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The Latest Breaking News from Pfizer Inc

U.S. FDA extends review of Pfizer and Myovant Sciences supplemental New Drug Application (sNDA) For MYFEMBREE by three months

The U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) from Pfizer Inc.

Benzinga

FDA Berates Pfizer CEO's Suggestion To Take More Paxlovid If COVID-19 Symptoms Rebound

The FDA berates Pfizer Inc (NYSE: PFE) CEO Albert Bourla's proposed solution in cases where virus levels rebound after the first course of treatment.

Benzinga

FDA contradicts Pfizer’s advice on 2nd course of COVID drug

There is “no evidence” that a second course of Pfizer Inc.’s Paxlovid will help COVID-19 patients whose symptoms return after an initial course of the antiviral, a U.S. Food and Drug Administration official said a day after Pfizer executives advocated the idea.

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3 Mega-Cap Stocks You'll Regret Not Buying on the Dip

The Fed's plan to raise interest rates aggressively has aggravated bearish investor sentiment ahead of the Federal Reserve Board meeting this week. And rising recessionary fears are expected to sustain the bearish mood in the near term. However, quality mega-cap stocks Abbott (ABT), Broadcom (AVGO), and Pfizer (PFE) are expected…

StockNews.com

Pfizer Posts Street Beating Q1 Earnings, Revises FY22 Profit Outlook

Pfizer Inc (NYSE:PFE) has reported a Q1 adjusted EPS of $1.62, up 72% Y/Y, well ahead of the consensus of $1.50. The company achieved revenues of $25.66 billion, up 77%, beating the Wall Street estimate of $23.95 billion. Its COVID-19 vaccine, Comirnaty, contributed $13.2 billion in direct sales and alliance revenues. Eliquis…

Benzinga

Moderna Bullish On COVID-19 Vaccine For Younger Kids To Be Ready Next Month: Reuters

Moderna Inc's (NASDAQ:MRNA) chief medical officer said that its COVID-19 vaccine for children under six years old would be ready for review by the FDA panel when it meets in June. "I think the FDA now has all of the core fundamental data they need to be able to begin an application review.…

Benzinga

The Week Ahead In Biotech (May 1-7): Phathom FDA Decision, Pfizer, Vertex Pharma Lead Earnings News, Ophthalmology Conference Presentations, And More

Biotech stocks posted weekly declines yet again in the week ending April 29, taking cues from the weak broader market sentiment. Big pharma earnings, clinical readouts and pipeline updates moved stocks during the week.

Benzinga

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FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA

The FDA has set up June meeting dates to review COVID-19 vaccine submissions, noting that the dates are tentative as none of the submissions are complete. The agency reserved June 8, 21, and 22 for virtual meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review Moderna Inc (NASDAQ: MRNA) and Pfizer Inc (NYSE: PFE)…

Benzinga

FDA Gives Green Signal To Pfizer's Duchenne Gene Therapy Trial

After the FDA lifted its hold on a late-stage study, Pfizer Inc (NYSE:PFE) said it would open the first U.S. trial sites for its experimental gene therapy for a muscle-wasting disorder. The FDA had put Pfizer's Investigational New Drug (IND) application for fordadistrogene movaparvovec on hold, and Pfizer has addressed the agency's requests related…

Benzinga

Pfizer Injects $25M Via Equity In Zentalis Pharma

Zentalis Pharmaceuticals Inc (NASDAQ:ZNTL) will sell 953,834 common shares at $26.21 per share to Pfizer Inc (NYSE:PFE) for $25 million. The offering is expected to close by April 29. Zentalis will use the proceeds to fund ongoing and planned clinical trials, including studies of ZN-c3 and ZN-d5, and for working capital and general corporate…

Benzinga

The Daily Biotech Pulse: Molecular Partners Plunges On Double Bad News, Pfizer/BioNTech Seek Nod For COVID-19 Shot In Kids, Pfizer Invests In Zentalis

Here's a roundup of top developments in the biotech space over the last 24 hours.

Benzinga

Pfizer, BioNTech Seeks Emergency Use Nod For COVID-19 Vaccine For Kids 5-11 Years

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted an FDA Emergency Use Authorization (EUA) application for a 10-µg booster dose of COVID-19 Vaccine for children 5 through 11 years of age. The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose…

Benzinga

Pfizer asks FDA to clear COVID booster shot for kids 5-11

Pfizer Inc. asked U.S. regulators for emergency-use authorization of a booster shot of its COVID-19 vaccine in children ages 5 to 11, setting in motion an effort to provide extra protection to kids.

Tribune News Service

Valneva - Pfizer Post Encouraging Data From Lyme Disease Vaccine Candidate

Valneva SE (NASDAQ:VALN) and Pfizer Inc (NYSE:PFE) have reported Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. In pediatric participants (5-17 years old) who received VLA15 in either the two-dose schedule (N=93) or three-dose schedule (N=97), VLA15 was found to be more immunogenic than in adults with both vaccination schedules tested. These…

Benzinga

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Benzinga

Poland, Moderna Working Towards Increased Flexibility Of COVID-19 Vaccine Contracts: Reuters

Poland can compromise with Moderna Inc (NASDAQ:MRNA) on increasing the flexibility of COVID-19 vaccine contracts, Reuters reported citing the health minister, striking an upbeat tone after initial talks with the company. Poland has said it will not take or pay for more doses of the COVID-19 vaccine under the European Union's supply contract. Reuters…

Benzinga

Pfizer Recalls Some Batches Of Another Hypertension Drug Over Cancer-Causing Impurity

Pfizer Inc (NYSE:PFE) said it is voluntarily recalling five batches of its Accupril blood pressure tablets after finding elevated levels of a potential cancer-causing agent in the medicine. Accupril is indicated for hypertension to lower blood pressure. It is also indicated for the management of heart failure as adjunctive therapy when added to…

Tribune News Service

Pfizer's COVID-19 pill will soon be available across the US

WASHINGTON — The U.S. government is finishing plans to make Pfizer Inc.’s COVID-19 pill available at any pharmacy across the country, with supply increasing as the BA.2 subvariant drives an uptick in cases and hospitalizations.

StockNews.com

Looking for Value Stocks to Add to Your Portfolio? Here are 5 For Your List

Heightened inflationary pressure, deepening supply chain disruptions, and the possibility of aggressive interest rate hikes later this year have fostered a volatile stock market. Because these factors are not expected to abate anytime soon, we think investors looking to generate solid long-term returns could consider betting on the stocks of…

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Tribune News Service

Pfizer's COVID pill is poised to be among the fastest-selling treatments of all time

Demand for Covid pills is set to make Pfizer Inc.’s Paxlovid among the fastest-selling treatments of all time, with revenue of almost $24 billion expected in 2022, according to a forecast from analytics group Airfinity Ltd.

Benzinga

Read Why Demand For Pfizer's COVID-19 Antiviral Therapy Is Unexpectedly Low: Reuters

Global demand for Pfizer Inc's (NYSE: PFE) Paxlovid has been unexpectedly light due to complicated eligibility requirements, reduced testing, and potential for drug interactions, a

Benzinga

Pfizer/BioNTech Fourth COVID-19 Vaccine Dose Protects Against Omicron For At Least One Month

A fourth dose of the COVID-19 vaccine from Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) provided significant protection against severe disease, hospitalization, and death for at least a month i

Benzinga

Two long COVID Patients Recover After Pfizer's Therapy; Side Effects, Safety Needs To Be Assessed: Reuters

Reuters reported that two patients found relief from long COVID after taking Pfizer Inc's (NYSE:PFE) antiviral Paxlovid, including a researcher who tested it on herself. Long COVID is estimated to affect up to 30% of people infected with the coronavirus. It can last for months. More than 200 symptoms have been associated with the…

Benzinga

Japan's Health Ministry Panel OKs Approval Of Novavax's COVID-19 Vaccine: Report

Japan's health ministry panel authorized a plan to approve Novavax Inc's (NASDAQ:NVAX) COVID-19 vaccine, which is set to be the fourth such vaccine to be approved in Japan. It will be available for first and second shots with an interval of three weeks. The Novavax product is a recombinant protein vaccine that uses…

Tribune News Service

Pfizer says third COVID shot boosts antibodies in kids 5 to 11

Pfizer Inc. and BioNTech SE said a third dose of their COVID vaccine increased antibodies against the omicron strain by 36-fold in a clinical trial.

Benzinga

Pfizer/BioNTech's COVID-19 Vaccine Booster Shows High Immune Response In Kids Aged 5-11 Years

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have announced results from a Phase 2/3 trial of a 10 µg booster (third) dose of COVID-19 vaccine in children aged 5-11 years.

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