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☆ FDA advisors recommend replacing original Covid vaccine with bivalent omicron shots for all doses
▼ + stars: | 2023-01-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration's independent advisory committee on Thursday unanimously recommended replacing Pfizer and Moderna's original Covid vaccine used in the U.S. for everyone's first two immunizations with the new bivalent omicron shots. Instead, the drugmakers' bivalent omicron shots that target the omicron BA.5 subvariant as well as the original strain would be used for the entire vaccination series. Currently, Pfizer's and Moderna's omicron shots are only authorized as a booster, while the first two doses are still their old shots based on the original Covid strain. The FDA has proposed moving to a system that resembles how the agency updates and rolls out flu shots every year. The agency would select a Covid vaccine formulation in June to target the variant that is expected to dominate in the fall and winter.

☆ FDA says Covid vaccines will probably get an annual update but most people will likely need only one shot
▼ + stars: | 2023-01-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

In a briefing document published Monday, the FDA said the vaccines will probably need an annual update as the virus continues to evolve. Most people would receive one shot to restore their protection against the virus moving forward, according to the briefing document. The FDA released the road map ahead of a meeting of the agency's independent vaccine experts scheduled for Thursday. The proposed system for updating Covid vaccines resembles how the FDA selects flu shots every year. The agency said it could update and rollout the Covid vaccines without clinical data, which is also the case with the annual process to change the flu shot.

☆ Moderna's mRNA RSV vaccine propels stock gains
▼ + stars: | 2023-01-18 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailModerna's mRNA RSV vaccine propels stock gainsMichael Yee, managing director at Jefferies, joins 'The Exchange' to discuss what's driving Moderna's stock activity, the unique mRNA technology behind the company's RSV vaccine and portfolio opportunities in the biotech business.

☆ Moderna, Pfizer's new race: The RSV vaccine FDA approval process
▼ + stars: | 2023-01-18 | by ( Eric Rosenbaum | ) www.cnbc.com time to read: +8 min

Both companies have released results from RSV vaccine trials with efficacy results strong enough to expect expedited approval from the FDA. The companies — which have been involved in litigation brought by Moderna alleging mRNA patent infringement, a claim Pfizer disputes — are both expected the FDA approval process for the RSV vaccine to occur soon. We can use the same, the same equipment and raw materials as the Covid vaccine." The RSV approval process is just one part of a widening vaccine industry for these two companies. "Every strain is treated as suspicious and we start working on it to see if it can overcome the vaccine," Bourla said.

☆ Moderna's phase three RSV trial found to be 83.7% effective in older adults
▼ + stars: | 2023-01-17 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailModerna's phase three RSV trial found to be 83.7% effective in older adultsCNBC's Meg Tirrell joins 'Closing Bell' to discuss Moderna's phase three trial results for its RSV vaccine, the decision to submit the vaccine for regulatory review and the competitive landscape for RSV vaccines.

☆ Moderna says RSV vaccine is 84% effective at preventing disease in older adults
▼ + stars: | 2023-01-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Moderna on Tuesday said its vaccine targeting respiratory syncytial virus is effective at preventing disease in older adults. The vaccine was 83.7% effective at preventing lower respiratory tract disease, defined as two or more symptoms, in people ages 60 and older, according to the Boston biotech company. It was 82.4% effective at preventing lower respiratory tract disease with three or more symptoms. Moderna's RSV vaccine uses the same messenger RNA technology as the company's successful Covid shots. Morgan Stanley estimates the market for an adult RSV vaccine is $7 billion to $10 billion.

RSV, which produces symptoms similar to a cold but can be fatal for young children and older adults, causes about 14,000 deaths annually in adults ages 65 and older. Moderna, Pfizer Inc (PFE.N) and GSK Plc (GSK.L) are racing to get their RSV vaccines to market first. Pfizer's RSV vaccine was found to be 66.7% effective against two or more symptoms in late-stage trials. "It's very exciting to see progress in RSV vaccines in older adults, and I think both of those vaccines have shown pretty remarkable results as well," Hoge said. The RSV vaccine market could be worth more than $10 billion globally, half of which would come from the United States, according to Cowen analyst Tyler Van Buren.

☆ Goldman Sachs' bad quarter is the result of environmental factors, says Steve Weiss
▼ + stars: | 2023-01-17 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailGoldman Sachs' bad quarter is the result of environmental factors, says Steve WeissSteve Weiss, chief investment officer and managing partner of Short Hills Capital Partners LLC, joins 'Closing Bell Overtime' to discuss Goldman Sachs' earnings miss, the environmental factors impacting the company's margins and Moderna's RSV vaccine news.

☆ CDC says it’s ‘very unlikely’ Pfizer booster carries stroke risk for seniors after launching review
▼ + stars: | 2023-01-13 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

A CDC spokesperson said this issue was first detected in late November. By mid-December, the CDC concluded the concern was persisting and launched an investigation into whether seniors are more likely to have a stroke in the first 21 days after receiving the Pfizer booster, the spokesperson said. The VSD monitoring system found that 130 people ages 65 and older had a stroke within 21 days of receiving the Pfizer omicron booster among about 550,000 seniors who received the shot, the CDC spokesperson said. No other surveillance system has detected a similar safety concern for the Pfizer booster so far, according to the CDC. The CDC has not changed its recommendation for the Pfizer omicron shot.

☆ U.S. FDA, CDC see early signal of Pfizer bivalent COVID shot's link to stroke
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +2 min

Jan 13 (Reuters) - A safety monitoring system flagged that U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech's updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities. An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain. "Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public," the health authorities said. Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot. This safety concern has not been identified with Moderna's (MRNA.O) bivalent shot and both the CDC and FDA continue to recommend that everyone aged 6 months and older stay up-to-date with their COVID-19 vaccination.

☆ Sen. Sanders asks Moderna not to hike COVID vaccine price
▼ + stars: | 2023-01-10 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

[1/5] Boxes containing the Moderna COVID-19 vaccine are prepared to be shipped at the McKesson distribution center in Olive Branch, Mississippi, U.S. December 20, 2020. Senator Bernie Sanders sent Moderna Inc (MRNA.O) a letter this week asking the drug company to halt planned U.S. price increases on its COVID-19 vaccine, saying price hikes could make the shot unaffordable for millions of Americans. Sanders said in his letter that raising prices would be particularly egregious after the U.S. government provided around $1.7 billion to fund development of the vaccine. The Vermont senator has railed against high drug prices and backed Medicare-for-all, and his chairmanship of the HELP committee could put drug companies in his crosshairs. Moderna's COVID-19 vaccine sales were around $18.4 billion in 2022.

☆ Sen. Bernie Sanders urges Moderna not to hike price of Covid-19 vaccines
▼ + stars: | 2023-01-10 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Sen. Bernie Sanders on Tuesday urged Moderna not to quadruple the price of its Covid-19 vaccine once distribution of the shots moves to the commercial market. In a letter to Moderna CEO Stephane Bancel, Sanders called the price increase "outrageous." Private health insurance premiums would also rise as a consequence of a vaccine price hike , Sanders wrote. Pfizer is also considering raising the price of its Covid vaccine to $110 to $130 per dose. Moderna's Covid vaccine is the company's only commercially available product.

☆ Here are Friday's biggest analyst calls of the day: Apple, Amazon, Uber, Nike, Boeing, Netflix & more
▼ + stars: | 2023-01-06 | by ( Michael Bloom | ) www.cnbc.com time to read: +10 min

Baird names Boeing a top 2023 pick Baird named Boeing as a top idea this year and says it sees a recovery in aerospace. UBS names Target a top pick in 2023 UBS says it sees Target as a market share gainer in 2023. Wells Fargo initiates Snowflake as overweight Wells said in its initiation of the stock that it's built to "weather the storm." Piper Sandler names Amazon a top 2023 pick Piper Sandler says it sees share gains and easing comps for the e-commerce giant. " Bank of America names Domino's a top 2023 pick The firm says Domino's is well positioned in a declining macroeconomic environment.

☆ Moderna signs $35 million deal with cancer drug developer CytomX
▼ + stars: | 2023-01-05 | by ( ) www.reuters.com time to read: +1 min

Jan 5 (Reuters) - Moderna Inc (MRNA.O) on Thursday announced a $35 million licensing deal with cancer-focused drug developer CytomX Therapeutics (CTMX.O) to work on messenger RNA-based therapies for a wide range of diseases. The news comes a month after an experimental cancer vaccine from Moderna based on mRNA technology was shown to work against a type of skin cancer. The deal offers CytomX access to Moderna's mRNA technology, which has been used to develop COVID-19 vaccines, while Moderna would get access to CytomX's Probody platform, used in the development of cancer therapies targeting diseased tissues. Moderna said it will also pay tiered royalties to CytomX on global sales of any products which enter the market under the deal. The companies will work together to discover experimental therapies and Moderna will be responsible for human trials and commercial activities of products.

☆ This week's best-performing stocks include a popular sports apparel name and a drug maker
▼ + stars: | 2022-12-23 | by ( Samantha Subin | ) www.cnbc.com time to read: +2 min

Stocks struggled this week as recession fears resurfaced, putting a damper on last hopes for a market uptick. CNBC Pro used FactSet data to screen for the stocks with the greatest week-to-date percentage changes as of Friday's open. About 46% of analysts rate the stocks as a buy, with the consensus price target implying upside of more than 7% from Thursday's close. The stock's down about 49% this year, but the consensus price target suggests shares stand to gain more than 41% from Thursday's close. Energy stocks APA Corp and Halliburton also made the list, with shares rising 4% and 6.4%, respectively, this week, as of Friday's open.

☆ Moderna's vaccine facility in Britain to create over 150 new jobs
▼ + stars: | 2022-12-22 | by ( ) www.reuters.com time to read: +1 min

[1/2] A sign marks the headquarters of the coronavirus disease (COVID-19) vaccine maker Moderna in Cambridge, Massachusetts, U.S., April 28, 2022. REUTERS/Brian Snyder/LONDON, Dec 22 (Reuters) - U.S. biotech Moderna's (MRNA.O) planned vaccine manufacturing centre in Britain will create more than 150 new jobs in the country, the UK government said on Thursday. Moderna's COVID-19 vaccines, which use messenger RNA (mRNA) technology, were among those deployed in Britain in the effort to tackle the coronavirus crisis, including in the ongoing autumn booster campaign. The facility, which is expected to start producing shots in 2025, will provide patients in Britain access to domestically manufactured mRNA respiratory shots, including the company's COVID vaccine that can protect against multiple variants. ($1 = 0.8288 pounds)Reporting by Natalie Grover in London; Editing by Leslie AdlerOur Standards: The Thomson Reuters Trust Principles.

☆ Investor Steve Weiss prefers Moderna over Merck, says it’s a high quality stock with a bigger pipeline
▼ + stars: | 2022-12-21 | by ( Sarah Min | ) www.cnbc.com time to read: +1 min

Stephen Weiss, chief investment officer and managing partner at Short Hills Capital Partners, bought Moderna , and sold Merck — though he still expects the latter is a solid pharmaceutical stock. "Some days I regret selling because it's still a cheap stock, still extremely well-run, I think the best-run pharma company." Moderna shares have recently attracted investors' interest following the announcement of an experimental melanoma vaccine . Shares of Moderna are down roughly 18% this year, while shares of Merck is up nearly 45% in 2022. To this, Weiss added that "there's no other drug company, biotech company" with the pipeline that Moderna has.

☆ Moderna shifts focus to developing cancer vaccinations
▼ + stars: | 2022-12-19 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailModerna shifts focus to developing cancer vaccinationsMichael Yee of Jefferies joins 'Closing Bell' to discuss Moderna's shift away from Covid-focused pharmaceuticals toward PCV cancer vaccination, the market size for personalized cancer vaccines and the Moderna-Merck partnership.

☆ Moderna's CEO predicts how the biotech's work in cancer vaccines could transform healthcare, starting with your annual physical
▼ + stars: | 2022-12-14 | by ( Andrew Dunn | ) www.businessinsider.com time to read: +5 min

Personalized cancer vaccines could provide a new way to fight early cancer cases. Moderna CEO Stéphane Bancel told Insider he thinks cancer vaccines can upend cancer care. In an interview, Bancel shared his vision on how these personalized cancer vaccines could transform cancer care. Based off the blood work, Moderna would design vaccines that target the genetic mutations in cancerous cells that stand out from healthy cells. The blood tests could find cancer before it grows too much, and mRNA vaccines could squash it.

☆ Stocks making the biggest moves midday: SoFi Technologies, Charter Communications, Delta and more
▼ + stars: | 2022-12-14 | by ( Michelle Fox | ) www.cnbc.com time to read: +3 min

Check out the companies making the biggest moves midday:SoFi Technologies — The fintech stock jumped more than 7% after a filing showed CEO Anthony Noto bought $5 million in common stock. Charter Communications — Charter Communications dropped more than 13% after CEO Chris Winfrey said at an investor event the company will invest $5.5 billion over three years to upgrade its high-speed internet network. Morgan Stanley said it was a top auto pick for 2023. RingCentral — Shares of RingCentral climbed 4.8% after being upgraded by Morgan Stanley to overweight from equal weight. In its call, Morgan Stanley said the software company is underappreciated.

☆ DeSantis' latest anti-COVID-19 vaccine push puts him on a collision course with Trump over the pandemic
▼ + stars: | 2022-12-14 | by ( Kimberly Leonard | ) www.businessinsider.com time to read: +11 min

Ron DeSantis intensified his attacks on the COVID-19 vaccines on Tuesday, in a move that positions the Republican governor to contrast his pandemic record with that of former President Donald Trump. It's not clear whether Trump will lean into his success on the COVID-19 vaccine through his Operation Warp Speed program. Then-President Donald Trump with then-Florida governor candidate Ron DeSantis at a July 2018 “Make America Great Again” rally in Tampa, Florida. For instance, the FDA and CDC have cleared the bivalent booster for those as young as 6 months of age depending on what COVID-19 vaccine a person has previously had. The committee will issue guidance about COVID vaccines and other healthcare matters.

☆ Moderna just used a personalized vaccine to treat cancer, and it could signal a major breakthrough in how we treat the disease
▼ + stars: | 2022-12-13 | by ( Andrew Dunn | ) www.businessinsider.com time to read: +4 min

Moderna's cancer vaccine lowered the risk of death or skin-cancer recurrence in a midstage study. Moderna's CEO Stéphane Bancel compared the cancer study results to the initial outbreak of COVID-19, when Moderna scrambled to respond and develop a vaccine. Bancel said Moderna and its partner, Merck, would launch multiple late-stage studies in 2023 to test the cancer vaccine in not just melanoma patients but other types of cancer. Merck paid $250 million earlier this year to jointly develop Moderna's vaccine, extending a partnership between the two drugmakers that began in 2016. Study results have yet to be presented at a conference or published in a journal.

☆ U.S. FDA authorizes bivalent COVID shots for kids as young as 6 months old
▼ + stars: | 2022-12-08 | by ( ) www.reuters.com time to read: +2 min

The amended authorization on Thursday from the Food and Drug Administration allows use of Moderna's bivalent shot as a booster in children 6 months through 5 years of age, two months after their initial vaccination. Children who have completed their initial three-dose vaccination with Pfizer's original shot are not yet eligible to receive the bivalent booster, the agency said. The regulator added that data supporting use of Pfizer/BioNTech's bivalent shot as a booster in this age group is expected in January. Moderna's vaccine for children under 6 is a two-dose, 25 microgram vaccine, with the shots given about four weeks apart. Overall, 39.7 million people in United States have received a bivalent booster as of Nov. 30, data from the Centers for Disease Control and Prevention showed.

☆ FDA authorizes Covid omicron vaccines for children as young as 6 months old
▼ + stars: | 2022-12-08 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

REUTERS/Shannon StapletonThe Food and Drug Administration on Thursday authorized updated Covid shots that target the omicron variant for children as young as 6 months old. The eligibility rules vary depending on whether children received Moderna's or Pfizer's original vaccines as their primary series. The new shots target the omicron BA.5 subvariant and the original Covid strain. U.S. health officials expect the new shots to provide superior protection compared to the original vaccines, which only target the original Covid strain. The FDA authorized the shots based on adult immune response data for similar vaccines developed by Pfizer and Moderna that target the original omicron BA.1 variant.

[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."

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