Clinical Development, FDA Approval, Hospitals and Vaccine

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Cancer vaccine shows sustained improvement in survival rates

Drug Discovery World

JUNE 6, 2024

Cancer vaccine mRNA-4157 (V940) in combination with Keytruda reduced the risk of recurrence or death by 49% in patients with resected high-risk melanoma, according to follow-up data presented at ASCO 2024. Ultimately it will contribute to survival rates improving continually over the next decades and more.” .”

Vaccine

Vaccine Clinical Trials FDA Approval Research Laboratories

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19

The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. Available safety data have been consistent in participants across the EPIC clinical program, as well as across reported post-authorization safety experience in millions of patients prescribed PAXLOVID to date.

FDA Approval

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FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG. KENILWORTH, N.J.–(BUSINESS –(BUSINESS WIRE)– Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S.

FDA Approval

FDA Approval FDA Hospitals Treatment

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Evidence of Efficacy in First Interim Analysis from Phase 3 Study

The Pharma Data

NOVEMBER 9, 2020

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

Vaccine

Vaccine Clinical Trials Trials FDA

Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19

The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Related Articles: Calquence (acalabrutinib) FDA Approval History. CALAVI US).

Trials

Trials Clinical Trials Immune Response FDA Approval

VERQUVO® (vericiguat) Approved in the European Union

The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.”.

Treatment

Treatment Production Hospitals FDA Approval

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

The Pharma Data

SEPTEMBER 1, 2020

At the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting, Bristol Myers Squibb and collaborators will present 15 clinical and non-clinical abstracts that reinforce the breadth and depth of the company’s research in MS. Presentation Topic: Clinical Trials. FDA-APPROVED INDICATION FOR ZEPOSIA. Author: Selmaj.

Clinical Trials

Clinical Trials Treatment Trials Disease

Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial

The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options. In the U.S.

Trials

Trials Disease Treatment Therapies

Gilead Sciences Announces Second Quarter 2021 Financial Results

The Pharma Data

JULY 29, 2021

Launch activities continue following the full FDA approval for second-line metastatic triple-negative breast cancer (“mTNBC”) and accelerated approval for metastatic urothelial cancer. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations. Viral Diseases.

Science

Science Production Treatment FDA

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine.

Therapies

Therapies Treatment Disease Clinical Trials

Cell and gene therapy – where is the innovation?

Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . The UK stands as one of the key markets for cell and gene therapies.

Therapies

Therapies Clinical Trials Production Trials

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

Vaccine

Vaccine FDA Clinical Trials Disease

Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial

The Pharma Data

MARCH 4, 2021

This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s).

Trials

Trials Treatment Therapies Clinical Trials

XELJANZ® (TOFACITINIB CITRATE) RECEIVES MARKETING AUTHORIZATION IN THE EUROPEAN UNION.

The Pharma Data

AUGUST 22, 2021

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012. FDA-APPROVED INDICATIONS. VACCINATIONS. Avoid use of live vaccines concurrently with XELJANZ.

Marketing

Marketing Clinical Trials Treatment Therapies

Takeda FY2020 H1 Results Demonstrate Portfolio Resilience; Confirms Full-Year Management Guidance & Raises Forecasts for Free Cash Flow, Reported OP & Reported EPS

The Pharma Data

OCTOBER 28, 2020

Wave 1 Q2 highlights include: TAK-721 completed the rolling NDA submission and remains on track to be the first FDA-approved agent to treat eosinophilic esophagitis. TAK-003 is on track for a regulatory filing for Dengue vaccine in endemic countries in Asia and Latin America, and in the EU in Q4 FY2020.

Pharmaceutical Companies

Pharmaceutical Companies Engineering Therapies Clinical Trials

Drug Discovery Digest

Cancer vaccine shows sustained improvement in survival rates

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19

Trending Sources

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Evidence of Efficacy in First Interim Analysis from Phase 3 Study

Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19

VERQUVO® (vericiguat) Approved in the European Union

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial

Gilead Sciences Announces Second Quarter 2021 Financial Results

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

Cell and gene therapy – where is the innovation?

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial

XELJANZ® (TOFACITINIB CITRATE) RECEIVES MARKETING AUTHORIZATION IN THE EUROPEAN UNION.

Takeda FY2020 H1 Results Demonstrate Portfolio Resilience; Confirms Full-Year Management Guidance & Raises Forecasts for Free Cash Flow, Reported OP & Reported EPS

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