Remove Antibody Remove Dermatology Remove FDA Approval Remove Licensing
article thumbnail

Lebrikizumab Could Soon Be a New Treatment for Atopic Dermatitis

XTalks

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Most TEAEs were mildly or moderately severe and resulted in a low frequency of treatment discontinuation.

article thumbnail

Dermavant claims its first approval as FDA clears psoriasis drug

pharmaphorum

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder.

Drugs 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours

The Pharma Data

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [i]

article thumbnail

Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly’s Lebrikizumab Atopic Dermatitis Monotherapy Trials

The Pharma Data

. “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.” With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s

Trials 40
article thumbnail

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S., For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies.

Sales 52
article thumbnail

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

XTalks

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98
article thumbnail

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

Delveinsight

SAR440340 History: Regeneron and Sanofi are currently studying REGN3500 in respiratory and dermatological diseases where inflammation is thought to play an underlying role. Along the way, Regeneron has opted to co-promote Dupixent, now approved to treat severe eczema, asthma and nasal polyps; Praluent; and Kevzara in the U.S.