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☆ As earnings season winds down, investors turn to Tuesday's debt ceiling meeting
▼ + stars: | 2023-05-06 | by ( Zev Fima | ) www.cnbc.com time to read: +12 min

With only a small fraction of the S & P 500 left to report quarterly earnings, investors are now turning their focus to another major hurdle for the markets and economy: the debt ceiling crisis. Earlier this week, we looked back to debt limit crisis of 2011 for potential lessons. The protracted fight ultimately ended in an agreement in early August of that year, but it was a choppy summertime ride for investors. Within the portfolio, Wynn Resorts will report Tuesday, after the closing bell, and Disney will report on Wednesday, after the closing bell. Estee Lauder (EL) and Emerson Electric (EMR) reported earnings before the opening bell.

☆ Fact Check-COVID ‘monovalent’ vaccines not banned, FDA approval not withdrawn
▼ + stars: | 2023-04-25 | by ( Reuters Fact Check | ) www.reuters.com time to read: +6 min

But the original vaccines remain licensed in the United States and are not “banned” as suggested by some social media users. An FDA spokesperson also commented on the agency’s official Twitter account: “It's probably worth clarifying that the monovalent vaccines are still approved (licensed). EUA information for the Moderna and Pfizer vaccines can be seen on the FDA website (here) , (here). The FDA withdrew authorizations for emergency use of Pfizer-BioNTech and Moderna monovalent COVID vaccines while authorizing use of the updated, bivalent versions in all age groups. The agency did not withdraw its approval or license of the original vaccines, nor “ban” their use.

☆ US CDC signs off on second Omicron-updated COVID booster for older adults
▼ + stars: | 2023-04-19 | by ( ) www.reuters.com time to read: +1 min

April 19 (Reuters) - Older people and those with weakened immune systems may get a second dose of Omicron-targeting COVID-19 vaccines, the U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday. The agency's decision after its advisory committee's meeting aligns it with the U.S. Food and Drug Administration's authorization on Tuesday for a second dose of Omicron-updated booster for the specified high-risk population. Adults aged 65 years and older can take a second dose of the updated vaccine, the CDC said, while people who are immunocompromised can get additional doses. It also said the original COVID-19 vaccine will no longer be recommended for use in the United States. Monovalent COVID-19 vaccines from Novavax (NVAX.O) or Johnson & Johnson's (JNJ.N) Janssen were not affected by the changes made today, the agency said.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took Moderna about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.

April 11 (Reuters) - A U.S. appeals court handed Moderna Inc (MRNA.O) a win on Tuesday, affirming a decision to cancel an Arbutus Biopharma Corp (ABUS.O) patent related to the companies' legal fight over Moderna's blockbuster COVID-19 vaccines. The U.S. Court of Appeals for the Federal Circuit upheld a U.S. Patent and Trademark Office tribunal's ruling that the patent for Arbutus' lipid nanoparticle (LNP) technology was invalid based on an earlier Arbutus patent that disclosed the same invention. Moderna challenged the patent at the PTO's Patent Trial and Appeal Board in 2018, and the board invalidated it in 2019. Arbutus separately sued Pfizer and BioNTech for patent infringement last week over their COVID-19 shots, in a lawsuit that also does not include the canceled patent. The Federal Circuit case is Arbutus Biopharma Corp v. ModernaTX Inc, U.S. Court of Appeals for the Federal Circuit, No.

☆ Fact Check-Document mentioning cryogenic-electron microscopy does not prove Pfizer COVID-19 vaccine contains graphene oxide
▼ + stars: | 2023-04-04 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

Graphene oxide is not an ingredient in the vaccine,” she said. When contacted by Reuters, a Pfizer spokesperson sent a link with the full list of ingredients of the Pfizer-BioNTech COVID-19 vaccine (here, see page six). No graphene oxide is listed. “We confirm that graphene oxide is not used in the manufacture of the Pfizer-BioNTech COVID-19 vaccine,” the spokesperson said. The Pfizer COVID-19 vaccine does not contain graphene oxide.

☆ Fact Check-Experts say Pfizer COVID vaccine trials did not cause more miscarriages and there is no evidence of COVID-19 vaccine impact on fertility
▼ + stars: | 2023-03-31 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

Women who got pregnant during Pfizer’s COVID vaccine trials did not have an unusual rate of miscarriage, experts said as they responded to an online video. This is a miscarriage rate of 14%, which is within the “normal” or expected rate of miscarriage per pregnancy, Male said. They also said there is no evidence of impact from COVID-19 vaccines on fertility. Pfizer started a global trial of pregnant women in February 2021. There is no evidence that COVID-19 vaccines affect fertility and pregnancies during Pfizer’s COVID vaccine trials did not have an unusual rate of miscarriage.

☆ BioNTech shares slip on gloomy Covid vaccine sales outlook
▼ + stars: | 2023-03-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Shares of BioNTech on Monday slid by more than 6% in morning trading after the German drugmaker shared a gloomy 2023 sales outlook for its Covid vaccine jointly developed with Pfizer . The drugmaker expects that demand to fall further this year, forecasting Covid vaccine revenue to hit 5 billion euros, or $5.4 billion. BioNTech noted in an earnings release that its efforts to adapt the Covid vaccine to new strains of the virus are expected to increase demand for the product this year. BioNTech is the latest company to forecast a slump in demand for Covid products as the world emerges from the pandemic. Its partner Pfizer told investors in January that it expects Covid vaccine sales to plummet by 64% this year and sales of its Covid antiviral treatment Paxlovid to drop by 58%.

☆ The Street awaits key inflation report next week as banking worries persist
▼ + stars: | 2023-03-25 | by ( Zev Fima | ) www.cnbc.com time to read: +8 min

The personal spending and income report, out this coming Friday, has the Federal Reserve's preferred measure of inflation: the core personal consumption expenditure (PCE) price index. In comparison, the consumer price index (CPI), released this past week, only tracks price changes over time. It was a positive week for the major averages, despite some midweek volatility driven by comments from Treasury officials. The PCE price index and other inflation reports face heightened scrutiny in the coming months as the market is becoming more at odds with the Fed's base case. ET: Gross Domestic Product; Price Index Friday, March 31 Before the bell: 8:30 a.m.

☆ 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.

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