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☆ 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.

☆ UBS downgrades Pfizer, cites lower Covid expectations and a slow pipeline
▼ + stars: | 2023-01-26 | by ( Sarah Min | ) www.cnbc.com time to read: +2 min

Analyst Colin Bristow downgraded shares to neutral from buy, and lowered his price target, citing weaker Covid expectations and a sluggish pipeline for new products. Pfizer shares are down more than 12% this year on expectations that the number and severity of Covid cases will stabilize. At the same time, UBS did not make any "meaningful changes" to its pipeline estimates for Pfizer following the firm's R & D day. The new target is just about in line with where Pfizer shares closed Wednesday at $44.66. "While we see minimal downside from here, the lack of catalysts (see inside) and potential for further downside to COVID estimates drives our move to the sidelines," Bristow wrote.

☆ 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.

"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.

☆ Merck scraps Keytruda trial for prostate cancer after dismal interim data
▼ + stars: | 2023-01-25 | by ( ) www.reuters.com time to read: +1 min

Jan 25 (Reuters) - Merck & Co Inc (MRK.N) said on Wednesday it was discontinuing a late-stage trial of its blockbuster immunotherapy Keytruda in some prostate cancer patients after interim data showed it was unlikely to meet the study's main goals. The interim analysis showed the therapy did not extend survival or help extend the time a patient lives without the disease worsening, the U.S. drugmaker said. The trial had enrolled 1,251 patients who received the combination therapy with Keytruda or a placebo. Prostate cancer is the most common cancer in the United States with nearly 270,000 new cases and 34,500 deaths in the country in 2022, according to government data estimates. Separately, Merck said Keytruda in combination with a chemotherapy showed significant improvement in overall survival in patients with an advanced type of bile duct cancer.

☆ U.S. FDA proposes shift to annual COVID vaccine shots
▼ + stars: | 2023-01-23 | by ( ) www.reuters.com time to read: +2 min

It has also asked the panel to consider the usage of two COVID vaccine shots a year for some young children, and in older adults and persons with compromised immunity. The regulator also sought its advisers' views on the need for routine selection of variants for updating the vaccine, similar to the way strains for flu vaccines are changed annually. The agency expects that simplifying the COVID vaccine composition and annual immunization schedules may contribute to less complicated vaccine deployment, fewer vaccine administration errors and less complex communication, which could potentially lead to improved vaccine coverage rates. Currently, most people in the United States need to first get two doses of the original COVID vaccine spaced 3-4 weeks apart, depending on the vaccine, followed by a booster a few months later. The FDA's proposal follows the European regulator's backing last month for the use of bivalent COVID shots for primary vaccination.

China said last Saturday that nearly 60,000 people with COVID died in hospitals between Dec. 8 and Jan. 12 - a roughly ten-fold increase from previous disclosures. However, that number excludes those who die at home, and some doctors in China have said they are discouraged from putting COVID on death certificates. China's chaotic exit from a regime of mass lockdowns, travel restrictions and frequent COVID testing, has also prompted a run on drugs as people fend for themselves against the disease. To meet soaring demand, drugmakers in China are ramping up operations to triple their capacity to make key fever and cough medicines, the state-run China Daily reported on Thursday. Medical facilities are relatively weak in rural areas, thus prevention is difficult and the task is arduous," Xi said, adding that the elderly were a top priority.

☆ 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.

☆ Wells Fargo downgrades Pfizer, says the stock needs a 'Covid reset' to work again
▼ + stars: | 2023-01-17 | by ( Carmen Reinicke | ) www.cnbc.com time to read: +2 min

Shares of Pfizer need a reset from the Covid-19 pandemic before they will work again, according to Wells Fargo. "We think PFE needs a COVID reset before the stock could work again," analyst Mohit Bansal wrote in a note. Lower revenue, higher expenses Wells Fargo lowered its 2023-2025 earnings per share estimates on the company due to lower Covid revenues and higher expenses. Even including China demand, Wells Fargo is below consensus on the drug, seeing limited opportunity in the country without national reimbursement. The Covid reset could happen when guidance is provided on the company's fourth-quarter 2022 earnings call, Bansal said.

☆ Pfizer to sell all its drugs in low-income countries at non-profit price
▼ + stars: | 2023-01-17 | by ( ) www.reuters.com time to read: 1 min

Companies Pfizer Inc FollowJan 17 (Reuters) - U.S. drugmaker Pfizer Inc (PFE.N) said on Tuesday it will offer its full portfolio of drugs, including off-patent medicines such as chemotherapies and oral cancer treatments, on a not-for-profit basis to 45 low-income countries in the world. In an expansion of the company's "An Accord for a Healthier World" program, which is aimed at increasing access to innovative treatments in some of the world's poorest countries, Pfizer said it will now offer a total of 500 products. When the drugmaker launched the program in May 2022, it offered only its patented medicines including COVID-19 treatment Paxlovid and its big-selling breast cancer drug, Ibrance, at a not-for-profit price. Reporting by Bhanvi Satija in BengaluruOur Standards: The Thomson Reuters Trust Principles.

☆ Jim Cramer's top 10 things to watch in the market Tuesday: Morgan Stanley beat, Goldman Sachs miss, Estee Lauder boost
▼ + stars: | 2023-01-17 | by ( Jim Cramer | ) www.cnbc.com time to read: +4 min

Piper Sandler raises price target on Club stock Cisco Systems (CSCO) to $49 per share from $47; keeps neutral rating. Wells Fargo has an overweight (buy) rating and a $125-per-share price target. Wells Fargo downgrades Pfizer (PFE) to equal weight from overweight (hold from buy), with a $4-per-share price target cut to $50. Bank of America lowers price target on TSLA shares to $130 each from $135. Jefferies is concerned, too; catch-up price target cut to $180 from $350.

RSV, which produces symptoms similar to a cold but can be fatal for young children and older adults, causes about 14,000 deaths annually in adults ages 65 and older. Moderna, Pfizer Inc (PFE.N) and GSK Plc (GSK.L) are racing to get their RSV vaccines to market first. Pfizer's RSV vaccine was found to be 66.7% effective against two or more symptoms in late-stage trials. "It's very exciting to see progress in RSV vaccines in older adults, and I think both of those vaccines have shown pretty remarkable results as well," Hoge said. The RSV vaccine market could be worth more than $10 billion globally, half of which would come from the United States, according to Cowen analyst Tyler Van Buren.

He heard at that time that Pfizer's (PFE.N) anti-viral drug Paxlovid was an effective treatment, but patients could only get it prescribed if they were admitted to hospital, and only if the drug was in stock. Li's experience, local media reports and online posts bear testimony to the difficulties faced obtaining Paxlovid in China through official channels. "Pfizer is actively collaborating with Chinese authorities and all stakeholders to secure an adequate supply of Paxlovid in China. We remain committed to fulfilling the COVID-19 treatment needs of Chinese patients and partnering with the Chinese government," the company said in a statement. PAXLOVID GIFTSeveral other people described to Reuters how they turned to the grey market to purchase Paxlovid.

☆ U.S. FDA, CDC see early signal of Pfizer bivalent COVID shot's link to stroke
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +2 min

Jan 13 (Reuters) - A safety monitoring system flagged that U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech's updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities. An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain. "Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public," the health authorities said. Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot. This safety concern has not been identified with Moderna's (MRNA.O) bivalent shot and both the CDC and FDA continue to recommend that everyone aged 6 months and older stay up-to-date with their COVID-19 vaccination.

☆ Pfizer not in talks on licensing generic COVID pill in China
▼ + stars: | 2023-01-10 | by ( ) www.reuters.com time to read: +1 min

[1/2] Paxlovid, Pfizer's anti-viral medication to treat the coronavirus disease (COVID-19), is displayed in this picture illustration taken October 7, 2022. A morning and an evening does consists of one white 100-milligram tablet of Ritonavir and two pink 150-milligram tablets of PF-07321332. REUTERS/Wolfgang Rattay/IllustrationNEW YORK, Jan 9 (Reuters) - Pfizer Inc (PFE.N) Chief Executive Albert Bourla said on Monday that the company is not in talks with Chinese authorities to license a generic version of its COVID-19 treatment Paxlovid for use there. Bourla, speaking at J.P. Morgan's healthcare conference in San Francisco, also said that talks with China on future pricing for the treatment had broken off after China had asked for a lower price than Pfizer is charging for most lower middle income countries. "They are the second highest economy in the world and I don't think that they should pay less than El Salvador," Bourla said.

☆ Morning Bid: Knocking on CPI's door
▼ + stars: | 2023-01-09 | by ( Stephen Culp | ) www.reuters.com time to read: +3 min

Jan 10 (Reuters) - A look at the day ahead in Asian markets from Stephen Culp. Economists at many big banks are revising up their GDP growth forecasts for the second half of this year. Further signs of cooling inflation could raise the possibility of a pause in monetary policy. On Monday, Atlanta Fed President Raphael Bostic provided assurances that it will be "appropriate and important" for the Fed to exercise caution as it calibrates its war on inflation. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.

☆ Private equity acquires a taste for drug development
▼ + stars: | 2023-01-09 | by ( David Carnevali | ) www.reuters.com time to read: +6 min

Jan 9 (Reuters) - Private equity firms that deemed drug development too risky for their liking in the past are increasingly investing in the sector, raising dedicated funds and coming up with deals that compensate them for the uncertainty involved. These deals are not structured as the leveraged buyouts that private equity firms are mostly known for. In most cases, the drug makers start paying the money back to the private equity firms when the drug is being developed, either by issuing equity, tapping cash on hand or borrowing. They also share a slice of the newly developed drug's revenue with the private equity firms once it's approved. Private equity firms also provide capital to spin out drugs into new companies.

☆ Omicron COVID booster cuts hospitalization in over 65s, Israeli study finds
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

The study by researchers from healthcare provider Clalit, Ben-Gurion University of the Negev and Sapir College has not yet been peer reviewed. The study was carried out from the end of September until mid-December and looked at 622,701 people aged 65 and over who were eligible for the bivalent booster. "Hospitalization due to Covid-19 occurred in 6 bivalent recipients and 297 participants who did not" receive it, the study said. "Participants who received the bivalent vaccine had lower hospitalization and mortality rates due to Covid-19 than non-recipients up to 70 days after vaccination." While the bivalent vaccine targets the original strain and its BA.4/BA.5 Omicron subvariant, scientists have been closely watching another Omicron subvariant, XBB.1.5, which has been rapidly spreading in the United States.

☆ Ocugen-Bharat Biotech COVID vaccine meets main goals in U.S. trial
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

Jan 9 (Reuters) - Ocugen Inc (OCGN.O) said on Monday the COVID-19 vaccine developed by its Indian partner Bharat Biotech International Ltd met the main goals of a trial in the United States. The vaccine, sold under brand name Covaxin, showed an immune response in individuals who had not received a COVID vaccine previously as well as those vaccinated with mRNA vaccines by Pfizer Inc (PFE.N) and Moderna Inc (MRNA.O), meeting its main goals, Ocugen said. Ocugen did not provide details about its submission to the U.S. FDA for the vaccine. The company is responsible for conducting trials and commercialization of the shot in the United States under a partnership with Bharat Biotech. The U.S. Food and Drug Administration had also paused trials of the shot after WHO's inspection of Bharat Biotech's facility.

The law targets fraud and abuse, such as bribery, in federal healthcare programs including Medicare, which provides coverage for the elderly and disabled. Pfizer contends the government's interpretation of the law was blocking access to critical medical care. New York-based Pfizer's medication, also known as tafamidis, treats a rare heart condition known as transthyretin amyloid cardiomyopathy that can lead to progressive heart failure. Given the drug's high price, patients would need to bear yearly co-payments of roughly $13,000, with Medicare covering the rest. Pfizer's proposal sought to assist "middle-income" patients who do not qualify for low-income co-pay support but might still be deterred by its cost.

☆ Pfizer working to send COVID pill Paxlovid to China - CNBC
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

Jan 9 (Reuters) - Pfizer Inc (PFE.N) is working with Chinese authorities to send its COVID-19 pill, Paxlovid, to the country that is dealing with a surge in COVID-19 cases, Chief Executive Officer Albert Bourla said in an interview with CNBC on Monday. In February last year, China approved Paxlovid to treat high-risk patients in several provinces. Pfizer has also reached an agreement to export Paxlovid to China through a local company to make the medicine more widely available. China has also been in talks with the drugmaker to secure a license that will allow domestic drugmakers to manufacture and distribute a generic version of Paxlovid in China, Reuters reported last week, citing sources. Chinese hospitals have been under intense pressure after the government abruptly abandoned its "zero-COVID" policy last month, sending infections soaring.

☆ China's 'great migration' kicks-off under shadow of COVID
▼ + stars: | 2023-01-07 | by ( Casey Hall | ) www.reuters.com time to read: +6 min

BORDER REOPENINGSunday marks the reopening of China's border with Hong Kong and the end of China's requirement for inbound international travellers to quarantine. More than a dozen countries are now demanding COVID tests from Chinese travellers, as the World Health Organisation said China's official virus data underreported the true extent of its outbreak. In Shanghai, for example, the city government on Friday announced an end to free PCR tests for residents from Jan. 8. China has relied on nine domestically-developed COVID vaccines approved for use, including inactivated vaccines, but none have been adapted to target the highly-transmissible Omicron variant and its offshoots currently in circulation. China reported three new COVID deaths in the mainland for Friday, bringing its official virus death toll to 5,267, one of the lowest in the world.

HONG KONG/BEIJING, Jan 6 (Reuters) - China is in talks with Pfizer Inc (PFE.N) to secure a licence that will allow domestic drugmakers to manufacture and distribute a generic version of the U.S. firm's COVID-19 antiviral drug Paxlovid in China, three sources told Reuters. In February last year, China approved Paxlovid, which was supposed to be largely available via hospitals, to treat high-risk patients in several provinces. Pfizer last month reached an agreement to export Paxlovid to China through a local company to make the medicine more widely available. A Pfizer spokesperson said the company is actively collaborating with Chinese authorities and all stakeholders to secure an adequate supply of Paxlovid in China. That licence does not allow the companies to sell generic Paxlovid in China.

The two companies are in arbitration to decide what Sanofi's obligations might be, given Sanofi acquired the marketing rights to Zantac from Boehringer in 2017. A decision was initially expected by the end of 2022. Now, Sanofi sees it some time this year, and at the end of the first quarter at the earliest. Originally marketed by a forerunner of GSK (GSK.L), the medicine has been sold at different times by companies including Pfizer (PFE.N), Boehringer and Sanofi as well as several generic drugmakers. On Wednesday, Sanofi also said it expected fourth-quarter results next month to benefit from a stronger dollar and flu vaccine sales.

☆ Jim Cramer's top 10 things to watch in the market Wednesday: Tech layoffs, bank double downgrade, opportunities in industrials
▼ + stars: | 2023-01-04 | by ( Jim Cramer | ) www.cnbc.com time to read: +4 min

Analysts lower their rating on the tech giant to neutral from buy and their price target to $250 per share from $300. Analysts also cut price target to $100 per share from $118. Analysts trim price target to $193 per share from $220. BofA raises Merck (MRK) rating to buy from neutral and price target to $130 per share from $110. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade.

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