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DARK SECRETS: 10 - The Real Truth

Pfizer, NIH Mulling Study For Longer Paxlovid Course To Combat Reinfections

The U.S. National Institutes of Health and Pfizer Inc (NYSE:PFE) are discussing testing a longer course of COVID-19 antiviral treatment Paxlovid, required to prevent reinfections, White House Chief Medical Officer Anthony Fauci said. "We're going to be planning what studies we're going to be doing relatively soon, within the next few days," to…

Benzinga

Read Why Pfizer Is Limiting Supply Of Paxlovid For Combination Studies: Bloomberg

Amid rising concerns over the potential development of resistance to Pfizer Inc's (NYSE:PFE) COVID-19 pill Paxlovid, the company has declined to supply researchers with the antiviral for use in combination studies, according to a Bloomberg report. Researchers say that Paxlovid combined with other drugs might stave off resistance. Pfizer hasn't started any combination…

Benzinga

FDA Declines Emergency Use Request For An Antidepressant As COVID-19 Treatment

The FDA has decided not to authorize fluvoxamine, an antidepressant, to treat COVID-19. The agency that data has not shown the drug to be an effective therapeutic for fighting the virus. "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine…

Benzinga

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FDA May Authorize Pfizer-BioNTech's COVID-19 Booster For 5-11 Year Kids Soon: NYT

The FDA is expected to authorize a booster shot of Pfizer Inc (NYSE:PFE) / BioNTech SE's (NASDAQ:BNTX) COVID-19 vaccine for children aged 5 to 11 probably by today, the New York Times reported, citing people familiar with the matter. The companies submitted an application to the FDA for authorization last month. They have cited data from…

Benzinga

Price Of Pfizer's Paxlovid Generic Version Capped At $25 Or Less For Low-Income Countries

Several generic drugmakers will produce cheaper versions of Pfizer Inc's (NYSE:PFE) COVID-19 antiviral treatment Paxlovid at $25/course or less for low- and middle-income countries, Reuters reported citing the Clinton Health Access Initiative (CHAI). CHAI said it could not disclose the manufacturers' names who have agreed to the price ceiling because they are still in…

Benzinga

COVID-19 Symptoms Rebound After Pfizer's COVID-19 Therapy, What Could Be The Reason?

Some patients have reported that COVID-19 symptoms recurred after completing treatment and experiencing improvement after Pfizer Inc's (NYSE: PFE) COVID-19 oral antiviral treatment Paxlovid.

Benzinga

Pfizer Acquires This Migraine Drug Maker For $11B: What Investors Need To Know

Pfizer Inc (NYSE:PFE) will acquire Biohaven Pharmaceutical Holding Company Ltd (NYSE:BHVN) for $148.50 per share, equivalent to $11.6 billion. Pfizer will also make payments at closing to settle Biohaven's third-party debt and for the redemption of all outstanding shares of Biohaven's redeemable preferred stock. The deal includes the acquisition of rimegepant (NURTEC ODT), a dual-acting…

Benzinga

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BioNTech Clocks Over $6B In Q1 Sales, Sticks To FY22 Guidance

BioNTech SE (NASDAQ:BNTX) has reported Q1 FY22 revenues of €6.37 billion compared to €2.05 billion a year ago, mainly due to high demand for the company's COVID-19 vaccine. In Q1 FY22, BioNTech and its partner Pfizer Inc (NYSE:PFE) have invoiced approximately 750 million COVID-19 vaccine doses. As of end-April 2022, the companies have signed orders…

Benzinga

Researchers Want Pfizer's Therapy Studied As Evidence Suggests Benefit for Long COVID Patients: Reuters

Additional reports of patients with long COVID who were helped by Pfizer Inc's (NYSE: PFE) oral antiviral treatment Paxlovid have surfaced, providing momentum for conducting clinical trials to test the treatment,

Benzinga

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.

Tribune News Service

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

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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

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…

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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…

Tribune News Service

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.

Benzinga

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

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…

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