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☆ Moderna says personalized mRNA cancer vaccine is effective for advanced melanoma
▼ + stars: | 2022-12-13 | by ( The Associated Press | ) www.nbcnews.com time to read: +2 min

The company said a possible melanoma vaccine it is studying with pharmaceutical giant Merck fared well in a small study of patients who had the cancer surgically removed. The drugmakers said a combination of the vaccine and Merck’s immunotherapy Keytruda led to a statistically significant improvement in survival before the cancer returned in patients with advanced melanoma. “We are very excited, we are moving very quickly with Merck onto phase 3 for this study,” Moderna CEO Stephane Bancel told CNBC Tuesday morning. Like Spikevax, the potential skin cancer vaccine uses mRNA technology. The patient group that took the potential vaccine and Keytruda saw a 44% reduction in the risk of death or the cancer returning, the companies said.

☆ S&P 500, Nasdaq snap losing streaks after jobless claims rise
▼ + stars: | 2022-12-08 | by ( David French | ) www.reuters.com time to read: +4 min

Wall Street's main indexes had come under pressure in recent days, with the S&P 500 shedding 3.6% since the beginning of December on expectations of a longer rate-hike cycle and downbeat economic views from some top company executives. Such thinking had also weighed on the Nasdaq Composite (.IXIC), which had posted four straight losing sessions prior to Thursday's advance on the tech-heavy index. Traders work on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., December 7, 2022. REUTERS/Brendan McDermidNine of the 11 major S&P 500 sectors rose, led by a 1.6% gain in technology stocks (.SPLRCT). The S&P 500 posted 15 new 52-week highs and three new lows; the Nasdaq Composite recorded 82 new highs and 232 new lows.

[1/2] Test tubes are seen in front of displayed Pfizer and Biontech logos in this illustration taken, May 21, 2021. Moderna first sued Pfizer in August, accusing the company of violating its rights in three patents related to innovations that Cambridge, Massachusetts-based Moderna said it pioneered before the COVID-19 pandemic. Moderna has also filed a related lawsuit against Pfizer and BioNTech in Germany. In its lawsuit, Moderna asked for an undisclosed amount of money damages from Pfizer COVID-19 vaccines sold since March. Pfizer and BioNTech said in their Monday filing that they developed their vaccine independently, calling Moderna's lawsuit "revisionist history" and arguing its patents "far exceed its actual contributions to the field."

☆ Moderna exec says COVID trials improved diversity recruiting
▼ + stars: | 2022-11-30 | by ( Caroline Humer | ) www.reuters.com time to read: +1 min

[1/4] Chief Medical Officer of Moderna Paul Burton attends the Reuters NEXT Newsmaker event in New York City, U.S., November 30, 2022. REUTERS/Brendan McDermidNEW YORK, Nov 30 (Reuters) - Moderna Inc's top scientist said on Tuesday that the vaccine maker has learned how to better recruit from diverse populations for its clinical trials from running its COVID-19 vaccine studies. Moderna has worked to match that diverse enrollment in its other ongoing trials, Burton said. He said enrollment of people of color in its Respiratory Syncytial Virus (RSV) and Cytomegalovirus (CMV) vaccine trials was probably over 35%. To view the Reuters NEXT conference live on Nov. 30 and Dec. 1, please click here.

☆ Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1
▼ + stars: | 2022-11-18 | by ( ) www.reuters.com time to read: +2 min

Nov 18 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Friday their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine. Antibody levels against the variant rose nearly nine-fold in older adults, aged 55 and above, who received the Omicron shot compared to a roughly 2-fold increase in participants with the original shot, according to data posted on online archive bioRxiv. The variant and related BQ.1 are gaining ground in the United States, and are expected to cause a rise in cases in the winter in Europe. The companies had recently released data that showed their Omicron-tailored shot produced a strong antibody response in older adults than the original shot after one month against the BA.4/5 subvariants. Pfizer and BioNTech said the bivalent shot also produced an immune response against newer Omicron subvariants including BA.4.6, BA.2.75.2 and XBB.1.

☆ Japan's Daiichi Sankyo says mRNA COVID vaccine successful in booster trial
▼ + stars: | 2022-11-15 | by ( ) www.reuters.com time to read: +1 min

TOKYO, Nov 15 (Reuters) - Japan's Daiichi Sankyo Co (4568.T) said on Tuesday its mRNA-based COVID-19 vaccine had reached its primary endpoint in a trial of the shot as a booster. Based on the results, Daiichi Sankyo will file a new-drug application to regulators in January 2023. Approval would give Japan a home-grown source for mRNA vaccines, which have made up the bulk of its COVID inoculations to date. Japan has relied on imports of shots developed by U.S.-based drugmakers Pfizer Inc (PFE.N) and Moderna Inc (MRNA.O). Daiichi Sankyo's shares jumped on the news, rising 3.3% versus a 0.1% advance in the benchmark Nikkei (.n225) gauge.

☆ Moderna’s New Covid-19 Booster Produced Strong Immune Response in Study
▼ + stars: | 2022-11-14 | by ( Peter Loftus | ) www.wsj.com time to read: 1 min

Moderna’s updated booster shot targets both the original strain of the coronavirus and the BA.4 and BA.5 subvariants, which share an identical surface protein. Moderna Inc.’s new updated Covid-19 booster shot for the U.S. generated strong immune responses in people against Omicron subvariants, according to the first data from a company-sponsored study testing the new doses in volunteers. Moderna said Monday that people receiving the updated booster shot had more than five times the neutralizing antibodies against Omicron subvariants BA.4 and BA.5 than people who received Moderna’s original booster shot, which targeted an earlier strain of the coronavirus.

☆ Moderna's Omicron shots shows better immune response than original COVID vaccine
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +1 min

Nov 14 (Reuters) - Moderna Inc (MRNA.O) said on Monday its Omicron-tailored vaccines produced a better immune response against the BA.4/5 subvariants in a mid-to-late stage study, when given as a booster dose, compared with its original shot. Data shows that both of Moderna's Omicron-tailored shots, mRNA-1273.214 and mRNA-1273.222, produced a higher antibody response against BA.4/5 subvariants than its original shot in vaccinated and boosted adults, the company said. Moderna, however, said levels of neutralizing antibody response dropped nearly 5-fold against the emerging subvariant BQ.1.1 when compared with BA.4/5, in an analysis of about 40 participants, although the virus neutralizing activity still remained "robust". Rival Pfizer Inc (PFE.N) and its German partner, BioNTech SE , said earlier this month their Omicron-tailored shot targeting the BA.4/5 subvariants produced a strong antibody response in older adults than the original shot after one month. Reporting by Bhanvi Satija in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

☆ Sanofi, GSK score late win with EU COVID booster approval
▼ + stars: | 2022-11-10 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

The shot is based on lab-made viral proteins provided by Sanofi and an adjuvant ingredient from GSK that increases the immune response. Adapting the older protein technology chosen by Sanofi and GSK to a new virus variant requires several months longer than under the mRNA approach, which saw a breakthrough during the pandemic. Work on the shot by Sanofi and GSK, two of the world's largest vaccine makers by sales, was delayed repeatedly. The partners later pivoted to targeting the Beta variant, requiring months in additional development time. While the shot tested at the time was bivalent - meaning it was based both on original Wuhan strain of the virus and Beta - Sanofi and GSK later focused on a monovalent shot based on Beta only.

☆ European regulator recommends Pfizer's Omicron booster for children
▼ + stars: | 2022-11-10 | by ( ) www.reuters.com time to read: 1 min

Nov 10 (Reuters) - Pfizer Inc (PFE.N) and its partner BioNTech said on Thursday the EU health regulator has recommended authorising the use of their bivalent COVID-19 shot as a booster in children aged 5 through 11. The Omicron-tailored vaccine is already authorised by the European Commission for individuals aged 12 years and above. The updated bivalent booster shot targets the original coronavirus strain as well as the BA.4 and BA.5 sub-variants of Omicron. In October, European Medical Agency backed authorization of Moderna Inc's (MRNA.O) COVID-19 tailored booster shots for 12 and above to further vaccination campaigns in the region. Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru; Editing by Shounak Dasgupta amd Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Novavax says Omicron shot shows strong immune response as second booster
▼ + stars: | 2022-11-08 | by ( ) www.reuters.com time to read: +2 min

Nov 8 (Reuters) - Vaccine maker Novavax Inc (NVAX.O) said on Tuesday its COVID-19 shot retooled against the Omicron BA.1 variant showed a strong immune response as the fourth dose and met the main goal of strain change in a late-stage study. Data showed the shot, NVX-CoV2515, produced 1.6 times the amount of neutralizing antibodies in people who had previously not been exposed to COVID-19 compared to Novavax's original coronavirus vaccine. The trial included Novavax's so-called bivalent vaccine, the BA.1-tailored shot and its prototype vaccine. Novavax says the results from the study showed its Omicron-tailored shot can be changed to target a new variant vaccine if necessary. Novavax's COVID shot has not yet received approval in the United States as a second booster dose.

☆ Moderna Cuts Outlook Amid Supply Constraints
▼ + stars: | 2022-11-03 | by ( Sabela Ojea | ) www.wsj.com time to read: 1 min

Moderna said higher costs and a decline in demand for its Omicron-targeting Covid-19 doses hit its performance in its latest quarter. Moderna Inc. said third-quarter revenue fell by nearly a third and cut its outlook as supply constraints sap up to $3 billion in sales this year. The Cambridge, Mass.-based pharmaceutical company on Thursday said higher costs and a decline in demand for its Omicron-targeting Covid-19 doses also hit its performance.

☆ Moderna cuts COVID vaccine sales forecast on supply woes, shares tumble
▼ + stars: | 2022-11-03 | by ( ) www.reuters.com time to read: +1 min

Nov 3 (Reuters) - Moderna Inc (MRNA.O) cut its annual sales forecast for its COVID-19 vaccine on Thursday, citing short-term supply constraints that would push some deliveries out to next year, sending its shares down nearly 16% before the bell. It now expects vaccine sales of $18 billion and $19 billion this year compared to a prior forecast of $21 billion. Some U.S. pharmacies in September had reported that government supply of Moderna's updated shot remains limited, causing appointments for the product to vary across the country. Moderna's forecast cut comes just two days after rival Pfizer Inc's (PFE.N) quarterly sales of its COVID-19 vaccine exceeded market expectations and the drugmaker raised the full-year sales forecast for its shots. The vaccine maker reported sales of $3.36 billion in the third quarter, missing Wall Street estimates of $3.53 billion.

☆ Pfizer, BioNTech start COVID-flu combination vaccine study
▼ + stars: | 2022-11-03 | by ( ) www.reuters.com time to read: +1 min

Nov 3 (Reuters) - U.S. drugmaker Pfizer Inc (PFE.N) and its German partner BioNTech SE have started an early-stage study to evaluate a combination vaccine targeting COVID-19 and influenza, the companies said on Thursday. The single-dose vaccine candidate is a combination of Pfizer's mRNA-based flu shot and the companies' Omicron-tailored COVID-19 booster shot. The early-stage study, which is being sponsored by BioNTech, aims to evaluate the combination shot's safety, tolerability and immunogenicity, or the ability to generate immune response. Rivals Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are also developing combination vaccines targeting both COVID-19 and influenza. read moreReporting by Bhanvi Satija in Bengaluru; Editing by Savio D'Souza and Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised its forecast for 2022 sales of its COVID-19 vaccine by $2 billion to $34 billion, and said new deals and drugs in development should help replace future declining vaccine sales and lost revenue from patent expirations. Sales of the Pfizer/BioNTech COVID vaccine are down from pandemic highs as many countries have neared the end of their primary vaccination campaigns. Third-quarter sales of the COVID vaccine came in at $4.40 billion, blowing past estimates of $2.60 billion. However, $7.51 billion in sales of Paxlovid, the company's COVID-19 antiviral treatment, fell short of estimates of $7.66 billion. Pfizer reported adjusted earnings of $1.78 per share in the third quarter, beating analysts' estimates by 39 cents.

☆ Pfizer boosts COVID vaccine sales forecast by $2 bln
▼ + stars: | 2022-11-01 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised its forecast for annual sales of its COVID-19 vaccine by $2 billion to $34 billion on demand for Omicron-targeted boosters, helping allay some investor worries over growth for the vaccinations. The U.S. drugmaker's shares rose 2.4% to $447.67 in morning trading as its third-quarter profit beat estimates, mainly due to better-than-expected sales of the vaccine. The upbeat earnings also sent shares of rival COVID-19 vaccine makers higher. Sales of the COVID-19 vaccine have eased from pandemic highs on soft demand for the original shots, sparking concerns over demand over the next few years. Third-quarter sales of the COVID-19 vaccine came in at $4.40 billion, blowing past estimates of $2.60 billion.

☆ Pfizer COVID vaccine price hike seen giving revenue boost for years
▼ + stars: | 2022-10-21 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

Oct 21 (Reuters) - Pfizer's plan to as much as quadruple current U.S. prices for its COVID-19 vaccines going forward could spur revenue for years, analysts said. Outside the United States, Pfizer said it already has contracts with governments in many developed markets that extend through 2023 with prices that have already been set. Moderna had previously suggested commercial price expectations in a range of $64 to $100 a shot. Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant manufacturers would need to hike prices to meet revenue forecasts for 2023 and beyond. Around 19.4 million people in the United States received the updated booster over the first seven weeks of its rollout.

☆ Analysis: Falling demand for COVID boosters puts price hikes on the table
▼ + stars: | 2022-10-20 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

Last year, many on Wall Street were estimating the number of COVID-19 shots would be in line with the annual flu vaccine, which is the vaccine market leader with more than 160 million shots per year in the United States and 600 million shots globally. A recent poll by Kaiser Family Foundation found that two-thirds of American adults do not plan on getting a COVID vaccine soon. He added that instances of COVID infections in those who have been vaccinated has left many to question the effectiveness of the vaccine. The companies could make up for some of the weaker demand with price increases. That would mean annual revenue of $3 billion to $5 billion over the long-term for a company like Moderna, he added.

☆ EMA recommends Moderna's new Omicron-tailored vaccine
▼ + stars: | 2022-10-19 | by ( ) www.reuters.com time to read: 1 min

Oct 19 (Reuters) - The European Medical Agency on Wednesday recommended authorization of Moderna Inc's (MRNA.O) COVID-19 vaccine tailored towards targeting the Omicron sub-variants BA.4 and BA.5 for 12 and above ages. The European Commission has already approved Moderna's vaccine targeting Omicron BA.1 last month. Register now for FREE unlimited access to Reuters.com RegisterReporting by Khushi Mandowara; Editing by Maju SamuelOur 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.

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.

☆ Covid-19 Boosters Targeting Omicron Authorized for Kids as Young as 5
▼ + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com time to read: 1 min

U.S. health regulators on Wednesday expanded eligibility for the new Covid-19 booster shots to children as young as 5 years old, broadening access to help bolster protection against Omicron strains of the coronavirus. The U.S. Food and Drug Administration authorized the updated booster from Pfizer Inc. and its partner BioNTech SE for children ages 5 through 11, and Moderna Inc.’s updated booster for children 6 through 17.

☆ Covid-19 Boosters Targeting Omicron Authorized by FDA for Kids as Young as 5
▼ + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com time to read: 1 min

☆ Omicron-Targeting Covid-19 Boosters Recommended for Kids as Young as 5
▼ + stars: | 2022-10-12 | by ( Peter Loftus | Liz Essley Whyte | ) www.wsj.com time to read: 1 min

☆ 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.

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