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 If the body fails to make the right protein, diseases such as cancer, type II diabetes, neurological conditions, and metabolic diseases can occur.

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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. 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. appeared first on Drug Discovery World (DDW).

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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.

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Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. I work on a rare disease called primary mitochondrial myopathy, for which there is currently no approved treatment.

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Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo.

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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 Oral and nasal administration routes are both physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits.”.

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The Pharma Data

JUNE 18, 2021

1 Clinical remission was defined by Crohn’s Disease Activity Index (CDAI) in the U.S. “These results represent another step towards the development of risankizumab for these patients, many of whom do not find sufficient disease control with current treatments.” NORTH CHICAGO, Ill. vice chairman and president, AbbVie.

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The Pharma Data

MARCH 1, 2022

The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. senior vice president, R&D, chief scientific officer, AbbVie.

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The Pharma Data

DECEMBER 3, 2020

Today, transplant patients who do not respond or experience adverse events related to existing therapies may be at higher risk for complications from the virus, including transplant failure and death. Orphan status is granted to certain investigational medicines intended for the treatment or prevention of a rare, life-threatening disease.

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The Pharma Data

NOVEMBER 24, 2020

Currently, mCRPC remains an incurable disease, and despite advancements in available therapies, the 5 year survival rate for men with metastatic prostate cancer is only 28 per cent. 2 Approximately 34 per cent of men are diagnosed with mCRPC annually, and despite currently approved therapies, 16 per cent die each year.

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Drug Target Review

APRIL 3, 2024

Making a little tangle of DNA visible to the eye and understanding that this is the basis of complex organisms, which might be altered in disease, was the defining moment for my future path in life sciences. Everything started in school with an experiment on isolating DNA from bananas.

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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The Pharma Data

SEPTEMBER 9, 2020

Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. 0.86, p=0.015). A relapse was categorised as severe if it resulted in a change of ?

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The Pharma Data

OCTOBER 26, 2020

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. ” Market Abuse Regulation (MAR) Disclosure. For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. [link]. .

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Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

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The Pharma Data

MARCH 23, 2022

In fact, antiviral therapies designed to treat viruses such as hepatitis C (Sofosbuvir/SOVALDI) work by blocking viral polymerase. Back in 2018, researchers tested a broad-spectrum antiviral candidate called remdesivir/VEKLURY, which acts as a nucleotide decoy to get incorporated into the viral RNA genome and stop viral polymerase.

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NIH Director's Blog: Drug Discovery

MAY 9, 2019

Among those taking on this ambitious challenge is a recipient of a 2018 NIH Director’s New Innovator Award, Srivatsan Raman of the University of Wisconsin-Madison. In fact, he hopes the data generated—and there will be a massive amount—will reveal novel sites to control or exploit allosteric signaling. ’ Fenton AW.

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The Pharma Data

AUGUST 16, 2020

First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. Chief Medical Officer and Head of Global Product Development. “We with placebo.

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The Pharma Data

FEBRUARY 8, 2021

Based on these data, ADT alone should no longer be considered sufficient for patients with advanced, castration-sensitive disease.”. In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®. About ERLEADA ® (apalutamide).

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. and a disease control rate (DCR) of 86.2% SHANGHAI, China, Jan.

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The Pharma Data

DECEMBER 17, 2020

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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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. How are disease targets selected for challenge trials?

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The Pharma Data

NOVEMBER 8, 2020

Following the data releases in 2018 and 2019, this will be the third time that Ascentage Pharma has presented updated clinical data of HQP1351 at the ASH Annual Meeting. HK) is a globally, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. Qian Jiang , M.D.,

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The Pharma Data

APRIL 28, 2021

1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). HAQ-DI score ?0.5;

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Agency IQ

JULY 21, 2023

subsequent superior/inferior supportive care, lifestyle changes, and/or use of additional therapies). That’s why, according to FDA’s Oncology Center of Excellence, the determination of an appropriate endpoint in oncology is based on the specific disease and is highly dependent upon numerous factors.

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The Pharma Data

JUNE 18, 2021

4,5 Between 20 and 46 percent of adults with atopic dermatitis have moderate to severe disease. 6 The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease. Nat Rev Dis Primers 4, 1(2018). About RINVOQ ® (upadacitinib). 14 In August 2019 , RINVOQ received U.S.

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The Pharma Data

AUGUST 5, 2020

Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis 1 . Hauser, Director of the UCSF Weill Institute for Neurosciences and co-chair of the steering committee for the ASCLEPIOS I and II studies. “A

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Agency IQ

JULY 7, 2023

regulators have previously discussed , using RWE “for regulatory decision-making is already a reality, and there is increasing interest in using big data and advanced analytics as a complementary source of evidence.” Regulators have been investing in ways to understand better how RWE can be used and how RWD is generated.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. In fact, CDER received a perfect 100% for meeting PDUFA dates for novel drugs in 2013, 2017, 2018 and 2020.

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The Pharma Data

NOVEMBER 9, 2020

On August 20, 2018, the Company signed the Exclusive Dealing Agreement with Prof. Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S. Dr. Löbenberg with respect to exclusive commercial development rights under his cannabis licences and to related intellectual property.

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The Pharma Data

OCTOBER 15, 2020

Using blue light cystoscopy with Hexvix, they trust their detection capabilities in the office and can treat the lesions immediately, perform confirmatory biopsies or initiate intravesical therapy. About Bladder Cancer. 75% of all bladder cancer cases occur in men. 75% of all bladder cancer cases occur in men.

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The Pharma Data

JANUARY 13, 2021

Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called Fc?RII, RII, which resulted in an increased risk of thrombosis. 1 Lederman, S. International Immunol. (11):1583

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The Pharma Data

SEPTEMBER 9, 2020

The announcement was made during the virtual European Society of Minimally Invasive Neurological Therapy (ESMINT). 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC6288566/. [ii] Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 31 Jan. Stroke Research and Treatment, Hindawi, 27 Nov.

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The Pharma Data

FEBRUARY 22, 2021

. “These positive results confirm the findings of the previous induction study and underscore the potential impact upadacitinib could have on patients struggling to manage their disease.” lead study investigator and head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, Milan, Italy.

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The Pharma Data

NOVEMBER 2, 2020

If approved, 1st Therapy in U.S. Although the FDA did not identify any filing issues with the NDA, the Agency reiterated a position raised during the Pediatric Advisory Committee (PAC) and Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) held on May 11, 2018 recommending two-year controlled trials in different age groups.

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Drug Target Review

JULY 7, 2023

The epigenome (meaning ‘above the genome’) is a system of reversible marks regulating how the DNA is read, translated and used. Many disease states are caused by a web of complex interactions rather than single-gene mutations. 2 Additionally, the epigenetic editing toolkit allows for precise temporal regulation.

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