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[1/2] The roof of a Pfizer facility shows heavy damage after a tornado passed the area in Rocky Mount, North Carolina, U.S. July 19, 2023. ABC Affiliate WTVD via REUTERSJuly 21 (Reuters) - Most of the tornado damage at Pfizer Inc's (PFE.N) Rocky Mount, North Carolina plant was to the warehouse and not manufacturing facilities, CEO Albert Bourla said on Friday, easing concerns about long-term drug shortages from the plant. Nonetheless, Bourla told a news conference in Rocky Mount that it will be a monumental task to repair the damage. "We are moving full speed to bring this manufacturing plant into action again," Bourla said, noting that crews were working to restore power to the plant. The Rocky Mount plant is one of the largest factories for sterile injectable medicines in the world.

Persons: Albert Bourla, Bourla, Soumi Saha, Saha, Lisa Mulloy, Erin Fox, David Ljunggren, Michael Erman, Shivani Tanna, Rami Ayyub, Doina Chiacu, Cynthia Osterman, Diane Craft Organizations: Pfizer, ABC, WTVD, REUTERS, Pfizer Inc's, U.S, American Society of Health, System Pharmacists, U.S . Food, Drug Administration, FDA, Premier Inc, University of Utah Health, Thomson Locations: Rocky Mount, North Carolina, U.S, Rocky, Bengaluru

☆ US FDA approves Pfizer's next-generation pneumococcal vaccine
▼ + stars: | 2023-04-28 | by ( ) www.reuters.com time to read: +1 min

April 28 (Reuters) - The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc's (PFE.N) next-generation vaccine to prevent pneumococcal disease in children aged six weeks to 17 years, the company said late on Thursday. The vaccine, Prevnar 20, offers more protection against the disease versus the company's widely-used Prevnar 13 vaccine, by targeting seven more serotypes of the streptococcus pneumoniae bacteria that causes those infections. The pneumococcal disease can lead to infections in several parts of the body including the lungs, where they can cause pneumonia. The approval is based on results from mid-stage and late-stage studies that showed the vaccine's safety and tolerability was similar to Prevnar 13. Reporting by Sriparna Roy in Bengaluru; Editing by Subhranshu SahuOur Standards: The Thomson Reuters Trust Principles.

[1/2] Sanofi logo at the company's headquarters during the annual results news conference in Paris, France, February 4, 2022. Sanofi in 2009 acquired the rights to Auvi-Q, an epinephrine auto-injector intended to compete with EpiPen. Injection of epinephrine is used to treat serious and sometimes life-threatening allergic reactions to foods, medications, bee stings and other causes. Circuit Court of Appeals last July agreed, noting that the exclusive contracts in question were "a normal competitive tool within the epinephrine auto-injector industry." The 10th Circuit added that Sanofi could have competed on those terms, but instead chose initially to market Auvi-Q as a more expensive, premium product.

And that has the impact of postponing some announcements," said Anu Aiyengar, global head of M&A at JPMorgan Chase & Co (JPM.N). M&A volumes dropped 44% to $282.7 billion in the U.S. and 70% to $81.87 billion in Europe. Reuters Graphics"Having a well-functioning financing market is a critical ingredient for M&A. Global M&A volumes in Q1 2023LACK OF CONFIDENCEThe depressed market valuations also presented an opportunity for prominent activist investors to launch new proxy fights, with dealmakers anticipating a boost to M&A volumes from activist campaigns in the coming quarters. "Inflationary pressures aren't subsiding as fast as people expected; there's still a lot of geopolitical tensions, and in a lot of ways, the disruption in the financing market is intensifying," Langston said.

☆ Exclusive: ICU Medical to compete against GE Healthcare for Medtronic units -sources
▼ + stars: | 2023-03-29 | by ( David Carnevali | ) www.reuters.com time to read: +2 min

GE Healthcare and private equity firms Carlyle Group Inc (CG.O) and Clayton, Dubilier & Rice (CD&R), which have been pursuing rival offers separately, are also through to the second round, the sources added. Carlyle is bidding through its newly formed healthcare investment platform Atmas Health, according to one of the sources. Medtronic has been taking offers for its patient monitoring and respiratory interventions businesses even as it presses on with preparations to spin them off to its shareholders. ICU Medical, GE Healthcare, Carlyle and CD&R declined to comment. The patient monitoring technology portfolio includes Nellcor pulse oximetry and BIS brain monitoring, while the respiratory interventions business comprises ventilators and breathing systems.

The Food and Drug Administration made its assessment in briefing documents ahead of a meeting of the agency's external advisers on Thursday to discuss full approval to use Pfizer's oral pill for high-risk COVID-19 patients exhibiting mild to moderate symptoms. Paxlovid has been authorized for emergency use since late 2021, and a full approval is likely to allow Pfizer to expand its advertising campaign for the drug. Over 12 million courses have been delivered to pharmacies, and patients have used over 8 million courses of the treatment, according to Federal data. Paxlovid has shown reduction in risk of hospitalization or death by 86% in non-hospitalized, high-risk adult patients in Pfizer' study, which did not include vaccinated participants. Reporting by Leroy Leo and Khushi Mandowara in Bengaluru; Editing by Shailesh Kuber and Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

Feb 28 (Reuters) - A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States. GSK (GSK.L), which is another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts to the FDA on Wednesday. "The population where the vaccine is going to potentially have the biggest impact is less represented in this study," said Hana Sahly, one of the 12 FDA panelists. The FDA is scheduled to decide on the vaccines by May, and typically follows the recommendations of its independent panel of experts. Pfizer's vaccine was 66.7% effective in preventing RSV-related lower respiratory tract illness with over two symptoms, while GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over.

☆ U.S. FDA panel votes for Pfizer's RSV vaccine
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: 1 min

Feb 28 (Reuters) - A panel of outside advisers to the U.S. Food and Drug Administration (FDA) on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, paving the way for one of the first approved RSV shots in the United States for older adults. The FDA advisory committee voted 7 to 4 in favor of the drug, saying data from the clinical study conducted by the company established that the treatment was effective and safe in preventing the lower respiratory tract disease caused by RSV in 60 years and older. (This story has been corrected to change the voting ratio to "7 to 4" from "7 to 12" in paragraph 2)Reporting by Mariam E Sunny and Khushi Mandowara in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ 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.

☆ 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.

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.

☆ 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.

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.

☆ 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.

☆ Factbox: What are the new BQ.1 and BQ.1.1 coronavirus variants, and why it matters
▼ + stars: | 2022-11-04 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +3 min

The following describes the new coronavirus subvariants and how they may impact people. WHAT ARE BQ.1 AND BQ.1.1? In early July, BA.5 became the dominant subvariant of the coronavirus circulating in the United States, but in October it started giving way to BQ.1 and BQ.1.1. A study of blood from three dozen adults showed the shot increased neutralizing antibodies against the BA.4/BA.5 Omicron subvariants by fourfold compared with the original shot after one month. read moreIt is not yet clear whether that will translate into higher protection against the BQ.1 and BQ.1.1 subvariants, but their close relationship to BA.5 may work in the booster's favor.

☆ Moderna cuts COVID vaccine sales forecast on supply woes, shares tumble
▼ + stars: | 2022-11-03 | by ( ) www.reuters.com time to read: +1 min

Nov 3 (Reuters) - Moderna Inc (MRNA.O) cut its annual sales forecast for its COVID-19 vaccine on Thursday, citing short-term supply constraints that would push some deliveries out to next year, sending its shares down nearly 16% before the bell. It now expects vaccine sales of $18 billion and $19 billion this year compared to a prior forecast of $21 billion. Some U.S. pharmacies in September had reported that government supply of Moderna's updated shot remains limited, causing appointments for the product to vary across the country. Moderna's forecast cut comes just two days after rival Pfizer Inc's (PFE.N) quarterly sales of its COVID-19 vaccine exceeded market expectations and the drugmaker raised the full-year sales forecast for its shots. The vaccine maker reported sales of $3.36 billion in the third quarter, missing Wall Street estimates of $3.53 billion.

☆ U.S. CDC director experiences COVID rebound after taking Pfizer's Paxlovid
▼ + stars: | 2022-10-31 | by ( ) www.reuters.com time to read: +1 min

Oct 31 (Reuters) - The director of the U.S. Centers for Disease Control and Prevention (CDC), Rochelle Walensky, experienced a COVID-19 rebound after completing a course of Pfizer Inc's (PFE.N) COVID-19 pill, the agency said on Monday. Walensky had experienced mild COVID-19 symptoms less than ten days ago. After completing a course of Pfizer's Paxlovid, and a period of isolation, she had tested negative for the virus, but on Sunday, she tested positive again, CDC added. Some people who took the antiviral drug have suffered from a relapse or a rebound that occurred days after the five-day treatment course had ended, studies have shown. Last month, the U.S. Food and Drug Administration asked Pfizer to test the effects of an additional course of its antiviral Paxlovid among people who had experienced a rebound in COVID-19 after treatment.

☆ U.S. government to test Pfizer's Paxlovid for long COVID
▼ + stars: | 2022-10-27 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +2 min

According to details of the study, posted on Clinicaltrials.gov, the randomized, placebo-controlled trial will test Pfizer's treatment or a placebo in 1,700 volunteers aged 18 and older. The trial will investigate a leading theory of the cause of long COVID, which holds that fragments of the virus persist in the tissues of some individuals, causing prolonged symptoms. Patients in several case studies have reported improvements in their symptoms after taking Pfizer's antiviral treatment, and several physicians have called for the drug to be studied in a large, scientifically rigorous study in patients with long COVID. Estimates of long COVID prevalence range from 5 to 50% of people who have had a COVID-19 infection. It affects people who have had both mild and severe COVID-19, including children, and can be severe enough to keep people out of work.

☆ Addiction drug shows promise lifting long COVID brain fog, fatigue
▼ + stars: | 2022-10-18 | by ( Julie Steenhuysen | Nancy Lapid | ) www.reuters.com time to read: +6 min

Lauren Nichols, who has long COVID, takes a break and rests in a lounge bed in the office in her home in Andover, Massachusetts, U.S., August 3, 2022. Register now for FREE unlimited access to Reuters.com RegisterResearchers chasing long COVID cures are eager to learn whether the drug can offer similar benefits to millions suffering from pain, fatigue and brain fog months after a coronavirus infection. Younger, author of a scientific review of the drug as a novel anti-inflammatory, in September submitted a grant application to study LDN for long COVID. It worked so well that he ran a pilot study among 38 long COVID patients. He studied LDN in 18 long COVID patients, with 11 showing improvements, and said he believes larger, formal trials could determine whether LDN offers a true benefit.

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