Pharmacy Times

JUNE 18, 2024

V116 (Capvaxive; Merck) elicited higher immune responses than the comparator for the serotypes that are unique to the vaccine, according to studies submitted to the FDA.

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pharmaphorum

OCTOBER 18, 2021

An FDA advisory committee voted unanimously in favour of a booster dose of Johnson & Johnson’s one-shot COVID-19 vaccine on Friday, as panellists suggested it should have been used as a two-dose regimen from the start. All told, 15 million people in the US have been vaccinated with Ad26.COV2.S,

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Vaccines FDA Immunization 97

STAT

MAY 18, 2023

A committee of vaccine experts voted to recommend the Food and Drug Administration approve Pfizer’s maternal RSV vaccine on Thursday, though the panel expressed some safety concerns. Read the rest…

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Vaccines Immunization FDA 109

pharmaphorum

DECEMBER 6, 2022

Pfizer and BioNTech have announced that they have submitted an Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) for their Omicron BA.4/BA.5-adapted It is thought the updated vaccine might help to prevent severe illnesses and hospitalisation. 5-adapted bivalent vaccine. 5-adapted bivalent vaccine.

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Vaccines FDA Immunization 105

Pharmaceutical Technology

MAY 2, 2023

The FDA recently announced the expansion of the emergency use authorizations (EUAs) of both Pfizer/BioNTech’s and Moderna’s bivalent original/Omicron BA.4/5 4/5 Covid-19 messenger RNA (mRNA) vaccines. 1 vaccines by both companies were revoked by the FDA in August 2022, after the BA.5

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Vaccines FDA Immunization 21

pharmaphorum

JANUARY 15, 2021

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

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Vaccines Immunization FDA 119

European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

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Vaccines Immunization FDA 105

The Checkup by Singlecare

SEPTEMBER 22, 2023

This year, there are new vaccines to help at-risk populations ward off severe sickness, including that caused by RSV. Here’s what you need to know about the new FDA-approved RSV vaccine. In older adults, the risk is heightened due to weakened immune systems and, in some cases, chronic lung or heart conditions.

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Vaccines Immunization Insurance FDA 105

pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. Non-injectables remove the need for health professional-led immunisation programmes, making widespread vaccine roll-outs quicker and easier and more affordable,” Channon told pharmaphorum.

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Vaccines Immunization Dosage FDA 119

pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

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pharmaphorum

DECEMBER 9, 2021

AstraZeneca’s antibody cocktail for COVID-19, now called Evushield, has become the first drug in the class to be authorised for prevention of infection by the US FDA. The post AZ’s antibody first to be cleared by FDA for COVID prevention appeared first on.

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Pharmacy Times

JULY 12, 2024

RSVpreF is currently the only FDA-approved RSV vaccine for pregnant individuals.

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Immunization Vaccines FDA 101

Pharmaceutical Technology

JULY 25, 2024

JNJ-2056 is being investigated in the Phase IIb ReTain study which enrols participants who are yet to show Alzheimer’s symptoms.

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Immunization Vaccines FDA 98

Pharmacy Times

SEPTEMBER 20, 2024

The approval enables more convenient flu immunization options for patients.

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Immunization Vaccines FDA 111

Digital Pharmacist

OCTOBER 26, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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Vaccines FDA Hospitals Immunization 98

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

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Vaccines Immunization FDA 98

pharmaphorum

DECEMBER 17, 2020

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

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Vaccines FDA Immunization Hospitals 105

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.

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Vaccines Immunization FDA 111

European Pharmaceutical Review

APRIL 25, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

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Vaccines Immunization FDA 111

The Checkup by Singlecare

SEPTEMBER 12, 2023

Luckily, there’s a shot to help prevent it: Shingrix, the shingles vaccine. The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California.

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Vaccines Immunization Pharmacy Program Director Chemotherapy 105

pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. Nath told CNN: “The highest levels of NIH are very concerned.

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Vaccines FDA Documentation Immunization 105

Fierce Pharma

MARCH 4, 2024

After decades of research into respiratory syncytial virus (RSV), Pfizer and GSK’s groundbreaking vaccines made waves as the first immunizations against the common respiratory illness.

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Vaccines Immunization FDA 92

pharmaphorum

OCTOBER 21, 2021

The FDA has authorised booster shots with Moderna and Johnson & Johnson’s COVID-19 vaccines, a month after giving the go-ahead to a third-dose of Pfizer/BioNTech’s shot. S vaccine, which is initially administered as one rather than two doses. The FDA has followed that advice.

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Pharmacy Times

JUNE 23, 2022

Vaxneuvance was approved for an expanded indication by the FDA on June 22, 2022, for active immunization in children 6 weeks of age and older.

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Immunization Vaccines FDA 123

pharmaphorum

AUGUST 16, 2021

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. Data from a larger phase 3 study of the third dose is also expected shortly and will be submitted to the FDA when available, said the drugmakers.

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FDA Vaccines Immunization 105

STAT

OCTOBER 8, 2024

Moreover, the trade group maintained the FDA move was “unlawful,” because it failed to follow so-called rule-making procedures and provide proper notice of its plans. A group of doctors and medical practices claimed they overpaid for the vaccine, which was the only mumps shot in the U.S. ” A U.S.

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Compounding FDA Compounding Pharmacies Vaccines 105

Pharmaceutical Technology

JUNE 24, 2022

As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 1 variant of concern.

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Vaccines Immunization FDA Hospitals 105

pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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Vaccines Immunization FDA 105

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

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FDA Chemotherapy Immunization Vaccines 135

Fierce Pharma

OCTOBER 20, 2023

approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. | FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease.

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pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

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Vaccines Immunization Dosage FDA 89

pharmaphorum

AUGUST 25, 2021

Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise.

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Fierce Pharma

MARCH 25, 2024

The four years since the start of the COVID-19 pandemic have yielded many advances against the coronavirus, including Moderna and Pfizer’s groundbreaking mRNA vaccines. |

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Immunization Vaccines FDA 94

European Pharmaceutical Review

AUGUST 30, 2022

Pfizer has announced positive top-line data from a Phase III clinical trial (NCT05035212) investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. In more severe disease with primary endpoint of LRTI-RSV defined by three or more symptoms, vaccine efficacy of 85.7

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Vaccines FDA Immunization 98

European Pharmaceutical Review

FEBRUARY 14, 2023

Recently there have been several key advances in the clinical development of messenger RNA (mRNA) vaccines, including vaccines for RSV and a personalised cancer vaccine. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

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Vaccines Immunization FDA 105

European Pharmaceutical Review

JANUARY 23, 2023

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. EVX-01 cancer immunotherapy EVX-01 is a peptide-based cancer immunotherapy generated based on gene analysis of a patient’s tumours and on matching with their immune system. Moderna, Inc.

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Immunization Vaccines FDA 124

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The post Budget 2021: Sunak focuses on vaccine development to restart economy appeared first on.

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