Pharmaceutical Technology

APRIL 17, 2023

The company will help in managing the clinical trials of the products once the regulators provide approvals for the proposed research and development programmes. CannQuit-Opioid, named CheWell, combines CBD and an opioid antagonist/agonist in a water-soluble chewable tablet to treat opioid addiction.

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BioPharma Reporter

JANUARY 23, 2024

Dermatology biopharma company Arcutis has launched ZORYVE, a topical foam for the treatment of seborrheic dermatitis, in the United States for individuals 9 years of age and older.

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Dermatology Regulation Marketing 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas provides products in various therapeutic areas which include psoriasis, eczema, dermatitis, chicken pox, constipation, laxative, neonatal, hormone regulation, dermatology, cardiovascular and measles, among others. Its investigational medicinal products comprise R-107, R-131 and R-147.

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Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas provides products in various therapeutic areas which include psoriasis, eczema, dermatitis, chicken pox, constipation, laxative, neonatal, hormone regulation, dermatology, cardiovascular and measles, among others. Its investigational medicinal products comprise R-107, R-131 and R-147.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

pharmaphorum

SEPTEMBER 8, 2022

Furthering DiME’s previous work on digital clinical measures, nocturnal scratch’s more widespread implementation aims to establish a firmer digital groundwork for future clinical research, technology development, and reimbursement decisions in the dermatological field, and thereby improve the lives of AD patients and caregivers.

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pharmaphorum

SEPTEMBER 15, 2022

.” The Swiss Competition Commission (COMCO) arrived unexpectedly at Novartis at dawn on Tuesday morning, to gather information on an unidentified dermatology drug, as part of a wider investigation into the drugmaker by the European Commission.

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Dermatology Production Pharma Companies Marketing 103

pharmaphorum

APRIL 26, 2021

The company thinks the data from the first-in-class tyrosine kinase 2 inhibitor are strong enough to file with regulators, setting up a potential launch next year. Results from the POETYK PSO-1 and POETYK PSO-2 were presented as late-breaking research at the weekend’s American Academy of Dermatology virtual meeting.

Dermatology 52

Dermatology Regulation Marketing Development 52

pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company.

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Dermatology Drugs Hormones FDA Approval 52

pharmaphorum

DECEMBER 29, 2021

IL-13 inhibitor tralokinumab has been cleared by the US regulator as Adbry as a treatment for moderate-to-severe atopic dermatitis in adults who can’t control symptoms using topical prescription therapies.

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Sales Dermatology Marketing Allergies 107

pharmaphorum

OCTOBER 1, 2021

KY1005 – now renamed amlitelimab – is one of a handful of new drugs targeting OX40 ligand, an immune system regulator delivered by intravenous infusion once every 28 days. Now, it says the drug has delivered “exciting” results in a proof-of-concept trial. It is also being developed in a subcutaneous formulation.

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Scienmag

MAY 21, 2021

UC San Diego School of Medicine researchers identify how the body regulates and prevents constant skin inflammation The human body is constantly exposed to various environmental actors, from viruses to bacteria to fungi, but most of these microbial organisms provoke little or no response from our skin, which is charged with monitoring and protecting (..)

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Bacteria Regulation Medicine Research 75

pharmaphorum

OCTOBER 11, 2022

In a statement , PureTech said it had been required to go public with the talks once they started to be reported in the media to comply with UK financial regulations, but said this morning that they “were early in nature and the required announcement created the impression that discussions were more advanced than they were.”

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The Pharma Data

JANUARY 6, 2021

Nasdaq: DMTK) (“DermTech”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today the pricing of its previously announced underwritten public offering of 4,237,288 shares of its common stock at a price to the public of $29.50 7, 2021 05:00 UTC. LA JOLLA, Calif.–(

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Dermatology Genome Genomics Production 40

pharmaphorum

MAY 14, 2021

Kintor is in talks with the Brazilian health regulator Anvisa about a further trials. But one of the study’s authors, Brown University dermatology professor Carlos Wambler, dismissed critics and called findings “very encouraging”. The post Scepticism in press over Kintor’s COVID-19 US drug trial appeared first on.

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Drug Trials Trials Drugs Dermatology 52

pharmaphorum

JULY 8, 2022

We have also seen the regulators actively support the use of these hybrid decentralised research approaches. These devices and/or the endpoints they generate are with the rigour required to be submitted to regulators. As Reites points out, “there are two main categories of digital sensors: 510(k) cleared and CE-marked medical devices.

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Clinical Trials Clinical Trials Trials Regulation 80

pharmaphorum

FEBRUARY 28, 2022

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB).

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Drugs Marketing Regulation FDA Approval 98

pharmaphorum

MAY 31, 2022

The US regulator has granted Dupixent (dupilumab) a six-month priority review in PN and is due to deliver a verdict by 30 September, offering patients hope of a first-approved therapy for the highly-debilitating disease.

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The Pharma Data

JULY 28, 2021

She will serve as Chair of the Board of Directors upon transformation of EUROAPI into a société anonyme , in compliance with applicable corporate governance regulations. a multinational dermatology company. She was CFO of the Business Excellence Division at Nestlé. She served as Group CFO at Galderma S.A.,

Dermatology 52

Dermatology Manufacturing Compliance Regulation 52

pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. million people in the US.

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Sales FDA Approval Regulation Drugs 97

WCG Clinical

MAY 15, 2023

Additionally, on the back end, the database didn’t allow for proper analysis to satisfy regulators. They can be inflexible, difficult to use, and inadequate for capturing seizure activity. In this case, this resulted in poor data quality and structure. Schedule a consultation with our experts today.

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Clinical Research Development Trials Research 52

pharmaphorum

SEPTEMBER 22, 2021

Its approval for atopic dermatitis was delayed by three months while the regulator completed the safety investigation, which focused mainly on Pfizer’s oral JAK inhibitor Xeljanz (tofacitinib), used to treat arthritis and some other inflammatory diseases.

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Sales Regulation FDA Approval Marketing 52

The Pharma Data

JANUARY 12, 2021

Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record for Developing and Accelerating Phase I–IV programs. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

The Pharma Data

OCTOBER 27, 2020

Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. For more information, log on to: www.drreddys.com.

HR 40

HR Dermatology Marketing Production 40

pharmaphorum

MAY 25, 2022

Vtama (tapinarof) – originally developed by GlaxoSmithKline – is a first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) and has been approved by the US regulator with a broad label spanning mild, moderate, and severe psoriasis and an unlimited duration of use.

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Drugs FDA Approval Licensing Licensing 52

Drug Discovery World

APRIL 16, 2023

as a master regulator of prostate differentiation and cancer initiation and progression, for generating unique and reliable murine bladder and prostate cancer models, and for steadfast commitment to serving as a leader, mentor, and supporter of women in cancer research.

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Clinical Trials Clinical Trials Research Vaccination 52

The Pharma Data

DECEMBER 17, 2020

Martin Carter Professor in Clinical Investigation and Head of the Laboratory of Investigative Dermatology at The Rockefeller University and Weinblatt is the co-director of Clinical Rheumatology at the Brigham and Women’s Hospital. Immune Regulation – U.K.-based based Immune Regulation Ltd. He spent 27 years at Merck & Co.

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Development Gene Therapy Engineer Life Science 52

pharmaphorum

MAY 25, 2022

The problems outlined in the US regulator’s complete response letter (CRL) for VP-102 centre around contract manufacturing organisation (CMO) Sterling Pharmaceuticals Services, which is producing VP-102 for Verrica. Sterling was classified by the FDA as voluntary action indicated (VAI) last November.

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pharmaphorum

OCTOBER 28, 2020

The US regulator has started a priority review of abrocitinib for mediate to severe atopic dermatitis in patients aged over 12, setting up a decision next April, while the EMA has also started a standard review that could lead to approval in the EU in the second half of 2021.

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Drugs Sales Marketing FDA Approval 52

The Pharma Data

AUGUST 1, 2021

4 Type I IFNs such as IFN-alpha, IFN-beta and IFN-kappa are cytokines involved in regulating the inflammatory pathways implicated in SLE. Saphnelo Saphnelo (anifrolumab) is a fully human monoclonal antibody that binds to subunit 1 of the type I IFN receptor, blocking the activity of type I IFNs.

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Trials Clinical Development Antibody Dermatology 52

The Pharma Data

JANUARY 13, 2021

(IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases. Source link.

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Clinical Trials Clinical Trials Trials In-Vitro 52

The Pharma Data

AUGUST 19, 2020

Nipocalimab gives Janssen the opportunity to reach significantly more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology. Food and Drug Administration. An estimated 2.5

Production 52

Production Dermatology Development Containment 52

Delveinsight

AUGUST 25, 2021

They are governed by a number of rules and regulations that govern drug patenting, testing, safety, efficacy, and marketing. . The Innovative Medicines Division focuses on Oncology, Immunology, Hepatology, Dermatology, Ophthalmology, Neuroscience, Cardiovascular, Renal and Metabolism, and Respiratory. trillion in 2021.

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Vaccination Vaccine Sales Drugs 98

The Pharma Data

JANUARY 26, 2021

Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr. Reddy’s operates in markets across the globe.

Life Science 40

Life Science Production Marketing Dermatology 40

The Pharma Data

AUGUST 19, 2020

Nipocalimab gives Janssen the opportunity to reach significantly more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology. Food and Drug Administration. An estimated 2.5

Production 40

Production Dermatology Development Containment 40

The Pharma Data

DECEMBER 15, 2020

We invest in differentiated and groundbreaking medical dermatology products to bring our innovative solutions to patients in need. Our Noble Purpose is at the core of our work: “Transform the patients’ world by helping them realize their hopes and dreams for a healthy life”.

FDA Approval 52

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The Pharma Data

APRIL 26, 2021

COVID-19 negatively impacted demand, particularly: dermatology, ophthalmology, the breast cancer portfolio, Sandoz Retail and Anti-Infectives. Adakveo sales reached USD 37 million. Sandoz sales declined -13% (cc, -9% USD), with Retail -18% (cc) and Biopharmaceuticals growing +7% (cc).

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The Pharma Data

JULY 22, 2021

Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.

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