pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. New sensor technology revolutionising data collection.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Regulation 100

Pharmaceutical Technology

APRIL 17, 2023

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases. The company will help in managing the clinical trials of the products once the regulators provide approvals for the proposed research and development programmes.

Dermatology 130

Dermatology Clinical Trials Clinical Trials Production 130

XTalks

APRIL 17, 2023

In clinical trials, patients experienced significantly clearer skin and less interference with sleep due to itch when taking lebrikizumab compared to placebo. The ADvocate1 and ADvocate2 Phase III studies were published in the New England Journal of Medicine and the British Journal of Dermatology , respectively.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

Rethinking Clinical Trials

SEPTEMBER 24, 2024

Mirza, MD, MPH Chief Resident Department of Dermatology Warren Alpert Medical School of Brown University Slides Keywords Artificial Intelligence; ChatGPT; Informed Consent Key Points Artificial Intelligence (AI), when implemented thoughtfully in clinical settings, can lead to meaningful results for patients.

Clinical Trials 100

Clinical Trials Clinical Trials Dermatology Trials 100

XTalks

MAY 26, 2023

The safety and efficacy of Vyjuvek were evaluated in the Phase III randomized, double-blinded, placebo-controlled GEM-3 trial involving 31 patients with DEB, including 30 with the recessive type and one with the dominant type. Results of the trials are published in the journals Nature Medicine and The New England Journal of Medicine.

Gene Therapy 97

Gene Therapy Gene Dermatology FDA Approval 97

XTalks

AUGUST 2, 2023

Eichenfield was also the principal investigator on clinical trials evaluating YCANTH. Verrica Pharmaceuticals is a dermatology therapeutics company developing medications for skin diseases that require medical interventions.

Life Science 52

Life Science FDA Approval Dermatology Pharmacy 52

Pharmaceutical Technology

FEBRUARY 28, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR).

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Clinical Trials Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 28, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR).

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Drugs Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 28, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR).

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Drugs Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Its investigational medicinal products comprise R-107, R-131 and R-147. The company offers consumer, prescription and automation products.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Its investigational medicinal products comprise R-107, R-131 and R-147. The company offers consumer, prescription and automation products.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

pharmaphorum

MAY 18, 2021

Incyte has made further progress with its ruxolitinib cream, notching up a phase 3 trial showing it can re-pigment skin in vitiligo ahead of a key FDA decision in atopic dermatitis. Filings with the FDA and the European Medicines Agency are planned for the second half of this year.

Trials 52

Trials Dermatology FDA Approval Medicine 52

The Pharma Data

OCTOBER 1, 2021

Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to extend through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis. CESTidentified through 52 weeks of knowledge. About Bristol Myers Squibb.

Dermatology 52

Dermatology Trials Research Clinical Development 52

The Pharma Data

NOVEMBER 29, 2021

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla ® (apremilast) and placebo in treating adults with moderate to severe plaque psoriasis. elderly vice chairman of Immunology and Fibrosis Development, Bristol Myers Squibb.

Medicine 52

Medicine Drugs Dermatology Trials 52

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.

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Trials Medicine Antibody Drugs 103

XTalks

DECEMBER 15, 2020

Related: An Integrated Development Plan in Rare & Orphan Medicinal Products – Accelerating Time to Approval and Strengthening Asset Value. Synteract has a solid reputation in the emerging biopharma sphere, providing therapeutic expertise in areas including oncology, rare and orphan diseases, neuroscience, dermatology and pediatrics.

Dermatology 98

Dermatology Clinical Trials Clinical Trials Branding 98

pharmaphorum

SEPTEMBER 8, 2022

The Digital Medicine Society (DiME) is today releasing a new set of open-access resources to advance the use of nocturnal scratch in the treatment of atopic dermatitis (AD). . It is hoped today’s event will serve as a “blueprint for the broader development and deployment of digital endpoints in medical product development”.

Dermatology 52

Dermatology Production Radiology Development 52

pharmaphorum

FEBRUARY 3, 2021

He also spent three years before that as Teva’s head of speciality medicines for Europe, and held previous senior roles at AstraZeneca, GSK and Eli Lilly. “Mr For the last three years he has served as executive vice president, growth markets commercial, at Israeli pharma Teva.

Dermatology 52

Dermatology Marketing Branding Medicine 52

Pharmaceutical Technology

FEBRUARY 18, 2023

According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others.

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Antibody Development 100

The Pharma Data

NOVEMBER 16, 2020

has sponsored and funded a new FDA Oversight Trial that seeks to restore respiratory function in adults who have suffered lung damage from the COVID-19 virus. Alexander, MD, DMD, FICS is the Principal Investigator, and his office is recruiting patients for enrollment in the trial. Alexander, MD, DMD, FICS.

Trials 52

Trials Clinical Trials Clinical Trials Dermatology 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. billion.

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Trials Sales Antibody Drugs 105

The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. vice president of immunology development at Lilly.

Trials 40

Trials Dermatology Bioavailability Medicine 40

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

The Pharma Data

SEPTEMBER 18, 2020

The results mark an improvement in overall response compared to data shared on the drug in this indication back in May, and no new safety signals were observed during the trial. . Sanofi confirmed that these data will be submitted to regulatory authorities in the pursuit of market approval in the US and Europe.

Dermatology 52

Dermatology Trials Medicine Marketing 52

Pharma Marketing Network

APRIL 30, 2021

Clinical trials may be one of the very last bastions of a non-customer-focused approach within the pharmaceutical industry. Across the board, from rheumatology to neurology, outcomes that matter most to patients, have traditionally not been captured in clinical trials. How do we increase the diversity of clinical trials?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

JANUARY 2, 2024

XTALKS WEBINAR: Strategic Design Decisions in Rare Disease Trials Live and On-Demand: Thursday, February 8, 2024, at 11 am EST (4 pm GMT/UK) Register for this free webinar to discover invaluable strategies to effectively navigate rare disease trials, enhancing endpoint adaptation, data quality and clinical interpretation.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. About Lebrikizumab.

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

Scienmag

MAY 21, 2021

The findings of a clinical trial by Trinity College Dublin researchers of treatment for atopic dermatitis have been published today in The Lancet journal (Friday, 21st May, 2021). Results of the clinical trial at […].

Clinical Trials 43

Clinical Trials Clinical Trials Trials Research 43

The Pharma Data

MARCH 23, 2022

Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. The safety profile was consistent with previous Phase 2 studies.

Trials 52

Trials Dermatology Development Medicine 52

pharmaphorum

JUNE 8, 2021

It’s the second unusual royalty-focused deal to be entered into by a biotech in the last few days, after MorphoSys signed over future revenues from out-licensed medicines to fund its $1.7 It is also due to start a phase 3 trial in atopic dermatitis later this year. billion takeover of Constellation Pharma. billion product.

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Sales Dermatology Licensing Licensing 52

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

The Pharma Data

MAY 1, 2023

. “The fluctuating symptoms and unpredictable nature of atopic dermatitis, along with limited medicines that can adequately manage long-term uncontrolled symptoms, represent major challenges in the treatment of this chronic disease,” said Jenny Murase, M.D.,

Dermatology 40

Dermatology Medicine Clinical Trials Clinical Trials 40

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. Waldman Department of Dermatology. Spevigo is the first approved treatment option for GPP in adults.

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

Scienmag

OCTOBER 25, 2020

A new drug designed to work on cancers with an altered BRAF gene has shown promise in an early patient trial presented at the 32nd EORTC-NCI-AACR [1] Symposium on Molecular Targets and Cancer Therapeutics, which is taking place online. The BRAF gene is involved in telling healthy cells when to grow and form new cells, […].

Trials 41

Trials Gene Drugs Clinical Trials 41

ACRP blog

OCTOBER 3, 2023

As reported by the Penn State College of Medicine , six interns spent 11 weeks taking active roles in existing research projects, immersing themselves in the conduct of research, and learning more about careers in clinical research at the college’s home in Hershey, Pa., alongside the Milton S. ACRP member and certificant Kevin Gardner, Jr.,

Clinical Research 59

Clinical Research Research Development Medicine 59

pharmaphorum

OCTOBER 26, 2022

has exited stealth with a $65 million Series A to create a new class of medicines that target novel I-O mechanisms, which free the body’s normal immunity against cancer. Called “immune normalisers”, these targets are drawn from an ongoing and interactive academic-biotech research alliance within the Yale School of Medicine.

Medicine 52

Medicine Dermatology Research Drugs 52