In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines…
Pfizer completes ReViral acquisition
Pfizer (NYSE:PFE) announced today that it completed its previously announced $525 million acquisition of ReViral. ReViral, a biopharmaceutical company, discovers, develops and commercializes novel antiviral therapeutics designed to target respiratory syncytial virus (RSV). Its portfolio includes the sisunatovir oral inhibitor for blocking the fusion of the RSV virus to the host cell. Sisunatovir has fast track…
FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11
The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said…
FDA and Pfizer differ in interpreting Paxlovid treatment recommendations
Pfizer CEO Dr. Albert Bourla recently said that patients who relapse after completing a course of the COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) could continue taking the drug. “Paxlovid does what it has to do: it reduces the viral load,” Bourla told Bloomberg. “Then your body is supposed to do the job.” “While the…
Pfizer ticks up on Street-beating Q1, lessens full-year guidance
Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…
FDA signals careful approach in mulling COVID-19 vaccine authorization in young children
FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months…
10 leading pharma executives you need to know
Given the complexity of the pharmaceutical business and the generally slow pace of new drug development, it can be challenging to identify leading pharma executives. Compensation is not necessarily an accurate barometer of success. That said, CEOs’ annualized return over tenure as CEO over their term can hint at performance. In addition, rating sites like Glassdoor…
15 of the best pharma companies to work for
The pharmaceutical industry continues to see strong growth and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research. The best pharma companies to work for continue to offer a number of advantages to skilled workers. Pharma positions remain in high demand, and…
Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11
Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11. The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant…
Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates
Pfizer (NYSE:PFE) announced today that it entered into an agreement to acquire biopharmaceutical company ReViral. ReViral discovers, develops and commercializes novel antiviral therapeutics designed to target respiratory syncytial virus (RSV). “At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine…
Pharma’s top 20 R&D spenders in 2021
If 2020 underscored the importance of the pharma industry’s social importance, 2021 demonstrated the ability of R&D spenders to yield profitable commercialized products. But while strong demand for COVID-19 therapies in 2021 provided unprecedented revenue levels for a handful of Big Pharma companies, it didn’t result in substantial changes in R&D spending. (Look out for more insights…
BioNTech 2021 revenue surges 39x year over year
The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021. Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth. Net revenues of the vaccine between Pfizer and BioNTech surpassed $59 billion. In 2020, BioNTech’s revenues were €482.3 million. “Looking back, 2021 was…
50 of 2021’s best-selling pharmaceuticals
Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments. This roundup of best-selling pharmaceuticals in 2021 highlighted a banner year for the industry. Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the…
Pfizer unveils promising data from Phase 3 study of etrasimod in ulcerative colitis
Pfizer (NYSE:PFE) has announced that the Phase 3 ELEVATE 12 study of etrasimod met primary and key secondary endpoints. The primary endpoint in the trial involved clinical remission in patients with severely active ulcerative colitis (UC) at week 12. Etrasimod is an experimental once-daily selective sphingosine 1-phosphate (S1P) receptor modulator similar to Bristol-Myers Squibb’s Zeposia…
Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older. The two companies submitted two real-world data sets from Israel while the omicron variant was widespread. Pfizer notes that an additional dose…
Pfizer-BioNTech vaccine moderately effective against omicron in children
The Pfizer-BioNTech COVID-19 vaccine lowered the incidence of omicron-based SARS-CoV-2 infection by 31% in children aged 5 to 15 in a recent study. The vaccine was more effective in children between the ages of 12 and 15, lowering the risk of omicron infection by 59%, according to the study from CDC and Abt Associates. Participants…
NIH to study allergic reactions to COVID-19 mRNA vaccine
Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…
Pfizer launches Phase 2/3 study of Paxlovid in children
Pfizer (NYSE:PFE) is looking to expand the use of the antiviral Paxlovid, which FDA has authorized to treat mild-to-moderate COVID-19 in individuals who are at least 12 years of age who weigh at least 40 kg. The authorization covers individuals with a risk of developing severe disease. A recently launched Phase 2/3 study will test…
Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA
COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg. The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine. Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose…
CDC recommends eight-week interval for some COVID-19 vaccine recipients
The CDC has recommended extending the interval between the first and second doses of the Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) COVID-19 vaccines up to eight weeks for some individuals. The guidance for those vaccines was formerly 21 and 28 days, respectively. CDC notes that an eight-week interval could be preferred for some individuals 12 and…
J&J and Roche named to Clarivate’s Top 100 Global Innovators list
Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT). Two companies in pharma and another in medtech, however, made the cut. Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator. Roche was included for the 11th consecutive year…
Pfizer-BioNTech omicron-based vaccine may be delayed
Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-specific version of their COVID-19 vaccine. The two companies initially vowed to launch the updated vaccine by the end of March, but that goal may shift depending on the volume of clinical data regulators demand, according to BioNTech. In…
FDA hits pause on COVID-19 vaccine for children under 5
FDA may wait several months before deciding to authorize a COVID-19 vaccine for children between the ages of 6 months to 4 years. The agency had planned on adjourning a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the potential use of the vaccine in younger children.…
Pfizer dips on Q4 revenue miss, provides 2022 guidance
Pfizer (NYSE:PFE) shares slid today on fourth-quarter results that came up shy of the consensus sales forecast. The pharmaceutical giant posted profits of $3.4 billion, or 59¢ per share, on sales of $23.8 billion for the three months ended Dec. 31, 2021, more than quadrupling its bottom-line on revenues that were more than doubled year-over-year.…
Omicron-specific mRNA vaccine elicited similar protection as original in early primate study
An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine. In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine. The study involved a total…