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. On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted

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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. The vaccine was previously made available to this age group in the U.S. Pfizer and BioNTech Announce U.S.

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Fierce Pharma

JULY 18, 2023

After bagging a highly anticipated FDA nod Monday, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody now has a date on a committee's calendar to determine its place in U.S. The panel has set a date for Aug. 3 to evaluate the new drug.

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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 is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains.

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Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Acting FDA Commissioner Janet Woodcock, M.D.

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XTalks

OCTOBER 14, 2022

This week, GSK announced in a press release that the US Food and Drug Administration (FDA) had approved Boostrix as an immunization for pregnant women for the prevention of whooping cough in newborn infants. Boostrix is the first vaccine in the US indicated for the protection of newborns under two months of age from pertussis.

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Pharmaceutical Technology

FEBRUARY 8, 2023

The 13 top players experienced significant growth over 2022 despite the decline in demand for COVID-19 vaccines and therapeutics, as well as uncertainty surrounding pricing due to the newly passed Inflation Reduction Act in the US. billion between Dec 31, 2021 and Dec 31, 2022, owing to expansion in its vaccine and oncology portfolio.

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XTalks

NOVEMBER 15, 2023

France-based biotech Valneva has won approval from the US Food and Drug Administration (FDA) for its chikungunya vaccine Ixchiq for the prevention of infection from the chikungunya virus. The vaccine is approved for adults 18 years of age and older who are at increased risk of exposure to the virus.

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pharmaphorum

FEBRUARY 11, 2021

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. . The vaccine stimulated antibodies against the protein in all 32 patients with early-stage AD in the study at levels that AC Immune thinks should have a therapeutic effect.

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Pharmaceutical Technology

DECEMBER 20, 2022

This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. Eli Lilly saw strong global drug sales of $187m in Q3 for Mounjaro (tirzepatide), its new type 2 diabetes therapy, which was approved by the FDA in May 2022, according to GlobalData’s Drugs Database Pharma Intelligence Center.

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BioSpace

DECEMBER 1, 2020

Food and Drug Administration has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood.

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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

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.

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Pharmaceutical Technology

JUNE 9, 2023

Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older.

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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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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. 45 years ago.

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pharmaphorum

FEBRUARY 11, 2021

AstraZeneca is aiming to get a next-generation vaccine targeting emerging variants approved and into the arms of patients by the autumn, company representatives said in a press conference. While the vaccine is approved in Europe, the UK and several other countries, FDA approval hangs on a study in the US.

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The Pharma Data

NOVEMBER 12, 2020

The World Health Organization (WHO)’s ACT-Accelerator program is focusing on increasing global access to dexamethasone and monoclonal antibodies and has built up significant vaccine manufacturing capabilities, but it has zero plans for facilitating access to the only FDA-approved COVID-19 treatment, remdesivir.

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XTalks

SEPTEMBER 22, 2023

In time for respiratory virus season this fall and winter, the US Food and Drug Administration (FDA) approved updated COVID vaccines from Pfizer/BioNTech and Moderna last week, followed by an endorsement from the Centers for Disease Control and Prevention (CDC) a day later. The updated COVID vaccines target the XBB.1.5

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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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Pharmaceutical Technology

NOVEMBER 22, 2022

Advanced biologic production involving cell and gene therapies is currently limited but concentrated in Eastern China in provinces such as Shanghai, Zhejiang and Jiangsu for US FDA-approved sites. The majority of FDA and EMA innovator and biosimilar marketed drugs produced by Chinese sites are small molecules.

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XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). Anktiva is mixed together with the BCG vaccine before administration.

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Pharmaceutical Commerce

FEBRUARY 2, 2024

New reservation program for Beyfortus (nirsevimab-alip) seeks to improve access to the monoclonal antibody that is FDA-approved to protect against respiratory syncytial virus-associated lower respiratory tract disease.

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XTalks

JUNE 15, 2022

Last week, Novavax announced that it received positive feedback from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the safety and efficacy of its COVID-9 vaccine (NVX-CoV2373). The Novavax COVID-19 Vaccine Candidate. Clinical Trial Results.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are pleased to work with U.S. AUTHORIZED USE IN THE U.S.:

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Pharmaceutical Technology

FEBRUARY 15, 2023

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. In terms of application diversity, Eli Lilly is the top company, followed by C.

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Pharmaceutical Technology

NOVEMBER 30, 2022

In late September, the European Commission approved the rare disease therapy Ultomiris (ravulizumab), developed by Alexion, a division of AstraZeneca to treat generalized myasthenia gravis. The monoclonal antibody (mAb) is already approved for treating paroxysmal nocturnal haemoglobinuria in children and adolescents.

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Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

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Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

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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. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

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The Pharma Data

JANUARY 17, 2021

FDA approval this year. At the same time, a robust study is being conducted that involves the bispecific antibody adopted from Phanes Therapeutics, Inc. Furthermore, clinical study on PD-1/HER2 bispecific antibody being co-developed with Innovent Biologics, Inc. Hanmi Pharmaceutical Co.,

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

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XTalks

NOVEMBER 3, 2021

In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The editorial team discussed the positive trial data, the importance of vaccinating kids amid rising infections among younger children, as well as vaccine hesitancy among parents.

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Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.

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Pfizer

DECEMBER 8, 2022

FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent, (Original and Omicron BA.4/BA.5)

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The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.

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