pharmaphorum

DECEMBER 15, 2022

However, this has led to increased transmission of other respiratory diseases and, as we’re already seeing, there are now some very real concerns about a lesser-known virus – respiratory syncytial virus, or RSV. RSV is one of the most common respiratory viruses, causing coughs and colds during the winter months.

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Leads Medical Management Patients 69

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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Pharmaceutical Technology

APRIL 7, 2023

Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). Consistent potency was also observed across a range of RSV clinical isolates in several cell types.

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Medgadget

SEPTEMBER 7, 2023

The device could be very useful fo screening large numbers of people prior to access to an indoor event, for instance, or in community clinics to quickly determine if people are infected. The nanobodies are bound to an ultrasensitive micro-immunoelectrode biosensor, which can provide a rapid readout if the virus is present.

Medicine 94

Medicine Leads 94

European Pharmaceutical Review

AUGUST 22, 2023

Abrysvo is approved for pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants. The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age.

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Food and Drug Administration FDA Government Food 84

Pharmaceutical Technology

JANUARY 16, 2023

Recent cases in the pharmaceutical sector include Poolbeg Pharma finding more than one respiratory syncytial virus (RSV) vaccine candidate with AI by going through a vast amount of early stage clinical data to prioritise candidates and reposition them as novel treatments for RSV infection.

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pharmaphorum

DECEMBER 22, 2022

It also said the alliance will see Moderna invest in R&D in the UK over the next 10 years, including running a number of clinical trials and providing grant funding to UK universities, while the manufacturing facility will create more than 150 highly skilled jobs. The first vaccines are due to be produced at the new facility in 2025.

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pharmaphorum

JULY 12, 2022

Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality rate of between 40% and 70%, developed by mRNA specialist Moderna. “The need for a preventive Nipah virus vaccine is significant,” he added.

Safety 52

Safety Leads 52

Pharmaceutical Technology

FEBRUARY 23, 2023

This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and Respiratory syncytial virus (RSV).

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Pharmaceutical Technology

NOVEMBER 21, 2022

This will aid in the production of new raw materials and possible clinical-grade assets to develop mRNA vaccines and therapies for infectious diseases, as well as other ailments with unmet needs. It commenced a first-in-human clinical trial of the vaccines in September this year. .

Medicine 52

Medicine Manufacturing Pharmaceutical Leads 52

pharmaphorum

JULY 21, 2022

GSK’s former head of vaccines R&D – Dr Emmanuel Hanon – is heading up a new biotech called Vicebio that will go up against his former employer with a vaccine against respiratory syncytial virus (RSV) infections. ” He said. ” The post Ex-GSK vaccine chief to lead new UK biotech Vicebio appeared first on.

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Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 5 clinical trials, which are ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. Pharma Mar also offers kits used for diagnosis of influenza A and B and respiratory syncytial virus.

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Pharma Marketing Sales Leads 40

pharmaphorum

JUNE 23, 2022

Enanta has a long heritage in the development of antiviral compounds, working with AbbVie on therapies for hepatitis C virus (HCV) infection including Viekira Pak (paritaprevir/ritonavir/ombitasvir/dasabuvir) and Mavyret/Maviret (glecaprevir/pibrentasvir).

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Distribution Pharma Sales Pharmaceutical 52

pharmaphorum

JANUARY 18, 2023

Moderna is looking to make a swift dash to the finish line with its respiratory syncytial virus (RSV) vaccine candidate, based on the same mRNA technology as its COVID-19 shots, with a filing in with the FDA in the first half of this year. Look out, Pfizer and GSK. for placebo.

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pharmaphorum

OCTOBER 12, 2022

“Continuing our strategic alliance with Merck is an important milestone as we continue to grow our mRNA platform with promising clinical programmes in multiple therapeutic areas.” The post Merck gets on board with Moderna cancer vaccine in $250m deal appeared first on.

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Patients Manufacturing Sales Management 89

pharmaphorum

JUNE 29, 2022

Already competing to bring the first vaccine against respiratory syncytial virus (RSV) to market, Pfizer and GSK are also fighting a patent infringement battle in the courts. com website.

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Marketing Leads Safety Sales 77

pharmaphorum

OCTOBER 13, 2022

GSK’s vaccine against respiratory syncytial virus (RSV) is one of the top prospects in its pipeline, but also one with considerable competition, so needs strong data to support the programme. Top of the list is an overall protective efficacy against RSV lower respiratory tract disease of 82.6%

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Prospecting Marketing Competition Safety 82

Clarivate

JANUARY 8, 2024

The annual Clarivate Drugs to Watch report for 2024 features 13 new therapeutics with standout commercial and/or clinical potential. New modalities, underpinned by scientific breakthroughs in the past decade, are achieving clinical successes and providing treatments for patients with previously unmet medical needs.

Marketing 59

Marketing Patients Healthcare Healthcare 59

pharmaphorum

JULY 15, 2022

Vaxart is a biotech currently working on vaccine candidates for COVID-19, norovirus, influenza, respiratory syncytial virus, and human papillomavirus. With an oral vaccine, all you need is a pill and a glass of water.”.

Manufacturing 95

Manufacturing Transportation Distribution Pharma 95

MedCity News

DECEMBER 12, 2023

Icosavax’s pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults. AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines.

Biopharma 114

Biopharma Pharma 114

MedCity News

JUNE 1, 2023

Pfizer’s Abrysvo is now approved for preventing illness caused by respiratory syncytial virus, or RSV, in adults 60 and older. The regulatory decision comes weeks after GSK won approval for its RSV vaccine, Arexvy.

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FDA Biopharma Pharma 114

MedCity News

MARCH 29, 2023

Johnson & Johnson’s pullback from RSV research thins the pack of companies aiming to develop a vaccine for the pathogen. GSK and Pfizer have vaccines under FDA review and a shot from Moderna could soon follow.

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FDA Pharmaceutical Biopharma Pharma 120

MedCity News

JULY 17, 2023

AstraZeneca and Sanofi drug Beyfortus is now FDA approved for preventing respiratory problems from RSV infection in infants and toddlers. Antibody engineering enables the drug to last longer in the body, providing protective effects for potentially the entire RSV season.

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MedCity News

MAY 12, 2023

The antibody drug, nirsevimab, is designed with a long half-life intended to protect infants from respiratory syncytial virus infection through the entire season. The drug, co-developed by AstraZeneca and Sanofi, is under FDA review.

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FDA Biopharma Pharma 104

MedCity News

MAY 3, 2023

FDA approval of GSK’s respiratory syncytial vaccine Arexvy covers adults age 60 and older—an age group at particular risk of developing severe complications from infection. GSK plans to launch Arexvy in time for the 2023/2024 RSV season.

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FDA Biopharma Pharma 102

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. Since the COVID-19 pandemic, the industry has seen a spike in interest in mRNA therapeutics, due to the success of mRNA vaccines treating the virus, observed GlobalData.

Food and Drug Administration 93

Food and Drug Administration Medicine Safety Consulting 93

European Pharmaceutical Review

MAY 4, 2023

For the first time, a respiratory syncytial virus (RSV) vaccine for older adults has been granted regulatory approval. It is authorised for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. Could GSK offer the first RSV older adult vaccine?

Food and Drug Administration 88

Food and Drug Administration Safety FDA Food 88

MedCity News

OCTOBER 13, 2022

Respiratory syncytial virus has no approved vaccines anywhere in the world, but the chase to bring the first one to the market is heating. GSK reported Phase 3 data that position it for regulatory submissions the pharma giant is planning for later this year.

Pharma 96

Pharma Marketing Biopharma 96

Pharmaceutical Technology

MAY 15, 2023

Sanofi announced data from a real-world clinical trial that demonstrated its RSV antibody nirsevimab delivered an 83% reduction in hospitalisations in infants with respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD). Nirsevimab is being jointly developed between Sanofi and AstraZeneca.

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Food and Drug Administration Consulting Food FDA 98

Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations. It is unknown if the introduction of vaccines will have any effect regarding resistance to mAbs.

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Marketing Pharmaceutical FDA Patients 64

pharmaphorum

SEPTEMBER 15, 2022

The 25,000-subject study is testing a nucleoside-modified mRNA (modRNA), quadrivalent vaccine that is targeted against four strains of the flu virus that the World Health Organization (WHO) expects will be circulating during the coming 2022/23 flu season in the northern hemisphere.

Leads 81

Leads Patients 81

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. Antibodies specific to the prefusion form were shown to be highly effective at blocking virus infection.

Patients 85

Patients Food and Drug Administration Safety FDA 85

Pharmaceutical Technology

NOVEMBER 7, 2022

The European Commission (EC) has granted approval for AstraZeneca and Sanofi ’s Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTI) in newborns and infants. compared with placebo through day 151.

Medicine 64

Medicine Safety Marketing Medical 64

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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FDA Food and Drug Administration Food Safety 72

European Pharmaceutical Review

JULY 18, 2023

The first preventive option authorised to protect a broad infant population against respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) has been approved by the US Food and Drug Administration (FDA). The decision was based data from three pivotal late-stage clinical trials.

Food and Drug Administration 90

Food and Drug Administration FDA Medical Food 90

Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

FDA 59

FDA Food and Drug Administration Food Patients 59

pharmaphorum

JANUARY 5, 2023

The clock has started ticking on the FDA’s review of Sanofi and AstraZeneca’s one-shot antibody to protect newborns and infants from respiratory syncytial virus (RSV), with a decision due in the third quarter – just in time for the 2023/24 RSV season.

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FDA Healthcare Provider Marketing Healthcare 52