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The Latest Breaking News from Pfizer

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

Novavax Surges As Its Covid Shot Approaches The FDA Finish Line

The Food and Drug Administration said Friday its panel of experts will discuss Novavax's Covid vaccine in June, leading NVAX stock to surge.

Investors Business Daily

FDA sets June meetings on COVID vaccines for youngest kids

The Food and Drug Administration has set tentative dates in June to publicly review COVID-19 vaccines for the youngest American children

The Independent UK

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Scottish campaigners protest at Pfizer office as 'vaccine equity' motion voted down

CAMPAIGNERS from Global Justice Now Scotland have stated they are “outraged” as shareholders at pharmaceutical multinationals Pfizer and Moderna…

The National (Scotland)

White House: Paxlovid shortage is over

As VP Harris takes Paxlovid after her COVID-19 diagnosis, the White House is making the drug easier to access

Salon

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

Moderna seeks FDA approval of Covid vaccine for children aged six months to five years old

The request arrives one month after the drug company said its two-dose jabs provided immune protection in youngest children

The Independent UK

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Covid vaccine: Moderna seeks US approval for jab for kids under 6

Trials showed the jab was 37 per cent effective for two and five-year-olds and 51 per cent for children between six months and the age of two

Evening Standard

Moderna applies for US clearance of COVID shot for young kids

Moderna Inc. applied for emergency use authorization for its COVID-19 vaccine in children from six months to under 6 years old after a successful trial showed two doses generate high levels of antibodies to the virus.

Tribune News Service

Moderna seeks to be 1st with COVID shots for littlest kids

Moderna is asking U.S. regulators to open its COVID-19 vaccine to the nation's youngest children

The Independent UK

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

EU estimates up to 80% of population has had COVID

The European Commission said that between 60% and 80% of the EU population was estimated to have been infected with COVID-19, as the bloc enters a post-emergency phase in which mass reporting of cases was no longer necessary.

Reuters

European Commission Granted Marketing Authorization For Pfizer and Biohaven's VYDURA® (Rimegepant) For Migraine

European Commission (EC) has granted marketing authorization for VYDURA® (rimegepant) for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month.

Benzinga

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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…

Salon

Another delay for five-and-under vaccine

The issue isn't around safety, but instead messaging and vaccine effectiveness

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.

The Independent UK

EXPLAINER: COVID-19 pills must be taken within 5 days

COVID-19 patients have two treatment options that can be taken at home

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The Guardian - US

US working to make Covid drugs more widely available as cases fall

But White House’s Covid response coordinator says more funding will be needed to supply pills beyond a few more months

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…

Daily Record

More Scots invited for fourth Covid jabs by NHS - check who is eligible

The rollout of first and second booster jabs for Scotland is underway.

Birmingham Post

Biotech firm ReViral acquired by Pfizer in £412m deal

ReViral was co-founded by former Durham University lecturer Professor Stuart Cockerill and has a North East research and development facility at Sedgfield's NETPark

Asharq Al-Awsat

US Administration Expands Availability of COVID Antiviral Pill

President Joe Biden's administration is taking steps to expand availability of the life-saving COVID-19 antiviral treatment Paxlovid, as it seeks to reassure doctors that there is ample supply for people at high risk of severe illness or death from the virus. Paxlovid, produced by Pfizer, was first approved in December.…

The Independent UK

Administration expands availability of COVID antiviral pill

President Joe Biden’s administration is taking steps to expand availability of the life-saving COVID-19 antiviral treatment Paxlovid

Salon

Poor nations left behind on vaccines

"Do not let history repeat itself," advocates warn as low-income countries lack access to Pfizer treatment

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