Drug Discovery World

AUGUST 23, 2023

Pfizer’s Abrysvo (Respiratory Syncytial Virus Vaccine) was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age. In infants and children, the risk of RSV-associated LRTD is highest during the first year of life.

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Drug Discovery World

JANUARY 23, 2023

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. Armed with this understanding, the researchers further demonstrated that the genetic inhibition of DGAT1 suppresses radioresistance.

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Drug Discovery World

DECEMBER 11, 2023

The US Food and Drug Administration (FDA) has approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD), Casgevy and Lyfgenia. Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is also the first FDA-approved treatment to use CRISPR gene editing technology.

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Drug Discovery World

FEBRUARY 2, 2023

Orserdu was approved under the FDA’s Priority Review and Fast Track designation based on the results of the registrational Phase III trial EMERALD, that demonstrated statistically significant progression-free survival (PFS) with elacestrant vs. SOC endocrine monotherapy.

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Drug Discovery World

APRIL 6, 2023

The data supporting the EUA were based on the previously announced results of the multicentre Phase III PANAMO trial. The trial is one of the largest 1:1 randomised, double-blind placebo-controlled trials in invasively mechanically ventilated Covid-19 patients in intensive care units.

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Drug Discovery World

OCTOBER 4, 2022

The approval is the result of a long advocacy campaign to convince the FDA to approve the treatment prior to completion of an ongoing Phase III trial. . “We In June 2016, the Association provided Amylyx, the producer of AMX0035, with a $750,000 grant for a clinical trial pilot.

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The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

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Drug Discovery World

OCTOBER 11, 2023

“We are very pleased to start the clinical evaluation of BI 771716, which resulted from collaborative efforts with CDR-Life,” said Clive Wood, Corporate Senior Vice President and Global Head of Discovery Research at Boehringer Ingelheim.

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Drug Discovery World

AUGUST 5, 2024

Peter Marks, Director of the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), said the approval of the “state-of-the-art immunotherapy technology” provides a “critical new option for a patient population in need”. The median duration of response was six months.

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Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study. In trying to fix the problem, the immune system causes even more damage,” said Evseenko.

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PLOS: DNA Science

MARCH 28, 2024

The New Drug Duvyzat (givinostat), a type of drug called an HDAC inhibitor, has been in clinical trials to treat cancers and other disorders of the blood, Crohn’s disease, and a form of juvenile arthritis. Research also took place in two facilities in Italy, with sponsorship from Italfarmaco S.p.A.

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Drug Discovery World

MARCH 29, 2024

FDA approves Covid-19 mAb for emergency use The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis of Covid-19.

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Drug Discovery World

MAY 24, 2023

Altering the chemical properties of an anti-nausea drug enables it to enter an interior compartment of the cell and provide long-lasting pain relief, according to a new study led by researchers at NYU College of Dentistry’s Pain Research Center. The researchers genetically modified mice to express the human NK1 receptor.

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Science Daily: Pharmacology News

APRIL 15, 2024

Researchers have discovered that an FDA-approved epilepsy drug can prevent or slow the growth of NF1-linked optic gliomas in mice, laying the groundwork for a clinical trial.

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Drug Discovery World

JUNE 6, 2024

Professor Charles Swanton, Cancer Research UK’s chief clinician, said the melanoma trial results were “extremely impressive”, adding: “The new vaccine approach is another piece of the puzzle that will allow more patients to be cured, hopefully, or fewer patients to suffer disease relapse. months after initial treatment.

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Drug Discovery World

JUNE 27, 2024

Novo Nordisk has announced results from the Phase III FRONTIER2 trial of 254 adults and adolescents aged 12 years and over with haemophilia A, with and without inhibitors. The trial assessed both once-weekly and once-monthly prophylactic treatment with the investigational treatment Mim8. with once-weekly and 98.7%

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Drug Discovery World

OCTOBER 18, 2023

Sara Donnelly, Director of Research Planning and Business Development at PhoenixBio USA explores why the right pre-clinical model is essential for teams wanting to advance adeno-associated virus vector-based gene therapies. Adeno-associated virus (AAV) vector-based gene therapies hold exceptional promise across a range of disease areas.

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DrugBank

FEBRUARY 1, 2024

was recently profiled in the January 5, 2024 issue of Nucleic Acids Research. The article highlights the myriad ways in which we have focused on making DrugBank not just a knowledgebase, but a vital partner in your healthcare research. Vastly Expanded Clinical Trial Information Our clinical trial data has grown by 89.5%.

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Drug Discovery World

MAY 1, 2024

AI’s significance is also evident in the science, where immuno-oncology company Aulos Bioscience recently revealed interim results from an ongoing Phase I/II trial of an AI-designed monoclonal antibody (mAb), AU-007, in solid tumours. Research will likely focus on expanding applications in infectious diseases and autoimmune disorders.”

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Drug Discovery World

JULY 7, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result.

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Drug Discovery World

JUNE 1, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2. A market research report published in late June 2018 by HTF market Intelligence Consulting suggested that the ADC market in China would grow exponentially by 2023 4.

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Drug Discovery World

DECEMBER 22, 2023

In other news, the FDA approved a promising antibody-drug conjugate for bladder cancer and trial results demonstrated that psilocybin could reduce depression symptoms in cancer patients.

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Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Oncology research is unique in many ways, including the challenges researchers face.

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The Pharma Data

JUNE 22, 2023

FDA approval Pfizer (NYSE: PFE) announced that the U.S. FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and global lead investigator for TALAPRO-2. The primary endpoint of the trial was rPFS, and overall survival (OS) was a key secondary endpoint.

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The Pharma Data

JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. The approval was built on the Phase III ATLAS and FLAIR trials. Janssen is a Johnson & Johnson company.

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Drug Discovery World

MARCH 8, 2024

The US Food and Drug Administration (FDA) has revealed plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial. The trial evaluated the efficacy and safety of Eli Lilly’s donanemab in early symptomatic Alzheimer’s disease.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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Drug Discovery World

DECEMBER 22, 2022

A new drug based on the active ingredient Lutetium-177 PSMA-617 has been approved by the European Commission for the treatment of metastatic prostate cancer carrying the surface molecule PSMA (prostate specific membrane antigen). . It had already received FDA approval for the United States in March of this year.

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Drug Discovery World

DECEMBER 21, 2023

In a record year for gene therapy approvals, it isn’t surprising that cell & gene therapy (CGT) has been a hot topic. Regulatory issues and diversity in clinical trials were also important in 2023, as well as the role that artificial intelligence tools like ChatGPT might play.

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The Pharma Data

AUGUST 4, 2020

. Janssen has received US Food and Drug Administration (FDA) approval for its Spravato (esketamine) CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour. Source link. .

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Alta Sciences

FEBRUARY 8, 2024

President of Cognitive Research Corporation , examine simple and cognitive domains in clinical and pharmacology studies, including analysis of driving impairment. Tags Clinical Trials Weight 12 In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G.

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Conversations in Drug Development Trends

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. It plays a significant role in patient recruitment and retention, both of which are vital to maintaining timelines, decreasing program costs, and gaining market approval.

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Drug Discovery World

FEBRUARY 21, 2024

The US Food and Drug Administration (FDA) has approved Eicos Sciences’ Aurlumyn (iloprost) injection, the first FDA-approved medication to treat severe frostbite. Iloprost’s efficacy in treating severe frostbite was established in an open-label, controlled trial that randomised 47 adults with severe frostbite.

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Drug Discovery World

SEPTEMBER 7, 2023

1 There are a number of challenges faced in paediatric R&D, including the fact that the overall group includes five different age groups, the need for specific biomarkers, the extra length of time needed for trials, and the ethical concerns of conducting clinical trials in children. Read more: $1.5

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The Pharma Data

AUGUST 24, 2020

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC.

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The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Professional. MONDAY, Dec. Food and Drug Administration announced Friday.

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Drug Discovery World

OCTOBER 10, 2023

Read more: Preclinical study proves antidepressant effects of drug Psychedelic-based drug options Later the same month, Cybin announced it had completed dosing in Cohort 5 of a Phase II trial evaluating CYB003, an investigational proprietary deuterated analog of psilocybin for the potential treatment of major depressive disorder (MDD).

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