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☆ FDA pulls U.S. authorization for Eli Lilly's COVID drug bebtelovimab
▼ + stars: | 2022-11-30 | by ( ) www.reuters.com time to read: +1 min

Nov 30 (Reuters) - Eli Lilly and Co's COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron. Wednesday's announcement takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer Inc's (PFE.N) antiviral drug Paxlovid, Merck's (MRK.N) Lagevrio and Gilead Sciences' (GILD.O) Veklury as treatments for the disease, besides convalescent plasma for some patients. AstraZeneca Plc's monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people. The drug, which was discovered by Abcellera (ABCL.O) and commercialized by Eli Lilly, received an authorization from the FDA in February. BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last two months, surpassing Omicron's BA.5 sub-variant, which had driven cases earlier in the year.

☆ Big Pharma will muscle in on obesity gold rush
▼ + stars: | 2022-11-28 | by ( Aimee Donnellan | ) www.reuters.com time to read: +4 min

LONDON, Nov 28 (Reuters Breakingviews) - Obesity drugs are a modern day gold rush for drugmakers. By then, the obesity market could total $50 billion, according to Morgan Stanley. But a plausible 50% price cut would lower annual sales to $25 billion. Reuters GraphicsFollow @aimeedonnellan on TwitterCONTEXT NEWSSales of Novo Nordisk’s obesity drugs Wegovy and Saxenda reached nearly $1.2 billion in 2021, up 50% versus the previous year. Morgan Stanley analysts expect the obesity market to grow to $50 billion in annual sales by 2030.

Nov 24 (Reuters) - Recent uptake of COVID-19 vaccine booster doses in the European Union has been "rather disappointing," an official said on Thursday, amid concerns that protection against severe cases of the disease could weaken during the winter. WHO data released late on Wednesday showed that 724,000 new COVID-19 cases were reported in the EU over the past week, down 11% from the previous week. In early October, when experts were warning of a new COVID-19 wave, the number of weekly cases reached 1.5 million. The EMA intends to issue new guidelines for health care providers on the issue of such treatments, he said. But prompt access to Paxlovid remains an issue in the EU, and the EMA is working with governments to change this, he said.

☆ Researchers test mRNA technology for universal flu vaccine
▼ + stars: | 2022-11-24 | by ( Nancy Lapid | ) www.reuters.com time to read: +3 min

It delivers tiny lipid particles containing mRNA instructions for cells to create replicas of so-called hemagglutinin proteins that appear on influenza virus surfaces. A universal vaccine would not mean an end to flu seasons, but would replace the guess work that goes into developing annual shots months ahead of flu season each year. Moderna and Pfizer both have mRNA flu vaccines in late-stage human trials, and GSK (GSK.L) and partner CureVac (5CV.DE) are testing an mRNA flu vaccine in an early-stage safety trial in humans. These vaccines are designed to defend against only four recently-circulating influenza strains but could theoretically be changed up each year. The universal flu vaccine, if successful in human trials, would not necessarily prevent infection.

☆ Goldman Sachs says the S&P 500 will remain flat through 2023. Here's their 5-step playbook for finding returns — and avoiding crippling losses — next year.
▼ + stars: | 2022-11-23 | by ( William Edwards | ) www.businessinsider.com time to read: +4 min

Third, long-duration stocks that are unprofitable — typically these are growth stocks found in the tech sector — should be avoided, Kostin said. Fourth, Kostin likes stocks that have growing profit margins despite the tightening economic conditions. He shared a list of stocks with the most resilient profit margins over the last few year, and which are expected to grow margins next year. And finally, Kostin recommended avoiding stocks whose profit margin growth in recent years may have been due to a decrease in expenses as opposed to an increase in sales. Rising or normalizing expenses for these companies could chip away at profit margins.

Nov 22 (Reuters) - Australian drugmaker CSL Ltd (CSL.AX) on Tuesday set the list price of its one-time gene therapy for hemophilia B at $3.5 million, making it the world's most expensive treatment, following its approval by the U.S. health regulator. The first gene therapy for the rare genetic blood clotting disorder offers a long-term solution for patients as against current treatments from Biogen (BIIB.O), Pfizer (PFE.N) and others that focus on regular infusions. The gene therapy consists of an engineered virus carrying a gene expressed in the liver to produce clotting factor IX. While Zynteglo was priced at $2.8 million, Skysona had a wholesale cost of $3.0 million. CSL shares were up 1% at A$300.62 on the Australian stock exchange, while UniQure stock edged up 0.9% in extended trading.

☆ Updated COVID vaccines offer better protection than original -U.S. study
▼ + stars: | 2022-11-22 | by ( ) www.reuters.com time to read: +2 min

Nov 22 (Reuters) - Updated COVID-19 boosters offer increased protection against new variants in people who have previously received up to four doses of the older vaccine, a real-world study in the United States showed. The study of over 360,000 people, published in Morbidity and Mortality Weekly Report, offers the first evidence that the new vaccines by Pfizer-BioNTech (PFE.N)(22UAy.DE) and Moderna (MRNA.O) provide better protection compared to the original shots. Since their introduction in September, the vaccine boosters, which contain both original and Omicron BA.4/5 coronavirus strain, provided greater benefit to younger adults aged 18-49 years that those in the older age group. The variation in effectiveness was lower, in the range of 28-31%, when the boosters were given 2-3 months apart. The authors warned that the study may not be generalizable to future variants, as the dominant variants keep changing.

One of the biggest makers of generic drugs, Israeli-based Teva said it aims eventually to secure a 10% global market share of biosimilars. A division of Novartis (NOVN.S), Sandoz is currently the second biggest player after Pfizer Inc (PFE.N) in the biosimilar market by gross sales globally, per IQVIA data, cited by Sandoz. Sandoz launched eight biosimilar drugs between 2017 and 2021, including a version of Bristol-Myers’ multiple myeloma drug Revlimid. The analysis projected the value of the global biosimilar market could more than triple to an estimated $74 billion by 2030. Sandoz and Teva are both working on biosimilars for Humira.

☆ Final Trades: PFE, FLEX, SMH & FL
▼ + stars: | 2022-11-18 | by ( Melissa Lee | ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFinal Trades: PFE, FLEX, SMH & FLThe final trades of the week. With CNBC's Melissa Lee and the Fast Money traders, Karen Finerman, Steve Grasso, Tim Seymour and Jeff Mills.

☆ Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1
▼ + stars: | 2022-11-18 | by ( ) www.reuters.com time to read: +2 min

Nov 18 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Friday their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine. Antibody levels against the variant rose nearly nine-fold in older adults, aged 55 and above, who received the Omicron shot compared to a roughly 2-fold increase in participants with the original shot, according to data posted on online archive bioRxiv. The variant and related BQ.1 are gaining ground in the United States, and are expected to cause a rise in cases in the winter in Europe. The companies had recently released data that showed their Omicron-tailored shot produced a strong antibody response in older adults than the original shot after one month against the BA.4/5 subvariants. Pfizer and BioNTech said the bivalent shot also produced an immune response against newer Omicron subvariants including BA.4.6, BA.2.75.2 and XBB.1.

LONDON, Nov 17 (Reuters) - Pharmaceutical companies could be made to disclose prices and deals agreed for any products they make to fight future pandemics, under new rules being drawn up by the World Health Organization and reviewed by Reuters. During the pandemic, many deals that governments made with pharmaceutical companies have been kept confidential, giving them little scope to hold drugmakers accountable. A spokesperson for the WHO said it was member states that were driving the current process towards a new agreement. "The process is open, transparent, and with the input from other stakeholders, including any interested stakeholders and public, able to submit comments at public consultations." The draft will be presented to them in full in a meeting on Friday, after being circulated earlier in the week.

☆ German panel recommends COVID shot only for at-risk youngsters
▼ + stars: | 2022-11-17 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

The recommendation also covers a version of Moderna's (MRNA.O) Spikevax vaccine for the age group but that product is in short supply in Germany at the moment, the expert panel said. European regulators in October authorised a low-dose version of Pfizer-BioNTech's first-generation vaccine for children from six months to four years, when given as a three-dose series. "When there are parents that absolutely want the vaccine for their healthy children, there are no legal reason for physicians to deny them that," said STIKO's Terhardt. STIKO also reaffirmed a recommendation it issued in May for five- to 11-year-olds, saying one COVID-19 shot was enough for healthy youngsters in that age group because most of them had already had an infection. Only slightly more than 22% of five- to 11-year-old children in Germany have so far received at least one COVID shot.

☆ Britain's NICE recommends against NHS use of 5 COVID treatments as not cost-effective
▼ + stars: | 2022-11-16 | by ( Maggie Fick | ) www.reuters.com time to read: +3 min

The review, conducted by the National Institute for Health and Care Excellence (NICE) and published on Wednesday, is its first involving COVID-19 treatments as the pandemic enters a new phase. The recommendations are a draft, NICE said, and until final guidance is published, access to COVID-19 medicines will continue as is. NICE acknowledged that there is evidence that Merck's molnupiravir and Gilead Sciences Inc's (GILD.O) hospital-administered antiviral remdesivir are effective at treating COVID-19. It also recommended against three other COVID treatments, including GSK (GSK.L) and partner Vir Biotechnology's (VIR.O) sotrovimab, an antibody therapy that the World Health Organization recommended against in September. One expert said that some of the COVID treatments NICE recommended against are an important part of the British government's current strategy.

☆ Australia recommends against fifth vaccine dose as fresh COVID wave builds
▼ + stars: | 2022-11-15 | by ( Lewis Jackson | ) www.reuters.com time to read: +2 min

SYDNEY, Nov 15 (Reuters) - Australian health authorities have recommended against getting a fifth COVID-19 vaccine shot, even as they urged those eligible to sign up for their remaining booster doses as the country's latest COVID wave grows rapidly. "ATAGI has considered international evidence as well as the local data around vaccination numbers, as well as case numbers in the pandemic and decided not to recommend a fifth dose," said Butler. "They noted that severe disease and death during that wave in Singapore was very rare for people who had had at least two doses of vaccine for COVID." New booster recommendations will be made early next year ahead of the southern-hemisphere winter. The company's vaccine for children aged six months to five years will also be approved for use on the severely immunocompromised.

☆ Australia recommends against fifth vaccine dose as fresh Covid wave builds
▼ + stars: | 2022-11-15 | by ( Lewis Jackson | ) www.reuters.com time to read: +2 min

☆ Japan's Daiichi Sankyo says mRNA COVID vaccine successful in booster trial
▼ + stars: | 2022-11-15 | by ( ) www.reuters.com time to read: +1 min

TOKYO, Nov 15 (Reuters) - Japan's Daiichi Sankyo Co (4568.T) said on Tuesday its mRNA-based COVID-19 vaccine had reached its primary endpoint in a trial of the shot as a booster. Based on the results, Daiichi Sankyo will file a new-drug application to regulators in January 2023. Approval would give Japan a home-grown source for mRNA vaccines, which have made up the bulk of its COVID inoculations to date. Japan has relied on imports of shots developed by U.S.-based drugmakers Pfizer Inc (PFE.N) and Moderna Inc (MRNA.O). Daiichi Sankyo's shares jumped on the news, rising 3.3% versus a 0.1% advance in the benchmark Nikkei (.n225) gauge.

☆ Moderna's Omicron shots shows better immune response than original COVID vaccine
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +1 min

Nov 14 (Reuters) - Moderna Inc (MRNA.O) said on Monday its Omicron-tailored vaccines produced a better immune response against the BA.4/5 subvariants in a mid-to-late stage study, when given as a booster dose, compared with its original shot. Data shows that both of Moderna's Omicron-tailored shots, mRNA-1273.214 and mRNA-1273.222, produced a higher antibody response against BA.4/5 subvariants than its original shot in vaccinated and boosted adults, the company said. Moderna, however, said levels of neutralizing antibody response dropped nearly 5-fold against the emerging subvariant BQ.1.1 when compared with BA.4/5, in an analysis of about 40 participants, although the virus neutralizing activity still remained "robust". Rival Pfizer Inc (PFE.N) and its German partner, BioNTech SE , said earlier this month their Omicron-tailored shot targeting the BA.4/5 subvariants produced a strong antibody response in older adults than the original shot after one month. Reporting by Bhanvi Satija in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

☆ Germany's BioNTech says to set up mRNA vaccine facility in Singapore
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +1 min

[1/2] Test tubes are seen in front of a displayed Biontech logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/IllustrationNov 14 (Reuters) - BioNTech SE (22UAy.DE), the German biotech that developed a widely used COVID-19 vaccine with Pfizer Inc (PFE.N), acquired a manufacturing facility in Singapore, its first in Asia, the company said on Monday. The facility, bought from a Novartis (NOVN.S) unit, will be its first messenger ribonucleic acid, or mRNA, facility in Singapore and support its vaccines production for the Asia Pacific region, BioNTech said in a statement, without disclosing financial details. The aim is to eventually expand production to other drug classes such as cell therapies, said BioNTech, which also plans to set up research and manufacturing centres in Australia. The Singapore facility is expected to be fully operational by 2023 and create more than 100 jobs by 2024.

☆ Pfizer's India arm posts profit jump on lower costs, price hikes
▼ + stars: | 2022-11-11 | by ( ) www.reuters.com time to read: +1 min

BENGALURU, Nov 11 - Pfizer Ltd (PFIZ.NS), the Indian arm of U.S. pharma giant Pfizer Inc (PFE.N), reported a rise in second-quarter profit on Friday, boosted by price hikes and lower input costs. Profit before tax and exceptional item rose to 2.26 billion Indian rupees ($27.97 million) in the three months ended Sept. 30, from 1.75 billion rupees in the year-ago period. The company booked a one-time gain of 1.89 billion rupees on the sale its off-patent and generic medicines business, Upjohn. Pfizer's revenue from operations rose 0.3% to 6.38 billion rupees. Earlier in the day, peer Zydus Lifesciences (ZYDU.NS) reported an 82.6% slump in second-quarter profit, hit by rising expenses.

☆ Twitter gives big advertisers the excuse they need
▼ + stars: | 2022-11-11 | by ( ) www.reuters.com time to read: +2 min

NEW YORK, Nov 11 (Reuters Breakingviews) - Twitter’s new owner Elon Musk is making it too easy to hit the pause on ad spending. loadingSocial media companies are no stranger to ad boycotts. That’s because Facebook and Instagram rely more on small business advertising, which is a diverse scattered group. Twitter reaps almost all its revenue from big brands, and those big advertisers are already looking for an excuse to put the brakes on spending. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.

☆ European regulator recommends Pfizer's Omicron booster for children
▼ + stars: | 2022-11-10 | by ( ) www.reuters.com time to read: 1 min

Nov 10 (Reuters) - Pfizer Inc (PFE.N) and its partner BioNTech said on Thursday the EU health regulator has recommended authorising the use of their bivalent COVID-19 shot as a booster in children aged 5 through 11. The Omicron-tailored vaccine is already authorised by the European Commission for individuals aged 12 years and above. The updated bivalent booster shot targets the original coronavirus strain as well as the BA.4 and BA.5 sub-variants of Omicron. In October, European Medical Agency backed authorization of Moderna Inc's (MRNA.O) COVID-19 tailored booster shots for 12 and above to further vaccination campaigns in the region. Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru; Editing by Shounak Dasgupta amd Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ AstraZeneca lifts 2022 earnings outlook as cancer drugs boost results
▼ + stars: | 2022-11-10 | by ( Natalie Grover | ) www.reuters.com time to read: +4 min

AstraZeneca is seen as a bellwether for the pharmaceutical sector in China, which accounted for about 16% of the company's total revenue last year. Sales in China have been hurt by lower drug prices while COVID lockdown measures have kept some patients from being diagnosed and seeking care. Better-than-expected sales of AstraZeneca's cancer medicines, including Tagrisso, Imfinzi and Enhertu, helped the company's quarterly revenue beat, with sales of its broader oncology portfolio rising 24%. But global sales of the company's COVID therapy, Evusheld, have steadily grown, partially offsetting the rapid decline in COVID vaccine sales. Evusheld continues to demonstrate strong efficacy but there are a couple of variants that are resistant to it, Soriot said.

☆ Sanofi, GSK score late win with EU COVID booster approval
▼ + stars: | 2022-11-10 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

The shot is based on lab-made viral proteins provided by Sanofi and an adjuvant ingredient from GSK that increases the immune response. Adapting the older protein technology chosen by Sanofi and GSK to a new virus variant requires several months longer than under the mRNA approach, which saw a breakthrough during the pandemic. Work on the shot by Sanofi and GSK, two of the world's largest vaccine makers by sales, was delayed repeatedly. The partners later pivoted to targeting the Beta variant, requiring months in additional development time. While the shot tested at the time was bivalent - meaning it was based both on original Wuhan strain of the virus and Beta - Sanofi and GSK later focused on a monovalent shot based on Beta only.

☆ UK approves Pfizer-BioNTech's COVID booster targeting BA.4/5
▼ + stars: | 2022-11-09 | by ( ) www.reuters.com time to read: +1 min

Nov 9 (Reuters) - Britain's health regulator on Wednesday approved a COVID-19 booster from Pfizer Inc (PFE.N) and partner BioNTech SE (22UAy.DE) targeting the Omicron BA.4 and BA.5 sub-variants and the original coronavirus strain. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) said the vaccine was approved for use as a booster dose in people aged 12 years and older after it was found to meet safety, quality and effectiveness standards. "All approved COVID booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19," according to the MHRA. Pfizer and BioNTech last week said their so-called bivalent COVID-19 vaccine tailored for BA.4/5 produced a strong antibody response in older adults than the original shot after one month, and in October said it generated a strong immune response. Reporting by Pushkala Aripaka in Bengaluru; Editing by Shinjini Ganguli and Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

☆ Novavax says Omicron shot shows strong immune response as second booster
▼ + stars: | 2022-11-08 | by ( ) www.reuters.com time to read: +2 min

Nov 8 (Reuters) - Vaccine maker Novavax Inc (NVAX.O) said on Tuesday its COVID-19 shot retooled against the Omicron BA.1 variant showed a strong immune response as the fourth dose and met the main goal of strain change in a late-stage study. Data showed the shot, NVX-CoV2515, produced 1.6 times the amount of neutralizing antibodies in people who had previously not been exposed to COVID-19 compared to Novavax's original coronavirus vaccine. The trial included Novavax's so-called bivalent vaccine, the BA.1-tailored shot and its prototype vaccine. Novavax says the results from the study showed its Omicron-tailored shot can be changed to target a new variant vaccine if necessary. Novavax's COVID shot has not yet received approval in the United States as a second booster dose.

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