Drug Discovery World

FEBRUARY 5, 2024

Williams discussed the advantages of the company’s ‘disease agnostic’ small molecule degraders, and its success so far in translating results from preclinical to clinical tests in dermatology, inflammation and oncology indications. Product launches More than 400 exhibitors are at the event this year, many of whom are launching new products.

Gene Therapy 64

Gene Therapy Life Science Production Dermatology 64

XTalks

SEPTEMBER 22, 2022

Clinical Trial Behind Spevigo. The efficacy of Spevigo (spesolimab) was determined based on the results of the Effisayil 1 double-blind, randomized, Phase II clinical trial. The novel, selective monoclonal antibody spesolimab behind Spevigo reduces flares in individuals by inhibiting interleukin-36 (IL-36) signalling.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Dermatology 52

pharmaphorum

NOVEMBER 28, 2022

The EC and MHRA approvals are supported by data from the phase 3 ECZTRA 6 trial, and are valid for all European Union Member States, including Ireland and Northern Ireland, as well as Iceland, Norway, and Liechtenstein. The ECZTRA (ECZema TRAlokinumab trial No.6)

Dermatology 52

Dermatology Trials Medicine Antibody 52

pharmaphorum

OCTOBER 22, 2021

The two companies are still waiting for the results of a second phase 3 trial, due in the first half of next year, but if that is positive expect to file for approval of Dupixent (dupilumab) in the new indication before the end of 2022. PN is among a clutch of additional indications that could account for upwards of $2 billion of that total.

Trials 105

Trials Sales Antibody Drugs 105

The Pharma Data

MARCH 15, 2022

The sBLA submitted to the FDA by AstraZeneca included data from the OSTRO Phase III trial, which met both co-primary endpoints with a safety profile consistent with the known profile of the medicine. 8,9 Since 2019, other biologic medicines have been approved or recommended to treat nasal polyps.

Trials 52

Trials Medicine Licensing Licensing 52

The Pharma Data

AUGUST 1, 2021

Saphnelo is a first-in-class type I interferon receptor antibody and the only new medicine in over a decade for patients with systemic lupus erythematosus . This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often debilitating disease.”. 12,13,14,15.

Trials 52

Trials Clinical Development Antibody Dermatology 52

pharmaphorum

SEPTEMBER 29, 2022

The disorder – driven by type 2 inflammation characterised by an antibody-based immune response – causes hard lumps or nodules to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain. The suffering he notes from the #itch is 100… [link]. — Brian S.

Drugs 69

Drugs Immune Response Allergies Sales 69

The Pharma Data

MARCH 23, 2022

The only large-scale prospective study in dermatology designed to generate key disease insights among Black, Hispanic, Asian, Indigenous and other people of color Study reinforces Janssen’s commitments to inclusive clinical research and addressing health inequities. 11 TREMFYA is approved in the U.S.,

Dermatology 52

Dermatology Clinical Research Research Medicine 52

The Pharma Data

APRIL 28, 2021

PARIS – April 23, 2021 – New analyses from Dupixent ® (dupilumab) trials evaluated infection incidence reduction and reinforced the need for no laboratory monitoring in patients six years and older with moderate-to-severe atopic dermatitis. Head of Global Development in Immunology and Inflammation at Sanofi. “

Dermatology 40

Dermatology Trials Clinical Trials Clinical Trials 40

The Pharma Data

MAY 18, 2021

DUPIXENT ® is the only biologic medicine approved to treat atopic dermatitis for this patient population. Melinda Gooderham , Dermatologist and Medical Director at the SKiN Centre for Dermatology. AD, the most common form of eczema, is an inflammatory disease classified by dry, itchy skin. . ” About DUPIXENT ®.

Production 40

Production Dermatology Medicine Clinical Trials 40

The Pharma Data

MARCH 18, 2022

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab 1. 1 The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).1,2 months (95% Confidence Interval [CI]: 6.4

Antibody 52

Antibody HR Dermatology Trials 52

The Pharma Data

AUGUST 3, 2021

. “As we look to the balance of the year, we are excited to be launching LUMAKRAS , a first-in-class lung cancer treatment, and advancing a robust pipeline of potential new medicines to meet the demands of patients around the world.” 4% Dividends Paid Per Share $ 1.76 $ 1.60 Cost of Sales margin increased 1.6 Tax Rate increased 5.6

Sales 52

Sales Production Antibody Development 52

The Pharma Data

NOVEMBER 8, 2020

Almirall strengthens its leadership in medical dermatology by reinforcing its management team in France and obtaining reimbursement in France of Ilumetri ® (tildrakizumab) for treating moderate to severe chronic plaque psoriasis in adults. Dermatology shows resilience in Europe and initial signs of recovery in the US.

Dermatology 52

Dermatology Sales Marketing Production 52

pharmaphorum

SEPTEMBER 2, 2022

German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US. It is also under review by regulators in Europe, with a decision expected before the end of the year.

Drugs 105

Drugs Antibody FDA Approval Trials 105

pharmaphorum

DECEMBER 24, 2021

Fresh from being awarded a fast-track review from the FDA, Boehringer Ingelheim’s spesolimab has shown encouraging efficacy in a phase 2 trial in generalised pustular psoriasis (GPP), a rare and life-threatening skin disorder. It has also been filed with the EMA.

Trials 103

Trials Medicine Antibody Drugs 103

The Pharma Data

JULY 8, 2021

Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials. Despite recent advances in severe asthma, many patients may not qualify for or respond well to current biologic medicines.

Trials 52

Trials Medicine Sales Clinical Trials 52

Drug Discovery World

APRIL 15, 2024

The company has a biologics pipeline with a focus on differentiated antibodies targeting a range of indications. But we’ve never been able to be in that kind of design and test loop where it’s like, I have this hypothesis, I believe that if I design an antibody that has these attributes, it’s going to solve my biology.

Antibody 59

Antibody Drugs In-Vivo Life Science 59

The Pharma Data

MARCH 28, 2022

Boehringer Ingelheim announced today new data from the pivotal Effisayil™ 1 trial presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting in Boston. of patients had no visible pustules after the 12-week trial duration and 81.3% of patients had no visible pustules after the 12-week trial duration and 81.3%

Dermatology 52

Dermatology Trials Contract Manufacturing Medicine 52

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

OCTOBER 9, 2021

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. In EoE, a Phase III trial is planned. There are currently no approved treatments for eosinophilic esophagitis in the US.

Drugs 52

Drugs Sales Medicine Dermatology 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–( About Opdivo.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. for RSV A and 18.0

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. confirmatory trial for the accelerated approval. confirmatory trial for the accelerated approval.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

MARCH 11, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

JULY 23, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Hormones 52

Hormones Trials Genome Genomics 52

Delveinsight

AUGUST 13, 2020

In February 2020, GSK announced the acceptance of regulatory submission seeking an additional indication for the use of Trelegy Ellipta for the treatment of asthma in adults by the European Medicines Agency (EMA). REGN3500 is being studied in Phase II trials for asthma, chronic obstructive pulmonary disease and atopic dermatitis.

Antibody 40

Antibody Medicine Trials Development 40