantages stemming from Horizon's headquarters in Ireland. Analysts said the Horizon deal could also help Amgen's tax situation. The United States has largely eliminated once-lucrative corporate tax benefits for pharmaceutical manufacturing operations in Puerto Rico, a U.S. territory. Horizon offers Amgen "potentially a better tax jurisdiction related to Irish manufacturing plants ... Amgen has a new manufacturing process they could potentially move there," Cowen's Werber said.

Persons: Robert Galbraith, Abiel Garcia, John Kness, Donald Trump, Garcia, Evan Seigerman, Lina Khan, Cowen, Biden, Michael Yee, Amgen, Cowen's Werber, Deena Beasley, Peter Henderson, Paul Simao Organizations: REUTERS, U.S . Federal Trade, Horizon Therapeutics, U.S, District, Federal, Activision, Horizon, Amgen, BMO Capital Markets, FTC, Reuters, U.S . Food, Drug Administration, Jefferies, Medicare, Internal Revenue Service, United, Thomson Locations: South San Francisco , California, Amgen, Kesselman, Ireland, U.S, Puerto Rico, United States, Irish

Scientists are keeping an eye on the new lineage, named BA.2.86, because it has 36 mutations that distinguish it from the currently-dominant XBB.1.5 variant. So far there is no evidence that BA.2.86 spreads faster or causes more serious illness than previous versions. COVID infections and hospitalizations have been rising in the U.S., Europe and Asia, with more cases in recent months attributed to the EG.5 "Eris" subvariant, a descendant of the Omicron lineage that originally emerged in November 2021. But many countries have drastically reduced testing of patients and their efforts to analyze the genomes of the viruses causing new COVID cases. Updated COVID booster shots now being developed have been designed to target the Omicron subvariant XBB.1.5.

Persons: Emily Elconin, Wesley Long, Eric Topol, Topol, Long, Moderna, Eris, Deena Beasley, Nancy Lapid, David Gregorio Our Organizations: REUTERS, Moderna Inc, Pfizer, World Health Organization, U.S . Centers for Disease Control, CDC, EG, Omicron, Houston Methodist Hospital, Scripps Research, COVID, U.S, Pfizer Inc, Thomson Locations: Waterford , Michigan, U.S, Europe, Asia, United States, Israel, Denmark, La Jolla , California

☆ US CDC tracks new lineage of virus that causes COVID
▼ + stars: | 2023-08-18 | by ( Deena Beasley | ) www.reuters.com time to read: +2 min

The lineage is named BA.2.86, and has been detected in the United States, Denmark and Israel, the CDC said in a post on messaging platform X. "As we learn more about BA.2.86, CDC's advice on protecting yourself from COVID-19 remains the same," the agency said. The WHO said that, so far, only a few sequences of the variant have been reported from a handful of countries. The new lineage, which has 36 mutations from the currently-dominant XXB.1.5 COVID variant "harkens back to an earlier branch" of the virus, explained Dr. S. Wesley Long, medical director of diagnostic microbiology at Houston Methodist. https://slides.com/jbloom/new_2nd_gen_ba2_variant?ftag=YHF4eb9d17#/12The Omicron subvariant XBB.1.5 is the strain targeted by vaccines in upcoming COVID booster shots.

Persons: Wesley Long, Jesse Bloom, Fred Hutch, Dr, Long, Shivani Tanna, Himani Sarkar, Simon Cameron, Moore Organizations: Science, Trinity College, Reuters, U.S . Centers for Disease Control, CDC, World Health Organization, WHO, Houston Methodist, Fred Hutch Cancer Center, Thomson Locations: Dublin, Wuhan, United States, Denmark, Israel, Bengaluru

☆ Insight: What happens when a $2 million gene therapy is not enough
▼ + stars: | 2023-08-12 | by ( Deena Beasley | ) www.reuters.com time to read: +13 min

Their experience raises broader questions around other high-cost gene therapies coming to market, sometimes after accelerated regulatory approvals, drug pricing experts said. Gene therapies work by replacing genes – the body's blueprint for its development. The gene Zolgensma delivers instructs the body to make a protein vital for muscle control. If gene therapies do fall short, it becomes harder to justify prices that researchers have argued are already poor value. More recently, the first hemophilia gene therapy approved by the U.S. Food and Drug Administration was priced by CSL Behring at $3.5 million; 26 more gene therapies are in late-stage development, according to IQVIA.

Persons: Elizabeth Kutschke, Ben, Zolgensma, Ben Kutschke, neurologists, Sitra Tauscher, Wisniewski, Ben's, Roger Hajjar, Brigham Gene, Kutschke, Vasant Narasimhan, Stacie Dusetzina, Roche's, Biogen, Roche, Maha Radhakrishnan, Steven Pearson, It's, Sree Chaguturu, Amanda Cook, Weston, Jackson, Cook, Elizabeth, Jerry Mendell, Russell Butterfield, –, Biogen's, Mendell, UMR, Spinraza, Eric Cox, Caroline Humer, Sara Ledwith Organizations: Reuters, U.S, Novartis, IQVIA Institute, Human Data, Novartis Gene Therapies, Mass, Cell Therapy, U.S . Food, Drug Administration, CSL Behring, CSL, Nashville's Vanderbilt University School of Medicine, Clinical, Economic, CVS Health, Aetna, SMA, Nationwide Children's Hospital, University of Utah Health, Children's, UnitedHealth, Thomson Locations: Oak Park, Berwyn , Illinois, Swiss, U.S, Lebanon , Virginia, United States, Columbus , Ohio, Russia, Kazakhstan, Chicago

☆ Gilead quarterly profit falls on COVID sales drop, legal settlement charge
▼ + stars: | 2023-08-03 | by ( ) www.reuters.com time to read: +2 min

[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

☆ Lilly drug slows Alzheimer's by 60% for mildly impaired patients in trial
▼ + stars: | 2023-07-17 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

Lilly expects the U.S. Food and Drug Administration to decide by the end of this year whether to approve donanemab. The company had previously reported that 24% of the overall donanemab treatment group had brain swelling. The deaths of three trial patients were linked to the treatment, researchers reported. For high tau patients, donanemab was shown to slow disease progression by about 17%, while the benefit was 35% for those with low-to-intermediate tau levels. Both medications are also being studied in large trials to see if they have an impact on delaying onset of Alzheimer's disease symptoms.

Persons: Seth Gale, Brian Snyder, Eli Lilly, Anne White, Lilly, Susan Kohlhaas, Liana Apostolova, White, Liz Coulthard, donanemab, Deena Beasley, Ludwig Burger, Will Dunham, Bill Berkrot, Caroline Humer Organizations: Alzheimer Research, Brigham, Women’s, REUTERS, Alzheimer's Association International, U.S . Food, Drug Administration, Alzheimer’s Research, Indiana University School of Medicine, Doctors, University of Bristol, JAMA, FDA, Alzheimer's Association, Health Organization, New York Stock Exchange, Thomson Locations: Boston , Massachusetts, U.S, Amsterdam, Eisai

Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Persons: Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis Organizations: U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson Locations: ANGELES, U.S, Los Angeles, Chicago

☆ 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

☆ Analysis: Weight loss drug candidates multiply, spurring hopes of better outcomes, lower costs
▼ + stars: | 2023-06-27 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

More than 40% of Americans are obese, according to the U.S. Centers for Disease Control and Prevention, and demand is strong for treatments to reduce body weight as well as maintain weight loss. The company said it would continue to develop its twice-daily weight loss drug candidate. Structure Therapeutics (GPCR.O) is developing oral obesity drugs that it says are simpler to manufacture than the current injectables. "We define weight loss quality as the percentage of weight loss attributed to fat loss," said Versanis Chief Scientific Officer Lloyd Klickstein. "With diets, bariatric surgery, incretin drugs or other weight loss drugs, two-thirds to three-quarters of the weight loss is fat, but one-quarter to one-third is lean."

Persons: Robert Gabbay, Eli Lilly, Lilly's, Wegovy, Mico Guevarra, Lilly, Jeff Emmick, Ray Stevens, Boehringer Ingelheim, Versanis, Lloyd Klickstein, Chaguturu, Deena Beasley, Michele Gershberg, Jamie Freed Organizations: DIEGO, Novo Nordisk's, American Diabetes Association, Novo, U.S . Centers for Disease Control, ADA, Pfizer, Therapeutics, Zealand Pharma, Novartis, CVS Health, Aetna, Thomson Locations: San Diego, GLP

☆ Novo Nordisk says obesity pill leads to 15% weight loss; availability "to be determined"
▼ + stars: | 2023-06-26 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

Novo plans to seek U.S. Food and Drug Administration approval of the high-dose pill later this year, but timing of a market launch is "to be determined," according to Mico Guevarra, medical director at Novo Nordisk. Novo Nordisk already markets an oral semaglutide, under the brand name Rybelsus, for treatment of type 2 diabetes, but its highest dose is 14mg. Oral semaglutide, according to the FDA label, needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking, or using any other oral medication - you are allowed only 4 ounces of plain water. If you eat too soon, the pill is less effective, but if you wait longer than 30 minutes its absorption may be enhanced. read moreNovo Nordisk said most patients in its obesity trial reported gastrointestinal side effects from oral semaglutide, including mostly mild-to-moderate nausea, constipation, diarrhea and vomiting.

Persons: semaglutide, Mico, Guevarra, Eli Lilly, LLY.N, Deena Beasley, Diane Craft Organizations: DIEGO, Nordisk, Food, Drug, Novo Nordisk, American Diabetes Association, FDA, Thomson Locations: Danish

☆ Lilly experimental 'triple G' obesity drug leads to 24.2% weight loss in trial
▼ + stars: | 2023-06-26 | by ( Deena Beasley | ) www.reuters.com time to read: +2 min

Companies Eli Lilly and Co FollowJune 26 (Reuters) - Eli Lilly (LLY.N) on Monday said a mid-stage trial of its next-generation obesity drug candidate "triple G" showed that it led to weight loss of up to 24.2% after 48 weeks, surpassing results seen with other weight loss drugs. Lilly's Mounjaro, which is awaiting U.S. regulatory approval for treatment of obesity, targets GLP-1 as well as a second obesity-related hormone called GIP. Retatrutide targets GLP-1, GIP and the body's receptors for a third hormone, glucagon. Given the three targets, Lilly has nicknamed the drug triple G.The company reported last year that a trial of Mounjaro in people who were obese or overweight found it led to weight loss of 22.5% after 72 weeks. Lilly is conducting longer-duration phase 3 trials of retatrutide to see if weight loss might be further improved.

Persons: Eli Lilly, Lilly's, Lilly, ” Dan Skovronsky, Deena Beasley, Deepa Babington, Cynthia Osterman Organizations: American Diabetes Association, New England, of Medicine, Thomson Locations: San Diego

☆ After weight loss, Alzheimer's may be next frontier for drugs like Ozempic
▼ + stars: | 2023-05-08 | by ( Natalie Grover | ) www.reuters.com time to read: +6 min

LONDON, May 8 (Reuters) - Diabetes drugs that also promote weight loss such as Novo Nordisk’s (NOVOb.CO) Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer’s disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs. She said she has since been approached by pharmaceutical companies at an increasing pace, and is currently running an Alzheimer’s trial evaluating intranasal insulin in combination with another diabetes drug. Four companies with GLP-1 drugs, including two larger drugmakers, say they are watching for results of trials testing Novo's drug in Alzheimer's. Dementia affects more than 55 million people globally and the market for Alzheimer’s drugs is expected to grow to $9.4 billion by 2028 and for Parkinson’s to $6.6 billion, according to pharmaceutical data provider Citeline.

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."

☆ Analysis: Twitter's advertising business seen facing slow recovery
▼ + stars: | 2023-04-13 | by ( Sheila Dang | ) www.reuters.com time to read: +5 min

Musk, who also runs electric carmaker Tesla Inc (TSLA.O), earlier this week told the BBC that most of Twitter's advertisers are returning to the platform and the business was "roughly breaking even." Research firm Insider Intelligence this week slashed its forecast for Twitter's global ad revenue this year by 37% to $2.98 billion. That would represent a 28% decline from Twitter's 2022 ad revenue of $4.14 billion. 33 among Twitter's top advertisers before Musk's acquisition, according to Sensor Tower. Twitter's ad business is "eroding" and its subscription product Twitter Blue is seeing only moderate success, Similarweb said in a blog post.

☆ Lilly says experimental Alzheimer's drug reduces amyloid in small study
▼ + stars: | 2023-03-31 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

The higher the dose of the antibody drug, which was given by subcutaneous injection, the larger the effect, Lilly said. The Indianapolis-based drugmaker is launching a Phase III study of the experimental antibody, remternetug, but declined to comment on which doses will be selected for larger, later-stage trials. Lilly, at a medical conference in Gothenburg, Sweden, presented interim data from 41 study participants. Trial results published last year showed that, in patients with early Alzheimer's, Leqembi reduced the rate of cognitive decline by 27% compared with a placebo. Brooks said that sharing its early remternetug data "reinforces Lilly's commitment and investment in the Alzheimer's disease space ...

☆ Amgen to cut 450 jobs in second round of layoffs this year
▼ + stars: | 2023-03-17 | by ( ) www.reuters.com time to read: +1 min

March 16 (Reuters) - Amgen Inc (AMGN.O) said on Thursday it would cut 450 jobs, or less than 2% of its workforce, making it the company's second round of layoffs this year amid intensifying pressure on drug prices and high inflation. "We made these changes to realign our expense base in the face of intensifying pressure on drug prices and high levels of inflation," a company spokeswoman said in a statement to Reuters. Layoffs by U.S. companies over January and February this year touched the highest since 2009, a report showed. The biotech company forecasted 2023 revenue in a range of $26 billion to $27.2 billion, while analysts had estimated $27.17 billion. Reporting by Akanksha Khushi and Deena Beasley; Editing by Rashmi Aich and Subhranshu SahuOur Standards: The Thomson Reuters Trust Principles.

☆ Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug
▼ + stars: | 2023-01-19 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

REUTERS/Mike SegarJan 19 (Reuters) - Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year. That study, Lilly said, would form the basis of donanemab's application for traditional FDA approval shortly thereafter. The FDA can grant "accelerated" approval to drugs based on their impact on a measurement, in this case amyloid brain plaques, likely to correlate with patient response. Donanemab is in the same class as aducanumab and lecanemab, the latter being a treatment for early Alzheimer's that was given accelerated approval by the FDA earlier this month. Sales of amyloid-lowering Alzheimer's drugs, which need to be given by infusion, are expected to be minimal until they receive standard FDA approval.

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