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FOUND: 9 | Mind Blowing Facts

US panel backs Moderna, Pfizer COVID shots for youngest kids

Infants and toddlers in the U.S. are now able to be vaccinated against COVID-19 after shots from Moderna Inc. and Pfizer Inc. won support from health advisers on Saturday.

Tribune News Service

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Nod For Kids As Young As Six Months

The FDA has granted emergency use authorization (EUA) to Pfizer Inc (NYSE:PFE) and BioNTech SE's (NASDAQ:BNTX) COVID-19 Vaccine as a three 3-µg dose series for children six months through 4 years of age. Based on safety, tolerability, and immunogenicity data, the 3-µg dose was carefully selected as the preferred dose for children under five. The EUA…

Benzinga

FDA clears Moderna, Pfizer COVID shots for children 5 and under

COVID vaccines for children ages 5 and under from Pfizer Inc. and Moderna Inc. received authorization from U.S. regulators, meaning almost all of the American population can soon get protected against COVID-19 disease.

Tribune News Service

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Bavarian Nordic Launches COVID-19 Booster Study To Compare Against Pfizer/BioNTech Shot

As Bavarian Nordic A/S (OTC: BVNRY) was in the headlines recently due to the smallpox vaccine amid rising cases of monkeypox, the company is also getting ready to evaluate its COVID-19 booster, ABNCoV2, in a pivotal study. ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac, Denmark using their proprietary capsid virus-like…

Benzinga

Akero Therapeutics Shares Surge After Equity Investment From This Famed Large Cap Biopharma

Akero Therapeutics Inc (NASDAQ:AKRO) announced a $25 million equity investment by Pfizer Inc (NYSE:PFE) at $9.90 per share. The company also announced a term loan facility providing Akero with access to up to $100 million from Hercules Capital Inc (NYSE:HTGC), of which $10 million will be drawn at transaction close. Together with existing cash, proceeds will support…

Benzinga

The Daily Biotech Pulse: FDA Committee Backs Moderna Shot For 5-17 Years, 180 Life Sciences Stock Plunges, Pfizer's Posts Disappointing Paxlovid Data

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

Benzinga

Morning Brief: Top Financial Stories Dominating on Wednesday, June 15

Reuters Warner Bros Discovery To Undergo Major Global Ad Sales Team Restructuring

Benzinga

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Pfizer Halts Enrollment In Paxlovid COVID-19 Trial In Standard-Risk Population

Pfizer Inc (NYSE:PFE) shared additional data from the Phase 2/3 EPIC-SR study of Paxlovid (nirmatrelvir and ritonavir tablets) in patients at standard risk for developing severe COVID-19. In previously reported interim analyses, the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met. Non-significant 70% relative…

Benzinga

EU Urges Pfizer To Further Delay COVID-19 Vaccine Deliveries: Reuters

Amid lower demand, Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) agreed to delay supplies of their Covid-19 shot to the European Union. Doses to be shipped from June to August would be sent in September and Q4. Reuters reports that the bloc is putting heat on Pfizer to restrict supplies further. The move comes two weeks after…

Benzinga

Moderna's COVID-19 Shot Likely Related To Higher Heart Inflammation Risk Than Pfizer's: Reuters

Moderna Inc's (NASDAQ:MRNA) COVID-19 vaccine may relate to a higher risk of heart inflammation in some age groups than Pfizer Inc (NYSE:PFE) - BioNTech SE's (NASDAQ:BNTX) shot, Reuters reported citing the Centers for Disease Control and Prevention. Citing recent data, CDC said that the findings on myocarditis and pericarditis, types of heart inflammation linked to both the…

Benzinga

Australia's ResApp Takeover Bid Undervalued - Read What Pfizer Did

Following an independent expert report suggesting that Australia-based ResApp Health Limited's current share price was undervalued, Pfizer Inc (NYSE: PFE) bolstered its takeover bid.

Benzinga

Pfizer COVID shot works, safe for youngest kids, FDA says

U.S. Food and Drug Administration staff said that Pfizer Inc.’s COVID-19 shot was effective for kids ages 4 and under with no new safety concerns, in a report released ahead of a key meeting of FDA advisers later this week.

Tribune News Service

5 Dividend Growth Stocks Currently on Sale

The stock market has been experiencing wild swings since the beginning of the year on various macroeconomic and geopolitical concerns. In an environment of elevated market volatility, dividend growth stocks are considered attractive investments to ensure a steady income stream and capital appreciation. Thus, it could be wise to invest…

StockNews.com

Pfizer submits COVID-19 shot for children under 5 for FDA authorization

WASHINGTON — Pfizer Inc. asked U.S. regulators to clear its COVID-19 vaccine for emergency use in children under age 5, an effort to extend protection against the virus to the country’s youngest.

Tribune News Service

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Benzinga

Pfizer To Quit GSK's Consumer Health JV Following Its Spin-Off

Pfizer Inc. (NYSE:PFE) intends to sell its 32% investment in Haleon, a consumer health joint venture with GSK plc (NYSE:GSK), after the business is spun out as an independent listed company in July, reported Reuters. Pfizer had previously indicated that it might seek to sell its stake in Haleon, a consumer health company and…

Benzinga

Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

May turned out to be a month of mixed fortunes as far as regulatory reviews are concerned. New molecular entity approvals, an indicator of innovation in drug research, totaled three during the month, bringing the total for the year to 15. This compares to the 24 NMEs the Food and…

Reuters

U.S. doctors reconsider Pfizer's Paxlovid for lower-risk COVID patients

Use of Pfizer Inc's COVID-19 antiviral Paxlovid spiked this week, but some doctors are reconsidering the pills for lower-risk patients after a U.S. public health agency warned that symptoms can recur after people complete a course of the drug, and that they should then isolate a second time.

Benzinga

Pfizer To Sell 23 Patented Drugs, Vaccines At Lower Prices To Poorer Countries

Pfizer Inc (NYSE:PFE) will sell over 20 patent-protected drugs and vaccines at not-for-profit prices to 45 of the world's poorest countries. Under the program, Pfizer will begin shipping the medicines first to Ghana, Malawi, Rwanda, Senegal, and Uganda before the end of this year, Chief Executive Albert Bourla said in an interview. This will…

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Bangkok Post

Cambodia, Laos to benefit as Pfizer slashes drug prices for poorest nations

Pfizer Inc plans to sell its entire portfolio of brand-name drugs at cost in as many as 45 lower-income countries, including Cambodia and Laos, one of the most comprehensive and ambitious drug-access programmes ever announced by a large pharmaceutical manufacturer.

Reuters

Pfizer to sell all its patented drugs at nonprofit price in low-income countries

Pfizer Inc will make all of its patented medicines including COVID-19 treatment Paxlovid and big-selling breast cancer drug Ibrance available at a not-for-profit price to 45 of the world's poorest countries, the drugmaker said on Wednesday.

Benzinga

Pfizer's Ulcerative Colitis Candidate Shows Remission In Over 30% Of Patients In Pivotal Studies

Pfizer Inc (NYSE:PFE) has announced detailed results from two pivotal studies from ELEVATE UC Phase 3 program evaluating etrasimod for active ulcerative colitis (UC). The drug, etrasimod, was Pfizer's key asset in its $6.7 billion deal for Arena Pharmaceuticals last year. UC is an inflammatory bowel disease that affects around 3.8 million people in North…

Benzinga

The Analyst Says 'Impressive Phase 3 Data Highlight Best-In-Class Opportunity' For Concert Pharma

Concert Pharmaceuticals Inc (NASDAQ:CNCE) has released highly positive Phase 3 data for their alopecia areata drug CTP-543 from the THRIVE-AA1 trial. Mizuho says that the efficacy supports its view that CTP-543 potentially has best-in-class efficacy amongst the three main oral JAK inhibitors in late-stage development for alopecia areata (CTP-543, Eli Lilly And Co's (NYSE: LLY)…

Tribune News Service

Pfizer COVID shot seems protective for children under 5 in early data

Pfizer Inc. and BioNTech SE said their COVID-19 vaccine was highly effective and prompted a strong immune response in children under age 5, based on early results from a trial that is likely to pave the way for infants and toddlers to finally get immunized.

Reuters

Pfizer/BioNTech say 3 COVID shots elicit good response in children under 5

Drugmakers Pfizer Inc and BioNTech SE said on Monday that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.

Benzinga

CDC Recommends Pfizer/BioNTech COVID-19 Booster Shots For Kids Aged 5-11 Years

The Centers for Disease Control and Prevention recommended that children ages 5 to 11 receive the newly authorized COVID-19 booster shot from Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX). Following the recommendation, many of the nation's doctors, pharmacies, and other vaccination sites are expected to begin offering the extra doses to the 28 million U.S. children…

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