Drug Discovery World

MAY 15, 2023

The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy.

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Drug Discovery World

JULY 25, 2023

The efficacy of quizartinib with chemotherapy was evaluated in the QuANTUM-First trial of 539 patients with newly diagnosed FLT3-ITD positive AML. FLT3-ITD status was determined prospectively with a clinical trial assay and verified retrospectively with the companion diagnostic LeukoStrat CDx FLT3 Mutation Assay.

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Drug Discovery World

JUNE 6, 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, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.

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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

SEPTEMBER 20, 2022

SKYSONA has become the first FDA approved therapy to slow the progression of neurologic dysfunction in boys with cerebral adrenoleukodystrophy (CALD). As a condition of the SKYSONA Accelerated Approval, the manufacturer will provide confirmatory long-term clinical data to the FDA.

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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

NOVEMBER 23, 2023

Minoryx has announced enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in the US Phase III clinical trial, CALYX. This will push the Phase III CALYX trial forward and bring leriglitazone to patients as quickly as possible,” said Sílvia Pascual, VP Clinical Development, Minoryx. “In

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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. There are endpoints that can be easily measured, that are already standardized, and they are FDA-approved,” says Dr. Ojeda.

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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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Drugs.com

JULY 2, 2024

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early. Food and Drug Administration on Tuesday.

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Drug Discovery World

SEPTEMBER 13, 2022

It is approved in patients who are candidates for systemic therapy or phototherapy, but not recommended in combination with other potent immunosuppressants. The post FDA approves new first-line treatment for plaque psoriasis appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JANUARY 23, 2023

As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics. Additionally, the clinical trial period will be considerably shorter than that required for new drug development.

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Alta Sciences

FEBRUARY 8, 2024

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment. Tags Clinical Trials Weight 12

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Drugs.com

JULY 2, 2024

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early. Food and Drug Administration on Tuesday.In

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Drug Discovery World

SEPTEMBER 12, 2024

In addition, small patient populations make clinical trials difficult and reduce incentives for investment. Only two drugs were approved exclusively for children and young people with cancer by the European Medicines Agency (EMA) and five by the US Food and Drug Administration (FDA) from 2007 to 2022.

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BioPharma Drive: Drug Pricing

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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Drug Discovery World

JUNE 16, 2023

Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Cancer Testing Guidelines.

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Drug Discovery World

OCTOBER 18, 2023

We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal muscular atrophy, 2 and haemophilia B.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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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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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children.

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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. Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary.

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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. The follow-up of the Phase IIb study took place 34.9

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Chemical Biology and Drug Design

OCTOBER 10, 2023

Later, a new type of non-nucleoside reverse transcriptase inhibitors (NNRTIs) were approved as anti-HIV drugs. Zidovudine, didanosine, and stavudine are FDA-approved NRTIs, while nevirapine, efavirenz, and delavirdine are FDA-approved NNRTIs.

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Drug Discovery World

MARCH 1, 2024

This is the first time the FDA has used the amended procedures for withdrawal of accelerated approval that were enacted in 2023, as part of the Food and Drug Omnibus Report Act of 2022 (FDORA). Oncopeptides was required to conduct the OCEAN trial as a post-approval requirement under the accelerated approval programme.

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Drug Discovery World

SEPTEMBER 2, 2024

Emphasis on manufacturing Experts were unanimous in their view of how far the cell & gene therapy (CGT) sector has come and the milestones achieved in both 2023 and early 2024, most referencing the first FDA-approved CRISPR therapeutic and the impact this will have on in-progress CRISPR clinical trials.

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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.

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Drug Discovery World

JUNE 10, 2024

The US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than Covid-19.”

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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.

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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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Drug Discovery World

DECEMBER 22, 2022

It had already received FDA approval for the United States in March of this year. The approval is limited to patients who had previously received chemotherapy and who do not respond to hormone withdrawal. .

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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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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Typical clinical development timelines for anticancer drugs average an estimated 6.7 Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community.

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Drug Discovery World

OCTOBER 12, 2023

His work remains a key component of every FDA-approved AAV therapeutic and will remain central to future advances. Dr Samulski has advanced therapeutics into human clinical trials for haemophilia, Duchenne muscular dystrophy, giant axonal neuropathy, Pompe disease and heart failure.

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Drug Discovery World

OCTOBER 12, 2023

His work remains a key component of every FDA-approved AAV therapeutic and will remain central to future advances. Dr Samulski has advanced therapeutics into human clinical trials for haemophilia, Duchenne muscular dystrophy, giant axonal neuropathy, Pompe disease and heart failure.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

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Drug Discovery World

FEBRUARY 14, 2024

“We believe that AlphaMedix has potential to demonstrate substantial benefit over currently FDA approved PRRT with beta-particle emitters for patients with metastatic or inoperable SSTR-expressing GEP-NETs,” said Ebrahim Delpassand, Chairman and Chief Executive Officer of RadioMedix.

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