AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 21, 2024

With a fatality rate 20 times that of COVID-19, and no vaccine, Disease X could swiftly bring humanity to its knees. Few would be left untouched by the pathogen were it to gain hold, causing healthcare systems to crumble and economies to collapse as the world once again tried to contain a force of nature. […]

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Containment Vaccination Vaccine Clinical Trials 182

Pharmaceutical Technology

NOVEMBER 9, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 Each booster dosage contains 15?g 1 vaccine as well as the safety results from a clinical trial underway.

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Vaccination Vaccine Regulation Medicine 264

Drug Discovery World

APRIL 13, 2023

The R21/Matrix-M malaria vaccine has received regulatory clearance for use in Ghana by the country’s Food and Drugs Authority, making it the first country to approve the vaccine. The vaccine has been approved for use in children aged five to 36 months, the age group at highest risk of death from malaria.

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Vaccination Vaccine Clinical Trials Clinical Trials 98

XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 These results came from data from Novavax’s Phase III UK trial where B.1.117

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Protein Vaccination Vaccine Trials 97

The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

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Clinical Trials Clinical Trials Trials Immune Response 52

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune Response Data.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

World of DTC Marketing

SEPTEMBER 27, 2021

SUMMARY : Vaccine mandates are only going to get us so far when it comes to COVID immunity. The reasons for people refusing vaccines are both safety and side effect concerns, although politics plays a big part as well. Two new accounts it set up were recommended 109 pages containing anti-vaccine information in just two days.

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Vaccination Vaccine Marketing Clinical Trials 173

XTalks

JANUARY 31, 2022

COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. Pfizer and BioNTech have started to enroll participants in a study that will evaluate the new version of their COVID-19 vaccine that targets the omicron variant of SARS-CoV-2.

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Vaccination Vaccine Trials Antibody 98

Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

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Vaccination Vaccine Immune Response Antibody 277

The Pharma Data

SEPTEMBER 23, 2020

September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J.,

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Clinical Trials Clinical Trials Vaccination Vaccine 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2023

Experts have advocated for immunizing both young boys and girls against human papillomavirus (HPV) with latest generation vaccines like Gardasil-9 to address the increasing incidences of cancer cases in India. Gardasil-9 is India’s first gender-neutral HPV vaccine.

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Containment Vaccination Vaccine Clinical Trials 151

STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. In their own statement, the companies acknowledged that they were aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated booster. Our choice today is a Mardi Gras blend. And how is your morning going?

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Clinical Trials Clinical Trials Regulation Drugs 97

XTalks

NOVEMBER 23, 2020

Adding to recent announcements from Pfizer and Moderna on the efficacy of their COVID-19 vaccine candidates, AstraZeneca and Oxford revealed today that their vaccine contender is 70 percent effective, and could be as high as 90 percent. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

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Vaccination Vaccine Clinical Trials Clinical Trials 97

Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. On 15 March, Eli Lilly (Indianapolis, Indiana) suspended the export of 'non-essential medicines' to Russia.

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Pharma Production Production Clinical Trials Clinical Trials 305

pharmaphorum

JUNE 9, 2022

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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Vaccination Vaccine Containment Clinical Trials 103

The Pharma Data

NOVEMBER 14, 2020

November 15, 2020 — The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. PHASE 3 ENSEMBLE 2 STUDY.

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Clinical Trials Clinical Trials Vaccination Vaccine 40

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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Vaccination Vaccine Trials Immune Response 52

Pharma Mirror

FEBRUARY 18, 2022

By Christopher Weikart, Chief Scientist, SiO2 Materials Science Even though drugs are meant to save lives, the primary packaging used for delivering drug therapies and vaccines may actually be putting us in danger. But the vials and containers that deliver these drugs haven’t evolved at nearly the same rate.

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Packaging Packaging Drugs Clinical Trials 130

Drug Discovery World

DECEMBER 26, 2023

The open-label, single patient cohort ascending dose trial followed promising preclinical data for LEU011 in a spectrum of solid tumour models. NMRA-266, an allosteric modulator that works through a mechanism that has been clinically validated in the treatment of disorders like schizophrenia, will be developed by Neumora Therapeutics.

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Development Clinical Trials Clinical Trials Drugs 64

The Pharma Data

SEPTEMBER 23, 2020

First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. Johnson & Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles.

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Clinical Trials Clinical Trials Vaccination Vaccine 40

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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Vaccination Vaccine Protein Immune Response 111

The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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Vaccination Vaccine Trials Clinical Trials 52

XTalks

SEPTEMBER 8, 2020

The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus. AMRI is proud to partner with AstraZeneca in pursuit of a vaccine that could protect people against the coronavirus pandemic,” said John Ratliff, CEO of AMRI, in a statement.

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Manufacturing Vaccination Vaccine Allergies 83

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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Regulation Vaccination Vaccine Protein 101

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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Vaccination Vaccine Immune Response Trials 105

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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Vaccination Vaccine Trials Immune Response 54

The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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Clinical Trials Clinical Trials Trials Containment 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.

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Gene Marketing Vaccination Vaccine 100

World of DTC Marketing

NOVEMBER 27, 2020

SUMMARY: Business by press release has made pharma executives a lot of money but we still haven’t seen any over reviewed data on COVID 19 vaccines. The American Nurses Association, a national professional organization, said one-third of its members do not intend to take the vaccine, and an additional third are undecided.

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Vaccination Vaccine Pharma Companies Trials 208

Delveinsight

JULY 27, 2021

Remarkable drop was observed in altered filamin A plasma levels after treatment with simufilam in Phase 2b trials. a biotechnology (clinical stage immuno-oncology) company from California publicized the design of its new XPro therapy in Phase 2 clinical trials. P-tau 181 plasma levels were also reduced in a good amount.

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Vaccination Vaccine Trials Manufacturing 96

XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

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Vaccination Vaccine Protein Trials 98

XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. Diamyd Medical is a clinical-stage biopharmaceutical company that develops therapies for type 1 diabetes.

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Vaccination Vaccine Insulin Trials 103

XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. Related: Moderna Unwilling to Share COVID-19 Vaccine Formula Amid Vaccine Inequities.

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Vaccination Vaccine Immune Response Antibody 98

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Fri, 07/08/2022 - 11:48.

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FDA Approval Vaccination Vaccine Clinical Trials 102

Pfizer

SEPTEMBER 28, 2022

5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. 5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age. 1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted

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Vaccination Vaccine Medicine Clinical Trials 101

Pfizer

JULY 19, 2022

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 Tue, 07/19/2022 - 11:22. Booster Series.

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Vaccination Vaccine Medicine Clinical Trials 100

pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. But the logistics of delivering the vaccine are hugely challenging, with up to 4 million sent out this month alone.

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Vaccination Vaccine Clinical Trials Clinical Trials 74