Establishing Patient Confidence in Emergency Use Authorization-Driven COVID-19 Vaccines
Drug Topics
NOVEMBER 11, 2022
Communication and education are critical to patient confidence in emergency use authorization vaccines.
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FDA Gives Drug Gohibic Emergency Use Authorization to Treat COVID-19
Drug Topics
APRIL 10, 2023
The FDA granted the EUA based on the phase 3 trial results that demonstrated vilobelimab's efficacy compared to placebo, with a 23.9% relative reduction in all-cause mortality from COVID-19 at 28 days.
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FDA Grants Pemivibart Emergency Use Authorization for PrEP of COVID-19 in Immunocompromised Patients
Pharmacy Times
MARCH 25, 2024
The indication is for adults and adolescents with moderate to severe immune compromise due to medical conditions or immunosuppressive medications and treatments.
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Novavax receives FDA emergency use authorization for Covid-19 vaccine
Pharmaceutical Technology
JULY 14, 2022
Novavax has obtained the US Food and Drug Administration (FDA) emergency use authorization (EUA) for its Covid-19 vaccine. Novavax president and CEO Stanley Erck said: “Today's FDA emergency use authorization of our Covid-19 vaccine provides the US with access to the first protein-based Covid-19 vaccine.
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Direct Relief’s Donations of Emergency Use Authorization Covid-19 Medical Products Reach Over 19 Million Worldwide
Fierce Pharma
JANUARY 12, 2023
Direct Relief’s Donations of Emergency Use Authorization Covid-19 Medical Products Reach Over 19 Million Worldwide jpiatt Thu, 01/12/2023 - 15:19
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FDA Issues Emergency Use Authorization to Novavax’s COVID-19 Vaccine 2023-24 Formula
Pharmacy Times
OCTOBER 3, 2023
NVX-CoV2601 vaccine adjuvanted 2023-2024 formula granted EUA for the prevention of COVID-19 in those 12 years of age and older.
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FDA Authorizes Novavax’s COVID-19 Vaccine for Emergency Use
PharmExec
OCTOBER 5, 2023
Company expects treatment to be available across the country.
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FDA Grants Emergency Use Authorization for Novavax Adjuvanted COVID-19 Vaccine as Booster for Adults
Pharmacy Times
OCTOBER 19, 2022
Neutralizing antibodies increased by 34- to 27-fold compared to pre-booster levels when administered at 8 or 11 months post-primary series.
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FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine in Adolescents Aged 12 Through 17
Pharmacy Times
AUGUST 22, 2022
The announcement marks the first protein-based COVID-19 vaccine authorized in the United States for this patient population.
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Pfizer, BioNTech Apply to FDA for Emergency Use Authorization of Omicron-Adapted COVID-19 Booster Vaccine
Pharmacy Times
AUGUST 23, 2022
The companies are prepared to deliver doses of the Omicron-adapted bivalent vaccine for September, pending authorization.
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After Cyfendus' full approval, Emergent clinches $75M anthrax vaccine supply pact in US
Fierce Pharma
NOVEMBER 28, 2023
Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the Uni | Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding (..)
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FDA Authorizes Updated COVID-19 Vaccine Formulations for Current Variants
Pharmacy Times
SEPTEMBER 11, 2023
FDA grants updated Moderna and Pfizer-BioNTech COVID-19 vaccines with emergency use authorization to target currently circulating variants of the virus.
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Paxlovid EUA Revision Narrows Emergency Use to Pediatric Patients
Drug Topics
JANUARY 29, 2024
The FDA states the revision to the emergency use authorization (EUA) is the next phase in the transition from the use of EUA-labeled nirmatrelvir and ritonavir to the use of NDA-labeled nirmatrelvir and ritonavir.
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FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
Pharmacy Times
APRIL 19, 2023
Agency updates emergency use authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccinations, which are no longer authorized for used in the United States.
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Invivyd's COVID prophylactic scores FDA emergency nod for people with weakened immune systems
Fierce Pharma
MARCH 25, 2024
The agency granted emergency use authorization to Invivyd's Pemgarda, a monoclonal antibody for those who are immunocompromised and unlikely to receive adequate protection from marketed mRNA vaccines.
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Pharmacists Are Empowered Yet Again
Pharmacy Times
SEPTEMBER 30, 2022
FDA revises emergency use authorization to grant prescribing authority for Pfizer’s Paxlovid antiviral treatment for COVID-19.
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Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines
Fierce Pharma
SEPTEMBER 11, 2023
Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. . | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease.
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Study: COVID-19 Vaccination Not Associated With Increased Risk of Heart Attack, Stroke
Pharmacy Times
JUNE 29, 2022
The study included the BNT162b2 and CoronaVac vaccines, which are the only COVID-19 vaccines authorized for emergency use in Hong Kong.
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STAT+: The FDA’s diagnostics chief, who led through Covid, has retired
STAT
JANUARY 18, 2024
Early on, using powers granted by the public health emergency, the FDA required labs to apply for emergency use authorization. The pandemic especially laid bare FDA’s inability to control lab-developed tests (LDTs). Many of the Covid-19 PCR tests fell in this category.
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Pfizer, BioNTech Announce Updated COVID-19 Vaccine Efficacy Data for Young Children
Pharmacy Times
AUGUST 25, 2022
Analysis is based on previously reported data collected in March and April 2022, with the FDA granting emergency use authorization for individuals aged 6 months to 4 years on June 17.
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The FDA has cleared the first home flu and Covid test — but its maker just declared bankruptcy
STAT
FEBRUARY 26, 2023
On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. Read the rest…
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Bivalent COVID-19 Boosters Authorized for Children 5 Years and Older
Drug Topics
OCTOBER 13, 2022
The emergency use authorization amendments extend availability of the bivalent booster to young children.
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President Biden to end Covid-19 emergencies on May 11
STAT
JANUARY 30, 2023
WASHINGTON — President Joe Biden informed Congress on Monday that he will end the twin national emergencies for addressing Covid-19 on May 11, as most of the world has returned closer to normalcy nearly three years after they were first declared. Read the rest…
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COVID-19 PCR Test Receives FDA Clearance for use on Cobas Systems
Pharmacy Times
OCTOBER 24, 2022
The test has been available under emergency use authorization (EUA) since March of 2020 and was the first commercial molecular test to receive EUA status.
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Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children
BioPharm
DECEMBER 13, 2022
mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.
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China grants EUA to Covid-19 vaccine against XBB descendent lineages
Pharmaceutical Technology
JUNE 9, 2023
WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta)
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Serotonin levels are depleted in long Covid patients, study says, pointing to a potential cause for ‘brain fog’
STAT
OCTOBER 16, 2023
If you’ve been following the mystery of long Covid since it emerged in 2020, you’ll recall interferons and serotonin have been clues from the start as combatants in the body’s prolonged battles against the virus. The authors hope further research will lead to testing potential treatments. Read the rest…
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FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt
STAT
MARCH 8, 2023
Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. Now the FDA has released a rare comment clarifying what happened during its authorization process. Read the rest…
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EMA task force begins review of Veru’s sabizabulin for Covid-19
Pharmaceutical Technology
JULY 28, 2022
The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk. The review will facilitate the use of the therapy for emergency usage in countries in the European Union (EU).
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Patent expiration to drive biosimilars market expansion to 2032
European Pharmaceutical Review
APRIL 11, 2024
Key drivers for the market include patent expirations of several biologic drugs and increasing demand for affordable biologic treatments, the author explained. The author wrote that biosimilar products allow companies to reduce their spending on the development and commercial side. million by 2032, at 17.6
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Study Spotlights Concerns With Direct-to-Consumer Online Advertising of COVID-19 Treatments
PharmExec
NOVEMBER 15, 2023
Dozens of companies are selling stem cell treatments and exosome therapies that have not been approved for use or authorized for emergency use by the FDA.
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Spotlight on Pediatric COVID-19 Vaccines
Drug Topics
OCTOBER 22, 2022
After multiple approvals and emergency use authorizations, It’s time to take stock of the state of pediatric COVID-19 vaccines.
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FDA authorizes updated Covid-19 boosters for youngest children
STAT
DECEMBER 8, 2022
The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.
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Inside the Pfizer/BioNTech COVID-19 vaccine trial: ‘We knew the world was watching and waiting for results’
Outsourcing Pharma
MARCH 3, 2021
The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic.
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STAT+: EU regulator recommends expanding diabetes drug Mounjaro’s approval to include obesity
STAT
NOVEMBER 10, 2023
Mounjaro, known scientifically as tirzepatide, is one of an emerging class of drugs that target receptors of the GLP-1 hormone, and sometimes other molecules, and that have had dramatic effects on weight loss.
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Study shows autistic people are more likely to engage in self-harm — but not because of autism
STAT
AUGUST 9, 2023
Autistic people are at a much higher risk of self-harm leading to emergency care or suicide, according to a recent study published in JAMA Network Open. Read the rest…
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STAT+: A new paper suggests a simple fix to the primary care physician shortage
STAT
SEPTEMBER 1, 2023
The dearth of doctors in this area has broad ramifications, ranging from more patients seeking care from specialty and emergency medicine to increased costs to the health care system and poorer public health outcomes. is running low on primary care physicians, with an estimated shortage of between 17,800 and 48,000 predicted by 2034.
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CDC Recommends Updated COVID-19 Boosters Incase of Fall Surge
Drug Topics
SEPTEMBER 2, 2022
Move comes after FDA give emergency use authorization for bivalent vaccines.
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Innovation to drive advanced drug delivery market
European Pharmaceutical Review
FEBRUARY 22, 2024
The year 2023 was “significant” for the progress of advanced drug delivery systems, the author reflected. In 2023, these systems captured 48 percent share of the market, according to report’s author. Geographically, North America emerged as a key player, gaining a 38 percent share of the market in 2023, the research found.
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CDC Endorses ACIP Recommendation of Novavax COVID-19 Adjuvanted Vaccine
Pharmacy Times
JULY 21, 2022
The FDA granted the vaccine series Emergency Use Authorization on July 14, based on clinical trial data showing significant efficacy and safety.
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Covid evolution wipes out another antibody treatment, threatening the country’s medicine cabinet
STAT
NOVEMBER 30, 2022
The Food and Drug Administration on Wednesday ended its emergency authorization for the only remaining Covid-19 antibody therapy cleared for use, saying variants that render it ineffective are now dominant in the United States. have been growing in prevalence.
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Novavax COVID-19 Vaccine Now Available at Numerous US Pharmacies
PharmExec
OCTOBER 13, 2023
Treatment previously received emergency use authorization by the FDA.
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IV diazepam offers similar relief of acute low back to methocarbamol in ED
Hospital Pharmacy Europe
APRIL 26, 2023
Diazepam appears only slightly better than methocarbamol for relief of acute low back pain within an emergency department Low back pain (LBP) accounts for nearly 5% of all emergency department visits. Both opioids and NSAIDs are useful emergency department (ED) treatments for acute LBP. hours vs DP = 4.8 hours, p=0.365).
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STAT+: How the FDA’s pandemic flexibilities boosted mental health apps — and what happens now
STAT
MAY 11, 2023
In April 2020, the Food and Drug Administration announced a pandemic enforcement policy allowing mental health app developers to release certain treatment products without seeking authorization from the agency.
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