Pharmaceutical Technology

APRIL 10, 2023

Health director-general Tan Sri Dr Noor Hisham Abdullah stated that the approval of Evusheld was granted at the 383rd Drug Control Authority (DCA) meeting. Evusheld (formerly AZD7442) is a combination of two long-acting antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061).

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Immune Response Antibody Vaccination Vaccine 264

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 emergency use authorisation (EUA) for Evushield activates a 700,000 order for the antibody from the US government, worth upwards of $726 million.

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Pharmaceutical Technology

AUGUST 24, 2022

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above.

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Pharmaceutical Technology

DECEMBER 16, 2022

Novel therapeutics and vaccines for malaria. Novartis and the non-profit Medicines for Malaria Venture (MMV) announced plans to collaborate on a Phase III study of a novel ganaplacide/lumefantrine-SDF combination for adults and children. Apart from vaccines, other approaches for preventing malaria are also being studied.

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Development Drugs Vaccination Vaccine 264

Pharmaceutical Technology

AUGUST 5, 2022

It is ultra-rare,” says Jesús Rodriguez Requena, PhD, associate professor in the Department of Medicine at the University of Santiago de Compostela. No progress in drug discovery. “We On the other hand, I think the progress in drug discovery is nil,” comments Requena on the prion disease landscape.

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pharmaphorum

MAY 18, 2022

Brand new UK startup RQ Biotechnology has been thrust into the spotlight after signing a $157 million licensing deal with AstraZeneca for monoclonal antibodies intended to protect vulnerable and immunosuppressed people from COVID-19. ” The post AstraZeneca buys into startup RQ Bio’s COVID antibodies appeared first on. .

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Antibody Licensing Licensing Medicine 90

Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . Hugo Fry, CEO of RQ Bio, comments: “We’re delighted that one of our discovered antibodies is now at the core of an innovative AstraZeneca investigational medicine reaching clinical trials.” .

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Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted 5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. 5-adapted bivalent vaccine.

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XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

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Antibody Drugs Clinical Trials Clinical Trials 98

Drug Discovery World

NOVEMBER 2, 2022

One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa. . The antibody was up to 88.2% The antibody was up to 88.2% We hope monoclonal antibodies will transform malaria prevention in endemic regions.” .

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Antibody Allergies Trials Medicine 52

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer.

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Vaccination Vaccine Protein Antibody 52

Drug Discovery World

MAY 29, 2024

SpyBiotech and the University of Oxford Biotechnology company SpyBiotech and University of Oxford have entered a research agreement for the development of a vaccine against Epstein-Barr virus (EBV). We see a great need for a vaccine against EBV.” Sartorius has been working with NVIDIA since 2020.

Drugs 52

Drugs Gene Editing Life Science Genome 52

Roots Analysis

FEBRUARY 23, 2024

Imagine a world where scientists work together to create special “soldiers” in our bodies called antibodies. Sometimes, scientists ask for help from experts who are really good at finding and designing these antibodies. This helps to speed up the process of making new medicines and finding cures for diseases.

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Antibody Research Marketing Scientist 40

Drug Discovery World

SEPTEMBER 8, 2023

Approval has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Pfizer/BioNTech Covid-19 vaccine that targets the Omicron XBB 1.5 The European Commission’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug for approval in the EU in August. subvariant.

Regulation 52

Regulation Vaccination Vaccine Medicine 52

Drug Discovery World

NOVEMBER 10, 2023

Researchers from Korea conducted a clinical trial to assess the immunogenicity and safety of GBP510/AS03 relative to the ChAdOx1-S vaccine. The participants were split in two groups: those with no prior SARS-CoV-2 infection or Covid-19 vaccination history and those irrespective of these parameters.

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Immune Response Vaccination Vaccine Clinical Trials 52

Drug Discovery World

JANUARY 19, 2024

The top stories: Antibody cocktail effective against emerging Covid-19 variants Biotech company ExeVir Bio has revealed new data demonstrating that its antibodies are effective in neutralising currently circulating Covid-19 Omicron variants.

Drugs 52

Drugs Vaccination Vaccine Genetics 52

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 1 Adapted Bivalent Vaccine Candidate. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 1 Adapted Bivalent Vaccine Candidate. 1 as compared to the companies’ current COVID-19 vaccine.

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Vaccination Vaccine Medicine Clinical Trials 100

Drug Discovery World

AUGUST 9, 2023

A new respiratory syncytial virus (RSV) vaccine candidate has achieved positive safety and immunogenicity results in a Phase I clinical study of RSV-naïve participants between the ages of six and 36 months. MV-012-968 is being developed by Meissa Vaccines as a needle-free, adjuvant-free vaccine to protect infants and toddlers from RSV.

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Vaccination Vaccine Antibody Medicine 52

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

APRIL 27, 2022

Vir Biotechnology-partnered COVID-19 antibody Xevudy (sotrovimab) was the big contributor to the improved result, adding £1.3 Turnover of the antibody is likely to fall sharply however as the drug has lower efficacy against the prevailing Omicron BA.2 billion ($1.6 billion) to the company’s top-line of £9.8

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Sales Antibody Vaccination Vaccine 83

Drug Discovery World

MARCH 27, 2023

The first subjects have been dosed in a Phase I clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor in heart disease. The drug works by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9).

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Vaccination Vaccine Antibody Immune Response 52

Drug Discovery World

MAY 3, 2024

The ongoing innovation and development in the drug discovery sector relies on a number of moving parts, one of which is financial support and backing. Cancer vaccine developer secures £12.8m The post This week in drug discovery (29 April – 3 May) appeared first on Drug Discovery World (DDW).

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Drugs Development Vaccination Vaccine 52

The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy. Food and Drug Administration (FDA).

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Antibody Vaccination Vaccine In-Vitro 52

Drug Discovery World

OCTOBER 13, 2023

The scientists say the tool can help inform the development of vaccines and therapies for SARS-CoV-2 and other rapidly mutating viruses. The University has also launched a new global consortium to research and develop next-generation Covid-19 and flu vaccines, backed by £8 ($9.8) million funding from UK Research and Innovation (UKRI).

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Vaccination Vaccine Immune Response Scientist 105

Drug Discovery World

APRIL 3, 2024

In the last few years, immunotherapies like immune checkpoint inhibitors, vaccines and cell and gene therapies have revolutionised the treatment of cancer, and targeted drugs like monoclonal antibodies (mAbs), poly-ADP ribose polymerase (PARP) inhibitors and targeted protein degraders are also playing an important role.

Research 52

Research Drugs Gene Therapy Genetics 52

pharmaphorum

SEPTEMBER 16, 2022

Sanofi and AstraZeneca are closing in on EU approval of nirsevimab, their long-acting antibody for the protection of newborns and infants from respiratory syncytial virus (RSV) infections. Both vaccines are also being tested in older adults. Sobi also has an interest in the new drug as part of its 2019 agreement with AZ over Synagis.

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Antibody Vaccination Vaccine Marketing 57

XTalks

JUNE 5, 2023

Pfizer has announced that its respiratory syncytial virus (RSV) vaccine, Abrysvo, has received approval from the US Food and Drug Administration (FDA). Abrysvo, the bivalent RSV prefusion F (RSVpreF) vaccine, is intended for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older.

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Vaccination Vaccine FDA Approval Protein 98

Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-adapted bivalent vaccine. 5) AUTHORIZED USES .

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Vaccination Vaccine Medicine Clinical Trials 101

Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

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FDA Approval Medicine Vaccination Vaccine 98

pharmaphorum

MARCH 29, 2021

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.

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Drug Discovery World

NOVEMBER 4, 2022

Meanwhile, the quest to understand Covid-19 continues, as study findings reveal how the virus affects the brain and the effectiveness of vaccines in those with compromised immunity. . Covid-19 vaccine less effective in the immunocompromised . Monoclonal antibody could transform malaria prevention . The top stories: .

Gene Therapy 52

Gene Therapy Drugs Antibody Gene 52

Drug Discovery World

NOVEMBER 15, 2022

Anita Ramanathan outlines four synthetic biology approaches that are improving and accelerating drug discovery. . It has made its way into almost every aspect of drug discovery, whether it’s exploring basic biology, modelling diseases, identifying and validating targets, or performing drug screens. .

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DNA Drugs Antibody Engineer 98

Drug Discovery World

FEBRUARY 23, 2023

Covid-19 booster candidate UB-612 has achieved its immunogenicity endpoints in a head-to-head trial against three vaccine platforms: mRNA (Pfizer-BioNTech’s BNT162b2), adenovirus vector (AstraZeneca’s ChAdOx1-S), and inactivated virus (Sinopharm’s BIBP). 5 variants compared to adenovirus vector (ChAdOx1-S) and inactivated (BIBP) vaccines.

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Vaccination Vaccine Immune Response Antibody 52

pharmaphorum

OCTOBER 12, 2022

Having spent 10 years working in the genomics field, Del Bourgo noticed manufacturers spending extensive resources on drug development without harnessing the transformative power of data. Genomic medicine is a rapidly growing space in which researchers use the information in a person’s genes to identify and administer medical treatment.”.

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Genome Genomics Medicine Development 92

Pharmaceutical Technology

NOVEMBER 30, 2022

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. The EMA had provided a positive opinion for this marketing authorization back in July.

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Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

Drug Discovery World

MARCH 14, 2023

For the first time, researchers have developed an mRNA vaccine that is 100% effective against a type of bacteria that is lethal to humans, paving the way for effective vaccination against antibiotic-resistant bacteria. However, until now scientists believed that mRNA vaccines against bacteria were biologically undoable.

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Bacteria Vaccination Vaccine Protein 59