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).

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The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. Source link: [link]

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Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

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pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. The biotech isn’t revealing how much it intends to charge for the new medicine, saying it will do so closer to launch later this year.

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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. Gil Yosipovitch, M.D.

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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. Spevigo is the first approved treatment option for GPP in adults. Waldman Department of Dermatology.

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pharmaphorum

SEPTEMBER 2, 2022

The lead investigator for the EFFISAYIL 1 trial, Mark Lebwohl of the Icahn School of Medicine at Mount Sinai in New York, US, described the approval as a “turning point” for patients with GPP and their clinicians.

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pharmaphorum

MAY 18, 2021

It’s the same active ingredient that is used in Incyte/Novartis Jakafi/Jakavi, which is FDA approved in oral form for myelofibrosis, polycythemia vera and graft-versus-host-disease. Filings with the FDA and the European Medicines Agency are planned for the second half of this year.

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The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. They have the ability to help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care.

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The Pharma Data

MARCH 27, 2022

Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. associate professor of dermatology at Yale School of Medicine and lead author of these analyses. In February 2022, the U.S. Lilly expects regulatory decisions in the U.S., ” About OLUMIANT®.

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The Pharma Data

APRIL 4, 2023

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. Nephritis resolved in 56% of the 9 patients.

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pharmaphorum

JANUARY 5, 2021

These are the crisis of healthcare system capacity and non COVID-19 patient backlog, and the economic crisis, still largely to come in impact, which will constrain healthcare spend, both public and private, across countries and have knock-on impacts for medicines spend. Even if they do, however, their savings will be lower.

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The Pharma Data

OCTOBER 9, 2021

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. There are currently no approved treatments for eosinophilic esophagitis in the US. Source link: [link].

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pharmaphorum

JULY 8, 2022

Thread is helping customers create and utilise digital endpoints in therapeutic areas like dermatology, respiratory, and CNS applications where the voice data capture is becoming important. It needs to be performed with a benchmark, an FDA-approved device.”. Digital technologies will become the new standard for clinical trials.

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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.

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The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. Visit [link] or call 1-800-FDA-1088.

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XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. Check out this article to learn about the biotech companies that went public this year.

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The Pharma Data

AUGUST 22, 2021

a CheckMate -274 primary investigator and Professor of Medicine, Director of Genitourinary Medical Oncology, Co-Director of the Center of Excellence for Bladder Cancer, and Associate Director for Translational Research at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai. Galsky,* M.D.,

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The Pharma Data

JUNE 7, 2022

“We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” Lilly unites caring with discovery to create medicines that make life better for people around the world.

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The Pharma Data

MARCH 18, 2022

The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.”. 1 Please see Important Safety Information below. 1 It is the third checkpoint inhibitor (along with anti-PD-1 and anti-CTLA-4) for Bristol Myers Squibb.

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The Pharma Data

APRIL 6, 2021

. “We look forward to continuing to work closely with the FDA to bring baricitinib to patients living with moderate to severe atopic dermatitis,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. About Lilly in Dermatology.

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The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. associate professor of Dermatology at Yale School of Medicine. AA is the second potential treatment indication in dermatology for baricitinib after AD. OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S.

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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. 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.

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Roots Analysis

JANUARY 3, 2024

Medical aesthetics is a growing area of modern medicine that focuses on improving the cosmetic appearance of an individual through various medical treatments. However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002. What is Medical Aesthetics?

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The Pharma Data

MARCH 16, 2021

These data will be presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, March 16–20, 2021. 1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. TREMFYA q4w is not currently FDA-approved. Read more: [link]. o chest tightness.

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The Pharma Data

JULY 23, 2021

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. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. endocrinopathies and dermatologic reactions) are discussed below.

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The Pharma Data

MARCH 11, 2021

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. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. endocrinopathies and dermatologic reactions) are discussed below.

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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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The Pharma Data

AUGUST 3, 2021

. “As we look to the balance of the year, we are excited to be launching LUMAKRAS , a first-in-class lung cancer treatment, and advancing a robust pipeline of potential new medicines to meet the demands of patients around the world.” LUMAKRAS received accelerated approval based on overall response rate and duration of response.

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Delveinsight

AUGUST 13, 2020

In February 2020, GSK announced the acceptance of regulatory submission seeking an additional indication for the use of Trelegy Ellipta for the treatment of asthma in adults by the European Medicines Agency (EMA). Conclusions : The addition of UMEC improved trough FEV, independently of baseline blood eosinophil and FeNO levels.

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The Pharma Data

AUGUST 11, 2020

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. About Opdivo.

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The Pharma Data

AUGUST 11, 2020

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. About Opdivo.

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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.

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XTalks

DECEMBER 18, 2024

Checkpoint intends to submit applications to the European Medicines Agency (EMA) and the UKs Medicines and Healthcare products Regulatory Agency (MHRA) as soon as possible. Checkpoint has indicated a commitment to ensuring broad access through patient assistance programs and affordability initiatives.

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XTalks

JANUARY 2, 2025

Since its FDA approval in 2017, Regeneron and Sanofi’s Dupixent has been hailed as an innovative treatment for patients with atopic dermatitis, with industry experts describing it as “life-changing.” ” Over the years, Regeneron has expanded Dupixents approved uses, most notably into asthma.

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XTalks

OCTOBER 31, 2024

Northwell Health also received a second mention in TIME for its Double Neural Bypass technology — a brain-computer interface designed to restore lasting movement and sensation in individuals with paralysis, first introduced last year in the field of bioelectronic medicine.

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