Pharmaceutical Technology

FEBRUARY 18, 2023

Gevokizumab is a monoclonal antibody commercialized by Novartis, with a leading Phase I program in Metastatic Renal Cell Carcinoma. According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. The company offers generic medicines and biosimilars through Sandoz.

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Antibody Development 100

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. 1-4 The U.S. . Almirall S.A.’s

Dermatology 40

Dermatology Trials Bioavailability Medicine 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. 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

SEPTEMBER 30, 2022

. “SIM0278 has great potential to treat a broad spectrum of immunological diseases, and we expect that its development will allow us to reinforce our biologic pipeline and our leading position in medical dermatology,” said Almirall’s chief scientific officer Karl Ziegelbauer in a statement. Last year, Merck & Co paid $1.85

Licensing 52

Licensing Licensing Dermatology Drugs 52

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. Source link: [link].

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Trials Clinical Trials Clinical Trials Medicine 40

pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. In trials, tralokinumab improved upon placebo on a range of outcome measures, including clearance of skin lesions and reduction of itch after 16 weeks.

Sales 111

Sales Dermatology Marketing Allergies 111

Drug Discovery World

SEPTEMBER 16, 2022

A biologic therapy for very young children with moderate to severe eczema (or atopic dermatitis) has been shown to be safe and effective in an international trial. These pivotal trial results strongly support the global approval of dupilumab in infants and children with eczema. It will revolutionise clinical practice worldwide.”.

Antibody 52

Antibody Licensing Licensing Trials 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

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

Drug Discovery World

DECEMBER 16, 2022

An immunotherapy that uses a new targeted approach to kill bone marrow cancer cells was successful in as many as 73% of patients in two clinical trials. . A novel, patient-tailored monoclonal antibody therapy has shown promise in treating moderate to severe atopic dermatitis. .

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Drugs Vaccination Vaccine Genetics 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

pharmaphorum

JANUARY 6, 2023

Meanwhile, ACELYRIN is due to accelerate its development of izokibep in patients with moderate-to-severe Hidradenitis Suppurativa (HS), following a 30-patient open-label Part A of a phase 2b/3 trial, the top-line 12-week data from which found that izokibep achieves higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR).

Trials 59

Trials Marketing Protein Antibody 59

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 . The Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.

Trials 52

Trials Clinical Development Antibody Dermatology 52

pharmaphorum

AUGUST 16, 2021

Eli Lilly had a lot riding on its two phase 3 trials of IL-13 inhibitor lebrikizumab in atopic dermatitis (AD) – and it now looks like it has backed a winner. Lilly is also running the Adhere trial of lebrikizumab in combination with topical corticosteroids, which should generate results in the coming months. Lilly shelled out $1.1

Antibody 52

Antibody Trials Marketing Drugs 52

pharmaphorum

MAY 31, 2022

The review is based on a pair of phase 3 trials of Dupixent in PN patients whose symptoms were inadequately controlled with current drugs. The PRIME and PRIME2 studies both showed that the IL-4 and IL-13 inhibitor significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions.

Sales 116

Sales Drugs Antibody Regulation 116

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. The Company remains committed to bringing Fasenra to patients with CRSwNP and a second Phase III trial, ORCHID , in this indication is ongoing.

Trials 52

Trials Medicine Licensing Licensing 52

Roots Analysis

MARCH 3, 2022

Since the approval of Soliris® in 2007, an anti-C5 antibody, the field of complement drug discovery has gained significant attention. Broad Clinical Trial Landscape. Currently, nine complement therapeutics are commercially available, while around 190 molecules are under development for various disease indications.

Drug Delivery Systems 52

Drug Delivery Systems Marketing Immune Response Dermatology 52

pharmaphorum

JUNE 2, 2021

The deal gives Amgen rights to the KHK4083 antibody in all countries except Kyowa’s home market of Japan, and is back-loaded with potential milestone payments worth another $850 million plus royalties on sales. Kyowa will co-promote the drug in the US if approved, with opt-in rights in some other countries as well.

Drugs 52

Drugs Licensing Licensing Sales 52

The Pharma Data

AUGUST 17, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). As we saw in the GARNET trial, of those patients who respond to treatment with dostarlimab, nearly all continued to respond for six months or longer.”. by blinded independent central review.

FDA Approval 52

FDA Approval Antibody DNA Hormones 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

pharmaphorum

APRIL 28, 2021

The IL-23p19 inhibitor has also been shown to be effective in the phase 3 OASIS trials, and in one outperformed Novartis’ $4 billion blockbuster IL-17 Cosentyx (secukinumab) at clearing skin lesions in patients with moderate-to-severe plaque psoriasis. It will still face some heavyweight competition in the gastrointestinal area.

Marketing 52

Marketing Trials Drugs Antibody 52

pharmaphorum

APRIL 26, 2021

The IL-17A and IL-17F inhibitor hit all its objectives in the phase 2 trial, which has now been published in The Lancet, and showed that it was significantly more effective than placebo at clearing up skin lesions in patients with moderate to severe plaque psoriasis.

Antibody 52

Antibody Drugs Marketing Licensing 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

pharmaphorum

AUGUST 24, 2021

Other biologics with blockbuster sales forecasts are also aiming to steal market share from Cosentyx however, and UCB will have to jostle for position alongside newer rivals like AbbVie’s IL-23 inhibitor Skyrizi (risankizumab) that also outperformed Cosentyx in comparative trials.

Sales 52

Sales Marketing Drugs Antibody 52

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

MAY 18, 2021

Melinda Gooderham , Dermatologist and Medical Director at the SKiN Centre for Dermatology. ” DUPIXENT ® is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins and is not an immunosuppressant. .”

Production 40

Production Dermatology Medicine Clinical Trials 40

pharmaphorum

MAY 4, 2021

The announcement comes a few days after Merck KGaA’s development partner Avillion announced supportive results in a phase 2 psoriasis trial. Sonelokimab is a single-domain antibody – a fragment of an antibody that can bind specifically to an antigen with high affinity.

Licensing 52

Licensing Licensing Dermatology Antibody 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

The Pharma Data

AUGUST 3, 2021

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S.,

Sales 52

Sales Production Antibody Development 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

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.

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Trials Medicine Antibody Drugs 103

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

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. Read on to see. COVID-19-Related. Non-COVID-19-Related.

Trials 52

Trials Allergies In-Vitro Antibody 52

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 52

Trials Medicine Sales Clinical Trials 52

XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 32.44

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Sales Manufacturing FDA Approval Life Science 98