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☆ Novavax shares plunge as company raises doubts about its ability to remain in business
▼ + stars: | 2023-02-28 | by ( ) 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. Covid-19 vaccine maker Novavax on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign. The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered.

☆ Novavax raises doubts about its ability to remain in business
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

NEW YORK, Feb 28 (Reuters) - COVID-19 vaccine maker Novavax Inc (NVAX.O) on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign. The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ Space, Life Science, and Quantum Computing Innovations
▼ + stars: | 2023-02-27 | by ( Sponsor Post | Created Insider Studios With The Uk'S Department For Business | ) www.businessinsider.com time to read: +8 min

According to the Global Innovation Index 2022, global government R&D investment is growing and the UK is ranked fourth for global innovation (and third most innovative economy in Europe). "Space observation is vital for our planet — the UK invests in the European Space Agency and at the Space Cluster at Harwell, a significant science and innovation park." Jo Hawley, deputy director for aerospace, space and automotive at DBT, reported that the UK space sector spent £836 million on R&D in 2021. The company has reported strong growth of its life science research tools business, reflected in the international footprint of its commercial and distribution operations. The Department for Business and Trade can connect you with dedicated, professional assistance to locate R&D investment opportunities and support.

☆ 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.

"When you think about traditional drug and vaccine development and longevity of sales, it's usually much more spread out," Morningstar analyst Damien Conover said. The sudden inflow of revenue should prod companies to strike deals and link up with new partners, he said. Vaccine maker Moderna also expects 2023 revenue to fall sharply. The company's only product - its messenger RNA COVID vaccine - pulled in around $18.4 billion in 2022. Eli Lilly and Co (LLY.N) made $2 billion in 2022 from monoclonal antibody COVID treatments and is not expecting any revenue from the business in 2023.

In 2023, it expects revenue to be $67 billion to $71 billion. Excluding the COVID-19 drugs, Pfizer expects 2023 revenue to grow 7% to 9%. Pfizer developed its COVID-19 vaccine with German partner BioNTech , and the companies split the profits. The U.S. drugmaker forecast 2023 sales of $13.5 billion from the shot, below Refinitiv estimates of $14.39 billion, and projected $8 billion in sales of Paxlovid, short of analysts' expectation of $10.33 billion. After that transition, the company hopes to roughly quadruple the U.S. price of the COVID-19 vaccine.

Shortly after the opening bell, we will be buying 50 shares of Johnson & Johnson (JNJ) at roughly $161.81 apiece. Shares of Johnson & Johnson were hit hard Monday after a federal appeals court rejected the company's bankruptcy strategy for tens of thousands of lawsuits related to the company's talc-based baby powder. J & J stock closed down 3.7% Monday, at $162 a share. Johnson & Johnson has won the majority of talc cases brought against it since these lawsuits began. Johnson & Johnson has won the majority of talc cases brought against it since these lawsuits began.

☆ Pfizer expects 2023 sales to decline by as much as 33% compared with record-breaking 2022
▼ + stars: | 2023-01-31 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Pfizer on Tuesday issued sales guidance of $67 billion to $71 billion for 2023, a decline from its record-breaking 2022 results. The pharmaceutical company booked $100.3 billion for full-year 2022, an all-time high driven by more than $50 billion in Covid vaccine and antiviral sales. Pfizer expects revenue for 2023 to decline up to 33% compared with 2022 as the pandemic eases and demand for its Covid portfolio slides. The company expects $13.5 billion in Covid vaccine sales in 2023 and $8 billion in revenue for Paxlovid. The company booked net income $31.4 billion in 2022, a 43% increase over 2021.

☆ The Covid pandemic drives Pfizer's 2022 revenue to a record $100 billion
▼ + stars: | 2023-01-31 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The ongoing Covid-19 pandemic propelled pharmaceutical company Pfizer's earnings to a record $100 billion last year, almost $57 billion of which was driven by its vaccine and antiviral pill Paxlovid. The vaccine accounted for $37.8 billion, up just 3% from 2021, of Pfizer's total sales as demand for the shots slowed. But sales of its blockbuster antiviral treatment made up for that softening, surging to $18.9 billion in 2022, the first full-year that Paxlovid was on the market. Covid vaccines sales are projected to plummet by 64% this year to $13.5 billion from $37.8 billion in 2022. Paxlovid sales are expected to drop 58% to $8 billion in 2023 from $18.9 billion in 2022.

☆ The Covid sales boom is over for Pfizer
▼ + stars: | 2023-01-31 | by ( Paul R. La Monica | ) edition.cnn.com time to read: +3 min

New York CNN —Pfizer generated nearly $57 billion in combined sales last year from its Comirnaty Covid-19 vaccine and Paxlovid antiviral pill. Pfizer (PFE) told Wall Street Tuesday that it expects Covid-related sales to plunge to $21.5 billion this year… below Wall Street’s forecasts. Pfizer noted that it now expects to sell just $13.5 billion of its vaccine and $8 billion of the Paxlovid pill this year. Wall Street was expecting vaccine revenue of $14.4 billion and $10.3 billion of Paxlovid for 2023, according to estimates tracked by Refinitiv. Pfizer reported Comirnaty sales of $37.8 billion last year and revenue of $18.9 billion from Paxlovid.

REUTERS/Athit Perawongmetha/Summary WHO's executive board meets from Jan. 30-Feb. 7WHO seeking $6.86 bln for 2024-2025 budgetBody seen pushing for bigger role in global health crisesGENEVA, Jan 30 (Reuters) - The World Health Organization will push at its board meeting this week for an expanded role in tackling the next global health emergency after COVID-19, but is still seeking answers on how to fund it, according to health policy experts. Also on his list was "the position of the World Health Organization, recognizing there is a need for a reinforced central role for WHO" in the global health emergency system. "It's a huge knot," said Nicoletta Dentico, the co-chair of the civil society platform the Geneval Global Health Hub. PANDEMIC PREPARATIONThe WHO, which celebrates its 75-year anniversary having been set up in 1948, will also use the meeting to advocate for a boosted role in pandemic preparedness, documents showed. Tedros will call for a Global Health Emergency Council to be set up linked to WHO governance.

☆ Stocks making the biggest moves midday: Carvana, Colgate-Palmolive, Tesla and more
▼ + stars: | 2023-01-30 | by ( Pia Singh | ) www.cnbc.com time to read: +2 min

Tesla — Shares dropped 2.8% after Berenberg lowered its earnings estimate for Tesla by around 25% for 2023 following the company's price cuts for its electric vehicles. Ford Motor Company — Shares fell nearly 1.4% after the company announced price cuts for its electric Mustang Mach-E crossover. The move in Ford comes after Tesla said earlier this month it would trim prices to counteract dwindling demand. AMC Entertainment — Common shares of the theater chain fell by more than 7% after AMC announced a shareholder meeting in March for a potential change to its capital structure. The preferred or "APE" shares, which trade at a large discount to the common shares, jumped by more than 16%.

An advisory committee to the Food and Drug Administration on Thursday raised doubts about shifting toward a yearly Covid booster for most adults and children, saying too many questions about the virus still remain unanswered. The FDA convened its Vaccine and Related Biology Products Advisory Committee to discuss how the Covid vaccines may change moving forward. On Monday, the agency published briefing documents proposing annual Covid shots that target the latest variants of the virus — an approach similar to the yearly flu shot. Some committee members said they would prefer to make multiple yearly meetings on the Covid vaccines the norm. In a unanimous vote, the committee recommended using the bivalent formula in all Covid vaccines moving forward, not just for booster shots.

☆ Exclusive: EU may pay more for Pfizer COVID shots in return for lower volume
▼ + stars: | 2023-01-27 | by ( Maggie Fick | ) www.reuters.com time to read: +5 min

A Pfizer spokesperson declined to comment on details of the discussions, but said the company has shown ongoing commitment to accommodating EU member state concerns. Most people in the EU who wanted a primary course of the COVID-19 vaccine, and those who were later eligible for boosters, have received them. In May 2021, Brussels signed a contract with Pfizer and BioNTech to buy 900 million doses, with an option for an additional 900 million doses, by the end of 2023. Around half or more of the first 900 million doses from that contract have not yet been delivered because demand dropped last year. That came after EU governments warned Pfizer and other companies that millions of doses could go to waste.

☆ Stocks making the biggest moves midday: American Express, Intel, Silvergate Capital and more
▼ + stars: | 2023-01-27 | by ( Tanaya Macheel | ) www.cnbc.com time to read: +3 min

Colgate-Palmolive — Shares fell more than 4% after Colgate-Palmolive released its latest earnings results. The guidance came even as the company reported earnings that beat on top and bottom lines. Visa — The payments stock rose by more than 2% after a better-than-expected fiscal first quarter. Analysts surveyed by Refinitiv had expected earnings of $2.01 per share on revenue of $7.7 billion. Net revenue rose 12% year over year, with total cross-border volume climbing 22%.

☆ U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot
▼ + stars: | 2023-01-26 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases. The new data was presented at a meeting of outside experts that advise the FDA on vaccine policy. Most of the confirmed cases had also received a flu vaccine at the same time, which might be a factor, she said. FDA scientist Richard Forshee said the agency plans to study whether there is any increased risk of stroke from receiving the two shots at the same time. Both agencies still recommend older adults receive the booster shots, now tailored to target Omicron variants as well as the original coronavirus.

☆ 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.

☆ FDA doesn't see increased risk of stroke for seniors who received Pfizer's omicron booster
▼ + stars: | 2023-01-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The CDC's Vaccine Safety Datalink, which monitors serious reactions to vaccines, showed a possible risk of stroke in late November. The FDA launched an extensive review of federal data after investigators at the Centers for Disease Control and Prevention detected a possible risk of stroke for seniors who received Pfizer's booster. The Food and Drug Administration hasn't found an increased risk of stroke for seniors who've received Pfizer's omicron booster shot, a federal health official said Thursday. The FDA reviewed CMS data from 4.25 million seniors who received Pfizer's omicron booster and did not identify any increased stroke risk. The Department of Veterans Affairs has also conducted preliminary review of its database and did not identify an increased stroke risk, Forshee said.

☆ 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.

"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.

☆ 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.

☆ 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.

☆ China should set aside politics and look at Covid jab imports, world's largest vaccine maker says
▼ + stars: | 2023-01-16 | by ( Jenni Reid | ) www.cnbc.com time to read: +1 min

China needs to move past political considerations and look at importing Covid-19 jabs to end the pandemic globally, according to the chief executive of the world's latest vaccine manufacturer. The main Covid vaccines approved for use in China are from Sinovac and Sinopharm. These jabs are less effective against the Omicron variant than are other mRNA vaccines, such as Pfizer and BioNTech's, several studies have found. Poonawalla said China's pandemic reaction of 2020 — which included building hospitals and infrastructure and taking precautions — showed that Beijing could respond rapidly. He stressed China's decision not to import vaccines from the U.S., India and elsewhere, which have been "very effective."

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