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.

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Drug Discovery World

OCTOBER 4, 2022

William Erhardt , President, Head of Development & Operations of biotech Oligomerix, tells Lu Rahman about the company’s differentiated approach to developing disease-modifying therapeutics for neurodegenerative diseases. . Global dementia prevalence is expected to increase to 152 million in 2050, a 204% increase compared to 2018.

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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. It saved my life.”

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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.

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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.” There are hundreds of known genetic metabolic diseases, most of which are rare and carry significant morbidity.

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Drug Discovery World

DECEMBER 5, 2022

A new partnership between industry and three rare disease foundations has formed with the goal of accelerating the development of precision drugs to treat rare neurodevelopmental disorders. . Understanding rare diseases remains a significant challenge. Understanding rare diseases remains a significant challenge.

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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.

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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.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . adults have been diagnosed with dry eye disease, a chronic, episodic, multifactorial disease. It also increases your risk for inflamed cornea, cornea eye disease, corneal ulcers and injuries, and eye infections. .

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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.

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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.

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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.

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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 . Varricchi G, et al. Li Y, et al.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. In my case, my daughter Iris has GM1 gangliosidosis.

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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.

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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.

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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. The history of gene therapy for MLD is compelling – DNA Science covered it for Rare Disease Day in 2021, here. Developmental milestones ebbed and vanished.

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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).

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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.

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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.

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The Pharma Data

NOVEMBER 1, 2020

The trial is expected to enroll 160 patients. MS is an autoimmune, inflammatory disease of the central nervous system. 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. billion by 2030 2.

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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.

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The Pharma Data

MAY 5, 2022

Validated Measurable Residual Disease Assays are Critical for the Rapid Development of Future Novel Therapeutics for Patients with Acute Myeloid Leukemia. 1 Clinical trials for new therapies in AML are becoming increasingly lengthy to complete based on the traditional clinical endpoint of survival. About Acute Myeloid Leukemia.

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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.”

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

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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).

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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]

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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] 29 (3): 615–622.

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Drug Target Review

NOVEMBER 6, 2023

Advances in research and development and the utilisation of combination treatment strategies are revolutionising the haematology care landscape, but more must be done to address patients’ individual needs. 2 It is this complexity that necessitates powerful, targeted combination therapies.

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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. For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.

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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.

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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.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. Based on these data, ADT alone should no longer be considered sufficient for patients with advanced, castration-sensitive disease.”. About ERLEADA ® (apalutamide).

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The Pharma Data

NOVEMBER 10, 2020

P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease. Crohn’s Disease Therapeutics Market Size $4.7 The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. Billion by 2025. NEW YORK and LONDON, Nov.

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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.,

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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.

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Drug Discovery World

OCTOBER 20, 2022

In 2018, for instance, Tohoku University signed a partnership agreement with Phillips Japan, a subsidiary of Dutch multinational Phillips, to conduct joint research in the field of healthcare. To this end, pharmaceutical company ViiV Healthcare received approval in Japan for its long-acting HIV treatment in May 2022 5.

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