DIRS.INFO The most relevant business & tech news

☆ 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.

☆ Novavax needs 6 months to produce annual COVID shots that match new variants
▼ + stars: | 2023-01-26 | by ( Leroy Leo | ) www.reuters.com time to read: +1 min

Jan 26 (Reuters) - Novavax Inc (NVAX.O) said on Thursday it would require six months to produce a COVID-19 vaccine designed to match whichever coronavirus variants are circulating for an annual immunization program each fall season in the United States. The FDA in documents released on Monday proposed June for deciding on an annual COVID shot's make-up. It took those companies about three months to produce the currently available boosters updated to target newer Omicron subvariants. The FDA is seeking recommendations from its panel of external experts on adopting an annual COVID shot for the United States and the process for choosing the vaccine's targets each year. Reporting by Leroy Leo in Bengaluru Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

☆ Updated Covid boosters cut the infection risk from XBB.1.5 subvariant by half, CDC finds
▼ + stars: | 2023-01-25 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The updated Covid boosters reduce the risk of Covid infection from the predominant omicron subvariant by nearly half, according to early data published Wednesday by the Centers for Disease Control and Prevention. The findings are “quite reassuring,” Dr. Brendan Jackson, the head of the CDC’s Covid response, said on a call with reporters Wednesday. As of last Wednesday, only about 15% of people in the U.S. had received an updated booster, according to CDC data. People who were vaccinated but had not received the updated booster were compared to those who got the updated booster in the previous two to three months. People who got the updated boosters are probably "much more likely to wear masks indoors or restrain their travel or not go to indoor restaurants," he said.

[1/2] A logo is pictured on the Ibex building of Lonza, where the Moderna mRNA coronavirus disease (COVID-19) vaccine will be produced, in Visp, Switzerland, September 29, 2020. REUTERS/Denis Balibouse/File PhotoJan 25 (Reuters) - Lonza (LONN.S) on Wednesday said it will buy back shares worth 2 billion Swiss francs ($2.17 billion), despite an expected drop in annual margins, as the Swiss drug contract manufacturer backed its growth prospects for the near future. Lonza expects its 2023 core earnings before interest, depreciation and amortization, or EBITDA margin, to slip between 30% and 31%, down from 32.1% in 2022, as last year's boost from COVID-19 vaccine manufacturing services waned. The Basel-based company, however, reiterated a target of 33%-35% for 2024 marginsand announced a 17% rise in its annual dividend. The Swiss group forecast sales growth in the "high single-digit" adjusted for currency swings, a slow-down from the 15.1% rise it saw last year.

"Today we have additional evidence to show that these updated vaccines are protecting people against the latest COVID-19 variants," Dr. Brendan Jackson, head of the U.S. Centers for Disease Control and Prevention's COVID-19 response, told reporters in a briefing. Released last fall, the updated boosters target the BA.4 and BA.5 Omicron variants of the SARS-CoV-2 virus, which are no longer dominant. It showed that the updated vaccine helped prevent illness in roughly half of the people who had previously received two to four doses of the original COVID-19 vaccine, CDC said. The CDC said the updated vaccine worked similarly against BA.5-related infections and XBB/XBB.1.5-related infections. Given the findings, the CDC urged people to stay up to date on their recommended COVID-19 vaccines.

☆ Omicron booster shots provide some protection against mild illness from Covid XBB subvariants, CDC says
▼ + stars: | 2023-01-25 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The CDC study published Wednesday provides the first estimate of the omicron booster shots' real-world effectiveness against the XBB family of subvariants. Some scientists have warned the XBB subvariants could cause another Covid wave because they are so good at evading the antibodies that block infections. The study compared people who received the new booster with those who received between two and four doses of the original vaccine. People who only received the original shots generally got their last dose about 13 months ago. But the CDC study found that the omicron boosters provide about as much protection against the XBB family as they do against the BA.5 subvariant and its descendants such as BQ.1 and BQ.1.1.

☆ FDA proposes simplifying the Covid vaccine schedule, making it similar to the flu shot
▼ + stars: | 2023-01-23 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

Food and Drug Administration advisers will meet Thursday to discuss simplifying the Covid vaccination schedule, allowing most people to get the currently available booster, regardless of how many doses they had received before that. The FDA is proposing skipping over that primary series, meaning that most unvaccinated individuals could go ahead and get the latest booster shot if they decided to get a Covid vaccine. The FDA’s proposal, experts say, would greatly simplify the Covid vaccination schedule in the United States — aligning it more closely with the annual flu shot. In another similarity to the flu shot, the FDA is considering whether the Covid vaccine should be updated at least once a year, based on what strains are in circulation. Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University in Baltimore, said simplifying the Covid vaccine schedule makes sense.

☆ 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.

☆ U.S. FDA proposes shift to annual COVID vaccine shots
▼ + stars: | 2023-01-23 | by ( ) www.reuters.com time to read: +2 min

It has also asked the panel to consider the usage of two COVID vaccine shots a year for some young children, and in older adults and persons with compromised immunity. The regulator also sought its advisers' views on the need for routine selection of variants for updating the vaccine, similar to the way strains for flu vaccines are changed annually. The agency expects that simplifying the COVID vaccine composition and annual immunization schedules may contribute to less complicated vaccine deployment, fewer vaccine administration errors and less complex communication, which could potentially lead to improved vaccine coverage rates. Currently, most people in the United States need to first get two doses of the original COVID vaccine spaced 3-4 weeks apart, depending on the vaccine, followed by a booster a few months later. The FDA's proposal follows the European regulator's backing last month for the use of bivalent COVID shots for primary vaccination.

☆ 16 breakout stocks are forming the bullish golden cross chart pattern
▼ + stars: | 2023-01-23 | by ( Michelle Fox | ) www.cnbc.com time to read: +3 min

The names are forming a "golden cross" pattern, which is when the 50-day moving average crosses above the 200-day moving average. Its 50-day moving average is 6% above its 200-day moving average. Another solar company, First Solar , also made the list, with its 50-day moving average 18% higher than its 200-day moving average. Its 50-day moving average is 10% above its 200-day moving average. The company's 50-day moving average is 9% above its 200-day moving average.

☆ This under-the-radar biotech stock is an overlooked buying opportunity that could almost double, UBS says
▼ + stars: | 2023-01-19 | by ( Sarah Min | ) www.cnbc.com time to read: +2 min

CureVac N.V. is an "underappreciated" buying opportunity, according to UBS. CureVac said this month that it plans to hold further patient trials of its mRNA vaccines for Covid-19 and the flu. But CureVac has surged more than 50% this year, and the UBS analyst expects the stock has further to climb. Her $18 price target, up from $8, implies the shares can surge roughly 90% from Wednesday's closing price. We note additional Ph1 data is expected near-term," the UBS analyst wrote.

Before the market opened, U.S. economic data showed retail sales and producer prices declined more than expected in December, while production at U.S. factories fell more than expected and November output was weaker than thought. The Dow Jones Industrial Average (.DJI) fell 613.89 points, or 1.81%, to 33,296.96 and the S&P 500 (.SPX) lost 62.11 points, or 1.56%, to 3,928.86. Today's economic data served as a trigger to initiate a profit taking spell and the groups with most profits to take have been the ones that have done best last year," said Stovall. Earlier in the day, St. Louis Fed President James Bullard and Cleveland Fed President Loretta Mester stressed on the need to raise rates beyond 5% to bring inflation to heel. The S&P 500 posted nine new 52-week highs and 2 new lows; the Nasdaq Composite recorded 78 new highs and 20 new lows.

☆ Moderna Finds Life After Covid-19
▼ + stars: | 2023-01-18 | by ( David Wainer | ) www.wsj.com time to read: 1 min

There are few examples in modern history of a company like Moderna . As recently chronicled by Wall Street Journal reporter Peter Loftus in his book “The Messenger,” at the start of 2020 Moderna was a tiny biotech company with dim prospects and an experimental technology—messenger RNA—that looked years away from delivering any products. Then came Covid-19, and everything changed.

☆ Davos 2023: What you need to know about the WEF on Wednesday
▼ + stars: | 2023-01-18 | by ( Kathryn Lurie | ) www.reuters.com time to read: +2 min

DAVOS, Switzerland, Jan 18 (Reuters) - Climate change came to the fore at the World Economic Forum's annual meeting, where U.N. Secretary-General Antonio Guterres called on business leaders to follow the principles outlined by an expert group to make credible net-zero pledges or risk greenwashing. The United Nations and standard setter the International Organization for Standardization launched the guidelines in November to become a reference text and help organizations come up with solid plans, avoiding slogans, hype and obfuscation. With activist Greta Thunberg set to arrive in Davos and meet International Energy Agency (IEA) executive director Fatih Birol on Thursday, climate change is set to remain centre stage. China could see a sharp recovery in economic growth from the second quarter onwards based on current infection trends after the dismantling of most COVID-19 restrictions, Gopinath said. For daily Davos updates in your inbox sign up for the Reuters Daily Briefing hereEditing by Alexander SmithOur Standards: The Thomson Reuters Trust Principles.

Markets reacted positively to data, which showed retail sales and producer prices declined more than expected in December. However, the gains were short-lived as St. Louis Fed President James Bullard and Cleveland Fed President Loretta Mester stressed on the need to raise rates beyond 5% to bring inflation to heel. U.S. stock markets have started 2023 on a strong footing on hopes that a moderation in inflationary pressures could give the Fed cover to dial down the size of its interest rate hikes. Declining issues outnumbered advancers for a 1.23-to-1 ratio on the NYSE and a 1.53-to-1 ratio on the Nasdaq. The S&P index recorded nine new 52-week highs and two new lows, while the Nasdaq recorded 63 new highs and 12 new lows.

☆ Moderna’s RSV Vaccine Reduces Risk of Respiratory Diseases, Study Finds
▼ + stars: | 2023-01-18 | by ( Peter Loftus | ) www.wsj.com time to read: 1 min

Moderna says it will apply in the coming months for regulatory approval to sell its vaccine against RSV. An experimental vaccine from Moderna Inc. significantly reduced the risk of a viral respiratory disease among older adults in a large clinical trial, the latest promising sign in drugmakers’ efforts to fight the deadly RSV virus. Based on the results, the Cambridge, Mass., company said Tuesday it would apply in the coming months for U.S. regulatory approval to sell its vaccine against RSV, which stands for respiratory syncytial virus. If regulators approve, it could become available by early 2024, the company said.

☆ Stocks making the biggest moves midday: Microsoft, Moderna, Mobileye, Chegg and more
▼ + stars: | 2023-01-18 | by ( Sarah Min | ) www.cnbc.com time to read: +3 min

The company reported fourth-quarter results fell short of analysts' expectations on both top and bottom lines, according to StreetAccount. Chegg — Shares fell 15% after Needham downgraded Chegg to hold from buy, saying the online education company will have trouble reaching consensus for full-year revenue growth in Chegg Services, according to StreetAccount. Mobileye — Shares of the assisted driving company gained 8% after Deutsche Bank initiated coverage of the stock as a buy. Oatly Group — Shares of Oatly Group fell nearly 2%, losing steam after Mizuho upgraded the stock to buy from neutral. Hancock Whitney — Shares fell more than 4% after the bank reported earnings that came mostly in line with expectations, but net interest income came in below expectations, according to StreetAccount.

☆ 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.

☆ Davos 2023: Moderna CEO in talks with China to supply COVID vaccines
▼ + stars: | 2023-01-18 | by ( Brenda Goh | ) www.reuters.com time to read: +2 min

DAVOS, Switzerland, Jan 18 (Reuters) - Moderna (MRNA.O) chief executive Stephane Bancel said on Wednesday the U.S. company was in active discussions to supply COVID-19 vaccines to China. Beijing has so far insisted on using only Chinese-made COVID-19 vaccines for its own population, but the country is beset by a raging COVID outbreak following a U-turn from Beijing on previously ultra-tight anti-pandemic curbs. China-made COVID vaccines are of the inactivated virus type and not based on the messenger RNA technology used in the most widely used shots developed by Moderna and Pfizer (PFE.N)-BioNTech (22UAy.DE). As regards cancer treatments, Moderna has been working with Merck (MRK.N) on an experimental vaccine against melanoma based on the mRNA technology used in successful COVID-19 vaccines. The company, whose COVID-19 vaccines are made in the United States and Switzerland, is building or planning to build plants in Canada, Australia, Britain and Kenya, he said.

☆ Stocks making the biggest moves premarket: United Airlines, Moderna, IBM and more
▼ + stars: | 2023-01-18 | by ( Samantha Subin | ) www.cnbc.com time to read: +3 min

United Airlines – Shares of United Airlines rose 3.5% after the company reported quarterly earnings that topped Wall Street's estimates for the fourth quarter, signaling strong demand amid higher prices. United posted adjusted earnings per share of $2.46 on $12.4 billion in revenue. Analysts expected adjusted earnings per share of $2.10 and $12.2 billion in revenue, per Refinitiv. Analysts surveyed by StreetAccount had anticipated adjusted earnings of $2.44 per share on revenues of $3.81 billion. PNC reported $3.49 in adjusted earnings per share on $3.68 billion of revenue.

☆ Three-Stock Lunch: MRNA, SCHW & KHC
▼ + 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 EmailThree-Stock Lunch: MRNA, SCHW & KHCCourtney Garcia, senior wealth advisors at Payne Capital Management, joins 'Power Lunch' to share recommendations for three stocks: Moderna, Schwab and Kraft Heinz.

☆ Jim Cramer's top 10 things to watch in the market Wednesday: Inflation cools, Microsoft job cuts
▼ + stars: | 2023-01-18 | by ( Jim Cramer | ) www.cnbc.com time to read: +4 min

But I think this Club stock has broken away from the pack. Wells Fargo cuts price target on Goldman Sachs (GS) to $390 per share from $400 after Tuesday's earnings disappointment. UBS cuts price target on UnitedHealth (UNH) to $550 per share from $590 after a largely solid quarter; keeps neutral (hold) rating. Analysts also reiterated their $185-per-share price target on the Club stock, which represents over 38% upside from Tuesday's close. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade.

☆ 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.

A reading from the Commerce Department showed retail sales fell 1.1% in December against expectations of a 0.8% drop, while a separate report showed producer prices declined more than expected in December. Traders' bets of a 25-basis point rate hike rose after the data, while U.S. 10-year Treasury yields fell to a four-month low. Analysts now expect year-over-year earnings from S&P 500 companies to decline 2.6% for the quarter, according to Refinitiv data, compared with a 1.6% decline in the beginning of 2023. Among major S&P 500 sectors, consumer discretionary stocks (.SPLRCD) were up 1%, leading gains. U.S. stock markets have started 2023 on a strong footing on hopes that a moderation in inflationary pressures could give the Fed cover to dial down the size of its interest rate hikes.

☆ Moderna CEO: We're preparing our FDA filing for our RSV vaccine
▼ + stars: | 2023-01-18 | 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 CEO: We're preparing our FDA filing for our RSV vaccineModerna CEO Stephane Bancel joins 'Squawk Box' to discuss the company's accomplishments in the last few years, insight into the company's RSV vaccine, and more.

Search resuls for: "modernă"

25 mentions found