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☆ China OKs its first mRNA vaccine, from drugmaker CSPC
▼ + stars: | 2023-03-22 | by ( ) www.reuters.com time to read: +2 min

BEIJING, March 22 (Reuters) - China's CSPC Pharmaceutical Group Limited (1093.HK) said on Wednesday its messenger RNA (mRNA) COVID-19 vaccine had received emergency use authorisation from Chinese health authorities, making it the country's first domestically developed mRNA shot. China has declined to use mRNA vaccines from abroad and vaccines available in China are widely considered less effective than the Moderna (MRNA.O) and Pfizer (PFE.N)-BioNTech (22UAy.DE) mRNA shots. The company said its independently developed mRNA vaccine SYS6006 targets some major Omicron variants and its booster dose showed good neutralization effect against Omicron subvariants BA.5, BF.7, BQ.1.1., XBB.1.5 and CH.1.1. The firm got emergency approval to conduct clinical trials of the mRNA shot in April last year, around the same time as CanSino, another China-based company that is testing an mRNA Omicron booster shot. Shares in the company rose as much as 7.7% after the result and the announcement of the mRNA approval.

☆ U.S. FDA to soon decide on second round of Omicron-tailored boosters - WSJ
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

The agency continues to closely monitor the emerging data in the United States and globally, and that data will dictate any decision on additional updated boosters, the FDA said in a statement. The Centers for Disease Control and Prevention would have to recommend the shots after the FDA authorizes the second Omicron-tailored boosters from Pfizer-BioNTech (PFE.N)/(22UAy.DE) and Moderna (MRNA.O) for them to become widely available. Updated boosters have helped prevent symptomatic infections against the new XBB-related subvariants, according to data released by the CDC in January. The FDA authorized the so-called bivalent COVID boosters in August that target the BA.4 and BA.5 Omicron subvariants, along with the original strain of the coronavirus. Rollout of the updated boosters in the United States started the following month.

☆ Moderna expects to price its COVID vaccine at about $130 in the US
▼ + stars: | 2023-03-21 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

REUTERS/Hannah BeierMarch 20 (Reuters) - Moderna Inc (MRNA.O) expects to price its COVID-19 vaccine at around $130 per dose in the U.S. going forward as purchases move to the private sector from the government, the company’s president Stephen Hoge said in an interview on Monday. Hoge said the government's Medicare health plan for seniors pays $70 per dose for the seasonal influenza vaccine. Sanders, chair of the Senate’s powerful Health, Education, Labor and Pensions Committee, has said Moderna should not raise the price of its vaccine because of the government funding it received. He plans to question Moderna Chief Executive Stephane Bancel on the price increase at the hearing on Wednesday. Moderna in February forecast significantly declining 2023 COVID-19 vaccine sales, which reached $18.4 billion in 2022.

☆ BioNTech to develop, produce cancer drugs and vaccines in Jerusalem -Israel Fin Min
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: 1 min

Companies BioNTech SE FollowJERUSALEM, March 21 (Reuters) - Germany's BioNTech SE (22UAy.DE) signed a preliminary deal to set up a facility to produce cancer-related drugs and vaccines in Jerusalem, Israel's Finance Ministry said on Tuesday. Under the memorandum of understanding, BioNTech will develop the drugs and vaccines using mRNA technology in the Har Hotzvim technology park. It will also set up a research centre at the Weizmann Institute in central Israel. Reporting by Steven Scheer Editing by Ari RabinovitchOur Standards: The Thomson Reuters Trust Principles.

☆ If you had Covid before you were vaccinated, you might have less immunity than you think, study says
▼ + stars: | 2023-03-21 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Co-funded by the National Institutes of Health, the study released Monday challenges older research that suggested a prior Covid infection enhanced a vaccinated individual's immune response — a phenomenon known as hybrid immunity, which some scientists believe provides the best protection against reinfection. In the study, researchers from Stanford University analyzed how immune cells found in the blood called CD4+ T cells and CD8+ T cells respond to Covid infection and vaccination. The study found that vaccinating people who had never been infected with Covid before produced "robust" CD4+ and CD8+ T cell responses to the virus. Vaccination in those people also generated cell-signaling molecules that recruit other immune cells to help fight Covid, they said. Ray said the study, while interesting, needs to factor in long-term knowledge about how Covid immunity works: "It's probably not the last chapter in this story."

☆ U.S. FDA expands authorization of Pfizer bivalent COVID-19 shots in kids
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

March 14 (Reuters) - Pfizer Inc (PFE.N) said on Tuesday that the U.S. Food and Drug Administration had expanded the emergency use authorization (EUA) of the company and its partner BioNTech SE's (22UAy.DE) bivalent COVID-19 vaccine as a single booster dose in certain children. The amended authorization is for children six months through four years of age who have completed their initial three-dose vaccination with Pfizer's original shot. In December, the U.S. health regulator had authorized Pfizer/BioNTech's updated shot as a third dose to those aged six months through four years, who have not completed their primary vaccination series or are yet to receive the third dose. Shots for youngest children in the United States were only approved in June last year, making them the last group to become eligible for vaccination. Reporting by Pratik Jain; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ Pfizer agrees to revise EU COVID vaccine contract -FT
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +2 min

[1/2] Pfizer company logo is seen at a Pfizer office in Puurs, Belgium, December 2, 2022. Under the revised terms, Pfizer is asking for payment for doses ordered that will never be manufactured, the FT report said. Medzhidiev added that he believed other EU members also would not support the proposed deal in its current form. "The proposed Pfizer amendment to the Pfizer agreement is clearly unacceptable to us given the critical situation of vaccine oversupply in Bulgaria and unjustified financial burden for products destined for destruction," Medzhidiev said. The discussions included the possibility that Pfizer would reduce the up to 500 million COVID-19 vaccine doses the EU has committed to buy this year in return for a higher price.

☆ FDA authorizes Pfizer's Covid omicron booster as fourth shot for kids under 5
▼ + stars: | 2023-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration on Tuesday authorized Pfizer's omicron booster shot for kids under five years old who were previously vaccinated with three doses of the company's original vaccine. The new shot is bivalent, meaning it targets the original Covid strain as well as omicron BA.4 and BA.5. Pfizer's primary series for young children consists of three doses, while rival drugmaker Moderna's primary series for that same age group is only two. Since December, children in that age group who completed two doses of Pfizer's original vaccine have been eligible to receive the omicron booster as their third shot, or last dose in their primary series. One month after the children received the omicron booster, they demonstrated an immune response to both the original Covid strain and omicron BA.5 and BA.5

☆ Pfizer CEO says it will be able to deliver Seagen's cancer therapy at a scale not seen before with $43 billion deal
▼ + stars: | 2023-03-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Pfizer CEO Albert Bourla on Monday said the pharmaceutical giant will be able to deliver Seagen's cancer therapy to the world "at a scale that has not been seen before" with its $43 billion acquisition. Seagen will bulk up Pfizer's cancer treatment portfolio, bringing four approved cancer therapies with combined sales of nearly $2 billion in 2022. "These medicines are on a strong growth trajectory, with significant lifecycle programs anticipated to drive continued impact uptake and growth," Bourla said on a conference call earlier Monday morning. Seagen expects to generate about $2.2 billion in revenue this year, representing 12% year-over-year growth, according to a Pfizer press release. Pfizer added that Seagen could contribute more than $10 billion in risk-adjusted sales by 2030, "with potential for significant growth" beyond that year.

The company — which has its COVID-19 vaccine as the only marketed product after 35 years in business — on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. "While there is the potential for a substantial booster market ... we don't expect Novavax to be a major player in the booster opportunity." As of last close, Novavax's U.S.-listed shares were down 97% from their February 2021 record high of $331.68.

☆ Pfizer/BioNTech seeks U.S. nod for updated COVID vaccine as booster in kids under 5
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +1 min

March 1 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE (22UAy.DE) have applied for emergency use authorization of their Omicron-adapted COVID-19 vaccine in the United States as a booster dose for children aged six months through four years, the companies said on Wednesday. The Omicron-adapted vaccine is currently authorized by the U.S. health regulator as the third dose of the three-dose primary course of vaccination in the country for children in this age group. If the Food and Drug Administration (FDA) authorizes the vaccine as a booster dose, children who have completed their primary series - either with three doses of the Pfizer-BioNTech's original vaccine or with two doses of their original and one dose of the adapted vaccine - would be eligible to receive the booster dose at least two months after the completion of their primary series. Last week, the companies also filed an application to the FDA for a full approval of their Omicron-adapted COVID vaccine as a primary course and a booster dose for individuals 12 years of age and above. Reporting by Sriparna Roy in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ EU silence over Pfizer COVID contract talks is problem that won't go away -watchdog
▼ + stars: | 2023-03-01 | by ( Maggie Fick | ) www.reuters.com time to read: +3 min

[1/2] The European Ombudsman Emily O'Reilly speaks during an interview with Reuters in Brussels, Belgium February 28, 2023. The Commission said in June 2022 that it no longer had the texts, which later drew criticism from the EU ombudsman. O’Reilly argued many people would understand why von der Leyen approached Bourla to plead Europe’s case for vaccines, as tens of thousands of people on the continent were dying from COVID-19. It has proposed to other EU institutions that they do the same, the spokesperson added. In February, the New York Times said it was suing the Commission over failure to release the text messages.

☆ Covid vaccine maker Novavax says it may not survive
▼ + stars: | 2023-03-01 | by ( Paul R. La Monica | ) edition.cnn.com time to read: +2 min

New York CNN —Novavax, which makes the Nuvaxovid vaccine used to treat Covid-19, posted huge sales gains for the past three years during the height of the pandemic. But the company is now facing serious financial challenges — and has even warned it may not be able to survive. Shares of Novavax (NVAX) plunged more than 25% in early morning trading to a new multi-year low of under $7. Novavax hit a 52-week high of about $91 last year and was trading above $330 in February 2021. Novavax isn’t the only Covid-vaccine maker to disappoint Wall Street, though.

The stock had dropped 26.2% to $6.83 around 8:55 ET (13:55 GMT), while its Frankfurt-listed shares slumped more than 27%. The company - whose COVID vaccine is its only marketed product after 35 years in business - on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. As of last close, Novavax's U.S.-listed shares are down 97% from their February 2021 record high of $331.68.

☆ Novavax raises doubts about ability to remain in business, shares fall
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. Novavax's shares closed at $9.26 on Tuesday and fell to $6.90 in extended trading after reporting on its financial situation. "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.

☆ 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.

☆ 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 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.

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.

☆ 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.

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