Antidote

JULY 29, 2022

Between 2009 and 2018, U.S. billion to bring a new therapy to market. The process of getting a new drug to market is an expensive one. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8

Clinical Trials 96

Clinical Trials Trials Pharmaceuticals Therapies 96

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

APRIL 11, 2023

12 The trial Tezepelumab was well tolerated in patients with severe asthma and resulted in clinically meaningful reductions in asthma exacerbations in NAVIAGTOR & SOURCE clinical trials and no clinically meaningful differences in safety results between the tezepelumab and placebo groups. 2018; 10 (1): 34‐45 Duchesne M, et al.

Treatment 246

Treatment Clinical Trials Trials Science 246

Drug Discovery World

DECEMBER 13, 2022

An immunotherapy that uses a new targeted approach to kill bone marrow cancer cells was successful in as many as 73% of patients in two clinical trials. . The trial results have been revealed by researchers from The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. . Clinical trial details .

Clinical Trials 130

Clinical Trials Trials Therapies Clinical Research 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

Advarra

OCTOBER 19, 2023

The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology, and an increased demand for accelerated timelines in getting therapies to market. Sponsor Technology and Training The role of technology in clinical trials has never been more pronounced.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Drug Target Review

NOVEMBER 7, 2023

Although PROTACs are currently in clinical trials and have shown efficacy in treating cancer , they can only target a protein if it is inside the cell, which is 60 percent of the time. To test which patients are more likely to respond to LYTAC therapy, the level of neddylated CUL3 could be measured. This study was published in Science.

Therapies 59

Therapies Science Disease Treatment 59

Drug Discovery World

JUNE 1, 2023

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. Varying sources suggest that China has been one to watch over recent years and continues to be going forward.

Marketing 245

Marketing FDA Approval Licensing Licensing 245

Drug Discovery World

AUGUST 8, 2024

The standard therapy has traditionally been non-specific immunosuppressants, particularly mycophenolate mofetil or cyclophosphamide. With limited treatment options available for SSc-ILD, the commencement of this clinical trial is a step forward in the attempt to meet a critical need for people living with this debilitating condition.

Disease 147

Disease Clinical Trials Treatment Trials 147

Conversations in Drug Development Trends

FEBRUARY 28, 2023

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. If we don’t fund this research, we never have the chance for treatments, cures, or innovative therapies. But what was truly remarkable? It really has to start from square one,” says Rob.

Clinical Trials 52

Clinical Trials Disease Trials Research 52

Drug Discovery World

SEPTEMBER 26, 2022

The approval by the European Commission was based on results from the Pathfinder clinical trial programme, which included the pivotal Navigator Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

Clinical Trials 130

Clinical Trials Trials Disease Production 130

Drug Discovery World

MAY 15, 2024

Dr Catherine Beech , CEO at Exonate and Dr Pete Adamson , CSO at Breye Therapeutics discuss the need for better therapies to treat diabetic retinal disease and current progress in the field. Selective targeting would enable the therapy to treat the disease whilst not impacting the natural processes of VEGF. Diabetes Res Clin Pract.

Disease 162

Disease Treatment Therapies Pharmaceuticals 162

The Pharma Data

DECEMBER 22, 2020

Tagrisso Approved as Adjuvant Therapy for NSCLC With EGFR Mutations. Tagrisso was approved in 2018 for first-line treatment of patients with metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations. Professional. TUESDAY, Dec. Food and Drug Administration announced Friday.

Therapies 52

Therapies FDA Treatment Disease 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] 5] History The effectiveness of palopegteriparatide was evaluated in a 26-week, randomized, double-blind, placebo-controlled trial that enrolled 82 adults with hypoparathyroidism. [5]

FDA 62

FDA International FDA Approval Trials 62

Drug Discovery World

NOVEMBER 7, 2022

In 2018, the UK’s department of health announced an NHS Genomic Medicine Service, which allows patients with rare diseases to have their entire genetic code read in the hope of providing a much-needed diagnosis. This included additional check-ups for heart problems, hearing loss, and diabetes, and access to clinical trials.” .

Disease 130

Disease Bioinformatics Laboratories DNA 130

New Drug Approvals

SEPTEMBER 10, 2024

2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2] April 2018). mol), (R)-1,1,1-trifluoropropan-2-amine hydrochloride (0.39 6 August 2024.

FDA Approval 62

FDA Approval FDA Clinical Trials Trials 62

Drug Discovery World

JULY 22, 2022

Although immunotherapy has revolutionised cancer therapy, the effectiveness of currently available immunotherapies varies significantly across patients and treatment types. To mitigate these risks, clinicians are turning to other immunomodulators, such as cell-based therapies, bispecific antibodies, and cytokine treatments.

Therapies 130

Therapies Treatment Engineering Clinical Trials 130

Drug Target Review

JANUARY 25, 2024

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. Currently, they are exploring the drug’s potential for clinical trials. This study was published in Molecular Cancer Therapeutics. References 1 Marqus S, Pirogova E, Piva TJ.

Clinical Trials 105

Clinical Trials Treatment Science Research 105

Drug Discovery World

AUGUST 10, 2022

But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic.

Therapies 246

Therapies Virus Treatment Engineering 246

New Drug Approvals

SEPTEMBER 6, 2024

2 History Efficacy was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multicenter trial of 1074 participants with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic non-small cell lung cancer and no prior systemic therapy for advanced disease. [2] hdl : 10665/330941.

FDA Approval 62

FDA Approval FDA International Clinical Trials 62

Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). 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

FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

An Opportunity to Convene this New Advisory Committee for All Rare Disease Therapies In 2018, HP&M attorneys Frank Sasinowski and James Valentine proposed a Rare Disease Center of Excellence (which we blogged about here ). Note that FDA is currently soliciting applications to staff this committee.

Disease 59

Disease Production FDA Drug Development 59

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. study centers. ABOUT THE EXHALE STUDY.

Trials 52

Trials Small Molecule Clinical Trials Treatment 52

Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. 4, 5 More recently, new combination regimens have emerged that incorporate targeted therapies to treat a variety of blood cancers, including multiple myeloma (MM), chronic lymphocytic leukaemia (CLL) and acute myelogenous leukaemia (AML).

Small Molecule 111

Small Molecule Therapies Treatment Immune Response 111

Drug Discovery World

APRIL 30, 2024

Reece Armstrong explores the potential and future opportunities for mRNA-based therapies. For instance, consider how at the end of 2018, the mRNA therapies market was valued at $3.43 At the start of 2024, the first patients in a clinical trial investigating an mRNA cancer therapy were dosed.

Therapies 130

Therapies RNA Vaccine Small Molecule 130

Drug Target Review

OCTOBER 11, 2023

1,2 Many, however, do have dysfunctional proteins at their core, and for these diseases, a new option is being explored: autophagy-boosting therapies. Symptoms were reversed in mouse models and a clinical trial is planned for later this year. Gene therapy, of course, also holds great promise. 2018 [cited 2023 Sep 5].

Disease 113

Disease Treatment Small Molecule Therapies 113

Drug Discovery World

OCTOBER 4, 2022

million from the National Institute on Aging of the National Institutes of Health, the company plans to begin a Phase Ia clinical trial evaluating its lead tau self- association small molecule inhibitor OLX-07010. . 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

The Pharma Data

MAY 2, 2023

a clinical trial data collection company, since 2021. including Executive Vice President and Chief Financial Officer from 2018 through the company’s sale to ICON plc, and previously as Senior Vice President, Accounting and Corporate Controller from 2008 to 2018. a clinical trial data collection company, since 2021.

Clinical Trials 40

Clinical Trials Clinical Research Science Clinical Development 40

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 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 I am very delighted to learn the swift IND clearance by the US FDA, and we are initiating the phase II clinical trial immediately,” said Dr. Jasmine Cui, the co-founder, chairman, and Chief Executive Officer of InnoCare.

Clinical Trials 52

Clinical Trials FDA Trials Treatment 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

The Pharma Data

OCTOBER 20, 2020

In hopes to advance the best and brightest, MD Anderson, in partnership with The Focus Fund GP, has launched the Cancer Focus Fund to propel compelling investigational cancer therapies from preclinical development through Phase II clinical trials. But now they’ll be choosing the therapies themselves. . Cancer is still the No.

Clinical Trials 52

Clinical Trials Pharma Companies Therapies Trials 52

The Pharma Data

MAY 5, 2022

1 Clinical trials for new therapies in AML are becoming increasingly lengthy to complete based on the traditional clinical endpoint of survival. “Measuring MRD as a surrogate endpoint may help forge a path to bring new AML therapies to patients quickly.”

Disease 52

Disease Drug Development Clinical Trials Pharmaceutical Companies 52

Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

Clinical Trials 130

Clinical Trials Research Science Clinical Research 130

The Pharma Data

DECEMBER 9, 2020

9, 2020 — More women with early-stage breast cancer may be able to safely skip chemotherapy after having surgery, according to initial results from a major clinical trial. The trial, conducted in nine countries, found that adding chemotherapy to hormone-blocking drugs brought no added benefit to a particular group of patients.

Trials 52

Trials Therapies Clinical Trials Treatment 52

Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

Therapies 130

Therapies Clinical Trials Production Trials 130

Agency IQ

MARCH 29, 2024

FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint Yesterday, the FDA announced that its Oncologic Drugs Advisory Committee would weigh in on the potential use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials.

FDA 40

FDA Clinical Trials Trials Treatment 40