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.

Vaccine 277

Vaccine Vaccination Immune Response Antibody 277

Pharmaceutical Technology

JULY 12, 2022

million doses of the company’s Covid-19 vaccine, NVX-CoV2373, in the initial stage. The order is contingent on the vaccine obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) as well as the Centers for Disease Control and Prevention (CDC) recommendation. The post US to procure 3.2

Vaccine 162

Vaccine Vaccination Protein Pharmacy 162

Pharmaceutical Technology

FEBRUARY 14, 2023

The US Department of Health and Human Services (HHS) and the Department of Defense have modified their existing agreement with Novavax to secure additional doses of the Covid-19 vaccine, Adjuvanted (NVX-CoV2373). million additional doses of its Covid-19 vaccine. Under the modified deal, Novavax will deliver up to 1.5

Vaccine 162

Vaccine Vaccination Protein Engineer 162

Pharmaceutical Technology

SEPTEMBER 14, 2022

Novavax and Serum Institute of India (SII) have reported that the former’s Covid-19 vaccine, NVX-CoV2373, has received full product registration from the South African Health Products Regulatory Authority (SAHPRA), with conditions. It is marketed under the brand name Covovax in the country.

Vaccine 147

Vaccine Vaccination Clinical Trials Clinical Trials 147

Pharmaceutical Technology

JULY 14, 2022

Novavax has obtained the US Food and Drug Administration (FDA) emergency use authorization (EUA) for its Covid-19 vaccine. The EUA for the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has been granted for providing a two-dose primary series for active immunisation aimed at preventing the disease in individuals aged 18 years and above.

Vaccine 162

Vaccine Vaccination Clinical Trials Clinical Trials 162

Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

Vaccine 147

Vaccine Vaccination Immune Response Protein 147

Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). The safety and efficacy of Nuvaxovid was evaluated as a primary series.

Vaccine 130

Vaccine Vaccination Protein Immune Response 130

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.

Vaccine 111

Vaccine Vaccination Protein Immune Response 111

BioPharma Reporter

AUGUST 21, 2022

EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.

Vaccine 105

Vaccine Vaccination Protein Marketing 105

World of DTC Marketing

APRIL 11, 2021

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome.

Vaccination 303

Vaccination Vaccine Clinical Trials Clinical Trials 303

Pharmaceutical Technology

SEPTEMBER 2, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above.

Vaccine 147

Vaccine Vaccination Trials Clinical Trials 147

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

Vaccine 162

Vaccine Vaccination Antibody Development 162

Pharmaceutical Technology

AUGUST 14, 2022

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

Vaccine 147

Vaccine Vaccination Clinical Trials Clinical Trials 147

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

Vaccine 119

Vaccine Vaccination Bacterium Protein 119

Pharmaceutical Technology

FEBRUARY 15, 2023

Clover Biopharmaceuticals has launched its recombinant SARS-CoV-2 subunit vaccine , a protein-based Covid-19 vaccine, in China. In December last year, Clover’s Covid-19 vaccine received emergency use authorisation in the country. 5, in a separate Phase III trial.

Vaccine 130

Vaccine Vaccination Clinical Trials Clinical Trials 130

Pharmaceutical Technology

AUGUST 17, 2022

Merck (MSD outside North America) has entered a partnership agreement with Orna Therapeutics for discovering, developing and marketing various programmes based on next-generation RNA technology. These programmes will include therapies and vaccines in infectious disease and oncology areas.

RNA 147

RNA Vaccine Vaccination In-Vivo 147

BioPharma Reporter

DECEMBER 20, 2021

The European Commission has granted conditional marketing authorisation to Novavax for its COVID-19 vaccine: making it the first protein-based COVID-19 vaccine in the EU.

Vaccine 98

Vaccine Vaccination Protein Marketing 98

Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5 variant spike protein.

Vaccine 130

Vaccine Vaccination Gene Therapy Protein 130

XTalks

FEBRUARY 7, 2025

In the biotechnology sector, a biotech IPO occurs when a biotech firm lists its shares on a stock exchange, thereby attracting investment from public markets. The companys approach combines small molecule therapies and targeted protein degradation.

Marketing 66

Marketing Genetics Vaccination Vaccine 66

Pharmaceutical Technology

DECEMBER 5, 2022

With the establishment of this Translational Science Hub, Queensland is set to become an international messenger ribonucleic acid (mRNA) vaccine hub. With an initial focus on enchaining mRNA technology and developing a vaccine for Chlamydia, the research at the hub is anticipated to commence in the first quarter of next year.

Research 246

Research Gene Therapy Vaccination Vaccine 246

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. Arexvy costs $280 per dose while Abrysvo is $295.

Vaccine 105

Vaccine Vaccination Containment Marketing 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.

Regulation 105

Regulation Vaccine Vaccination Protein 105

Pharmaceutical Technology

JULY 29, 2022

An antibody cytokine fusion protein, N-803 is a new interleukin-15 (IL-15) superagonist complex. In January, ImmunityBio and Amyris have concluded a joint venture (JV) agreement announced previously to accelerate the marketing of a Covid-19 vaccine.

Trials 264

Trials Clinical Trials Clinical Trials Licensing 264

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.

Vaccine 98

Vaccine Vaccination FDA Approval Protein 98

XTalks

NOVEMBER 6, 2024

per share, the offering included 1,300,000 ordinary shares, which began trading on the Nasdaq Global Market under the ticker symbol GELS on October 29, 2024. With an expanding patent portfolio and partnerships in human and animal health, Gelteq promotes therapeutic efficacy and patient adherence across diverse health markets.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “But it may be; and if it doesn’t other novel vaccines with similar benefits may well take on this role.”

Protein 126

Protein Vaccination Vaccine Immune Response 126

pharmaphorum

SEPTEMBER 28, 2021

Prospects for Valneva’s COVID-19 vaccine are up in the air, but another candidate partnered with Pfizer looks increasingly like it could fill the void of an effective shot for Lyme disease. billion contract to supply up to 100 million doses of its COVID-19 vaccine VLA2001.

Vaccine 105

Vaccine Vaccination Bacteria Protein 105

BioPharma Reporter

DECEMBER 11, 2020

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

Immune Response 105

Immune Response Vaccine Vaccination Trials 105

pharmaphorum

AUGUST 23, 2021

The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting emergency use authorisation in India. Proponents of the approach claim that DNA vaccines may have advantages over other technologies like mRNA.

DNA 98

DNA Vaccine Vaccination Genetic Engineering 98

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.

Vaccine 111

Vaccine Vaccination Immune Response Trials 111

XTalks

JULY 1, 2021

Moderna has won approval from the European Medicines Association (EMA) for branding its COVID-19 vaccine with the name Spikevax. Now the vaccine maker is awaiting the same approval from the US Food and Drug Administration (FDA). Pfizer’s Comirnaty was the first COVID-19 vaccine brand name created by the company.

Branding 98

Branding Vaccine Vaccination Clinical Trials 98

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.

Vaccine 89

Vaccine Vaccination Recombinant DNA Technology Trials 89

pharmaphorum

OCTOBER 27, 2020

Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for use in many countries around the world. The vaccine is based on two adenovirus vectors (Ad5 and Ad26) fused with the spike protein from the SARS-CoV-2 coronavirus.

Vaccination 102

Vaccination Vaccine Medicine Manufacturing 102

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.

Vaccine 98

Vaccine Vaccination Trials Antibody 98

XTalks

OCTOBER 26, 2023

The best way to prevent the flu is by getting vaccinated every year. The CDC and the World Health Organization (WHO) recommend annual flu vaccination for most people, especially those at high risk of serious complications, like pregnant women, elderly individuals, children and people with certain chronic health conditions.

Vaccine 105

Vaccine Vaccination RNA Manufacturing 105

Pharma Mirror

OCTOBER 16, 2023

The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021.

Immune Response 130

Immune Response Drugs Protein Vaccination 130

pharmaphorum

FEBRUARY 5, 2021

Johnson & Johnson’s Janssen unit has filed its single dose COVID-19 vaccine candidate with the FDA, asking for an Emergency Use Authorization (EUA). The European Medicines Agency (EMA) has already begun a rolling review of the vaccine, allowing for a faster decision if data is supportive.

Vaccine 84

Vaccine Vaccination Protein Medicine 84