Clinical Trials, Dermatology and Licensing - Clinical Research Informer

UNION Therapeutics-Innovent’s collaboration; Delix Therapeutics bags $ 70 M; Biohaven’s Verdiperstat clinical trial result; Intra-Cellular’s CAPLYTA Phase III study

Delveinsight

SEPTEMBER 28, 2021

Innovent, UNION Therapeutics Set to Advance Dermatology Market in China. Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast , a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China.

Clinical Trials

Clinical Trials Clinical Trials Trials Dermatology

Lebrikizumab Could Soon Be a New Treatment for Atopic Dermatitis

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

Dermatology Antibody Clinical Trials Clinical Trials

J&J presents successful data from plaque psoriasis trial

Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor.

Trials

Trials Dermatology Clinical Trials Clinical Trials

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. 10x ULN were observed in patients in Olumiant clinical trials.

Dermatology

Dermatology Development Medicine Clinical Trials

Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly’s Lebrikizumab Atopic Dermatitis Monotherapy Trials

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. Almirall S.A.’s Almirall S.A.’s

Trials

Trials Clinical Trials Clinical Trials Medicine

Lilly’s lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials

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. About Lilly in Dermatology.

Dermatology

Dermatology Trials Bioavailability Medicine

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

NOVEMBER 4, 2020

Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. Initial data from an ongoing long-term, open label extension study with CTP-543 were presented in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Virtual Congress on October 29, 2020. G&A Expenses. .

Clinical Trials

Clinical Trials Clinical Trials Trials Dermatology

Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps

The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). 2 The trial is expected to read out in the second half of 2023.

Trials

Trials Medicine Licensing Licensing

New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis

The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues. About Lilly in Dermatology.

Drugs

Drugs Dermatology Clinical Trials Clinical Trials

MoonLake launches, licensing in Merck KGaA’s Cosentyx challenger sonelokimab

pharmaphorum

MAY 4, 2021

There’s a new biotech on the scene after MoonLake Immunotherapeutics launched on a mission to develop sonelokimab, a potential inflammatory diseases drug in-licensed from Germany’s Merck KGaA. The announcement comes a few days after Merck KGaA’s development partner Avillion announced supportive results in a phase 2 psoriasis trial.

Licensing

Licensing Licensing Dermatology Antibody

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. Dermatologic Adverse Reactions 7. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. 8] , [9] , [10] , [11] , [12]. 8] , [9] , [10] , [11] , [12]. **In In 2018, Janssen Biotech, Inc.

FDA Approval

FDA Approval Dermatology Genetics Development

Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus

The Pharma Data

AUGUST 1, 2021

The adverse reactions that occurred more frequently in patients who received Saphnelo in the three clinical trials included nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster and cough. 12,13,14,15.

Trials

Trials Clinical Development Antibody Dermatology

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials

Clinical Trials Clinical Trials Trials In-Vitro

SkinVive by Juvéderm: The New Dermal Filler Coming to the US

XTalks

MAY 22, 2023

According to Allergan Aesthetics, SkinVive is slated for commercial availability within the next six months, exclusively through licensed physicians and practitioners. I am excited to add this unique offering to my dermatologic treatment regimen for my patients,” added Dr.

Filler

Filler FDA Approval Dermatology Production

Dermavant raises $200m to ease launch of Otezla rival tapinarof

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 billion takeover of Constellation Pharma.

Sales

Sales Dermatology Licensing Licensing

Tezepelumab regulatory submission accepted and granted FDA Priority Review in the US for the treatment of patients with asthma

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. The BLA was based on results from the PATHFINDER clinical trials programme, including results from the pivotal NAVIGATOR Phase III trial.

Trials

Trials Medicine Sales Clinical Trials

Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. The drug was licensed from Immutep Limited.

Trials

Trials Allergies In-Vitro Antibody

Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial

The Pharma Data

MARCH 4, 2021

associate professor of Dermatology at Yale School of Medicine. AA is the second potential treatment indication in dermatology for baricitinib after AD. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. 10x ULN were observed in patients in Olumiant clinical trials.

Trials

Trials Development Dermatology Clinical Trials

Novartis key growth drivers and launches continue momentum in Q1, maintaining confidence in growth. Group guidance for FY 2021 confirmed. | Novartis

The Pharma Data

APRIL 26, 2021

COVID-19 negatively impacted demand, particularly: dermatology, ophthalmology, the breast cancer portfolio, Sandoz Retail and Anti-Infectives. billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. Adakveo sales reached USD 37 million. Free cash flow¹ of USD 1.6

Sales

Sales Medicine Production Manufacturing

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. Based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October. Protease Inhibitor Program.

Gene Therapy

Gene Therapy Vaccination Vaccine Trials

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

Late in 2022, AbbVie partnered with HotSpot Therapeutics and announced an exclusive worldwide collaboration and option to license agreement for their interferon regulatory factor 5 (IRF5) inhibitor program for autoimmune disease treatment. This partnership will expand the company’s immunology pipeline. billion ($3.65 billion ($2.85

Sales

Sales Manufacturing FDA Approval Life Science

How GSK, Chiesi Farmaceutici, Regeneron/Sanofi, Novartis, and AB Science are trying to benefit patients afflicted with Inadequately Controlled Asthma?

Delveinsight

AUGUST 13, 2020

SAR440340 History: Regeneron and Sanofi are currently studying REGN3500 in respiratory and dermatological diseases where inflammation is thought to play an underlying role. REGN3500 is being studied in Phase II trials for asthma, chronic obstructive pulmonary disease and atopic dermatitis. for use in QVM149 (Worldwide excluding US).

Antibody

Antibody Medicine Trials Development

Clinical Research Informer

UNION Therapeutics-Innovent’s collaboration; Delix Therapeutics bags $ 70 M; Biohaven’s Verdiperstat clinical trial result; Intra-Cellular’s CAPLYTA Phase III study

Lebrikizumab Could Soon Be a New Treatment for Atopic Dermatitis

Trending Sources

J&J presents successful data from plaque psoriasis trial

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly’s Lebrikizumab Atopic Dermatitis Monotherapy Trials

Lilly’s lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps

New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis

MoonLake launches, licensing in Merck KGaA’s Cosentyx challenger sonelokimab

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

SkinVive by Juvéderm: The New Dermal Filler Coming to the US

Dermavant raises $200m to ease launch of Otezla rival tapinarof

Tezepelumab regulatory submission accepted and granted FDA Priority Review in the US for the treatment of patients with asthma

Clinical Catch-Up: January 18-22 | BioSpace

Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial

Novartis key growth drivers and launches continue momentum in Q1, maintaining confidence in growth. Group guidance for FY 2021 confirmed. | Novartis

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

How GSK, Chiesi Farmaceutici, Regeneron/Sanofi, Novartis, and AB Science are trying to benefit patients afflicted with Inadequately Controlled Asthma?

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