The Pharma Data

JANUARY 3, 2021

This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. The last patients in the trial received their final dose on 21 December 2020. The topline data from the trial is expected to be available in January 2021. NEW YORK and LONDON, Jan.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

The Pharma Data

APRIL 27, 2021

The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial , which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC. About the Phase 1/2 Trial. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. and around the globe.”.

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

Agency IQ

SEPTEMBER 22, 2023

Traditionally, FDA has interpreted the need for “well-controlled investigations” to mean at least two clinical trials for new drugs, or applications for supplemental indications. When looking at all drugs approved between 2011 and May 2020, 136 drugs were approved on the basis of a single pivotal trial, according to AgencyIQ’s research.

FDA 40

FDA Science Trials Clinical Trials 40

FDA Law Blog: Drug Discovery

JANUARY 7, 2024

This review was limited to drugs with approved New Drug Applications (NDAs); biologics and vaccines were excluded. Additionally, this review excluded pharmacokinetic and animal studies. In that ten-year period, there were 67 drugs approved with a requirement to conduct a postmarketing pregnancy study, and 99 studies.

Marketing 59

Marketing FDA Regulations Pharmacokinetics 59

The Pharma Data

MARCH 8, 2021

Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months. “We For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases.

Trials 52

Trials Clinical Trials Research Laboratories Pharmacokinetics 52

The Pharma Data

APRIL 14, 2021

Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg alone or placebo were nausea (3% vs 4%), diarrhea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%). volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Government 52

Government Hospitals Long-Term Care Facilities Treatment 52

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Although much of the U.S. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

Codon

APRIL 2, 2023

mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Read How well do different antibodies, created by people who got two or three doses of the COVID-19 mRNA vaccine, fight off new viral variants, such as BA.4 ” Clinical trials are underway. Andreano E. Nature Communications. Ricciardi M.J.

DNA 52

DNA RNA Engineering Licensing 52

PPD

JUNE 20, 2023

Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article. We have you covered in our comprehensive overview of outsourced clinical trial models. And for sponsors, this strategy reduces overhead, in turn offering business continuity, flexibility and potential cost savings.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

Agency IQ

JUNE 9, 2023

However, nonclinical studies are not conducted exclusively before human trials begin; they usually continue throughout the early phases of clinical trials to further assess a product’s performance on different metabolic pathways and at different doses.

FDA 40

FDA Science Small Molecule Immune Response 40

Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. Each class of immunomodulator has a defined complexity and mechanism of action.

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52

DrugBank

FEBRUARY 5, 2025

Conversely, conjugation involves chemically attaching the drug to the nanoparticle surface, allowing for targeted delivery and improved pharmacokinetics. Nanoparticles are being explored as innovative carriers for antibiotics, antivirals, and vaccines, with the potential to significantly enhance their effectiveness.

Drugs 52

Drugs Engineering Vaccine Treatment 52

The Pharma Data

MARCH 23, 2021

This Phase 1 trial is being conducted in the United States. Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus. Together, the two have the potential to create an end to end treatment paradigm that complements vaccination in cases where disease still occurs.”.

Virus 52

Virus Vaccine Hospitals Pharmacokinetics 52

Agency IQ

DECEMBER 1, 2023

It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19. Further, a “trial should aim to minimize missing data” by distinguishing between discontinuation from the study drug and withdrawal from study assessments.

FDA 40

FDA Clinical Trials Vaccine Drugs 40

The Pharma Data

DECEMBER 23, 2020

Additionally, Avacta announced it submitted a Clinical Trial Application in the UK for a Phase 1, first-in-human, open label, dose-escalation and expansion study of its lead pre|CISION prodrug, AVA6000, in patients with locally advanced or metastatic selected solid tumors.

Licensing 52

Licensing Licensing Vaccine Drugs 52

The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. BNT162 mRNA-based Vaccine Program. Protease Inhibitor Program.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Agency IQ

AUGUST 16, 2024

chemotherapies), sponsors have historically pushed the envelope to find the highest tolerable dose when conducting clinical trials for oncology products, since higher doses generally mean increased efficacy for these products. In early-stage development of traditional cytotoxic oncology drugs (i.e.,

Production 40

Production FDA Science Clinical Trials 40

The Pharma Data

FEBRUARY 8, 2021

Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

The Pharma Data

JULY 23, 2021

In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066). On 16 March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

The Pharma Data

JANUARY 26, 2021

“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. INDIANAPOLIS, Jan. Across 1,035 patients, there were 11 events (2.1

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] v] ERLEADA ® is being studied in five Phase 3 clinical trials. For more information about ERLEADA ® , visit www.ERLEADA.com. *© All rights reserved.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

The Pharma Data

APRIL 7, 2021

The addition of the SC administration also offers people living with MS another option at a time when they are being encouraged to discuss considerations around COVID-19 vaccination and their MS treatment with their physicians. About TYSABRI ® (natalizumab).

Clinical Trials 52

Clinical Trials Treatment Virus Pharmacokinetics 52

The Pharma Data

MARCH 11, 2021

In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Bamlanivimab alone. patients who recovered from COVID-19.

Hospitals 40

Hospitals Trials Long-Term Care Facilities Treatment 40

The Pharma Data

APRIL 16, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

MARCH 9, 2022

The Phase 2/3 trial is an open-label, multi-center, single-arm study in approximately 140 pediatric participants under 18 years of age. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Treatment 52

Treatment Hospitals Pharmacokinetics Trials 52

The Pharma Data

MARCH 5, 2021

” To support the opinion, the EMA reviewed Phase 2 and Phase 3 results from Lilly’s BLAZE-1 trial. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

The Pharma Data

MAY 4, 2021

” “Even as the world makes progress on vaccine roll-outs, it remains vital for treatments to be available that can make a meaningful difference for those fighting COVID-19,” said David A. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Ricks , Lilly chairman and CEO.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

The Pharma Data

OCTOBER 6, 2021

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said” Vulnerable populations suchlike as the immunocompromised hourly are n’t suitable to mount a self-protective response following vaccination and continue to be at trouble of developing COVID-19. AZD7442 was well- let.

Pharmacokinetics 52

Pharmacokinetics Trials Government Vaccine 52

PerkinElmer

JUNE 3, 2022

1 Although effective COVID-19 vaccines have been developed, variants of SARS-CoV-2 have already emerged for which vaccines are less effective, and many people remain unvaccinated due to certain medical conditions, personal choice, or global access challenges.

Fragment Screening 52

Fragment Screening Clinical Trials Vaccine Pharmacokinetics 52

The Pharma Data

MAY 7, 2021

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease. About the COMET-ICE Study Design.

Treatment 40

Treatment Virus Vaccine Trials 40

The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About COMET-ICE.

Treatment 52

Treatment FDA Vaccine Trials 52

The Pharma Data

APRIL 26, 2022

As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D., The FDA urges the public to get vaccinated and receive a booster when eligible.

FDA Approval 52

FDA Approval FDA Treatment Vaccine 52

The Pharma Data

SEPTEMBER 1, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). of participants in the trial, respectively.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. A lifelong HIV vaccine would be ideal, but developing one has proved difficult. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months.

Clinical Trials 80

Clinical Trials Virus Vaccine DNA 80