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YOU WONT BELIEVE: 12 - You Need To See This

FDA clears way for millions to get additional COVID-19 boosters

U.S. regulators cleared second booster doses of COVID-19 vaccine from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE for adults 50 and older, making millions more people eligible for the shots as concern grows about a potential new wave of infections.

Tribune News Service

FDA clears way for millions to get additional COVID-19 boosters

Tribune News Service

Pfizer's Second Etrasimod Phase 3 Ulcerative Colitis Trial Hits Primary Goal

Pfizer Inc (NYSE:PFE) has announced topline results from a second Phase 3 study of etrasimod for moderately to severely active ulcerative colitis (UC). The 12- and 52-week ELEVATE UC 52 follow the recent announcement of 12-week findings from the ELEVATE UC 12 trial. In this 52-week study, also known as ELEVATE UC 52,…

Benzinga

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Pfizer's COVID-19 Oral Therapy To Be Tested In Hospitalized COVID-19 Patients In UK: Reuters

Pfizer Inc's (NYSE: PFE) oral COVID-19 therapy will be evaluated as a potential treatment for hospitalized COVID-19 patients in a major British trial.

Benzinga

FDA Says Current Dose Of GSK-Vir's COVID-19 Therapy Unlikely To Work Against Omicron Subvariant

The FDA said that the currently authorized 500mg dose of GlaxoSmithKline Plc (NYSE:GSK) and Vir Biotechnology Inc's (NASDAQ:VIR) COVID-19 antibody therapy is unlikely to be effective against the omicron BA.2 variant. The agency updated its website to exclude sotrovimab use in geographic regions where the infection is likely caused by the omicron BA.2 variant. GSK…

Benzinga

3 Vaccine Stocks to Buy Following the Surge in COVID-19 Cases in China

China is battling with its worst COVID-19 outbreak since 2020. Surging cases of a new omicron variant worldwide are raising concerns that another COVID-19 wave is coming, which could drive demand for future vaccine orders. This bodes well for popular vaccine stocks Pfizer (PFE), Moderna (MRNA), and BioNTech (BNTX), and…

StockNews.com

Pfizer's RSV Vaccine Candidate Receives FDA Breakthrough Therapy Tag For Prevention of RSV In Older Adults

The FDA has granted Breakthrough Therapy Designation to Pfizer Inc's (NYSE:PFE) respiratory syncytial virus (RSV) vaccine candidate (PF-06928316 or RSVpreF) to prevent lower respiratory tract disease caused by RSV in 60 years of age or older. The positive results primarily inform the FDA decision of Phase 2a study evaluating the safety, immunogenicity, and efficacy…

Benzinga

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Moderna's COVID-19 Vaccine Shows Neutralizing Antibody Response In Kids Under 6

Moderna Inc (NASDAQ:MRNA) has announced interim data from the Phase 2/3 KidCOVE study of its COVID-19 vaccine (mRNA-1273) in children six months to under six years. The interim analysis showed that two 25 μg doses of mRNA-1273 in participants 6 months to under six years met the primary endpoint with robust neutralizing antibody…

Benzinga

Pfizer's Ulcerative Colitis Candidate Aces Late-Stage Study

Pfizer Inc (NYSE:PFE) has announced topline results from a Phase 3 study of etrasimod in moderately to severely active ulcerative colitis (UC). In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 compared with placebo. Statistically significant improvements were achieved in all key secondary…

Benzinga

Pfizer Recalls Some Lots Of Hypertension Med Due To Potential Cancer-Causing Impurity

Pfizer Inc (NYSE:PFE) voluntarily recalls Accuretic (quinapril HCl/hydrochlorothiazide) and two authorized generic versions due to the presence of nitrosamine, N-nitroso-quinapril, above an acceptable level. Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets. Nitrosamines are common in water and…

Benzinga

The Future of Boosters Is Somewhere Between Unnecessary and Urgent

Until there’s a universal coronavirus vaccine, the future of additional shots is a murky work in progress—but more rounds seem increasingly likely.

Businessweek

35 Generic Drugmakers Sign To Manufacture Low-Cost Version Of Pfizer's COVID Pill

Thirty-five generic drugmakers will produce low-cost versions of Pfizer Inc's (NYSE:PFE) COVID-19 pill, Paxlovid, to expand supplies of the highly effective drug in lower-income regions. Pfizer struck a deal last year with the group to allow generic drugmakers to make the pills for 95 low- and middle-income countries, covering up to approximately 53% of the…

Benzinga

Alnylam Hits Pfizer, Moderna With Patent Infringement Suits

Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) has filed separate lawsuits in the Delaware federal court against Pfizer Inc (NYSE:PFE) and Moderna Inc (NASDAQ:MRNA), seeking damages for infringement of a patent in the manufacture and sale of their mRNA COVID-19 vaccines. Alnylam said it was seeking compensation for the use of its lipid nanoparticles (LNP) technology that carries and delivers…

Benzinga

Pfizer-BioNTech Seek FDA Approval For Second COVID-19 Booster In Elderly Population

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) filed an application with the

Benzinga

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Benzinga

Pfizer To Stop New Clinical Trials In Russia: Reuters

Reuters reported that Pfizer Inc (NYSE: PFE) said it wo

Benzinga

GeoVax Labs Retains CATO SMS To Manage Its Mid-Stage COVID-19 Vaccine Trials

GeoVax Labs Inc (NASDAQ:GOVX) has engaged CATO SMS to manage its two ongoing Phase 2 trials of its COVID-19 vaccine candidate, GEO-CM04S1. One is testing the safety and effectiveness of GEO-CM04S1 compared to the Pfizer Inc (NASDAQ:PFE) / BioNTech SE (NASDAQ:BNTX) in immunosuppressed patients with blood cancer. The other trial is testing GEO-CM04S1 as a booster in…

Reuters

Pfizer, Bayer to maintain drug supply to Russia

Pfizer Inc and Bayer said on Monday they would maintain humanitarian supply of medicines to Russia, but would pull back from other non-essential spending in the country.

Benzinga

Pfizer's Paxlovid Becomes First Oral COVID-19 Therapy To Be Evaluated In Pediatric Clinical Study

Pfizer Inc (NYSE: PFE) has initiated a Phase 2/3 EPIC-PEDS trial to evaluate Paxlovid (nirmatrelvir and ritonavir tablets)

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Benzinga

Lung-Disease Focused AN2 Therapeutics Files Plans For NASDAQ Debut

AN2 Therapeutics Inc filed plans on Friday to go public in an initial public offering in which it reportedly hopes to raise about $75 million. AN2 plans to list on the Nasdaq with the symbol of ANTX. The Menlo Park-based biotech is developing a therapy for non-tuberculous mycobacterial (NTM) lung disease, which…

Benzinga

Pfizer Commits 10M Courses Of COVID-19 Oral Antiviral To Developing Countries: Reuters

Pfizer Inc (NYSE:PFE) is expected to provide around 10 million courses of its highly effective COVID-19 antiviral treatment Paxlovid to low- and middle-income countries in 2022, reports Reuters citing an official with the Global Fund. The Fund's head of strategy for policy, Harley Feldbaum, said Pfizer had committed at least that many…

Benzinga

Johnson & Johnson's COVID-19 Vaccine Less Effective Against Hospitalization, French Study Shows

According to a large French study, the risk of hospitalization after vaccination with Johnson & Johnson's (NYSE: JNJ) COVID-19 vaccine was about five times higher than those who received the Pfizer Inc (NYSE:

Benzinga

Why Pfizer Shares Are Trading Higher Today

Pfizer Inc (NYSE: PFE) is trading higher Wednesday after the company received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for PF-06482077, or RSVpreF, the company's respiratory syncytial virus vaccine candidate.

Reuters

Pfizer to provide 10 million courses of COVID pill to developing countries -the Global Fund

Pfizer Inc is expected to provide around 10 million courses of its highly effective COVID-19 antiviral treatment Paxlovid to low- and middle-income countries this year, according to an official with the Global Fund, a healthcare NGO working to buy the pills from the drugmaker.

Benzinga

Pfizer/BioNTech's COVID-19 Vaccine Mere 12% Effective In Kids 5-11 Years, New York Study Shows

According to a published study, Pfizer Inc (NYSE: PFE) and BioNTech SE's (NASDAQ: BNTX) two-dose COVID-19 vaccine provided very little protection for children aged 5 to 11 years during the wave of o

Benzinga

Pfizer's Clostridioides Difficile Vaccine Fails To Prevent C. Difficile Infection

Pfizer Inc (NYSE: PFE) announced data from the CLOVER Phase 3 trial evaluating Clostridioides difficile vaccine candidate to prevent C. difficile infection (CDI).

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