The Pharma Data

MAY 15, 2023

Positive data from two Phase 3 Dupixent ® (dupilumab) trials in prurigo nodularis published in Nature Medicine Positive results from two Phase 3 Dupixent ® (dupilumab) trials in adults with uncontrolled prurigo nodularis have been published in Nature Medicine. Results from the trials were the basis for the U.S.

Medicine 40

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Drug Discovery World

DECEMBER 13, 2022

A novel, patient-tailored monoclonal antibody therapy has shown promise in treating moderate to severe atopic dermatitis. . Patients who participated in a clinical trial of rocatinlimab showed positive results while taking the drug and up to 20 weeks after stopping therapy, Mount Sinai researchers have reported in The Lancet. .

Dermatology 52

Dermatology Clinical Trials Clinical Trials Antibody 52

pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. The post FDA clears Dupixent as first drug for rare skin disorder appeared first on. — Brian S.

Drugs 69

Drugs Immune Response Allergies Sales 69

pharmaphorum

SEPTEMBER 30, 2022

Almirall has licensed an interleukin-2 (IL-2) drug from China’s Simcere Pharma, joining the ranks of companies looking at blocking the cytokine as a way to treat autoimmune diseases. It has also reached a deal with Ablexis to use its antibody development platform in therapeutics. Last year, Merck & Co paid $1.85

Licensing 52

Licensing Licensing Dermatology Drugs 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

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

pharmaphorum

JUNE 2, 2021

Amgen has made a play in a hot area of immunology R&D, paying $400 million upfront to claim rights to an OX40-targeting drug from Kyowa Kirin that is ready for phase 3 testing for atopic dermatitis or eczema. . 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 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. 1-4 The U.S. Almirall S.A.’s

Dermatology 40

Dermatology Trials Bioavailability Medicine 40

XTalks

SEPTEMBER 22, 2022

On September 1, 2022, Boehringer Ingelheim Pharmaceuticals announced in a press release that the US Food and Drug Administration (FDA) approved Spevigo (spesolimab-sbzo) intravenous injections for GPP flares in adults. Clinical Trial Behind Spevigo. Waldman Department of Dermatology.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Dermatology 52

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

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 About Lebrikizumab.

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

pharmaphorum

OCTOBER 22, 2021

Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option for the rare and highly debilitating skin disease. 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

MAY 31, 2022

Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare skin disease prurigo nodularis (PN). The review is based on a pair of phase 3 trials of Dupixent in PN patients whose symptoms were inadequately controlled with current drugs.

Sales 116

Sales Drugs Antibody Regulation 116

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

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. Web: [link].

Drug Delivery Systems 52

Drug Delivery Systems Marketing Immune Response Dermatology 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

UK biotech Avillion has reported positive mid-stage results with chronic psoriasis drug sonelokimab, which it is developing with Merck KGaA as an alternative to drugs like Novartis’ Cosentyx. . The drug is a nanobody, a molecule around one-tenth the size of a regular antibody derived from camelid species such as the llama.

Antibody 52

Antibody Drugs Marketing 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 . 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

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 52

Trials Medicine Licensing Licensing 52

pharmaphorum

AUGUST 24, 2021

UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it can mount a stiff challenge to the leaders, including Novartis’ big-selling Cosentyx. It says there is evidence to suggest that IL-17F is also a key contributor chronic tissue inflammation.

Sales 52

Sales Marketing Drugs Antibody 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

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

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. The post Boehringer bags first approval for rare skin disease drug appeared first on.

Drugs 105

Drugs Antibody FDA Approval Trials 105

Drug Discovery World

APRIL 15, 2024

The company has a biologics pipeline with a focus on differentiated antibodies targeting a range of indications. AI is undoubtedly one of the key technologies that is set to impact drug discovery and development practices. AI is undoubtedly one of the key technologies that is set to impact drug discovery and development practices.

Antibody 59

Antibody Drugs In-Vivo Life Science 59

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. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1 months (95% CI: 3.4

Antibody 52

Antibody HR Dermatology Trials 52

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 52

Licensing Licensing Dermatology Antibody 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

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

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion, a 26.55

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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

OCTOBER 9, 2021

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). In EoE, a Phase III trial is planned. Currently there are no FDA-approved treatments for EoE.

Drugs 52

Drugs Sales Medicine Dermatology 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. 1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.

Trials 52

Trials Medicine Sales Clinical Trials 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

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.–(

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