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☆ Moderna teams up with IBM to put AI, quantum computing to work on mRNA technology used in vaccines
▼ + stars: | 2023-04-20 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Moderna and IBM are teaming up to use generative artificial intelligence and quantum computing to advance mRNA technology, the development at the core of the company's blockbuster Covid vaccine, the companies announced Thursday. The companies said they signed an agreement for Moderna to access IBM's quantum computing systems. IBM will also provide experts who can help Moderna scientists explore the use of quantum technologies, the companies added. Unlike traditional computers, which store information as either zeroes or ones, Quantum computing hinges on quantum physics. The companies said Moderna will use IBM's model to understand "the characteristics of potential mRNA medicines" and design a new class of vaccines and therapies.

☆ FDA authorizes additional omicron Covid booster for seniors and people with weak immune systems
▼ + stars: | 2023-04-18 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

(Photo by Scott Olson/Getty Images)The Food and Drug Administration on Tuesday authorized an additional dose of Pfizer and Moderna 's Covid-19 vaccines targeting the omicron variant for seniors and people with weak immune systems. People with weak immune systems can receive another omicron shot at least two months after their last dose and receive additional shots at the discretion of their doctor. Children 6 months through 5 years of age who are unvaccinated can now receive the full two-dose series of Moderna's omicron vaccine. The FDA first authorized the omicron BA.5 shots last August, but that subvariant has long since been displaced by a version of omicron called XBB.1.5. In June, the agency will likely update the variant that the Covid vaccines target, ahead of the fall respiratory virus season.

☆ Moderna shares fall despite promising data from cancer vaccine trial
▼ + stars: | 2023-04-17 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Shares of Moderna fell Monday as Wall Street chewed over new trial results on the personalized cancer vaccine it is developing with Merck . Those results, presented at an American Association for Cancer Research meeting in Florida, add to the initial results on the treatment combination released in December. Analysts from SVB Securities said the results suggest the personalized cancer vaccine shows promise. Wells Fargo analyst Mohit Bansal also said he's expressing "cautious optimism" about the treatment combination. In a Sunday note, Bansal pointed to "trial imbalances" that potentially produced more favorable results for the personalized cancer vaccine.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took Moderna about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.

April 11 (Reuters) - A U.S. appeals court handed Moderna Inc (MRNA.O) a win on Tuesday, affirming a decision to cancel an Arbutus Biopharma Corp (ABUS.O) patent related to the companies' legal fight over Moderna's blockbuster COVID-19 vaccines. The U.S. Court of Appeals for the Federal Circuit upheld a U.S. Patent and Trademark Office tribunal's ruling that the patent for Arbutus' lipid nanoparticle (LNP) technology was invalid based on an earlier Arbutus patent that disclosed the same invention. Moderna challenged the patent at the PTO's Patent Trial and Appeal Board in 2018, and the board invalidated it in 2019. Arbutus separately sued Pfizer and BioNTech for patent infringement last week over their COVID-19 shots, in a lawsuit that also does not include the canceled patent. The Federal Circuit case is Arbutus Biopharma Corp v. ModernaTX Inc, U.S. Court of Appeals for the Federal Circuit, No.

☆ Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027
▼ + stars: | 2023-04-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion "over the next few years," Moderna added. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company's Covid vaccine remains its only commercially available product.

☆ Moderna says it hopes to offer new vaccines for cancer, heart disease, and other conditions by 2030
▼ + stars: | 2023-04-10 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Moderna hopes to offer a new set of life-saving vaccines targeting cancer, heart disease and other conditions by 2030, a spokesperson for the company told CNBC on Monday. "It can be applied to all sorts of disease areas; we are in cancer, infectious disease, cardiovascular disease, autoimmune diseases, rare disease." Burton's remarks also come ahead of Moderna's Vaccine Day on Tuesday. He highlighted Moderna's personalized cancer vaccine, a highly anticipated mRNA shot being developed to target different tumor types. In February, the Food and Drug Administration granted Breakthrough Therapy Designation to Moderna's personalized cancer vaccine in combination with Merck's immunotherapy drug Keytruda for patients with a deadly form of skin cancer called melanoma.

☆ These S&P 500 stocks crushed it in the first quarter. Here's where analysts see them going
▼ + stars: | 2023-04-02 | by ( Fred Imbert | ) www.cnbc.com time to read: +4 min

The S & P 500 just wrapped up a wild first quarter with surprisingly strong results. The tech and communication services sectors powered the S & P 500 higher, rising more than 20% each. Here are the 10 best S & P 500 stocks for the first quarter, and where analysts see them going based on the implied upside (or downside) to their average price targets. Nvidia led the way higher among S & P 500 stocks, surging 90.1%. As for Catalent, analysts see the stock rallying 24.5% after surging 46% in the first quarter.

☆ Watch live: Moderna CEO Stephane Bancel testifies before Senate on Covid vaccine price hike
▼ + stars: | 2023-03-22 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Moderna's CEO, Stephane Bancel, is testifying Wednesday before the Senate health committee on pricing of the company's Covid-19 vaccine. The Boston biotech company plans to charge $130 per dose once the vaccination program moves to the private market as early as this fall. Sen. Bernie Sanders, I-Vt., chair of the health committee, slammed Moderna in a letter to Bancel in January, calling the price hike "outrageous." Learn more and register today: http://bit.ly/3DUNbRoAfter Sanders sent the letter, Moderna said it will create an assistance program to keep the vaccine free for people who are uninsured or underinsured. People who have Medicare, Medicaid or private insurance should still receive the shot at no cost, but Sanders said the price increase "will cost taxpayers billions of dollars."

☆ Moderna CEO Stephane Bancel defends fivefold price hike of Covid vaccine during Senate grilling
▼ + stars: | 2023-03-22 | by ( Spencer Kimball | ) www.cnbc.com time to read: +4 min

Moderna plans to raise the list price of its vaccine 400% to $130 when the shots are sold on the private market as early as this fall. Moderna CEO Stephane Bancel on Wednesday defended the company's plans to hike the price of its Covid shots fivefold, deflecting pressure at a Senate hearing to abandon the increase while taking barbs over his compensation. Chairman Bernie Sanders, I-Vt., questions Stephane Bancel, CEO of Moderna, during the Senate Health, Education, Labor and Pensions Committee hearing titled Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine? He told the committee that the Covid vaccine market is changing substantially as the U.S. government stops buying and distributing the shots for the entire country. The Covid vaccine remains Moderna's only product on the market at the moment.

[1/3] CEO of Moderna Stephane Bancel looks up at the session "State of the Pandemic" during the World Economic Forum (WEF) in Davos, Switzerland, January 18, 2023. Moderna (MRNA.O) CEO Stephane Bancel was called to testify after the company flagged plans to raise the vaccine's price to as much as $130 per dose, drawing the ire of Democratic U.S. Senator Bernie Sanders, who chairs the influential Committee on Health, Education, Labor and Pensions (HELP). The government in May plans to end the COVID public health emergency, putting much of the vaccine purchasing in the hands of the private sector. Moderna in February forecast $5 billion in COVID vaccine sales this year, far less than the $18.4 billion windfall in 2022, due to decreasing demand for the shots.

☆ FDA authorizes Pfizer's Covid omicron booster as fourth shot for kids under 5
▼ + stars: | 2023-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration on Tuesday authorized Pfizer's omicron booster shot for kids under five years old who were previously vaccinated with three doses of the company's original vaccine. The new shot is bivalent, meaning it targets the original Covid strain as well as omicron BA.4 and BA.5. Pfizer's primary series for young children consists of three doses, while rival drugmaker Moderna's primary series for that same age group is only two. Since December, children in that age group who completed two doses of Pfizer's original vaccine have been eligible to receive the omicron booster as their third shot, or last dose in their primary series. One month after the children received the omicron booster, they demonstrated an immune response to both the original Covid strain and omicron BA.5 and BA.5

☆ Moderna shares pop 7% after Cowen upgrades stock, saying it 'will be a leader' in RSV vaccines
▼ + stars: | 2023-03-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Moderna shares jumped by nearly 7% on Wednesday after TD Cowen upgraded the stock, saying the company will "be a leader" in the RSV vaccine market. Cowen pointed to the company's potential RSV vaccine, noting that key opinion leaders believe RSV will be a "three-player vaccine market" between Moderna and drugmakers Pfizer and GSK. Moderna's RSV vaccine performed well in clinical trials and was well tolerated by patients, the note said. Moderna's RSV vaccines for adults ages 60 and older received Breakthrough Therapy Designation from the Food and Drug Administration in late January. Cowen noted that Moderna believes the regulatory support of its competitors' RSV candidates "should read-through" to its own.

☆ FDA advisors recommend GSK's RSV vaccine for older adults, but flag potential safety risks
▼ + stars: | 2023-03-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

Ten of the FDA advisors said the safety data on GSK's vaccine was adequate, while two said it was not. The panel reached a similar conclusion in a narrow 7 to 4 vote Tuesday on Pfizer's application to clear its RSV vaccine. While the advisors erred toward recommending approval, they also raised concern over a possible link to Guillain-Barre syndrome. Both companies have asked the FDA to approve their RSV shot for adults ages 60 and older. The FDA said the cases are possibly related to either GSK's RSV vaccine or the flu shot that was administered with it.

☆ Moderna reaffirms 2023 COVID vaccine sales forecast of $5 billion
▼ + stars: | 2023-02-23 | by ( ) www.reuters.com time to read: 1 min

Companies Moderna Inc FollowFeb 23 (Reuters) - Moderna Inc (MRNA.O) reaffirmed its annual sales forecast of $5 billion for its COVID-19 vaccines, which was below market expectations as the company anticipated lower demand in the fourth year of the pandemic. Sales of the COVID vaccine, Moderna's sole commercial product, were widely expected to fall sharply this year from $18.4 billion in 2022. Moderna's forecast was lower than Refinitiv estimates of $6.98 billion. The company also reiterated its plans to file for regulatory approval its respiratory syncytial virus vaccine in the first half of 2023 as it looks to build its product portfolio beyond COVID vaccines. Reporting by Aditya Samal and Leroy Leo; Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.

☆ Bernie Sanders says 'we want to look at a shorter workweek' as part of his pro-worker agenda leading a key Senate panel on labor
▼ + stars: | 2023-02-23 | by ( Nicole Gaudiano | ) www.businessinsider.com time to read: +6 min

Sen. Bernie Sanders is the new head of a key Senate panel on labor issues. Sen. Bernie Sanders is pushing for a four-day workweek, worker-owned businesses, and taxing robots that replace workers. Sanders told Insider he plans to hold at least one hearing on the future of work, exploring how workers can benefit from a revolution in technology. "It is an outrage that you have a billionaire like Howard Schultz engaging in vicious anti-union activity and I think he has got to explain his illegal behavior to the Senate," Sanders told me. "As technology increases worker productivity, we want to look at a shorter workweek," he said.

☆ Moderna misses on earnings as costs rise from surplus production capacity, lower Covid shot demand
▼ + stars: | 2023-02-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Moderna on Thursday missed earnings expectation for the fourth quarter, as costs rose from surplus production capacity and lower demand for its Covid-19 vaccine, the company's only product on the market. Moderna reported quarterly earnings of $3.61 per share, a 68% decrease from the same period in 2021 when it booked $11.29 per share. Moderna has signed contracts for $5 billion in Covid vaccine deliveries for 2023. Moderna estimates U.S. market volume in fall 2023 will be 100 million doses, said Arpa Garay, the company's chief commercial officer. Garay said Moderna will leverage the infrastructure it already has in place for Covid to launch the RSV vaccine.

☆ Moderna's combination skin cancer therapy receives FDA's breakthrough tag
▼ + stars: | 2023-02-22 | by ( ) www.reuters.com time to read: +1 min

Feb 22 (Reuters) - Moderna Inc (MRNA.O) said on Wednesday its experimental personalised mRNA skin cancer vaccine in combination with Merck & Co Inc's (MRK.N) drug Keytruda has received breakthrough therapy designation from U.S. regulators as an additional treatment for high risk patients. The breakthrough tag is granted by the U.S. Food and Drug Administration (FDA) based on data from a mid-stage study of the drug that showed the therapy reduced risk of skin cancer's recurrence or death by 44% compared with Keytruda alone. The FDA's breakthrough therapy designation is granted to expedite the development and review of drugs that are intended to treat a serious condition. The companies said they plans to initiate a late-stage study in adjuvant treatment of melanoma in 2023. Reporting by Khushi Mandowara in Bengaluru; Editing by Shinjini Ganguli and Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ Pfizer/BioNTech, Moderna gear up for 2024 London trial over COVID vaccine patents
▼ + stars: | 2023-02-16 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Ivan AlvaradoLONDON, Feb 16 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE (22UAy.DE) are gearing up for a 2024 trial with Moderna Inc (MRNA.O) at London's High Court in competing patent lawsuits over their rival COVID-19 vaccines. The case reached London's High Court for the first time for a preliminary hearing on Thursday, ahead of a trial which is due to take place in April 2024. Pfizer and BioNTech sued Moderna in London in September, seeking to revoke two of Moderna's patents in relation to its messenger RNA (mRNA) vaccines. Moderna brought its own lawsuit that month over Pfizer and BioNTech’s Comirnaty vaccine, seeking damages for alleged infringement of its patents. Pfizer, BioNTech and Moderna are also engaged in litigation in Germany, the Netherlands and the United States.

It failed to meet its goal of non-inferiority compared to the conventional vaccine for the B/Victoria and B/Yamagata-lineage strains, the drugmaker said. "We have always said our goal is to produce a flu vaccine, and then to iterate it, and to fine tune it over time to really make it exceptional," Chief Medical Officer Paul Burton said in an interview. Seventy percent of those who received Moderna's shot reported mostly mild adverse reactions compared to 48% for the conventional flu vaccine. The company also has an ongoing late-stage efficacy study on the mRNA-1010 flu vaccine, which could have data within weeks. The flu, an infection of the nose, throat and lungs, kills 290,000 to 650,000 people worldwide annually.

☆ Moderna CEO to testify in senate on proposed vaccine price hike
▼ + stars: | 2023-02-15 | by ( ) www.reuters.com time to read: +1 min

Feb 15 (Reuters) - Senator Bernie Sanders said on Wednesday Moderna Inc's (MRNA.O) chief executive officer Stéphane Bancel will testify next month in front of the senate on the drugmaker's plans to raise the price of its coronavirus vaccine. In January, Sanders had written to Bancel to refrain from quadrupling the price of COVID-19 vaccine, after Moderna said it was considering pricing its vaccine at $110 to $130 per dose in the United States, when it shifts from government contracting to commercial distribution. Moderna also added that uninsured patient can buy the vaccine through Moderna's patient assistance program at no cost. Sanders, chairman of the Senate's Health, Education, Labor and Pensions committee, has railed against high drug prices and backed Medicare-for-all. Reporting by Khushi Mandowara in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

☆ Moderna CEO Stephane Bancel will testify before Senate next month on Covid vaccine price hike
▼ + stars: | 2023-02-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Moderna CEO, Stephane Bancel attends 2019 Forbes Healthcare Summit at the Jazz at Lincoln Center on December 05, 2019 in New York City. Moderna CEO Stephane Bancel will testify before the Senate health committee in March over the company's plans to hike the price of its Covid-19 vaccine. Sanders, in a letter to Bancel last month, slammed the proposed price hike as "outrageous" given that the vaccine was developed in cooperation with the National Institutes of Health using taxpayer money. When the federal supply runs out, uninsured adults may have to pay the full price for the shots. There is a federal free vaccine program for children whose families or caretakers can't afford the shots.

[1/2] People pose with syringe with needle in front of displayed Moderna logo in this illustration taken, December 11, 2021. REUTERS/Dado Ruvic/IllustrationFeb 15 (Reuters) - The U.S. government should face a patent lawsuit over COVID-19 vaccines, not vaccine maker Moderna Inc (MRNA.O), the Department of Justice told a Delaware federal court on Tuesday. Moderna made the same argument last year in an unsuccessful bid to win an early dismissal of the lawsuit. Both Moderna and Pfizer Inc (PFE.N) have been the target of multiple patent lawsuits over their COVID vaccines, including a lawsuit brought by Moderna against Pfizer in August. The case is Arbutus Biopharma Corp v. Moderna Inc, U.S. District Court for the District of Delaware, No.

☆ U.S. plans to stop buying Covid shots for the public this fall. Here's what that means
▼ + stars: | 2023-02-04 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

There is a federal program to provide free vaccines to children whose families or caretakers can't afford the shots. Sen. Bernie Sanders, I-Vt., slammed the vaccine price hike in a letter to Moderna's CEO last month. Under the ACA, private health insurance is required to cover all immunizations recommended by the CDC at no cost to the consumer. There may be a small number of legacy private health insurance plans from before the ACA that are not required to cover Covid vaccines, Cox said. Consumers could also see their health insurance premiums increase if Pfizer and Moderna hike the price of the shots, Cox said.

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