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☆ Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says
▼ + stars: | 2023-06-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign. That means all three companies will start selling their updated Covid shots directly to health-care providers. The FDA staff's decision comes weeks after an advisory group to the World Health Organization recommended that Covid booster shots target XBB variants. Scientists have said that XBB strains are some of the most immune-evasive subvariants to date. Last year's Covid boosters were bivalent, meaning they targeted the original strain of the virus and omicron variants BA.4 and BA.5.

Organizations: . Food, Drug Administration, FDA, Pfizer, Moderna, World Health Organization, Moderna's, Centers for Disease Control Locations: U.S

☆ Fact Check-EMA recommends COVID vaccine during pregnancy
▼ + stars: | 2023-06-07 | by ( Reuters Fact Check | ) www.reuters.com time to read: +2 min

The EMA said it found evidence showing heavy menstrual bleeding can occur after COVID vaccination, concluding there was a “reasonable possibility” the vaccines may cause it (here). The EMA in fact encourages pregnant women to get vaccinated (here). Reuters previously addressed false claims that COVID-19 vaccines impact fertility and cause miscarriage, including (here), (here), (here) and (here). The European Medicines Agency (EMA) did not say COVID-19 vaccines cause infertility, nor advise pregnant women not to get vaccinated. The EMA, in fact, advises vaccination during pregnancy.

Persons: “, Read Organizations: European Medicines Agency, COVID, EMA, Moderna, Pfizer, Victoria, Imperial College London, Reuters

☆ Cancer vaccines poised to unlock 'new treatment paradigm' with Merck/Moderna data
▼ + stars: | 2023-06-05 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +5 min

The hope is for "a completely new treatment paradigm in cancer that will be better tolerated and unique to individual patients' tumors," said Dr. Jane Healy, an executive overseeing in early cancer treatment development at Merck. The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. Aiming at these unique proteins allows the immune system to kill cancer cells while leaving healthy tissue unscathed. With standard treatment, 90% of pancreatic cancer patients die within five years of diagnosis. The approach first primes the immune system with an older technology called a chimpanzee adenovirus vaccine that targets patients' tumors.

Persons: Andrew Kelly, Keytruda, Jane Healy, Germany's BioNTech, Vinod Balachandran, we've, we're, Andrew Allen, Healy, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Merck & Co, REUTERS, CHICAGO, Moderna Inc, American Society of Clinical Oncology, Merck, Moderna, Memorial Sloan Kettering Cancer Center, Thomson Locations: Kenilworth , New Jersey, U.S, Chicago, New York, Nature

☆ Moderna and Merck cancer vaccine used with Keytruda reduces risk of deadly skin cancer spreading
▼ + stars: | 2023-06-05 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Moderna and Merck's experimental cancer vaccine, used in combination with Merck 's Keytruda, reduced the risk of the most deadly form of skin cancer spreading to other parts of the body in a clinical trial, according to the midstage trial results published Monday. Moderna and Merck's cancer vaccine reduced the risk of melanoma spreading to other parts of the body or death by 65% in patients with stage 3 or 4 of the disease compared with patients who received Merck's immunotherapy treatment alone, the trial has found. Moderna and Merck will present the data at the American Society of Clinical Oncology's annual conference in Chicago at 5 p.m. The clinical trial has enrolled 157 patients who have had their cancer surgically removed. Patients in the treatment group receive 1 milligram injections of the vaccine every three weeks for nine total doses and 200 mg intravenous infusions of Keytruda every three weeks for about a year.

Persons: Merck Organizations: Moderna, Merck, American Society, Clinical Locations: Chicago

☆ As the market starts to cool down, Cramer says don't be afraid to stay bullish
▼ + stars: | 2023-06-03 | by ( Julie Coleman | ) www.cnbc.com time to read: +2 min

CNBC's Jim Cramer told investors on Friday to stay bullish going into the week ahead, even as the market starts to cool down. "I liked [the market] more yesterday than I do today because it's higher, and that's how you have to think." On Monday, Cramer will be watching Apple 's Worldwide Developers Conference, where new products, ideas and software updates will be on display. Cramer's bottom line is to stay bullish, as he believes the Fed won't drastically raise rates at its next meeting. "We are not going to overstay our bullish welcome mat because others are stomping on it," Cramer said.

Persons: CNBC's Jim Cramer, Cramer, everybody's, Brinker, Chipotle — Organizations: Apple, American Society of Clinical Oncology, Moderna, Merck, Bristol, Myers, Darden

☆ Cramer's Lightning Round: Novavax is a no-go
▼ + stars: | 2023-05-31 | by ( Julie Coleman | ) www.cnbc.com time to read: +1 min

Stock Chart Icon Stock chart icon Jazz Pharmaceuticals' year-to-date stock performance. Stock Chart Icon Stock chart icon ON Semiconductor's year-to-date stock performance. Stock Chart Icon Stock chart icon Novavax's year-to-date stock performance. Stock Chart Icon Stock chart icon Golar LNG's year-to-date stock performance. Stock Chart Icon Stock chart icon Tyson Foods' year-to-date stock performance.

Persons: it's, I'd, You've, Golar, Tyson Organizations: Jazz Pharmaceuticals, Investing, ON, Golar, New Fortress Energy, Tyson Foods Locations: Moderna

☆ Cramer says the money's in tech this year, tread carefully when it comes to any other sector
▼ + stars: | 2023-05-30 | by ( Julie Coleman | ) www.cnbc.com time to read: +2 min

The safest spot for your money right now is tech -- otherwise, tread carefully. "That's the defining feature of this market, because if you stray from a small portion of the tech complex, you're gonna be destroyed." The industries seeing losses on the market right now include energy, utilities, healthcare, real estate, consumer staples, materials, industrials and even banks, especially regional ones. Real estate is being badly burned as remote work persists, with office building owners like Boston Properties and Alexandria Real Estate seeing huge losses. To Cramer, tech is only immune to this widespread turmoil because of the boon that is generative AI.

Persons: CNBC's Jim Cramer, Cramer, Leidos, GPT Organizations: Moderna, CVS, Boston Properties, CNBC, Club Charitable Trust, Nvidia Locations: Real, Alexandria

☆ Human metapneumovirus: Doctors say this is the most important virus you’ve never heard of
▼ + stars: | 2023-05-29 | by ( Brenda Goodman | ) edition.cnn.com time to read: +7 min

Cases of human metapneumovirus, or HMPV, spiked this spring, according to US Centers for Disease Control and Prevention’s respiratory virus surveillance systems. An underestimated threatStudies show that HMPV causes as much misery in the US each year as the flu and a closely related virus, RSV. Like those infections, HMPV can lead to intensive care and fatal cases of pneumonia in older adults. Leigh Davidson caught human metapneumovirus during a family celebration in early April. The new virus was dubbed human metapneumovirus.

☆ Here’s what Pfizer and Moderna say is next for their Covid vaccines
▼ + stars: | 2023-05-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +9 min

Scott Olson | Getty ImagesThree years and billions of Covid vaccinations into the pandemic, Pfizer and Moderna say their work is far from over. Here's what Moderna and Pfizer say is next for their Covid shots. Annual Covid shotsPfizer and Moderna aim to keep up with a shift in the U.S. toward annual Covid shots rather than frequent booster doses. Miller, who helped lead the development of Moderna's Covid shot in 2020, said the advantages of using mRNA became evident earlier on in the pandemic. 'Next-generation' Covid shotsPfizer's and Moderna's Covid vaccines both deliver robust protection against the virus, but that immunity can start to fade after four to six months.

☆ TipRanks reveals the top 10 health care sector analysts of the past decade
▼ + stars: | 2023-05-21 | by ( Tipranks.Com Staff | ) www.cnbc.com time to read: +5 min

TipRanks leveraged its Experts Center tool to recognize the ones with a high success rate. We also analyzed each stock recommendation made by health care sector analysts in the past decade. TipRanks' algorithms calculated the statistical significance of each rating, average return and the analysts' overall success rate. The buy recommendation generated a return of 397.9% from May 12, 2020 to May 12, 2021. Boris Peaker - TD CowenBoris Peaker has the 10th spot on the list, with a success rate of 47%.

☆ Catalent cuts annual forecast hurt by operational challenges
▼ + stars: | 2023-05-19 | by ( ) www.reuters.com time to read: +2 min

May 19 (Reuters) - Catalent Inc (CTLT.N) cut its full-year net revenue and profit forecast on Friday, reflecting operational challenges and higher-than-expected costs after it flagged an over $400 million hit to both its annual sales and core profit forecasts earlier this month. The contract drug manufacturer now sees its full-year revenue in the range of $4.25 billion to $4.35 billion compared with its prior forecast of $4.63 billion to $4.88 billion. Catalent said it now sees adjusted net income for the year in the range of $187 million to $228 million, compared with the previous forecast of $567 million to $648 million. Shares of Catalent reversed losses to be up 7.7% at $34.63 before the bell. Reporting by Bhanvi Satija, Sriparna Roy and Pratik Jain in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

☆ WHO recommends new COVID shots should target only XBB variants
▼ + stars: | 2023-05-18 | by ( ) www.reuters.com time to read: +2 min

May 18 (Reuters) - A World Health Organization (WHO) advisory group on Thursday recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants. New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered. The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected. The bivalent booster shots developed and distributed last year targeted two different strains - the Omicron variant as well as the original virus. WHO's advisory group, which recommends if changes are needed to the composition of future COVID-19 shots, said currently approved vaccines should continue to be used in accordance with the agency's recommendations.

☆ 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.

☆ 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.

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.

☆ 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.

☆ 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.

☆ 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.

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