Drug Discovery World

OCTOBER 4, 2022

This year’s event will cover some of the most exciting advancements in areas spanning screening, automation, high content imaging, disease models, cell and gene therapies and how innovation is being driven through partnerships and collaborations. Cell and gene therapies. billion, compared to $19.9

Drugs 130

Drugs Therapies Clinical Trials Cell Based Assays 130

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. These findings were presented today at the 2020 Infectious Diseases Society of America (IDSA) IDWeek.

Clinical Development 52

Clinical Development Therapies Clinical Trials FDA Approval 52

Drug Discovery World

SEPTEMBER 14, 2023

Total revenue from oncology medicines increased 22%, CVRM 20%, R&I8 10%, and rare disease 12%. Additionally, Abrysvo was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age.

Vaccine 147

Vaccine FDA Approval Drugs Licensing 147

The Premier Consulting Blog

OCTOBER 11, 2022

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness.

Disease 52

Disease FDA FDA Approval Regulations 52

Drug Discovery World

OCTOBER 2, 2023

DDW’s Megan Thomas heard from attendees about their key takeaways from the event. Dr Mindy Miller, Lead Research Scientist, Terumo Blood And Cell Technologies Conversations and data shared at the CAR-TCR 8 th Annual Summit highlighted the importance of optimising the science behind the therapies to broaden patient access.

Therapies 264

Therapies Treatment Hospitals Production 264

The Pharma Data

JUNE 25, 2021

First-Time Disease-Free Survival Data to be Presented During Plenary Session at the 2021 ASCO Annual Meeting. 41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; KENILWORTH, N.J.–(BUSINESS

Disease 52

Disease Therapies Treatment Medical Schools 52

Drug Discovery World

JUNE 16, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. DDW’s Megan Thomas heard from attendees about key trends in the sector.

Therapies 130

Therapies Compliance Production International 130

Drug Discovery World

JUNE 5, 2023

DDW’s Megan Thomas comments on the event. New approaches to partnering In this event in the Biotech track, Clive Cookson, Science Editor at the Financial Times, interviewed John McDonald, Corporate Vice President, Global R&D Business Development, Novo Nordisk.

Small Molecule 130

Small Molecule Treatment Science Disease 130

The Pharma Data

JULY 12, 2021

Finerenone 10 mg or 20 mg is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

The Pharma Data

JUNE 25, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) protofibril antibody for the treatment of Alzheimer’s disease (AD). 1 The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (A?)

Disease 40

Disease Treatment Therapies FDA 40

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.

Disease 52

Disease Clinical Trials Trials Treatment 52

The Pharma Data

APRIL 26, 2022

NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. No vaccine-related serious adverse events (SAEs) were observed. About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development. The study is being conducted at U.S.

Vaccine 52

Vaccine Disease Protein Expression Trials 52

The Pharma Data

OCTOBER 27, 2020

(NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. About Krabbe Disease. Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021.

Disease 40

Disease FDA Treatment Clinical Trials 40

The Pharma Data

DECEMBER 2, 2020

The incidence and severity of thrombotic events will also be assessed. treatments that “bypass” the need for clotting factor treatment to help the body form a normal clot). treatments that “bypass” the need for clotting factor treatment to help the body form a normal clot).

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

OCTOBER 18, 2020

ZURICH, Switzerland–( BUSINESS WIRE )– Versantis AG , a clinical-stage company developing novel therapies for orphan liver diseases, today announced that the U.S. Up to 90% of newborns do not survive the initial event of acute hyperammonemia or suffer from severe neurological sequelae.

FDA 40

FDA Disease Treatment Clinical Development 40

Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. The university aims to identify treatments for life-threatening anti-microbial diseases and metabolic disorders.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

The Pharma Data

OCTOBER 26, 2020

(Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

FDA 40

FDA Disease Treatment Therapies 40

The Pharma Data

JULY 27, 2021

AbbVie (NYSE: ABBV) and Calico Life Sciences today announced an extension of their leading-edge collaboration to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer. This is the second extension of the collaboration originally established in 2014.

Disease 52

Disease Science Production Therapies 52

The Pharma Data

JUNE 7, 2023

1,2 While first-line treatment with immune checkpoint inhibitors with or without chemotherapy has improved outcomes for patients with NSCLC without AGAs, like EGFR or ALK, most patients eventually experience disease progression. Rahway, NJ, USA), an anti-PD-1 therapy. Rahway, NJ, USA), an anti-PD-1 therapy.

Trials 40

Trials Protein Expression Therapies Treatment 40

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease).

Small Molecule 139

Small Molecule Trials Therapies Disease 139

Advarra

FEBRUARY 24, 2023

How do you know your experimental therapy is working? But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? All key questions to consider and address before the therapy even leaves the lab.

Clinical Trials 52

Clinical Trials Trials FDA Therapies 52

The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly.

Therapies 52

Therapies FDA Hospitals FDA Approval 52

DrugBank

SEPTEMBER 26, 2024

While some clinical trials are necessary to confirm safety and efficacy in humans, these are typically smaller and shorter in duration compared to the extensive trials required for novel biopharmaceuticals. These molecules pose major scientific and regulatory hurdles due to their intricate structures and potential for immunogenicity.

Biosimilars 69

Biosimilars Clinical Trials FDA Production 69

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 Phase1b/2 clinical study to be conducted in the United States and several European countries. Billion by 2025.

Clinical Trials 40

Clinical Trials Science Disease Trials 40

The Pharma Data

MARCH 23, 2023

The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

Trials 40

Trials Therapies Treatment Disease 40

The Pharma Data

AUGUST 30, 2021

years versus placebo when added to maximum tolerated dose of guideline-directed therapy. years versus placebo when added to maximum tolerated dose of guideline-directed therapy. 0.98]; p=0.0264) over a median duration of follow-up of 3.4 0.98]; p=0.0264) over a median duration of follow-up of 3.4

Hospitals 52

Hospitals Disease Clinical Trials Therapies 52

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.

Treatment 98

Treatment Therapies Clinical Development Cell Biology 98

The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

Clinical Development 52

Clinical Development Therapies Disease Research 52

The Pharma Data

JUNE 7, 2023

Patients who experience metastases at distant sites typically have worse survival outcomes and a poor prognosis, thus these results showing a reduction in the risk of distant recurrence underscore the potential of neoantigen therapy,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology.

Clinical Trials 40

Clinical Trials Therapies Research Laboratories Vaccine 40

The Pharma Data

MAY 27, 2022

of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy.¹ of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy.¹ Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0%

Treatment 52

Treatment Therapies Clinical Trials Disease 52

The Pharma Data

MARCH 2, 2021

This new collaboration builds on the positive experience from previous partnerships with Gubra and combines Gubra’s proprietary streaMLine platform and expertise in obesity and peptide chemistry with Boehringer Ingelheim’s expertise in lead optimization and clinical development. population will have obesity. About Boehringer Ingelheim.

Treatment 52

Treatment Bioinformatics Clinical Development Therapies 52

The Pharma Data

MARCH 28, 2022

The adverse events (AEs) were mostly mild to moderate in severity and occurred at a similar rate across BIIB078 and placebo groups. Based on these results, the BIIB078 clinical development program will be discontinued, including its ongoing open-label extension study. “We Biogen Inc. Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc.

RNA 52

RNA Therapies Biosimilars Disease 52

The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. This patient population is at significant risk of developing cardiovascular complications, which are frequently fatal, during their illness.

Hospitals 52

Hospitals Trials International Clinical Trials 52

LifeSciVC

AUGUST 21, 2024

This is especially true for rare disease trials with so few patients or trials involving patients with numerous concomitant or life-threatening conditions. An adverse event or serious adverse event (SAE) that turns out NOT to be related to the drug may take a while to sort out. It is keeping patients front and center.

Clinical Trials 62

Clinical Trials Trials Disease Clinical Supply 62

The Pharma Data

APRIL 27, 2023

It is also an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting treatment, which could be particularly important for patients who are at a high-risk of their disease progressing. Roche’s Chief Medical Officer and Head of Global Product Development.

Therapies 40

Therapies Treatment FDA Clinical Development 40

The Pharma Data

NOVEMBER 8, 2021

The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinical development.

Clinical Trials 52

Clinical Trials Trials Therapies Treatment 52