Containment, Dermatology, Medicine and 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

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . The data underscore Lilly’s commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). INDIANAPOLIS , Oct.

Dermatology

Dermatology Development Medicine Clinical Trials

Now Recruiting Patients for a New FDA Oversight Trial Evaluating the Use of a Patient’s Own Fat Tissue for the Treatment of Post-COVID-19 Lung Damage

The Pharma Data

NOVEMBER 16, 2020

has sponsored and funded a new FDA Oversight Trial that seeks to restore respiratory function in adults who have suffered lung damage from the COVID-19 virus. Alexander, MD, DMD, FICS is the Principal Investigator, and his office is recruiting patients for enrollment in the trial. Alexander, MD, DMD, FICS.

Trials

Trials Clinical Trials Clinical Trials Dermatology

Filsuvez Topical Gel Gets FDA Approval for Epidermolysis Bullosa

XTalks

JANUARY 2, 2024

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. In a global Phase III trial conducted across 58 sites in 28 countries involving patients with EB, Filsuvez demonstrated excellent tolerance and achieved the primary endpoint with statistical significance.

FDA Approval

FDA Approval Gene Therapy Gene Trials

Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status

The Pharma Data

APRIL 16, 2021

Opdivo is the first and only immunotherapy in combination with chemotherapy to deliver superior overall survival versus chemotherapy alone in a trial of this patient population 1. PRINCETON, N.J.–(BUSINESS to 0.90; P =0.0002), as well as in patients with PD-L1 combined positive score (CPS) ?

HR

HR Dermatology Trials Containment

Johnson & Johnson Remorseful Over Funding Human Asbestos Experiments, But Says They Were Common in the Past

XTalks

MARCH 10, 2022

The unsealed asbestos experiment files were unearthed in two trials last year pertaining to the baby powder. In another study, Kligman and his colleagues investigated whether the type of containers that the baby powder was stored could have an effect on the skin.

Containment

Containment Dermatology Contamination Sales

AstraZeneca progresses Ambition Zero Carbon programme with Honeywell partnership to develop next-generation respiratory inhalers

The Pharma Data

FEBRUARY 22, 2022

less Global Warming Potential (GWP) than propellants currently used in respiratory medicines. AstraZeneca expects Breztri to be the first medicine to transition to this new pMDI platform, subject to regulatory approval. In addition to offering next-generation pMDIs, AstraZeneca will continue offering dry powder inhaled medicines.

Development

Development Medicine Containment Dermatology

17 creams to STOP ITCHING FAST

Druggist

DECEMBER 9, 2020

Lotions: contain the least amount of oils and higher amounts of water with non-greasy consistency. Topical steroids are not directly classified as anti-itch medicines; however, it is thought that reduced skin itchiness comes from controlling skin inflammation (ibid). Daktacort cream is another pharmacy-only medicine.

Pharmacy

Pharmacy Containment Sales Production

Top Life Science News and Trends in 2023 at Xtalks

XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. The companies include a diverse range engaged in innovative approaches in areas like oncology, genetic medicines, inflammatory diseases, dermatology and cardiorenal therapy.

Life Science

Life Science Clinical Trials Clinical Trials FDA Approval

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

The Pharma Data

AUGUST 22, 2021

1 The approval is based on the Phase 3 CheckMate -274 trial, which compared Opdivo 240 mg (n=353) to placebo (n=356). In the trial, among patients who received Opdivo, median disease-free survival (DFS) was nearly twice as long as in those who received placebo (20.8 months [95% Confidence Interval (CI): 16.5 months [95% CI: 8.3

Drugs

Drugs HR FDA Approval Trials

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

The Pharma Data

NOVEMBER 4, 2020

“Both of our clinical candidates represent important opportunities for new medicines that we hope will have a meaningful impact on the lives of patients.”. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The trial will evaluate 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S.,

Clinical Trials

Clinical Trials Clinical Trials Trials Dermatology

FDA approves Octapharma’s Octagam® 10% for adult dermatomyositis

Bioengineer

JULY 20, 2021

The FDA approval is based on the results of ProDERM (ClinicalTrials.gov Identifier: NCT02728752), a pivotal randomized clinical trial and the first study to evaluate the long term efficacy and safety of intravenous immunoglobulin (IVIg) for adults with dermatomyositis. Octagam® 10% does not contain sucrose. residents. . residents.

FDA Approval

FDA Approval Clinical Trials Clinical Trials Trials

New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years

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

Dermatology Trials Clinical Trials Clinical Trials

Dr. Reddy’s and GRA announces Avigan Pivotal Studies Update

The Pharma Data

JANUARY 26, 2021

Reddy’s”) and Global Response Aid FZCO (GRA) today announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

Life Science

Life Science Production Marketing Dermatology

FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis

The Pharma Data

OCTOBER 26, 2020

The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for abrocitinib in the same patient population with a decision anticipated in the second half of 2021. Abrocitinib also demonstrated a consistent safety profile across trials and was generally well-tolerated.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

US court decision favours Symbicort in patent litigation

The Pharma Data

MARCH 3, 2021

Symbicort US patent trial. At trial, Mylan and Kindeva contended that each asserted patent claim is invalid under the US patent laws. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 3M was voluntarily dismissed from the case.

Dermatology

Dermatology Drug Delivery Medicine Containment

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

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

Trials Hormones Clinical Trials Clinical Trials

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

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.–( About Opdivo.

Trials

Trials Hormones Clinical Trials Clinical Trials

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

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

Sales

Sales Manufacturing FDA Approval Life Science

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

The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

Vaccination

Vaccination Vaccine Gene Therapy 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. Excluding prior year COVID-19 related forward purchasing , we estimate Q1 net sales grew +1% (cc, +4% USD), with Innovative Medicines growing +3% (cc, +7% USD)².

Sales

Sales Medicine Production Manufacturing

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy. in these patients. in these patients.

FDA Approval

FDA Approval Containment Hormones Dermatology

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

The Pharma Data

JULY 23, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Hormones

Hormones Trials Genome Genomics

Safety Recommendation on Janus kinase (JAK) Inhibitors Issued in the European Union

Pfizer

OCTOBER 28, 2022

NYSE: PFE) announced today that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded their assessment of Janus kinase (JAK) inhibitors authorized for the treatment of certain inflammatory diseases in the European Union (EU) and has provided updated recommendations for their use.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

The Pharma Data

MARCH 11, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials

Trials Hormones Genome Genomics

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

Delveinsight

AUGUST 13, 2020

It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler. REGN3500 is being studied in Phase II trials for asthma, chronic obstructive pulmonary disease and atopic dermatitis.

Antibody

Antibody Medicine Trials Development

Clinical Research Informer

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

Now Recruiting Patients for a New FDA Oversight Trial Evaluating the Use of a Patient’s Own Fat Tissue for the Treatment of Post-COVID-19 Lung Damage

Trending Sources

Filsuvez Topical Gel Gets FDA Approval for Epidermolysis Bullosa

Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status

Johnson & Johnson Remorseful Over Funding Human Asbestos Experiments, But Says They Were Common in the Past

AstraZeneca progresses Ambition Zero Carbon programme with Honeywell partnership to develop next-generation respiratory inhalers

17 creams to STOP ITCHING FAST

Top Life Science News and Trends in 2023 at Xtalks

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

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

FDA approves Octapharma’s Octagam® 10% for adult dermatomyositis

New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years

Dr. Reddy’s and GRA announces Avigan Pivotal Studies Update

FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis

US court decision favours Symbicort in patent litigation

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

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

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

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

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

Safety Recommendation on Janus kinase (JAK) Inhibitors Issued in the European Union

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

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

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