Pharmaceutical Technology

APRIL 24, 2023

In 1974, Dr. Robert Langer was part of the first cohort of researchers to begin nanoparticle research , as his lab at Cornell University developed tiny particles to deliver large molecules for angiogenesis. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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Drug Delivery Vaccination Vaccine Research 147

XTalks

NOVEMBER 5, 2024

Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024. Polyrizon Ltd.

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Drug Delivery Drugs Immune Response Allergies 111

XTalks

DECEMBER 29, 2023

. “The FDA’s Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy,” said David M.

Clinical Trials 119

Clinical Trials Clinical Trials FDA Approval Trials 119

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. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

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FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

NOVEMBER 15, 2023

“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA’s press release.

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FDA Approval Vaccination Vaccine In-Vitro 59

XTalks

SEPTEMBER 25, 2024

Beyond FluMist, research into other routes of vaccine administration is ongoing. The candidate, MPV/S-2P, uses a murine pneumonia virus to deliver the stabilized spike protein, aiming to activate immunity both in the blood and in the respiratory tract’s mucosal tissues — where many respiratory viruses take hold.

FDA Approval 52

FDA Approval Vaccination Vaccine Pharmacy 52

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Development Production Immune Response Licensing 161

XTalks

NOVEMBER 30, 2023

Over the last 35 years, substantial strides have been made in tackling HIV/AIDS, propelled by advancements in medical research, enhanced accessibility to treatment and prevention and a more comprehensive understanding of the virus. World AIDS Day offers an occasion for reflection on the strides achieved thus far.

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FDA Approval Gene Therapy Gene Clinical Trials 111

Pharmaceutical Technology

NOVEMBER 22, 2022

Devex’s global COVID-19 funding dashboard recorded $172 million invested in vaccine research between 1 January 2020 and 27 June 2020. 326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). In 2022, global governments pledged a combined $1.5

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Manufacturing Vaccination Vaccine RNA 130

XTalks

JUNE 5, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, PhD, senior VP and chief scientific officer, Vaccine Research and Development at Pfizer, in the company’s news release.

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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. Malaria Vaccine Phase II Trial.

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Vaccination Vaccine Immune Response Trials 105

The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) Global Head, Janssen Research & Development, Johnson & Johnson. There is no FDA-approved vaccine to prevent COVID-19.

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Immune Response Vaccination Medicine Vaccine 52

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval. months of follow-up, 43.5

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

pharmaphorum

APRIL 26, 2022

PubMed cites 1,822 pieces of research relating to the microbiome in 2011, which grew to 25,153 published in 2021. As more research has been conducted, closer and unexpected links have been found between the microbiome of the gut, as one example, and other areas of the body, such as brain health and the immune system.

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Containment Development Production Drugs 115

The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

Immune Response 52

Immune Response Vaccination Vaccine FDA Approval 52

pharmaphorum

OCTOBER 31, 2022

It is the first FDA-approved treatment for Zaire ebolavirus. Yancopoulos continued: “Our scientists realised that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola.”.

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Production FDA Approval Antibody Gene 52

XTalks

MAY 1, 2023

While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. Attendees will explore how Virtual Research Coordination (VRCC) can help with attracting a more diverse patient population, and more. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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Vaccination Vaccine FDA Approval Containment 52

XTalks

OCTOBER 16, 2020

The FDA approval is based on results from the large, multi-center clinical trial called PALM (PAmoja TuLinde Maisha) in which Inmazeb showed superiority over other antiviral investigational agents, namely ZMapp and remdesivir, with respect to mortality. Related: First Ebola Vaccine Cleared by European Commission.

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Antibody Drugs Clinical Trials Clinical Trials 98

The Pharma Data

SEPTEMBER 8, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.

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Research Immune Response Antibody Trials 52

XTalks

JUNE 15, 2022

protein that triggers the immune system to generate antibodies against the virus. Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US. Novavax Vaccine Research.

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Vaccination Vaccine Immune Response Protein 59

The Pharma Data

MAY 7, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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Licensing Licensing Vaccination Vaccine 52

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. INTERCHANGEABILITY.

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Vaccination Vaccine Protein Immune Response 111

XTalks

JULY 14, 2021

It also green-lighted a Pfizer and AstraZeneca vaccine combination given data and evidence from research studies that support the mix. The interchanging of vaccines has been approved by health agencies in these countries due to delays they have experienced in vaccine shipments from the different vaccine makers.

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Vaccination Vaccine Immune Response FDA Approval 98

Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. 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.

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Vaccination Vaccine Protein Antibody 52

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection. About Clover Biopharmaceuticals.

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Vaccination Vaccine Immune Response Protein 52

pharmaphorum

APRIL 20, 2022

Adding vidutolimod gives Regeneron an opportunity for combination therapies with its own immuno-oncology drugs, headed by its Sanofi-partnered PD-1 inhibitor Libtayo (cemiplimab) which is FDA-approved for skin cancers cutaneous squamous cell carcinoma and basal cell carcinoma and non-small cell lung cancer.

Immune Response 52

Immune Response Antibody FDA Approval Trials 52

pharmaphorum

JANUARY 5, 2021

Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

Immune Response 52

Immune Response FDA Approval Drugs Sales 52

STAT News

MARCH 6, 2023

It works with commercial partners and researchers at the Washington University School of Medicine in St. Louis to create a promising but yet-to-be-approved treatment known as a personalized neoantigen synthetic long peptide vaccine. A doctor at Duke was skeptical and would not administer the shots, Kielty said.

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Vaccination Vaccine Drugs Clinical Trials 98

XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. The vaccines have moved through all preclinical and clinical phases.”.

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Vaccination Vaccine Immune Response Manufacturing 98

Delveinsight

AUGUST 4, 2021

Similarly, genetics, immune response, and environmental factors also influence the occurrence of Neurological Conditions. In June 2021, Aducanumab by Biogen received FDA approval to treat patients with Alzheimer’s disease. and Neurimmune are actively working in the Alzheimer’s Therapeutics Market.

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Marketing Genetics Development Clinical Development 98

XTalks

MAY 30, 2024

The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. Researchers estimate that the incidence of CIDP in the US ranges from 0.8 New CIDP Treatments on the Market In January 2024, the FDA approved Takeda’s Gammagard Liquid for the treatment of CIDP in adults.

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FDA Approval Immune Response Trials Drug Delivery 40

XTalks

AUGUST 5, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson this week announced the US Food and Drug Administration (FDA) approval of Stelara (ustekinumab) to treat active psoriatic arthritis in pediatric patients six years and older. As of 2021, over 35 companies are pursuing research on new therapies. in a press release.

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Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

NOVEMBER 9, 2020

“The FDA’s decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine,” said Gregory M. President of Research and Development, Novavax. Glenn, M.D., and globally.”.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates.

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Vaccination Vaccine Immune Response Protein 52

The Pharma Data

AUGUST 17, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.

Immune Response 52

Immune Response Trials Medicine FDA Approval 52