Pharmaceutical Technology

MARCH 18, 2024

Adalimumab biosimilar is under clinical development by Biocon and currently in Phase III for Plaque Psoriasis (Psoriasis Vulgaris).

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Pharmacy Times

JULY 18, 2022

Tildrakizumab-asmn is a humanized IgG1/k monoclonal anti-IL-23 antibody indicated for the treatment of adults with moderate-to-severe plaque psoriasis.

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European Pharmaceutical Review

DECEMBER 14, 2022

a wholly-owned subsidiary of Nimbus Therapeutics and Nimbus Therapeutics’ tyrosine kinase 2 (TYK2) inhibitor NDI-034858, an oral, potential best-in-class selective allosteric TYK2 inhibitor for multiple autoimmune diseases following successful recent Phase IIb results in psoriasis. For $4 billion , Takeda will acquire Nimbus Lakshmi, Inc.,

Medicine 84

Medicine Patients Sales Medical 84

Pharmaceutical Technology

DECEMBER 20, 2023

Zasocitinib is under clinical development by Takeda Pharmaceutical and currently in Phase III for Plaque Psoriasis (Psoriasis Vulgaris).

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Pharmaceutical 40

European Pharmaceutical Review

JULY 4, 2023

JNJ-2113, the first and only oral interleukin-23 receptor (IL-23R) antagonist peptide in development for moderate-to-severe plaque psoriasis (PsO) has demonstrated positive results in a Phase II trial. How does Janssen’s oral IL-23R antagonist for plaque psoriasis work? at the World Congress of Dermatology 2023. .

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Patients Pharmaceutical 73

Pharmaceutical Technology

DECEMBER 5, 2023

ONO-4685 is under clinical development by Ono Pharmaceutical and currently in Phase I for Plaque Psoriasis (Psoriasis Vulgaris).

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Pharmaceutical Technology

SEPTEMBER 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb ’s (BMS) Sotyktu (deucravacitinib) to treat adult patients with moderate-to-severe plaque psoriasis. The approval is based on data from the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials.

Food and Drug Administration 98

Food and Drug Administration FDA Food Safety 98

pharmaphorum

OCTOBER 26, 2022

Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. Anyone who watches television has heard the list of potential adverse reactions, considering that commercials for psoriasis treatments are seemingly only outnumbered by goofy ads for auto insurance. Manage it early.

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Side effects Food and Drug Administration Patients Management 91

European Pharmaceutical Review

JUNE 29, 2023

This is relevant in Crohn’s disease, ulcerative colitis and chronic skin disease psoriasis. Previous research has shown that blocking interleukin-23 with specific therapeutic antibodies is very effective in psoriasis and Crohn’s disease. Mirikizumab is the first such antibody tested for ulcerative colitis. percent versus 13.3

Medicine 88

Medicine Patients Safety Manufacturing 88

Pharmaceutical Technology

JULY 12, 2022

Health Canada has accepted to review Arcutis Biotherapeutics’ New Drug Submission (NDS) for roflumilast cream 0.3% (ARQ-151) to treat plaque psoriasis in adult and adolescent patients. The NDS submission by Arcutis is based on positive findings from the company’s pivotal Phase III programme and two long-term open-label clinical trials.

Food and Drug Administration 64

Food and Drug Administration Safety Food Pharmaceutical 64

European Pharmaceutical Review

APRIL 26, 2024

Recent biosimilar developments In February 2024, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for Pyzchiva as a biosimilar to treat the autoimmune condition plaque psoriasis.

Food and Drug Administration 52

Food and Drug Administration Medicine Marketing Food 52

European Pharmaceutical Review

NOVEMBER 2, 2023

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” Like Stelara, the most serious known side effect of Wezlana is infection.

Food and Drug Administration 90

Food and Drug Administration FDA Side effects Safety 90

European Pharmaceutical Review

FEBRUARY 26, 2024

Clinical data showed approximately 60 percent reductions in plasma NfL concentrations in patients given Qalsody compared to placebo. After 12 weeks, patients treated with danicopan had a clinically-relevant increase in haemoglobin (an average of 2.35 This indicated reduced neuronal injury, EMA noted.

Medicine 91

Medicine Patients Marketing Pharmaceutical 91

pharmaphorum

OCTOBER 31, 2022

Shares in French biotech Inventiva were on the slide this morning after AbbVie revealed that it had decided to abandon development of cedirogant, their drug candidate for autoimmune diseases including psoriasis. billion-plus product if approved.

Leads 52

Leads Pharma Patients Pharmaceutical 52

Pharmaceutical Technology

DECEMBER 14, 2022

The acquisition of this programme is expected to boost the growing late-stage pipeline, gastrointestinal (GI) clinical programmes and therapeutic focus of Takeda. In November, Nimbus reported positive topline data from a Phase IIb clinical trial of NDI-034858 in moderate-to-severe plaque psoriasis patients.

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Patients Sales Pharmaceutical 59

Pharmacy Times

NOVEMBER 10, 2023

The sBLA was based on data from a clinical study assessing the pharmacokinetics of switching between adalimumab and adalimumab-bwwd for patients with moderate to severe plaque psoriasis.

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FDA Patients 26

European Pharmaceutical Review

SEPTEMBER 11, 2023

The reference medicine Stelara (ustekinumab) is a monoclonal antibody (mAb) treatment to interleukin (IL)-12/23 indicated for autoimmune disorders including Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

Biopharma 76

Biopharma Manufacturing Medicine Safety 76

Pharmaceutical Technology

FEBRUARY 10, 2023

Phase III clinical trial of TAK-279 in psoriasis is expected to commence this year. TAK-279 is said to have the potential to demonstrate safety, efficacy and convenience in psoriasis and other immune-mediated diseases. With this transaction, Takeda has now acquired TAK-279, formerly known as NDI-034858 at Nimbus.

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Safety Sales Pharmaceutical Patients 52

pharmaphorum

AUGUST 17, 2022

Leading dermatologists discuss the innovations shaping 5 chronic skin diseases—psoriasis, atopic dermatitis, alopecia areata, vitiligo, and hidradenitis suppurativa—and share the challenges and opportunities for biopharmaceutical companies developing innovative treatments. CLICK HERE TO DOWNLOAD THE FULL ARTICLE.

Specialization 52

Specialization Consulting Training Networking 52

European Pharmaceutical Review

SEPTEMBER 15, 2022

Long-term data from the KEEPsAKE trials shows more than half of adult psoriatic arthritis patients receiving Skyrizi ® (risankizumab, 150mg) achieving a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College of Rheumatology 20 (ACR20) response at 100 weeks. Kristensen, L.E.,

Safety 71

Safety Physicians Patients Consulting 71

PM360

OCTOBER 13, 2023

HCPs therefore turn to resources not pharma-associated for identifying treatment options, drug-related information, and clinical trial updates. One HCP participant commented on pharma content: “They will often provide clinical trial information, and although I think the data’s correct, it’s presented in a way that is maybe skewed.

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Healthcare Healthcare Doctors Pharma 59

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.

Food and Drug Administration 52

Food and Drug Administration Management Food Pharmaceutical 52

pharmaphorum

SEPTEMBER 30, 2022

Simcere has taken SIM0278 to the brink of clinical testing, and says the drug can be delivered by subcutaneous injection to activate regulatory T cells (Tregs) that have been shown to dampen down inflammatory responses in preclinical disease models.

Pharma 52

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Pharmaceutical Technology

MAY 3, 2023

Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for spesolimab (SPEVIGO) to prevent generalised pustular psoriasis (GPP) flares. Safety data were found to be consistent with earlier clinical trials.

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Food and Drug Administration Food Safety Medical 52

Pharmaceutical Technology

JANUARY 11, 2023

With broad anti-inflammatory properties, the PDE4 inhibitor is also being developed to orally treat psoriasis and atopic dermatitis (AD). The company intends to discuss with the FDA the most suitable endpoints, and target disease severity, along with further steps in oral orismilast’s clinical development to treat HS.

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Food and Drug Administration FDA Ethics Food 52

Pharmaceutical Technology

APRIL 24, 2023

As healthcare confronts challenges such as antimicrobial resistance and the spread of previously geographically constrained diseases as a result of climate change, research into natural products used in traditional medicine, referred to as ‘ethnopharmacology’, could help in finding new, clinically effective drugs.

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Medicine Side effects Healthcare Healthcare 105

Pharmaceutical Technology

MAY 25, 2023

Yuflyma is indicated to treat juvenile idiopathic arthritis, hidradenitis suppurativa, Crohn’s disease, plaque psoriasis, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

MARCH 29, 2023

This programme has now proceeded into a Phase I clinical trial. In a separate development, Bristol Myers Squibb received regulatory approval from the European Commission (EC) for Sotyktu (deucravacitinib) , which treats moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.

Food and Drug Administration 52

Food and Drug Administration Medicine Food FDA 52

Clarivate

APRIL 4, 2024

Fortunately, RWD is beginning to offer a means of augmenting clinical trials, which can’t always furnish robust sample sizes for subpopulations. ” In the Clarivate study, researchers found that while differences in prevalence between racial and ethnic groups showed only modest variability, differences in comorbidity were substantial.

Electronics 52

Electronics Patients Medical FDA 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amlitelimab is under clinical development by Kymab and currently in Phase II for Asthma. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pharmaceutical 40

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pharmaphorum

AUGUST 3, 2022

The five-year-old Chinese company – which is developing drugs for age-related degenerative diseases – said it will use the proceeds of the Series B to support the clinical development of its RIPK1 inhibitors as well as to expand its pipeline of drug candidates in other classes. Beijing image by ? ?? from Pixabay.

Leads 59

Leads Pharmaceutical Patients 59

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It operates in New Zealand, Fiji and the US.

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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It operates in New Zealand, Fiji and the US.

Pharmaceutical 40

Pharmaceutical Prescription Manufacturing Medicine 40

Pharmaceutical Technology

JUNE 5, 2023

Izokibep is under clinical development by Acelyrin and currently in Phase II for Panuveitis. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Izokibep LoA Report.

Biopharma 40

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Pharmaceutical Technology

OCTOBER 17, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended granting conditional marketing authorization (CMA) for Boehringer Ingelheim’s spesolimab as a therapy option in adults with generalised pustular psoriasis (GPP) flares.

Medicine 52

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Pharmaceutical Technology

NOVEMBER 23, 2022

A substantially higher proportion of subjects who received Skyrizi attained the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response in all the trials. In the European Union, Skyrizi also received approval to treat adults with psoriasis and psoriatic arthritis.

Food and Drug Administration 52

Food and Drug Administration Safety Food Patients 52

Pharmaceutical Technology

FEBRUARY 27, 2023

Hydrocortisone is under clinical development by Antares Pharma and currently in Phase I for Adrenal Insufficiency. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It also develops products to reduce the risk of preterm birth in pregnant women.

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