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☆ Pfizer raises sales estimates for COVID vaccine by $2 billion
▼ + stars: | 2022-11-01 | by ( ) www.reuters.com time to read: +2 min

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised full-year estimates for sales of its COVID-19 vaccine by $2 billion to $34 billion, encouraged by demand for its new Omicron-focused booster shots. The company maintained its full-year sales forecast for COVID-19 pill Paxlovid at $22 billion. The company reported third-quarter sales of $22.60 billion, beating analysts' estimates of $21.04 billion, according to IBES data from Refinitiv. Third-quarter sales of the COVID-19 vaccine, which Pfizer sells with BioNTech , came in at $4.40 billion, blowing past estimates of $2.60 billion, according to five analysts polled by Refinitiv. However, Paxlovid, the company's pill to reduce the risk of severe COVID-19, brought in sales of $7.51 billion, missing estimates of $7.66 billion.

☆ Eli Lilly's growth tied to nascent diabetes drug sales
▼ + stars: | 2022-10-31 | by ( ) www.reuters.com time to read: +2 min

Oct 31 (Reuters) - Wall Street analysts will be focusing on sales of Eli Lilly and Co's (LLY.N) newly approved diabetes drug Mounjaro when the company reports results on Tuesday, as sales of its older drugs come under pressure from increased competition and low pricing. The company's sales could quickly jump once Lilly gets more insurers to cover its costs, according to Risinger. Analysts expect Mounjaro sales of $81 million in the third quarter, months into its U.S. launch, according to Refinitiv data. Lilly's sales are expected to increase to $30.23 billion in 2023, versus reported sales of $24.54 billion in 2021, with Mounjaro expected to bring in $1.34 billion in sales and become the company's third-biggest selling drug, according to Refinitiv data. Growth from older drugs such as Humalog and Alimta has slowed downTHE FUNDAMENTALS** Q3 sales expected to grow 1.8% to $6.89 billion.

☆ Tuberculosis deaths rose during pandemic, reversing years of decline, WHO says
▼ + stars: | 2022-10-27 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

Oct 27 (Reuters) - Global deaths from tuberculosis are estimated to have increased between 2019 and 2021, reversing years of decline as the COVID-19 pandemic severely derailed efforts to tackle the disease, the World Health Organization said on Thursday. Global efforts to tackle deadly diseases such as AIDS, tuberculosis and malaria have suffered during the COVID-19 pandemic. WHO urged the world to apply lessons learnt from the pandemic to tuberculosis, which severely affects countries such as India, Indonesia, the Philippines and Pakistan. WHO’s annual TB report estimates that tuberculosis killed 1.6 million people in 2021, above the estimated 1.5 million deaths in 2020, and 1.4 million deaths in 2019. Under its "End TB Strategy", the WHO set a target of reducing TB deaths by 35% from 2015 to 2020, but the net reduction was 5.9% between 2015 and 2021.

Oct 25 (Reuters) - Biogen Inc (BIIB.O) on Tuesday said the Alzheimer's disease drug it is developing with Japan's Eisai Co Ltd (4523.T) would be used by doctors in a competitive market as investors wait for data from rival therapies made by Eli Lilly and Co (LLY.N) and Roche (ROG.S). The drug, lecanemab was shown to slow the progress of the disease by 27% in a trial last month, and additional data is expected next month. "The data needs to be seen from the other anti-amyloid therapies before we decide what is going to be meaningful," said Biogen interim research chief Priya Singhal. Its costs were about halved as the company significantly cut back on commercial infrastructure around the launch of Aduhelm, its previous Alzheimer's drug that has sputtered amid controversy over efficacy and lack of coverage by health insurers. read moreInvestors have been pinning hopes on the Alzheimer's drug as cheaper generics of Biogen's multiple sclerosis treatment Tecfidera have entered the market, hurting sales.

☆ Biogen raises full-year profit forecast on cost control
▼ + stars: | 2022-10-25 | by ( ) www.reuters.com time to read: +1 min

Oct 25 (Reuters) - Biogen Inc (BIIB.O) on Tuesday raised its full-year profit forecast for the second straight quarter, driven by its efforts to cut costs, while investors awaited more data on its new Alzheimer's disease drug next month. The focus of investors as well as Wall Street is squarely on Biogen and Eisai Co Ltd's (4523.T) new drug lecanemab that slowed the progress of the disease by 27% in a trial last month. read moreThe company raised its full-year adjusted earnings per share forecast to between $16.50 and $17.15 from $15.25 to $16.75 previously. Investors have been pinning hopes on the new Alzheimer's disease drug as Biogen faces multiple setbacks including competition for blockbuster drug Tecfidera and a failed launch of Aduhelm, its earlier Alzheimer's drug. Register now for FREE unlimited access to Reuters.com RegisterReporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.

☆ Biogen sales fall 9.7% on Tecifdera competition
▼ + stars: | 2022-10-25 | by ( ) www.reuters.com time to read: 1 min

Oct 25 (Reuters) - Biogen Inc (BIIB.O) reported a 9.7% drop in quarterly sales on Tuesday due to rising competition for its blockbuster multiple sclerosis drug Tecfidera, while investors awaited more data on its new Alzheimer's disease drug next month. The focus of investors as well as Wall Street is squarely on Biogen and Eisai Co Ltd's (4523.T) new drug lecanemab that slowed progress of the disease by 27% in a trial last month. read moreRegister now for FREE unlimited access to Reuters.com RegisterReporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.

☆ Johnson & Johnson's blood cancer therapy gets U.S. FDA approval
▼ + stars: | 2022-10-25 | by ( Khushi Mandowara | ) www.reuters.com time to read: +2 min

Oct 25 (Reuters) - The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's (JNJ.N) therapy for treating a type of multiple myeloma, the company said on Tuesday, giving another treatment option to patients with the incurable blood cancer. Tecvayli is a bispecific antibody, which is engineered to redirect body's immune system to recognize and kill cancer cells. It is the first drug of its class to be approved for multiple myeloma. Though multiple myeloma is rare compared to breast or prostate cancer, it is a common type of blood cancer, which develops in the bone marrow and can spread throughout the body. According to the American Cancer Society's estimates, close to 35,000 new cases of multiple myeloma are likely to be diagnosed in the United States this year.

☆ COVID variants BQ.1, BQ 1.1 make up 16.6% of U.S. cases - CDC
▼ + stars: | 2022-10-21 | by ( ) www.reuters.com time to read: +2 min

The variants have spread quickly in the country in the last few weeks, particularly in New York. The CDC said on Friday that BQ.1 last week was estimated to make up 5.8% of circulating variants, while BQ.1.1 had made up 3.6% of all variants. New variants are monitored closely by regulators and vaccine manufacturers in case they start to evade protection offered by current shots. The World Health Organization this week said BQ.1.1 is circulating in at least 29 countries. The BA.5 variant is estimated to made up 62.2% of cases for the week of Oct 22, down from 70.2% in the week of Oct 15.

REUTERS/Dado Ruvic/Illustration/File PhotoOct 21 (Reuters) - U.S. health regulators on Friday estimated that BQ.1 and closely related BQ.1.1 accounted for 16.6% of coronavirus variants in the country, nearly doubling from last week, while Europe expects them to become the dominant variants in a month. The two variants are descendants of Omicron's BA.5 subvariant, which is the dominant form of the coronavirus in the United States. New variants are monitored closely by regulators and vaccine manufacturers in case they start to evade protection offered by current shots. The World Health Organization this week said BQ.1.1 is circulating in at least 29 countries. The U.S. CDC said on Friday BQ.1 and BQ.1.1 last week were estimated to make up 9.4% of circulating variants.

☆ U.S. DoJ seeks more details on $8 bln CVS-Signify Health deal
▼ + stars: | 2022-10-20 | by ( ) www.reuters.com time to read: 1 min

Oct 20 (Reuters) - The U.S. Department of Justice (DoJ) has asked for more details on CVS Health Corp's (CVS.N) proposed $8 billion deal to buy Signify Health (SGFY.N), the pharmacy chain operator said on Thursday. The deal, announced last month, was expected to face a tough antitrust review even though the two companies do not compete directly in any market, according to experts. read moreThe acquisition will enable CVS, one of the largest U.S. healthcare companies, to provide further care management to patients in their homes. The deal is still expected to close in the first half of 2023, CVS said in a filing. Register now for FREE unlimited access to Reuters.com RegisterReporting by Manas Mishra in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Moderna says Omicron booster response stays high through 3 months
▼ + stars: | 2022-10-19 | by ( ) www.reuters.com time to read: +1 min

Oct 19 (Reuters) - Moderna Inc (MRNA.O) said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months. Omicron-tailored shots by Pfizer Inc (PFE.N) and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron. "Clinical trial data now indicates that the superior immune response produced by our bivalent booster has durability for at least three months," Moderna Chief Executive Officer Stephane Bancel said in a statement. Moderna said it expects data from human trials of its BA.4/BA.5 targeted vaccine later this year.

☆ WHO says COVID-19 is still a global health emergency
▼ + stars: | 2022-10-19 | by ( Nancy Lapid | ) www.reuters.com time to read: +1 min

Oct 19 (Reuters) - The World Health Organization said on Wednesday that COVID-19 remains a global emergency, nearly three years after it was first declared as one. The WHO's emergency committee first made the declaration for COVID-19 on Jan 30, 2020. Such a determination can help accelerate research, funding and international public health measures to contain a disease. "This pandemic has surprised us before and very well may again," WHO Director-General Tedros Adhanom Ghebreyesus told reporters. Register now for FREE unlimited access to Reuters.com RegisterReporting by Manas Mishra in Bengaluru and Jennifer Rigby in London; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ J&J beats estimates on demand for cancer drug
▼ + stars: | 2022-10-18 | by ( Nancy Lapid | ) www.reuters.com time to read: +2 min

Oct 18 (Reuters) - Johnson & Johnson (JNJ.N) on Tuesday beat Wall Street estimates for quarterly revenue and profit on strong demand for its cancer drug Darzalex and Crohn's disease drug Stelara while projecting an easing of the hit from surging inflation. The company, which also sells medical devices and consumer health products such as Band Aids and painkiller Tylenol, tightened its full-year adjusted profit forecast range. J&J is the first drugmaker and medical devices firm to report third-quarter earnings and its shares rose 2.1% to $170.02 in premarket trading. The medical devices unit reported a 2.1% rise in sales to $6.78 billion on demand for contact lenses and wound-closure products. Total sales for the third-quarter rose 1.9% to $23.79 billion, topping estimates of $23.34 billion, according to Refinitiv IBES data.

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Companies Cigna Corp FollowNEW YORK, Oct 17 (Reuters) - U.S. prosecutors in Manhattan said on Monday they have filed a civil lawsuit against Cigna Corp (CI.N) accusing the health insurer of overcharging the government's Medicare Advantage program by making it appear patients were more ill than they actually were. Medicare Advantage is a program in which private insurers provide coverage to patients who opt out of the traditional Medicare program. Cigna this month announced it would expand its Medicare Advantage Plan next year. The two cases are among several Justice Department civil lawsuits against companies participating in Medicare Advantage. Enrollment in Medicare Advantage has doubled since 2013 to about 28.7 million, or approximately 49% of all eligible Medicare beneficiaries, government watchdog MedPac said in July.

☆ Abbott recalls some liquid baby formula over bottle defect
▼ + stars: | 2022-10-14 | by ( ) www.reuters.com time to read: +1 min

Oct 14 (Reuters) - Abbott Laboratories (ABT.N) said on Friday it was recalling some ready-to-feed baby formula liquid products including Similac-branded items due to inadequate sealing of some bottle caps. The recall, which equates to less than one day's worth of infant formula used in the United States, is not expected to impact the overall formula supply, Abbott said in a statement. Abbott has been at the center of a baby formula shortage in the United States that earlier this year sent parent scrambling for supplies. Register now for FREE unlimited access to Reuters.com RegisterThe recall of baby formula made at Abbott's Michigan plant following complaints of bacterial infection in February exacerbated its shortage in the United States. Shares in Abbott, which is recalling products made at the company's plant in Columbus, Ohio, were down 1.1% at $101.39 in afternoon trading.

Oct 13 (Reuters) - Pfizer (PFE.N) and its German partner BioNTech said their COVID-19 vaccine booster, adapted for the BA.4 and the BA.5 subvariants of Omicron, generated a strong immune response and was well-tolerated in testing on humans. With the results, which the companies described as consistent with preclinical data, the partners are following up with human trial data that had previously been missing from their successful filings for regulatory approval. Register now for FREE unlimited access to Reuters.com RegisterThey did not disclose the levels of antibodies generated in the preliminary analysis of the study. Healthcare regulators for the European Union and the United States had already approved the upgraded shot last month, even though trial data from testing on humans had at the time not been available. “While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults," said Pfizer Chief Executive Albert Bourla.

☆ U.S. authorizes updated COVID booster shots for children as young as 5
▼ + stars: | 2022-10-12 | by ( ) www.reuters.com time to read: +2 min

Oct 12 (Reuters) - U.S. health regulators authorized the use of Omicron-tailored COVID-19 booster shots from Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N) in children as young as 5, a move that will expand the government's fall vaccination campaign. The U.S. Food and Drug Administration on Wednesday green-lighted Moderna's bivalent vaccine for those aged six and above, while Pfizer's updated shot was authorized in children aged five and above. The U.S. Centers for Disease Control and Prevention also backed the FDA's authorization, clearing the way for the shots to be administered in children. Overall, COVID-19 vaccination rates in the United States have stayed low among kids, with nearly 40% of children aged 5-11 vaccinated with one dose of a vaccine so far. Around 11.5 million people received the updated shots over the first five weeks of the rollout last month, which represents just 5.4% of the people aged 12 or older who are eligible to receive them.

☆ Merck opts to develop, sell cancer vaccine with Moderna
▼ + stars: | 2022-10-12 | by ( ) www.reuters.com time to read: +1 min

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File PhotoOct 12 (Reuters) - Merck & Co Inc (MRK.N) opted to jointly develop and potentially sell a personalized mRNA vaccine with Moderna Inc (MRNA.O) for a $250 million upfront payment on Wednesday, sending the vaccine maker's shares up over 8%. In 2016, Merck and Moderna entered a strategic partnership to develop a personalized vaccine for treatment of various types of cancer. Merck in 2020 sold its equity investment in Moderna, benefiting from a surge in the vaccine-maker's stock price that year. Register now for FREE unlimited access to Reuters.com RegisterReporting by Manas Mishra and Khushi Mandowara in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Europe likely entering another COVID wave, says WHO and ECDC
▼ + stars: | 2022-10-12 | by ( ) www.reuters.com time to read: +1 min

Oct 12 (Reuters) - Another wave of COVID-19 infections may have begun in Europe as cases begin to tick up across the region, the World Health Organization and European Centre for Disease Prevention and Control (ECDC) said on Wednesday. "We are unfortunately seeing indicators rising again in Europe, suggesting that another wave of infections has begun." Public health experts have warned that vaccine fatigue and confusion over available vaccines will likely limit booster uptake in the region. read moreMillions of people across Europe remain unvaccinated against COVID-19, the WHO and ECDC noted. They urged European countries to administer both flu and COVID-19 vaccines ahead of an expected surge in cases of seasonal influenza.

☆ Factbox: U.S. companies brace for Hurricane Ian
▼ + stars: | 2022-09-28 | by ( ) www.reuters.com time to read: +5 min

Sept 28 (Reuters) - Hurricane Ian is set to make landfall in Florida on Wednesday, pushing residents to empty grocery shelves, board up windows and rush to evacuation shelters. Since then, it has been working to redeploy offshore personnel after determining Hurricane Ian no longer posed a significant threat to its assets. NextEra Energy Inc's (NEE.N) Florida Power & Light Co, the largest utility in the state, deployed nearly 16,000 workers from 27 states to restore power. A spokesperson said the company was monitoring the hurricane and making adjustments to operations to keep warehouse staff and drivers safe. CRUISE OPERATORSWalt Disney Co's Disney Cruise Line on Tuesday canceled its Disney Wish ship that was to set sail from Florida on Friday.

The trial results released on late Tuesday could mark a rare victory in the search for a treatment for the memory-robbing disease after years of clinical failures. Biogen's stock surged 46.6% to $290.99 in premarket trading, putting it on track to add over $13.5 billion in market capitalization. BMO analyst Evan Seigerman called the data an "unequivocal win" for Biogen and Alzheimer's patients. The latest trial boost for Biogen and Eisai's lecanemab has raised hope for success in trials testing Roche's gantenerumab and Lilly's donanemab. Shares of smaller Alzheimer's drug developers also rose in premarket U.S. trading.

☆ Factbox: U.S. companies gird themselves as Hurricane Ian makes landfall
▼ + stars: | 2022-09-28 | by ( ) www.reuters.com time to read: +6 min

Sept 28 (Reuters) - Hurricane Ian makes landfall in Florida with Category 4 fury on Wednesday, pushing residents to empty grocery shelves, board up windows and rush to evacuation shelters. Since then, it has been working to redeploy offshore personnel after determining Hurricane Ian no longer posed a significant threat to its assets. A spokesperson said the company was monitoring the hurricane and making adjustments to operations to keep warehouse staff and drivers safe. Costco Wholesale Corp closed nine stores located in Florida due to an impact of Hurricane Ian. CRUISE OPERATORSWalt Disney Co's Disney Cruise Line on Tuesday canceled its Disney Wish ship that was to set sail from Florida on Friday.

☆ U.S. rollout of new COVID boosters off to slow start
▼ + stars: | 2022-09-23 | by ( ) www.reuters.com time to read: +3 min

A nurse fills up syringes with the coronavirus disease (COVID-19) vaccines for residents who are over 50 years old and immunocompromised and are eligible to receive their second booster shots in Waterford, Michigan, U.S., April 8, 2022. The government said earlier this week it has shipped 25 million of the Omicron-tailored shots, mostly from Pfizer (PFE.N)/BioNTech (22UAy.DE). Last year, when the United States initially authorized COVID boosters just for older and immunocompromised people, nearly 10 million received their third shot in the first three weeks. The updated shots target the widely circulating BA.4 and BA.5 Omicron subvariants as well as the original version of the coronavirus included in all previous COVID vaccines. Moderna had been producing new boosters aimed at the older BA.1 Omicron subvariant when the FDA asked them to change course to address the currently dominant variants for the U.S. market.

☆ U.S. CDC expects Omicron COVID boosters for kids by mid-October
▼ + stars: | 2022-09-21 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Hannah BeierSept 21 (Reuters) - The U.S. Centers for Disease Control and Prevention expects COVID-19 vaccine boosters targeting circulating variants of the virus to be available for children aged 5-11 years by mid-October. Register now for FREE unlimited access to Reuters.com RegisterThe CDC said it expects Pfizer-BioNTech's (PFE.N), bivalent vaccine to be available for children aged 5-11 years, and Moderna's (MRNA.O) vaccine for those aged 6-17 years, pending FDA authorization. The Pfizer vaccine is already authorized as a booster dose for children over 12 years of age, while Moderna's bivalent vaccine is authorized for adults. The CDC expects pre-orders for the Pfizer shot to begin for the age group next week. The Moderna vaccine will have the same formulation for children and adults and will not require a separate pre-order period, the CDC said.

☆ Merck to start studying lower dose of HIV drug after FDA hold
▼ + stars: | 2022-09-20 | by ( ) www.reuters.com time to read: +1 min

Register now for FREE unlimited access to Reuters.com RegisterThe Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. The FDA has reviewed and agreed with the plan to study lower-dose versions of the once-daily pillfor treating HIV patients, the company said. The drugmaker, however, said it was discontinuing development of a once-a-month dose of islatravir for preventing HIV infection. Some studies using a higher-dose version of islatravir remain under clinical hold. Register now for FREE unlimited access to Reuters.com RegisterReporting by Manas Mishra and Khushi Mandowara in Bengaluru; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

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