Drug Discovery World

APRIL 22, 2024

The treatment becomes only the second CAR-T cell therapy to secure routine funding for use in the NHS, and the only one for treating ALL in children and young adults under 26 years old. It is approved in cancers that are refractory, in relapse post-transplant or in second or later relapse.

Doctors 130

Doctors Treatment Hospitals Therapies 130

Drug Discovery World

AUGUST 8, 2024

DDW Editor Reece Armstrong speaks to Roger Levy , Global Medical Expert Immunology & Specialty Medicine at GSK about the company’s work into treating systemic sclerosis-associated interstitial lung disease and its recent BLISSc-ILD study evaluating its belimumab treatment. RA: How effective are current treatments for SSc-ILD?

Disease 147

Disease Clinical Trials Treatment Trials 147

The Pharma Data

NOVEMBER 2, 2020

The World Health Organization’s (WHO) Global TB Programme welcomes the results from an important study on shortened treatment for drug-susceptible tuberculosis (TB) in children, presented at the 51 st virtual Union World Conference on Lung Health. Side-effects related to treatment were few, and similar across both groups.

Treatment 52

Treatment Trials Clinical Trials International 52

Drug Discovery World

JUNE 14, 2023

The recent clinical trial for metastatic breast cancer patients (DESTINY-Breast04) found that a treatment traditionally used for HER2 positive patients was also effective in patients considered HER2 negative. It used the current CAP/ASCO testing algorithm for HER2 protein expression levels.

Protein Expression 130

Protein Expression Clinical Trials Trials Laboratories 130

Drug Discovery World

SEPTEMBER 23, 2024

The research underpinning the CTLA-4 and PD-1 technologies resulted in the Nobel Prize in Physiology or Medicine 2018 for the researchers and teams who pioneered them – James Allison of the University of California, Berkeley, and Tasuku Honjo at Kyoto University, respectively.

RNA 173

RNA Immune Response Small Molecule Treatment 173

Drug Discovery World

JANUARY 31, 2023

Hundreds of people with an aggressive form of lymphoma are set to benefit from the first personalised immunotherapy treatment to be recommended for routine use in the NHS. Helen Knight, Director of Medicines Evaluation, NICE, said: “I am delighted that we have been able to recommend this pioneering treatment for people.

Therapies 130

Therapies Clinical Trials Treatment Trials 130

Conversations in Drug Development Trends

FEBRUARY 28, 2023

95% of rare diseases don’t have a treatment approved and won’t anytime soon. Miraculously, there was an approved treatment. Over the next few decades, that drug made its way through clinical trials, securing approval in 2007—just 36 months before Rob was diagnosed in 2010. Uplifting Athletes (UA) is on a mission to change that.

Clinical Trials 52

Clinical Trials Disease Trials Research 52

Drug Discovery World

MARCH 17, 2023

Since 2018, GARDP and the University of Liverpool have been working together to advance new treatment options for new-borns with sepsis. Their research has laid the groundwork for GARDP’s upcoming global clinical trial on neonatal sepsis.

Clinical Trials 130

Clinical Trials Trials Research Treatment 130

Drug Discovery World

OCTOBER 9, 2023

Despite the size of the market and the global impact, there are currently no effective treatments. The reported MOD framework advances the mechanistic rationale of the clinical benefits on fatigue observed in our clinical trial with AXA1125 in the context of the combination’s mechanism of action. Can you explain how it works?

Drug Development 147

Drug Development Clinical Trials Virus Drugs 147

Drug Discovery World

DECEMBER 5, 2022

A recent study revealed that traditional research sources are missing evidence for up to 70% of clinically encountered variants, information that is essential to developing treatments for genetic disorders. This lack of comprehensive data increases the risk of program failure in clinical trials. .

Drug Development 130

Drug Development Clinical Trials Drugs Disease 130

The Pharma Data

DECEMBER 17, 2020

18, 2020 /PRNewswire/ — Camurus AB (NASDAQ STO: CAMX) announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ® prolonged release buprenorphine for the treatment of opioid dependence in adults and adolescents from 16 years of age. LUND, Sweden , Dec. About Buvidal.

Treatment 52

Treatment Clinical Trials International Pharmaceutical Companies 52

Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. 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.

Marketing 245

Marketing FDA Approval Licensing Licensing 245

Drug Discovery World

SEPTEMBER 26, 2022

AstraZeneca’s Tezspire (tezepelumab) has been approved in the European Union as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product. . 2018; 9: 1595. Official comments . N Engl J Med. 2017;377: 936-946.

Clinical Trials 130

Clinical Trials Trials Disease Production 130

The Pharma Data

APRIL 17, 2021

Biogen’s expansion in China now includes treatment options approved for relapsing MS and spinal muscular atrophy. today announced that China’s National Medical Products Administration (NMPA) has approved TECFIDERA ® (dimethyl fumarate) for the treatment of relapsing multiple sclerosis (MS). About TECFIDERA ® (dimethyl fumarate) .

Treatment 52

Treatment Clinical Trials Disease Trials 52

The Pharma Data

NOVEMBER 1, 2020

The trial is expected to enroll 160 patients. billion in 2018, and it is expected to be up to US$48.9 BTK inhibitors have the potential to transform the treatment paradigm of autoimmune diseases including MS. MS is an autoimmune, inflammatory disease of the central nervous system. billion by 2030 2.

Clinical Trials 52

Clinical Trials FDA Trials Treatment 52

The Pharma Data

NOVEMBER 18, 2021

– CHALLENGE-MIG is the first and only clinical trial comparing two anti-calcitonin gene-related peptide (CGRP) medicines, Emgality and Nurtec ODT, which work differently – The study’s primary endpoint is the percentage of patients with ?50% 75% and 100% reductions from baseline in monthly migraine headache days.

Treatment 52

Treatment Clinical Trials Trials FDA 52

Drug Target Review

JANUARY 25, 2024

These findings offer a novel strategy for developing targeted treatments for triple-negative breast cancer, which currently has no approved options. The peptide in development is based on a 2018 Cleveland Clinic discovery and serves as a proof-of-concept for this type of drug for triple-negative breast cancer. Available from: [link]

Clinical Trials 105

Clinical Trials Treatment Science Research 105

The Pharma Data

DECEMBER 7, 2020

But studies exploring its impact on them remain scant, an analysis of clinical trials over the past decade shows. based clinical trials investigating interventions for high blood pressure between 2009-2018, just 52 were exclusively in Black people. This impedes our ability to develop new and novel interventions and treatments.”

Treatment 52

Treatment Clinical Trials Trials Doctors 52

PLOS: DNA Science

MARCH 21, 2024

million price tag for the one-time infusion, and for the older siblings who contributed to developing the gene treatment, but were too sick to receive it. A Long and Winding Diagnostic Road The story begins in 2011, with Alessandra Biffi, MD, head of the clinical trial for MLD at the San Raffaele Telethon Institute for Gene Therapy in Milan.

Therapies 89

Therapies Clinical Trials DNA Trials 89

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. Expected to enroll 415 participants; interim results expected in Q3 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

Agency IQ

OCTOBER 6, 2023

In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. SAMSHA published an “ evidence-based resource guide ” on substance use disorder treatment in June 2020.

FDA 40

FDA Treatment Production Trials 40

The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Over-the-counter treatments fail due to the body’s natural protective system. 25% for dry eye disease treatment.

FDA 52

FDA Disease Treatment FDA Approval 52

New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 1] [5] Medical uses Palopegteriparatide is indicated for the treatment of adults with hypoparathyroidism. [1] 48,000) consisting of 34 amino acid residues. 14 August 2024.

FDA 62

FDA International FDA Approval Trials 62

The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. ERLEADA ® is an androgen receptor (AR) inhibitor indicated for the treatment of patients with nmCRPC and for the treatment of patients with mCSPC. 10 months. [5]

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

The Pharma Data

MARCH 16, 2022

The Independent Data Monitoring Committee recommended that the EMPA-KIDNEY trial be stopped early, following a formal interim assessment EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease to date Detailed results are expected to be presented later this year.

Trials 52

Trials Disease Hospitals Clinical Trials 52

The Pharma Data

NOVEMBER 24, 2020

25, 2020 /CNW/ – On August 21, 2020 , Health Canada approved Lynparza® (olaparib), for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent (NHA).

Treatment 52

Treatment DNA Trials Therapies 52

The Pharma Data

JANUARY 13, 2021

PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. The trial was conducted at 28 U.S. 14, 2021 11:00 UTC. President and CEO of Knopp. “We study centers.

Trials 52

Trials Small Molecule Clinical Trials Treatment 52

Drug Discovery World

OCTOBER 4, 2022

Oligomerix’s portfolio of compounds is expected to provide a potentially lower-cost treatment alternative and/or complement to the newly emerging high-cost therapeutic options such as the monoclonal antibody products. Global dementia prevalence is expected to increase to 152 million in 2050, a 204% increase compared to 2018.

Disease 130

Disease Small Molecule Compound Screening Clinical Development 130

Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution. The potential of these digital tools is vast.

Clinical Research 147

Clinical Research Research Clinical Trials Trials 147

Drug Discovery World

MARCH 29, 2023

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 4 Lazertinib , sold under the brand name Lazcluze and Leclaza , is an anti-cancer medication used for the treatment of non-small cell lung cancer. [1]

FDA Approval 62

FDA Approval FDA International Clinical Trials 62

The Pharma Data

DECEMBER 17, 2020

He’s been off insulin since August 2018 — more than two years. No treatments are approved for reversing type 1 diabetes. Although the Australian trial will focus on people who are newly diagnosed, Martin suspects even people with long-standing type 1 diabetes may benefit from JAK inhibitors. WEDNESDAY, Oct.

Treatment 52

Treatment Doctors Clinical Trials Trials 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D., .

Trials 52

Trials Treatment Therapies Clinical Trials 52

New Drug Approvals

SEPTEMBER 10, 2024

2] Medical uses Vorasidenib is indicated for the treatment of people aged twelve years of age and older with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation, following surgery including biopsy , sub-total resection, or gross total resection. [2] April 2018).

FDA Approval 62

FDA Approval FDA Clinical Trials Trials 62

The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e.,

Treatment 52

Treatment Pharmaceutical Companies Therapies Virus 52

FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

Disease 59

Disease Production FDA Drug Development 59

The Pharma Data

MARCH 30, 2021

2] – The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine. .

Treatment 52

Treatment FDA Doctors FDA Approval 52