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). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

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Clinical Trials Clinical Trials FDA Approval Trials 52

Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

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Gene Clinical Trials Clinical Trials Gene Therapy 154

The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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Clinical Development Vaccination Vaccine Development 52

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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Gene Therapy Gene Trials Clinical Trials 264

pharmaphorum

JULY 25, 2022

The latest result has undermined the company’s hopes that PH94B would become the first FDA-approved, on-demand treatment for patients who suffer from SAD, but it’s not the first setback for the company. VistaGene meanwhile is also developing PH10, another pherine nasal spray heading for a phase 2b study in MDD.

Clinical Trials 57

Clinical Trials Clinical Trials Trials FDA Approval 57

pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

FDA Approval 57

FDA Approval Drugs Gene Therapy Protein 57

Pharmaceutical Technology

AUGUST 18, 2022

The latest approval is based on findings from the Phase III clinical trials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?

Gene Therapy 246

Gene Therapy Gene Genotype Genetics 246

pharmaphorum

MAY 30, 2022

Despite this, the first-ever FDA-approved KRAS G12C inhibitor has demonstrated that RAS is in fact druggable and that drugging this protein unlocks a world of successful therapeutic interventions. Continuing to advance valuable combination therapies into the clinic, and finally, crack resistance to RAS targeted therapeutics.

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Development Drugs FDA Approval Clinical Trials 52

XTalks

DECEMBER 10, 2021

Zavegepant has an advantage over the two as it’s the only CGRP receptor antagonist in both intranasal spray and oral pill formulations that is in clinical development for the treatment of acute or episodic migraines. The trial has enrolled over 1,400 adult participants with a history of migraines.

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FDA Approval Trials Drugs Sales 98

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. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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FDA Approval Vaccination Vaccine Clinical Trials 102

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. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. Source link: [link]

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FDA Approval HR Vaccination Vaccine 40

Pharmaceutical Technology

AUGUST 5, 2022

In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) recommended approving the treatment in this setting. This EC approval was based on findings from the parallel-group, double-blind, placebo-controlled, global Phase III OlympiA clinical trial of Lynparza versus placebo.

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FDA Approval DNA Clinical Trials Clinical Trials 147

Pharmaceutical Technology

MARCH 1, 2023

The Covid-19 pandemic led to massive developments and scientific advances within the field of messenger ribonucleic acid (mRNA) vaccines. Pfizer /BioNTech and Moderna’s mRNA-based vaccines were the first to receive emergency use authorisation (EUA) out of all other Covid-19 vaccines under development in late 2020.

RNA 147

RNA Vaccination Vaccine Genetics 147

XTalks

JULY 3, 2023

The US Food and Drug Administration (FDA) has given its approval to Suflave, a colonoscopy preparation product developed by Braintree Laboratories, a division of Sebela Pharmaceuticals. How Can Suflave Boost Patient Compliance? Sabela Pharmaceuticals says the product will be available by prescription starting in August.

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FDA Approval Compliance Clinical Trials Clinical Trials 97

XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. All except for Adstiladrin were cleared for rare disease indications.

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Gene Therapy Clinical Trials Clinical Trials Gene 52

The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

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Clinical Development Development Medicine Clinical Trials 52

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

pharmaphorum

JUNE 1, 2022

Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinical trials in oncology. The post Median Tech debuts AI-focused unit for cancer trial support appeared first on. sensitivity and 93.3%

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Trials Clinical Trials Clinical Trials FDA Approval 74

Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. GlobalData’s report assesses how Amivantamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. It is based on DuoBody technology platform.

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Recombinant DNA Technology Production Antibody FDA Approval 100

Roots Analysis

NOVEMBER 3, 2023

Despite their potential therapeutic benefits, NAMPT inhibitors have faced several challenges in clinical development. One of the main challenges is the development of drug resistance, as cancer cells can develop mechanisms to bypass the inhibition of NAMPT.

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Development Drugs Trials FDA Approval 40

Drug Discovery World

FEBRUARY 14, 2024

AlphaMedix is a targeted alpha therapy currently in Phase II clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. In the Phase I study, treatment was well-tolerated, with a response rate of 62.5%

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In-Vivo FDA Approval Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. and 2 trials planned by our sublicensee WPD in Poland. and 2 trials planned by our sublicensee WPD in Poland.

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

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

Trials 52

Trials Clinical Trials Clinical Trials FDA Approval 52

XTalks

MAY 9, 2024

XTALKS CLINICAL EDGE: Issue 2 — Genmab’s Interview Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. Genmab has achieved notable success with eight approved therapies and an impressive pipeline.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., times the human dose.

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” . CHENGDU, China , Feb. CHENGDU, China , Feb.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

FEBRUARY 21, 2022

One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. Clinical trial diversity improved during COVID-19 (but not enough) .

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Clinical Research Research Clinical Trials Clinical Trials 100

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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FDA Approval Production RNA Medicine 52

The Pharma Data

DECEMBER 17, 2020

The trial is a Phase 3 randomized, controlled, open-label, multicenter clinical trial, aiming to evaluate the efficacy and safety of ATG-010, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with rrMM who have received one to three prior lines of therapy.

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Clinical Trials Clinical Trials Trials Drugs 52

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. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. KENILWORTH, N.J.–(BUSINESS

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FDA Approval Production Trials Clinical Trials 52

XTalks

MAY 5, 2023

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). percent and the risk of developing severe RSV-associated LRTD by 94.1

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Vaccination Vaccine FDA Approval Development 105

pharmaphorum

SEPTEMBER 21, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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Medicine FDA Approval Clinical Trials Clinical Trials 132

pharmaphorum

SEPTEMBER 3, 2020

UK biotech Compass Pathways is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient that can be found in magic mushrooms.

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Drugs Life Science Clinical Development Regulation 101

Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

Trials 52

Trials Clinical Trials Clinical Trials FDA Approval 52

The Pharma Data

MAY 31, 2022

. “The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Pharmaceutical companies – and the FDA – are embracing FDCs.

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