Pharmaceutical Technology

JANUARY 31, 2023

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. It contains a single mRNA sequence encoding for a stabilised prefusion F glycoprotein. The findings showed 83.7%

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Pharmaceutical Technology

OCTOBER 6, 2022

from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine.

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pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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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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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20 , to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.

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Pharmaceutical Technology

JUNE 8, 2023

The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults.

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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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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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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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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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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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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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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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XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

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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. In the trial, the vaccine was injected directly into the lymph nodes of type 1 diabetic individuals.

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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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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. Health secretary Matt Hancock reportedly came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.

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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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XTalks

FEBRUARY 20, 2024

GlaxoSmithKline’s (GSK) Arexvy and Pfizer’s Abrysvo are the first-ever approved vaccines against respiratory syncytial virus (RSV). The vaccines received approvals from the US Food and Drug Administration (FDA) in May 2023 for the prevention of RSV infection.

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XTalks

FEBRUARY 12, 2021

On the heels of news that AstraZeneca/Oxford’s COVID-19 vaccine has markedly reduced effectiveness against the B.1.351 1.351 variant of SARS-CoV-2 that first appeared in South Africa, the vaccine makers are going full steam ahead to make a variant booster shot against the strain. 1.351 between the vaccine and placebo groups.

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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. gingivalis.

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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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XTalks

DECEMBER 23, 2024

Meanwhile, expanded malaria vaccine access in 17 countries offers hope, poised to save tens of thousands of lives annually. Preparing for these events involves strengthening early detection systems, expanding vaccine distribution networks and addressing critical public health gaps.

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XTalks

DECEMBER 7, 2021

VBI Vaccines got its first vaccine approval from the US Food and Drug Administration (FDA) for its hepatitis B shot PreHevbrio. And in another first, VBI’s shot is the only approved three-antigen HBV vaccine for adults in the US. PreHevbrio contains the S, pre-S2 and pre-S1 HBV surface antigens.

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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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Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.

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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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pharmaphorum

OCTOBER 5, 2022

million grant by the US government to develop an intranasal vaccine for gonorrhoea, a sexually-transmitted infection that is on the rise around the world. million in National Institutes of Health (NIH) funding to further develop a prophylactic vaccine based on its proprietary outer membrane vesicles (OMV) platform technology.

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pharmaphorum

JULY 27, 2022

Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. 1 subvariant of Omicron. Pfizer and Moderna have both started regulatory filings for approval of their BA.1-containing

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Pharmaceutical Technology

AUGUST 5, 2022

According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials. Since research needs to be done under containment conditions, samples cannot be moved across different facilities, he explains.

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XTalks

MAY 4, 2023

When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. However, there are ongoing clinical trials for celiac disease to investigate potential new treatments.

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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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pharmaphorum

NOVEMBER 30, 2020

The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. The vaccines can only be kept in a fridge for up to five days before being administered, although Pfizer has designed a “pizza box” style transportation container.

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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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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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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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