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☆ Universal flu vaccine based on mRNA tech to be tested by National Institutes of Health
▼ + stars: | 2023-05-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Patients are now enrolling in an early stage clinical trial to test a universal flu vaccine based on messenger RNA technology, the National Institutes of Health announced Monday. "A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic," Dr. Hugh Auchincloss, acting director of National Institute of Allergy and Infectious Diseases, said in a statement Monday. The universal flu vaccine trial will enroll up to 50 healthy people ages 18 through 49 to test whether the experimental shot is safe and produces an immune response, according to NIH. The universal shot was developed by researchers at the National Institute of Allergy and Infectious Diseases. The dominant flu strains can change between the time when experts select the strains and the manufacturers roll the shots out.

☆ Biden to nominate cancer surgeon Monica Bertagnolli to lead National Institutes of Health
▼ + stars: | 2023-05-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Dr. Monica Bertagnolli speaks during a visit from first lady Jill Biden to the University of California San Francisco Helen Diller Family Comprehensive Cancer Center in San Francisco, Oct. 7, 2022. President Joe Biden will nominate Dr. Monica Bertagnolli, a cancer surgeon, to lead the National Institutes of Health, the White House announced Monday. Bertagnolli is currently the director of the National Cancer Institute and is the first woman to lead the organization. The NIH, which has a budget of about $45 billion, funds medical research across the U.S. and around the world. The agency played a pivotal role in developing the messenger RNA technology that underlies the Covid-19 vaccine made by Moderna.

☆ Here's why Covid vaccines will still be free for uninsured Americans as public health emergency ends
▼ + stars: | 2023-05-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Vanessa Leroy | Bloomberg | Getty ImagesBut the vast majority of Americans will not have to pay out of pocket for Covid vaccines even after the federal government's stockpile runs out. Insured Americans will be able to access Covid shots as part of their coverage, without having to pay out of pocket. Under the arrangement, the CDC will continue to purchase Covid vaccines at a discount and distribute them through 64 state and local health departments. That HHS effort will leverage the "public commitments" by drug manufacturers to provide free Covid vaccines and treatments to uninsured people. Pfizer and Moderna have not said whether they would supply free shots to pharmacies.

☆ Pfizer CEO says Medicare will likely face legal action over drug price negotiations
▼ + stars: | 2023-05-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Pfizer CEO Albert Bourla on Thursday said pharmaceutical companies will likely take legal action against Medicare drug price negotiations, which aim to cut costs for older Americans, but will likely reduce company profits. Bourla referred to a provision in the Biden administration's Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. The first negotiations start in September and new prices will go into effect in 2026. Some drugmakers are already preparing to fight Medicare drug negotiations, industry sources told Reuters. Another provision of the Inflation Reduction Act requires Pfizer and other prescription drug companies to refund Medicare through rebates if the prices of their drugs rise faster than the rate of inflation.

Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects. Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year. Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.

☆ Novavax surges more than 25% after company unveils job cuts, positive vaccine data
▼ + stars: | 2023-05-09 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. The company's Covid vaccine is its lone marketed product after 35 years in business. The company reported R&D expenses of $258 million and SG&A expenses of $162 million last year. The company raced against Pfizer and Moderna to develop the first Covid vaccine early in the pandemic. Novavax's shot is the first Covid vaccine to use protein technology, a decades-old method for fighting viruses used in routine vaccinations against hepatitis B and shingles.

☆ Catalent shares tank on warning of $400 mln cut to annual revenue forecast
▼ + stars: | 2023-05-08 | by ( ) www.reuters.com time to read: +2 min

May 8 (Reuters) - Catalent Inc (CTLT.N) expects to cut by more than $400 million both its full-year revenue and core profit forecasts, the contract drug manufacturer said on Monday, sending its shares tumbling 27% to a three-year low. In April, Catalent had flagged productivity issues and warned that a slower-than-expected ramp up in production capacity would hit quarterly results. Catalent had been the sole contract manufacturer for Novo Nordisk's (NOVOb.CO) weight-loss drug Wegovy, but the Danish company last month unveiled a second contract manufacturer to help meet sky-rocketing demand. Catalent in February forecast full-year net revenue of $4.63 billion to $4.88 billion and adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) of $1.22 billion to $1.30 billion. Reporting by Sriparna Roy in Bengaluru; Editing by Savio D'SouzaOur Standards: The Thomson Reuters Trust Principles.

☆ Morning Bid: Hike and hold, bank angst and Apple
▼ + stars: | 2023-05-04 | by ( ) www.reuters.com time to read: +5 min

As the Fed delivered what markets assume will be the last rate hike of a brutal 13-month, 500-basis-point tightening cycle, further aftershocks from the March bank blowups reverberated in the background. And given they had advance knowledge of next week's quarterly loan survey before Wednesday's rate decision, it suggests the bigger picture they see remains somewhat equivocal. Norway's central bank raised interest rates as expected and signalled more to come. Events to watch for on Thursday:* European Central Bank policy decision, statement and news conference* U.S. first quarter unit labor costs and productivity, April layoffs, March trade balance, weekly jobless claims. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.

May 4 (Reuters) - Moderna Inc (MRNA.O) on Thursday reported stronger-than-expected sales of $1.9 billion for its COVID-19 vaccine in the first quarter, driven by a surge of revenue deferred from 2022, but left its 2023 sales expectations unchanged. Moderna said it continued to expect COVID vaccine sales of $5 billion for the year based on advance purchase agreements. Moderna expects an additional $3 billion in deferred vaccine revenue in the second half of 2023. The results came two days after the company's rival Pfizer reported better-than-expected COVID vaccine sales for the first quarter and maintained its expectations for full-year sales. Moderna had generated around $36 billion in sales over the last two years from its COVID vaccine, its only commercial product and one of the most widely used shots for the virus.

☆ Futures waver as PacWest slide offsets Fed pause optimism
▼ + stars: | 2023-05-04 | by ( ) www.reuters.com time to read: +3 min

The Fed over the past 14 months has raised rates by 500 basis points to tame price pressures in its most aggressive policy tightening since the 1980s. The KBW Regional Banking index (.KRX) and S&P 500 Banks index (.SPXBK) have lost around 29% and 15% so far in 2023. Investors will also monitor weekly jobless claims for further clues on the state of the labor market. Qualcomm Inc (QCOM.O) slumped 6.7% after third-quarter forecasts missed estimates, while Etsy Inc (ETSY.O) gained 3% on beating expectations for quarterly revenue. Reporting by Ankika Biswas in Bengaluru; Editing by Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

☆ Moderna posts surprise quarterly profit despite waning demand for Covid vaccines
▼ + stars: | 2023-05-04 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Moderna on Thursday blew past estimates for first-quarter earnings and revenue, posting a surprise quarterly profit, despite lower demand for Covid vaccines, its only marketable product. The biotech company generated first-quarter sales of $1.9 billion, driven by Covid shot revenue deferred from 2022. Moderna maintained its full-year guidance of around $5 billion in revenue from its Covid vaccine, which will come from signed government contracts for the shot. But Covid shot demand is still falling as the pandemic eases and the U.S. shifts to an annual vaccination schedule rather than repeated booster doses. Moderna in April said it hopes to offer a new set of life-saving vaccines targeting cancer, heart disease and other conditions by 2030.

☆ Watch CNBC's full interview with Moderna CEO Stéphane Bancel
▼ + stars: | 2023-05-04 | 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 EmailWatch CNBC's full interview with Moderna CEO Stéphane BancelModerna CEO Stéphane Bancel joins 'Squawk Box' to discuss the company's quarterly earnings results, what's next for the biotech company in a post-Covid future, and more.

☆ Moderna CEO Stéphane Bancel on surprise Q1 profit, post-Covid future
▼ + stars: | 2023-05-04 | 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 Stéphane Bancel on surprise Q1 profit, post-Covid futureModerna CEO Stéphane Bancel joins 'Squawk Box' to discuss the company's quarterly earnings results, what's next for the biotech company in a post-Covid future, and more.

☆ US FDA approves first RSV vaccine from GSK
▼ + stars: | 2023-05-03 | by ( ) www.reuters.com time to read: +1 min

May 3 (Reuters) - The U.S. Food and Drug Administration has approved GSK Plc's (GSK.L) respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people. The vaccine was approved for people aged 60 and older, the company said. The approval makes GSK, which has been neck-and-neck with Pfizer (PFE.N) in RSV vaccine development, the first company to tap into a multi-billion-dollar market and puts it ahead of rivals such as Moderna Inc (MRNA.O) and Bavarian Nordic (BAVA.CO). Analysts have estimated the market for RSV vaccines to cross $10 billion by 2030. GSK expects the vaccine to be available before the next RSV season in the United States, Chief Commercial Officer Luke Miels told Reuters on Wednesday before the approval.

☆ FDA approves GSK's RSV vaccine for older adults, world's first shot against virus
▼ + stars: | 2023-05-03 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. London-based GSK during an earnings presentation last week said it has "millions" of doses of the RSV vaccine ready to ship. In March, an independent panel of advisors to the FDA recommended GSK's RSV vaccine based on data from a phase three trial on older adults. A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving GSK's vaccine, according to an FDA briefing document. The FDA flagged the disorder as a potential safety issue with Pfizer's RSV vaccine for older adults.

☆ R.S.V. Vaccine Approved for Older Adults
▼ + stars: | 2023-05-03 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes. vaccine for older adults is also expected to receive F.D.A. in older adults and said it expected authorization in the first half of this year. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.

☆ Stock futures fall after the Federal Reserve hikes rates and bank contagion fears return: Live updates
▼ + stars: | 2023-05-03 | by ( Darla Mercado | Cfp | ) www.cnbc.com time to read: +2 min

Stock futures fell after the Federal Reserve hiked rates by another 25 basis points and investors' fears of contagion in the regional bank space returned. S&P 500 futures shed 0.46%. Regional bank shares sold off hard, with Western Alliance tumbling nearly 30% and Zions Bancorporation dropping nearly 12%. Since the closure of Silicon Valley Bank in March, First Republic has joined the ranks of failed institutions and was recently taken over by JPMorgan Chase. "I believe with a very high degree of probability there's going to be further regional bank failures."

☆ Moderna's billionaire CEO draws criticism for earning nearly $400 million in stock options last year, and then getting a raise on top of it
▼ + stars: | 2023-04-29 | by ( Jordan Hart | ) www.businessinsider.com time to read: +3 min

French businessman Stéphane Bancel made $393 million in stock options in 2022, according to securities filings. Bancel, 50, also owns stocks valued around at least $2.8 billion, and received a 50% raise from 2021 to 2022. Moderna's chief executive officer Stéphane Bancel raked in about $393 million in 2022 thanks to stock options, and then received a raise on top of it — compensation that's giving some analysts pause. In addition to exercising his stock options in 2022, 50-year-old Bancel earned a $1.5 million salary — a 50% jump from 2021, according to securities filings from March. Meanwhile, Amazon CEO Andy Jassy's pay dropped from $212 million in 2021 to $1.3 million in 2022 due to receiving any stock awards.

☆ A solid start to earnings season will be put to the test in the week ahead
▼ + stars: | 2023-04-29 | by ( Zev Fima | ) www.cnbc.com time to read: +14 min

The biggest week of this earnings season showed us that things aren't as bad as many feared. The week ahead of earnings, including several more Club names, should tell us more. The results are always important, but it's the guidance and management commentary we will really hone in on to better understand the path ahead. In Amazon's case, a solid first quarter for its AWS cloud business was overshadowed by management seeing a material slowdown in April. ET: Nonfarm Payrolls Looking back It was the biggest week of this earnings season for the Club as several of our mega-cap holdings and industry bellwethers reported results.

☆ Markets next week have to contend with how aggressive the Fed drumbeat sounds
▼ + stars: | 2023-04-28 | by ( Scott Schnipper | ) www.cnbc.com time to read: +8 min

"Is Chairman Powell going to say, 'It is likely that we pause now and assess what the economy is going to do?' "The tone on that balance is going to be very critical to how the market is going to move next week." "What is [Powell] going to do? June Fed meeting The betting on Wall Street right now is that, after next week, the Fed will standpat at its next meeting six weeks later, on June 13-14. Beyond Apple, some 161 other companies in the S & P 500 index are scheduled to report latest-quarter results next week.

☆ CDC eases certain Covid-19 vaccine requirements for international travelers to US
▼ + stars: | 2023-04-28 | by ( Brenda Goodman | ) edition.cnn.com time to read: +2 min

CNN —The US Centers for Disease Control and Prevention is still requiring international visitors boarding flights to the United States to be vaccinated against Covid-19, but it’s easing vaccine requirements for those travelers. International travelers boarding flights to the United States will now be considered fully vaccinated two weeks after getting a single dose of either the Pfizer or Moderna mRNA vaccine any time after August 16, 2022, when bivalent formulations first became available. Previously, foreign travelers entering the United States were considered fully vaccinated two weeks after the second dose of a vaccine that required two primary doses, or two weeks after a vaccine that only required a single shot, such as the Johnson & Johnson vaccine. A number of older, monovalent vaccine regimens also qualify a foreign visitor as fully vaccinated. As part of the update, the older monovalent mRNA Covid-19 vaccines are no longer recommended in the United States, and updated vaccines are recommended for everyone age 6 months and older.

☆ Marriott, Moderna and more: CNBC's 'Halftime Report' traders answer your questions
▼ + stars: | 2023-04-27 | by ( Christina Falso | ) www.cnbc.com time to read: 1 min

On Thursday's "Ask Halftime," our traders answered questions from CNBC Pro subscribers about stocks, bonds and ETFs during this period of heightened market volatility, including whether to buy, sell or hold individual names. Jason Snipe of Odyssey Capital Advisors discussed Marriott and why he expects there is still upside for the hotel stock. Steve Weiss of Short Hills Capital owns Moderna and said he sees a recovery in the stock over the next few months as it seeks approval for its RSV vaccine. With the expectation that the Federal Reserve will cut rates later this year, SoFi's Liz Young suggested investors start unloading their short-term bonds by the end of this summer.

☆ Merck revenue falls after dramatic drop in sales of Covid antiviral treatment
▼ + stars: | 2023-04-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Merck on Thursday reported first-quarter revenue that fell 9% from the same period a year ago largely due to a steep drop in sales of its Covid antiviral treatment molnupiravir. Sales of molnupiravir plunged to $392 million during the period, down 88% from the $3.2 billion reported in the first quarter of 2022. Merck said the decrease is primarily the result of lower sales in the U.S., U.K., Japan and Australia. The company reported total revenue of $14.5 billion during the quarter, down nearly $1.5 billion from the same period a year ago. But Merck's pharmaceutical unit saw higher sales of the blockbuster antibody treatment Keytruda, which increased 20% to $5.8 billion during the quarter.

Chief Judge Colm Connolly's ruling for Alnylam Pharmaceuticals Inc (ALNY.O) came just over a month after a different judge in Delaware rejected Moderna's similar motion in another vaccine patent lawsuit. Representatives for Moderna and Alnylam did not immediately respond to requests for comment. Moderna made the same argument in a motion to dismiss part of another patent lawsuit brought by Arbutus Biopharma Corp (ABUS.O) and Genevant Sciences GmbH. U.S. District Judge Mitchell Goldberg rejected Moderna's motion in that case last year and said it had not yet proven the government was more than an "incidental beneficiary" of the shots. Goldberg denied the motion for a second time last month after the federal government backed Moderna's position.

☆ GSK beats first-quarter profit, revenue estimates
▼ + stars: | 2023-04-26 | by ( ) www.reuters.com time to read: +2 min

LONDON, April 26 (Reuters) - GSK (GSK.L) on Wednesday beat expectations for its first-quarter revenue and profit, helped by sales of its blockbuster shingles vaccine Shingrix. The London-listed drugmaker reported adjusted profit of 37 pence per share on revenue of about 7 billion pounds ($8.70 billion). Analysts were expecting 33.2 pence per share on revenue of about 6.5 billion pounds, according to company-compiled consensus estimates. In February, GSK predicted sales growth would increase by 6% to 8% and adjusted operating profit to increase by 10% to 12%, at constant exchange rates in 2023, versus 2022. GSK is also leaning in part on its vaccine for RSV, which leads to thousands of hospitalisations and deaths each year.

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